Search Results
Found 24 results
510(k) Data Aggregation
(445 days)
Epilaser Absolute
Epilaser Absolute is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
The Epilaser Absolute is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system is designed to be manually targeted onto individual hairs and the laser activates when it is pressed against the skin. A skin tone sensor ensures the user has the correct skin tone prior to laser activation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Epilaser Absolute. Unfortunately, the provided document does not contain the detailed performance study results that would allow for a complete answer to all your questions. The "Performance Data" section lists the types of tests performed but does not elaborate on the specific acceptance criteria for each test or the reported performance data against those criteria.
However, I can extract the available information and highlight what is missing.
Description of Device and Intended Use:
The Epilaser Absolute is an over-the-counter, hand-held hair removal device that uses 808 or 980nm laser energy to kill hair follicle roots. It is intended for adjunctive use with shaving for sustained hair removal with periodic treatments, and for permanent reduction in hair regrowth, defined as a long-term, stable reduction in hair counts at 6, 9, and 12 months post-treatment.
1. Table of Acceptance Criteria and Reported Device Performance
Given the provided document, specific numerical acceptance criteria and reported performance values are NOT available for most categories. The document lists the types of tests conducted but doesn't provide the detailed results against specific thresholds.
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Hair Reduction Efficacy | Permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime, measured at 6, 9, and 12 months after the completion of the treatment regimen. (Specific quantitative thresholds for "reduction" are not provided in this document) | Implicitly, the device met this, as it applied for "permanent reduction in hair regrowth." No specific percentage reduction or hair count data is provided. |
| Biocompatibility | Compliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation) standards. (Specific pass/fail criteria from these standards apply) | Testing performed per ISO 10993-5 and ISO 10993-10. Implicitly passed to achieve substantial equivalence. No specific test results (e.g., irritation index) are provided. |
| Software Validation | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Specific requirements for documentation, testing, and risk management apply) | Software documentation and validation performed. Implicitly met. No details on software bugs or validation metrics are provided. |
| Electrical/EMC/Laser Safety | Compliance with AAMI/EN 60601-1, AAMI/EN IEC 60601-1-2, IEC 62471, IEC 60825-1, and IEC 60335-2-23. (Specific safety limits and performance criteria from these standards apply) | Electrical, EMC, and laser safety testing performed. Implicitly passed. No specific measurements (e.g., leakage current, EMC emissions/immunity in dB) are provided. |
| Skin Tone Sensor Validation | Ensured the user has the correct skin tone prior to laser activation. (Specific accuracy/reliability metrics for skin tone detection are not provided) | Skin tone sensor validation performed. Implicitly met its purpose. No specific accuracy metrics (e.g., sensitivity, specificity for skin tones) are provided. |
| Self-selection and Usability (Human Factors) | Demonstrated continued OTC use, despite user interface modification. (Specific usability metrics like completion rates, error rates, SUS scores, or risk identified/mitigated are not provided) | Self-selection and usability human factors testing performed. Implicitly demonstrated continued OTC use. No specific human factors study results are detailed. |
Missing Information & Assumptions:
The document clearly states the conclusion that "Performance data demonstrate that the Epilaser Absolute is substantially equivalent to predicate devices." This implies that the device did meet relevant acceptance criteria for the tests listed, but it does not provide the criteria or the specific performance results themselves.
For the hair reduction efficacy, which is a primary claim, the document defines what "permanent reduction" means (long-term, stable reduction at 6, 9, and 12 months) but does not provide a quantitative acceptance criterion (e.g., "minimum 50% hair count reduction") or the actual percentage reduction achieved in any study.
Further Questions Based on Missing Information:
Without the full study report, it's impossible to answer the following questions with specific numbers.
2. Sample size used for the test set and the data provenance:
- Not provided. The document only mentions that tests were performed but does not specify sample sizes for any human-based studies (e.g., usability, hair reduction). Data provenance (country of origin, retrospective/prospective) is also not mentioned for any performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. This information would typically be relevant for studies involving subjective assessments (e.g., hair count assessment by dermatologists). Since the document does not detail the hair reduction study, this information is absent. For human factors, the "experts" would typically be representative users, and their qualifications are often basic literacy and comprehension.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided. This would be relevant if there were subjective measurements requiring multiple opinions, such as assessments of hair count or adverse events.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. This device is a direct-to-consumer laser hair removal device, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-assistance comparison is not relevant to its type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is a user-operated laser system. Its "performance" inherently involves the user correctly operating it. It has a "skin tone sensor validation," which implies an algorithmic component, but no standalone performance metrics for just the algorithm are provided separate from the overall device performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For hair reduction efficacy, the ground truth would likely involve hair counts (outcomes data) observed over time. How these counts were established (e.g., photography, expert assessment) is not specified.
- For other engineering tests (bio-compatibility, safety), the ground truth is often established by adherence to international standards and validated test methods.
8. The sample size for the training set:
- Not provided. Training sets are typically relevant for machine learning algorithms. While the skin tone sensor might have used a training set, the document does not provide any details about it.
9. How the ground truth for the training set was established:
- Not provided. As with point 8, this information is not present in the document.
In summary, while the document confirms that various tests were conducted to establish substantial equivalence for the Epilaser Absolute, it largely omits the specific quantitative acceptance criteria and the detailed performance results of those tests. This level of detail is typically found in the full 510(k) submission, not in the summary document provided.
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(75 days)
FORE-SIGHT ELITE Absolute Tissue Oximeter
The non-invasive Fore-Sight Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensor in individuals at risk for reduced-flow or no-flow ischemic states and is indicated for use as follows:
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When used with Large Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 Kg.
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When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥ 3 Kg.
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When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects
The FORE-SIGHT ELITE Absolute Tissue Oximeter measures hemoglobin under the sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).
The Fore-Sight Elite Monitor is used together with the preamplifier assembly (cable), and Small, Medium and Large Sensors.
The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The Fore-Sight algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four Sensors with both numeric and real-time graphical display formats.
The monitor unit is a mains-powered device with a field-replaceable battery pack. A touchscreen user interface allows configuration of the oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.
This document is a 510(k) summary for the FORE-SIGHT ELITE Absolute Tissue Oximeter. It states that the device is substantially equivalent to a previously cleared predicate device (K143675). The primary reason for this 510(k) submission is an algorithm update and other minor enhancements.
Based on the provided text, the device measures tissue oxygen saturation (StO2). The studies mentioned are primarily verification activities to demonstrate that the algorithm update did not adversely affect the safety and effectiveness of the device, rather than a clinical study establishing initial accuracy against a gold standard.
Here's the information extracted and organized based on your request:
Acceptance Criteria and Device Performance (as inferred from the document):
Since this is a 510(k) submission for an algorithm update to an already cleared device, the "acceptance criteria" are implied to be that the updated device (specifically, the updated algorithm) performs comparably to or better than the original device, and that its safety and effectiveness are not adversely affected. There aren't explicit numerical acceptance criteria for StO2 accuracy presented in this summary; rather, the focus is on the verification that the changes don't degrade performance.
| Criterion | Reported Device Performance |
|---|---|
| Algorithm Update Impact on Clinical Accuracy | "the algorithm update did not adversely affect the safety and effectiveness of the subject device." (Page 6) |
| "the subject device has the same clinical accuracy when compared to the secondary predicate." (Page 5) | |
| Robustness to Sensor Disruption Scenarios | "the algorithm has been made more robust to better handle sensor disruption scenarios caused by user or environmental factors." (Page 5) |
| Responsiveness for Pediatric Applications | "It has been made more dynamic for pediatric applications by increasing StO2 responsiveness." (Page 5) |
| Usability (Human Factors) | "The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm." (Page 6) |
| System Requirement Verification (Non-Clinical Performance) | "Completion of all verification and validation activities demonstrated that the subject device meets its predetermined design and performance specifications." (Page 6) |
| "Verification activities performed confirmed that the algorithm upgrade did not adversely affect the safety and effectiveness of the subject device. The measured StO2 parameter was tested using a bench simulation. Additionally, verification of each system requirement was tested after upgrading to the latest algorithm version to verify safety and effectiveness of the subject device. All tests passed." (Page 6-7) | |
| Software Verification | "Software verification was performed per FDA's Guidance for Industry and FDA Staff. 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'. Software was tested at a subsystem level to ensure the safety of the device. All tests passed." (Page 7) |
Detailed Study Information:
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A table of acceptance criteria and the reported device performance:
- See table above. The document focuses on verification that the changes did not negatively impact the device's performance or safety, rather than presenting accuracy metrics against a ground truth for a new device.
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Sample size used for the test set and the data provenance:
- The document mentions "bench simulation" and "verification of each system requirement" but does not specify the sample size for any test sets related to the algorithm performance or the origin of any data used for these tests (e.g., country of origin, retrospective/prospective).
- A "Usability Study" was conducted, but its sample size or data provenance is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the document does not describe a clinical study against a human-adjudicated ground truth. The tests performed are described as "bench simulation," "system requirement verification," and "software verification."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the document does not describe a clinical study with human readers requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or human reader comparative effectiveness study is mentioned. This device is an oximeter, not an AI-assisted diagnostic imaging tool with human-in-the-loop analysis.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, "The measured StO2 parameter was tested using a bench simulation." (Page 7). Also, "Software was tested at a subsystem level to ensure the safety of the device. All tests passed." (Page 7). The results are qualitative (e.g., "All tests passed," "did not adversely affect").
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "bench simulation" of the StO2 parameter, the "ground truth" would likely be derived from the simulated conditions or established reference measurements in the lab, rather than expert consensus, pathology, or outcomes data, which are typically for clinical diagnostic AI. The document does not specify the method for establishing this "ground truth" in the bench simulation.
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The sample size for the training set:
- The document does not describe the training of a novel AI model. It discusses an "algorithm update" to an existing device. Therefore, a "training set" in the context of machine learning model development is not mentioned.
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How the ground truth for the training set was established:
- Not applicable, as no new training of a machine learning model is described in this submission summary. The "algorithm update" appears to be an enhancement to an existing, cleared algorithm.
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(100 days)
ABSOLU
The Quantel Medical ABSOLU is intended to be used for:
-Axial Length measurement of the eye by ultrasonic means;
-Implanted IOL power calculation, using the Axial Length measurement;
- Visualization of the interior of the eye and the orbit by A and B scans.
The ABSOLU is a high definition multifunction ophthalmic ultrasound system used for the following intended use:
- -Axial Length measurement of the eye by ultrasonic means;
- Implanted IOL power calculation, using the axial length measurements; -
- Visualization of the interior of the eve and the orbit by A and B scans. -
The Quantel Medical ABSOLU device is intended for axial length measurement of the eye, implanted IOL power calculation using axial length measurements, and visualization of the interior of the eye and orbit via A and B scans. The performance data and acceptance criteria are outlined below, primarily focusing on safety and compliance with recognized standards rather than specific diagnostic accuracy metrics of a standalone AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with AAMI ANSI ES60601-1:2005 + Corr. 1:2006+Corr. 2:2007+A1:2012 (Medical electrical equipment-Part 1: General requirements for basic safety and essential performance). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014 (Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests). |
| Usability | Complies with IEC 60601-1-6:2010+A1:2013 (Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability). This is supported by the improved, more intuitive user interface. |
| Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment | Complies with IEC 60601-2-37: "Ed2 + AM1 with 60601-1 (ed.3), AM1 with correc 1 & correc 2 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment". This specifically addresses performance of the B-scan probes. |
| Hardware and Software Validation | Hardware and software validation activities were performed to ensure the device performs as intended. Software documentation appropriate for the Moderate level of concern was provided. |
| Technological Changes (e.g., B-scan probe improvements, frequency changes) | The 20 MHz annular B-scan probe technology increases depth of field by 70%, allowing simultaneous examination of vitreous, retina, and orbit pathologies without compromising image quality. The 15 MHz B-scan probe offers superior resolution and improved measurement accuracy compared to the previous 10 MHz version, with a focal point change from 25 mm to 24 mm. These changes do not affect safety or performance. |
| Measurement Accuracy (Axial Length, IOL power calculation) | Improved with the 15 MHz B-scan probe due to increased frequency. (No specific quantitative metric provided in the document for comparison against a threshold.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes tests performed for regulatory compliance (safety, EMC, usability, and ultrasonic equipment safety standards) and validation of technological changes. It does not mention a specific "test set" in the context of clinical data for diagnostic or measurement accuracy of a standalone AI algorithm. The performance data refers to instrumental performance, safety, and functional validation against standards for the device as a whole and its components (probes, software). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not available in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document, as the evaluations described are primarily for device safety, EMC, usability, and technical performance against engineering standards, not a clinical diagnostic performance study with expert-adjudicated ground truth.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the document, as the evaluations described are for device safety and technical performance, not for clinical diagnostic performance adjudicated by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is present in the document. The device is an ultrasound system with specific measurement and visualization capabilities, and the performance data focuses on its compliance with operational, safety, and technical standards, rather than an AI-driven diagnostic accuracy study comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not describe a standalone performance study for an AI algorithm without human intervention. The ABSOLU is described as an "ultrasonic pulsed echo imaging system" intended for use by "trained medical personnel" where "the use of the different parameters of the ABSOLU® and the predicate device are under control of the physician for the different phases of the diagnostic." This strongly suggests a human-in-the-loop system, not a standalone AI.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not detail specific "ground truth" for clinical diagnostic or measurement accuracy in the context of expert consensus, pathology, or outcomes data. The "performance data" mentioned pertains to compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, usability, and ultrasonic medical device safety. These standards serve as the "ground truth" for the device's technical and safety performance.
8. Sample Size for the Training Set
No information regarding a training set sample size is provided. The document outlines a regulatory submission for an ultrasound imaging system, not an AI algorithm that typically requires a large training dataset for its development. The "software" mentioned as being revised is general device software, not an AI component trained on data.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI algorithm is mentioned, there is no information on how ground truth for such a set was established.
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(107 days)
FORE-SIGHT Elite Absolute Tissue Oximeter
The noninvasive FORE-SIGHT ELITE Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows:
When used with Large Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 kg.
When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥3 kg.
When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects
The FORE-SIGHT ELITE Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).
The Oximeter consists of a monitor unit, preamplifier assembly, and Small, Medium and Large Sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four Sensors with both numeric and real-time graphical display formats.
The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Bias & Precision) | Ranging from 0.05 ± 5.06% to 0.03 ± 5.69% compared to weighted co-oximetry reference. |
| Safety | No safety issues or adverse events related to the FORE-SIGHT ELITE Absolute Tissue Oximeter were encountered. |
| Compliance with Predetermined Specification | Test results demonstrated that the oximeter complies with its predetermined specification (System Functional and Performance Testing). |
| Electrical Safety | Met ANSI/AAMI ES60601-1: (2005), IEC 60601-1-8: (2006), IEC 60601-1-6: (2010), IEC 62366: (2007). |
| Electromagnetic Compatibility | Met IEC 60601-1-2: (2007). |
| Biological Safety (Materials) | Assured by biological testing under the standard ISO10993-1. |
Study Information
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): 136 subjects.
- Data Provenance: Not explicitly stated, but the study was conducted at "multiple institutions." Given the context of a 510(k) submission to the FDA in the US, it's highly probable the data is from the United States. The study involved a "demographically diverse population."
- Retrospective or Prospective: Not explicitly stated. However, the nature of "clinically validated" and "measurements... calibrated against a weighted co-oximetry reference of arterial and venous blood samples drawn simultaneously" suggests a prospective clinical study where measurements were taken for the purpose of validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth was established using a weighted co-oximetry reference of arterial and venous blood samples, not expert opinion.
4. Adjudication method for the test set:
- This information is not applicable/provided. The ground truth was based on objective blood sample analysis (co-oximetry), not expert consensus that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an oximeter, which provides a direct physiological measurement, rather than an AI-driven image analysis tool that typically involves human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the clinical validation was for the standalone performance of the FORE-SIGHT ELITE Absolute Tissue Oximeter. The accuracy values provided (0.05 ± 5.06% to 0.03 ± 5.69%) reflect the device's performance against the gold standard without human interpretation as part of the measurement. It's intended as an "adjunct monitor," meaning it provides data for clinicians but its core function is autonomous measurement.
7. The type of ground truth used:
- Weighted co-oximetry reference of arterial and venous blood samples. These samples were drawn simultaneously from vascular locations appropriate to the tissue of interest (jugular bulb, central venous, umbilical venous) and weighted with a 30% arterial and 70% venous contribution.
8. The sample size for the training set:
- The document does not explicitly state a separate training set size. The device was "designed and developed in accordance with CASMED development processes" and "verified and validated," which would include internal development and testing. The 136 subjects mentioned are for the clinical validation (test set) for substantial equivalence, not necessarily the internal training data for algorithm development.
9. How the ground truth for the training set was established:
- This information is not explicitly provided for a training set. For the clinical validation (test set), as stated in point 7, the ground truth was established using weighted co-oximetry reference of arterial and venous blood samples. It's reasonable to infer that similar methods (or other physiological gold standards) would have been used during the device's internal development and refinement.
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(351 days)
ABSOLUTE DENTIN 2
A dual-cure, composite resin core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated.
A dual-cure, composite resin, core build-up material that is usually used to restore missing tooth structure for which a dental restoration, usually a crown, is fabricated. It is substantially equivalent to many predicate materials that include self-, light-, and dual-cure types. This material incorporates fluoride-containing (trace amounts) glass filler particles. No Bisphenol-A or its precursors are used in the manufacturing process. The material is supplied in light-safe dual-barrel cartridges.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Parkell, Inc. Absolute Dentin II device:
Based on the provided 510(k) summary (K132115) for Absolute Dentin II, this document pertains to a dental material, specifically a composite resin core build-up material, and not an AI/ML-driven medical device. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.
The "acceptance criteria" for this type of device are primarily based on demonstrating substantial equivalence to predicate devices through biocompatibility testing and non-clinical performance testing of mechanical properties.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (as demonstrated by testing) and Reported Device Performance:
Since this is a material rather than a diagnostic or therapeutic AI device, "acceptance criteria" are typically defined by meeting established ISO standards for biocompatibility and demonstrating comparable physical properties to predicate devices. The document lists the tests conducted and states that all tests were passed.
| Acceptance Criterion (Test Standard/Property) | Reported Device Performance (Absolute Dentin II) |
|---|---|
| Biocompatibility: | |
| ISO 10993-5, 2009 (Cytotoxicity) | Passed (L929 MEM Elution Test) |
| ISO 10993-3, 2003 (Genotoxicity, Carcinogenicity, Reproductive Toxicity) | Passed (Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay) |
| ISO 10993-10, 2010 (Irritation and Skin Sensitization) | Passed (Intracutaneous Injection Test) |
| ISO 10993-10, 2010 (Irritation and Skin Sensitization) | Passed (Kligman Maximization Test) |
| ISO 10993-10, 2010 (Irritation and Skin Sensitization) | Passed (Oral Irritation Test - Acute Exposure) |
| Non-Clinical Performance Testing: | (Overall statement of compliance) |
| Flexural Strength | Tested (Implicitly met expectations for substantial equivalence) |
| Compressive Strength | Tested (Implicitly met expectations for substantial equivalence) |
| Surface Hardness | Tested (Implicitly met expectations for substantial equivalence) |
| Working Time | Tested (Implicitly met expectations for substantial equivalence) |
| Self-Curing Time | Tested (Implicitly met expectations for substantial equivalence) |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. Standard biocompatibility tests and material property tests typically use a predefined number of samples as per the relevant ISO or ASTM standards, but the exact count is not given in this summary.
- Data provenance: Not explicitly stated but assumed to be from laboratory testing as per the ISO standards mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a material testing conformity rather than a diagnostic device requiring expert interpretation of results for ground truth. Biocompatibility and mechanical property tests have objective readouts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective interpretations, which are not involved in these types of material tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Ground truth is established by the specific, objective criteria defined within each ISO standard (e.g., cell viability percentages, absence of specific reactions).
- For non-clinical performance (mechanical properties): Ground truth is established by physical measurement against established material science parameters and comparison to predicate device performance.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML model.
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(130 days)
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
The noninvasive FORE-SIGHT Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows: When used with large sensors, the FORE-SIGHT Oximeter is indicated for use on adults and transitional adolescents ≥ 40 kg.
The FORE-SIGHT Elite Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Oximeter consists of a monitor unit, preamplifier assembly, and sensor. The sensor uses multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four sensors with both numeric and real-time graphical display formats. The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB, RS-232 serial or wireless communications.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the FORE-SIGHT Elite™ Absolute Tissue Oximeter:
The provided text is a 510(k) summary for a medical device seeking substantial equivalence to existing devices. As such, it focuses on demonstrating that the new device performs similarly to predicate devices, rather than establishing novel absolute performance criteria with specific thresholds for accuracy, sensitivity, or specificity against a definitive ground truth.
Therefore, for many of your requested points, the answer will be "Not Applicable" or "Not Specified" because the nature of a 510(k) submission for this type of device does not typically require the same level of detailed performance metrics as, for example, an AI diagnostic algorithm. The primary "acceptance criterion" for a 510(k) is substantial equivalence to predicates.
Here's a breakdown based on your request:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for 510(k) of this device type) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Devices: | "The FORE-SIGHT Elite™ Absolute Tissue Oximeter has successfully undergone extensive performance, safety, electromagnetic, clinical, software and environmental testing to ensure it has been found to be substantially equivalent to the predicate devices." |
| - Optical Operating Principle: | "The FORE-SIGHT Elite Absolute Tissue Oximeter compares substantially to the cited predicate devices in that they use fundamentally the same optical operating principle, called multidistance diffuse reflectance spectroscopy." |
| - Hemoglobin Measurement: | "All cited monitors use light to examine a cross-section tissue microvasculature... The spectroscopic analysis determines concentrations of hemoglobin in its oxygenated and deoxygenated states. All cited monitors calculate oxygen saturation which reflects the percentage of oxygenated hemoglobin in the sampled tissue." |
| - Technical Capabilities: | "The FORE-SIGHT Elite Absolute Tissue Oximeter compares substantially to the predicates. All have 4-channel capability, an LED light source, similar user interface features and the benefits of portability." |
| Safety: | "Clinical evaluation, safety testing and software validation demonstrate the FORE-SIGHT Elite Absolute Tissue Oximeter is substantially equivalent to the predicate devices." (Implied to meet safety standards comparable to predicates) |
| Clinical Performance: | "The FORE-SIGHT Elite Absolute Tissue Oximeter has successfully undergone extensive clinical validation for the indicated use. The premarket notification cites a validation report: Validation of the CAS Medical System's FORE-SIGHT Elite™ Absolute Tissue Oximeter for Somatic Tissue Oxygen Saturation (StO2%) in Adult and Transitional Adolescent Subjects." |
| Software Validation: | "CAS has conducted a full program of individual hardware, software, systems verification and validation studies of the FORE-SIGHT monitor and sensors." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The document mentions "extensive clinical validation" and refers to a "validation report," but doesn't provide the sample size within this summary.
- Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective/prospective). It just states "Clinical Testing to Show Substantial Equivalence."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable/Not specified. For a tissue oximeter, the ground truth would typically be established by comparing the device's readings against a reference method for oxygen saturation, not by expert consensus on images. The text does not describe this reference method or any "experts" involved in establishing ground truth for individual cases in a traditional sense.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation studies where there is subjective human assessment. This device measures a physiological parameter, and its validation would involve comparison to a direct (e.g., invasive blood gas analysis) or a highly accurate reference method, not an adjudication of human interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: No. This device is a measurement device (oximeter), not an AI-assisted diagnostic tool that helps human readers interpret images or data. Therefore, an MRMC study and effect size in terms of human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in a sense. The device itself performs the measurement and algorithm calculation to derive StO2 values. The validation would assess the accuracy of these measurements compared to a reference method, which is inherently a "standalone" performance assessment of the device's measurement capabilities. However, it's not "standalone AI algorithm" in the context of recent AI-powered diagnostic devices. The summary states: "The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics." This implies standalone algorithmic processing for the measurement itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly stated in the provided text, but for an oximeter, the ground truth would typically be established through:
- Direct, invasive measurements: Such as arterial or venous blood gas analysis to determine oxygen saturation.
- Highly validated reference oximeters or spectrophotometers: Used in controlled experimental settings.
- The text only mentions "extensive clinical validation" for somatic tissue oxygen saturation (StO2%), implying a comparison against an accepted reference standard for StO2.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. The concept of a "training set" is primarily relevant for machine learning or AI models that learn from data. While the device uses a "FORE-SIGHT algorithm," it's described more as a pre-programmed computation based on physical principles (spectroscopy) rather than a continuously learning AI. Therefore, it may not have a "training set" in the modern AI sense. If the algorithm was developed empirically, the data used for that development is not mentioned.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/Not specified (as per point 8).
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(317 days)
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
Dental Morelli Orthodontic Dental Implant is a threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
The Orthodontic Miniscrew for Absolute Anchorage is an implantable medical device used as a temporary skeletal anchorage point for orthodontic movements. The mini screw is intended to receive low intensity static clinical loads. Maximum dynamic forces may occur at low frequencies for short periods; which is inadequate to compromise the performance of the product through fatigue. The device is available in different lengths (6, 8, 10, mm), diameter 1.5 mm, and supplied in sealed sterile polyethylene bags.
The provided document is a 510(k) summary for the "Orthodontic Miniscrew for Absolute Anchorage" and focuses on demonstrating substantial equivalence to a predicate device, the "Aarhus Anchorage System K041527." It does not describe a study involving a comparison of device performance against detailed acceptance criteria in the manner typically seen for novel device efficacy. Instead, it relies on demonstrating equivalence through material properties, dimensions, intended use, and general performance characteristics.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as the submission primarily focuses on equivalence based on established standards and similarity to a predicate.
Here's an analysis based on the information available in the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by compliance with established material and sterilization standards, and by demonstrating performance comparable to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Composition (conforms to surgical implant standards) | Titanium Alloy ASTM F 136 (same as predicate). Adheres to chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401). |
| Biocompatibility | Titanium Alloy in medical grade according to ASTM-F 136 is accepted for endosseous implant (same as predicate). |
| Sterility | Gamma Radiation (same as predicate). Conforms to ISO 11137 (requirements for developing, validating, and routinely controlling sterilization process). Conforms to ASTM F1980-07 (addresses loss of sterile barrier system integrity). |
| Mechanical Safety/Performance | Tensile strength of material according to ASTM - F 136 is accepted for endosseous implants (same as predicate). Performance testing conducted to determine torque levels, forces, and insertion lengths. Measured performance is "comparable to the Aarhus Anchorage System K041527." |
| Dimensions (comparable to predicate) | Diameter ranges from 1.5 mm, length ranges from 6-10 mm. (Predicate: Diameter ranges from 1.5-2 mm, length ranges from 9-11 mm). The submission states "similar dimensions." |
| Performance Characteristics (comparable to predicate) | Self-trapping/Self-drilling (same as predicate). |
| Intended Use / Indications for Use | Threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. Used temporarily. (Identical to predicate). |
| Substantial Equivalence Conclusion | "in all respects based on Intended Use, Indications of Use, Construction Material, Performance and Bench Tests that the Orthodontic Miniscrew for Absolute Anchorage and the Aarhus Anchorage System K041527 are substantially equivalent." Specifically, "Potential adverse effects are identical." and "made from the same material ... and has similar dimensions and characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "Performance Testing" which included "testing was done to determine the torque levels, forces and insertion lengths while inserting the Orthodontic Miniscrew for Absolute Anchorage." However, no specific sample sizes (N) for these tests are mentioned.
The data provenance is implied to be from bench testing conducted by Dental Morelli Ltda. The country of origin for the device manufacturer is Brazil. The data itself would be from laboratory experiments, not patient data, in this context of a 510(k) submission for mechanical equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This submission is for a medical device (orthodontic miniscrew) and focuses on demonstrating substantial equivalence through material and mechanical properties, as well as adherence to standards. It does not involve a diagnostic algorithm or a scenario where expert-established ground truth is required in the context of a "test set" as one might find in an AI/ML medical device submission. The "ground truth" here is adherence to engineering standards and established performance of the predicate.
4. Adjudication Method for the Test Set
Not Applicable. See point 3. No clinical or diagnostic "test set" requiring expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This document does not mention any MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices to assess human reader performance with and without AI assistance. This device is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing mentioned (torque levels, forces, insertion lengths), the ground truth is based on instrumentation measurements comparing the new device against the performance characteristics of the predicate device. For material and sterilization claims, the ground truth is demonstrated by conformance to established international standards (ASTM F136, ASTM F1980-07, ISO 11137). There is no "expert consensus" or "pathology" in the typical sense for this submission regarding performance.
8. The sample size for the training set
Not Applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not Applicable. See point 8.
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(129 days)
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
The noninvasive FORE-SIGHT Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows:
When used with large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and transitional adolescents ≥ 40 kg.
The FORE-SIGHT Elite Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).
The Oximeter consists of a monitor unit, preamplifier assembly, and sensor uses multiple wavelengths of light in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, regulating sensor light output and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four sensors with both numeric and real-time graphical display formats.
The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.
The provided text describes the CASMED FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (K123700) and its substantial equivalence to predicate devices, but it does not include detailed acceptance criteria tables or specific reported device performance metrics against those criteria. It also does not provide information about a study proving the device meets specific acceptance criteria in the format requested, particularly regarding sample sizes for test sets, data provenance, expert qualifications, or details about comparative effectiveness studies.
The document primarily focuses on establishing substantial equivalence to previously cleared devices through non-clinical and clinical testing, stating that it "successfully underwent extensive performance, safety, electromagnetic, clinical, software and environmental testing" and "extensive clinical validation for the indicated use." However, it does not provide the specifics of these tests as requested in the prompt.
Therefore, for aspects relating to specific performance criteria, reported device performance against those criteria, sample sizes, expert details, and adjudication methods, the provided document does not contain the necessary information.
Here's an attempt to answer based on the information provided and to explicitly state when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria or specific reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) against defined criteria. It generally states that the device "successfully underwent extensive performance... testing" to ensure substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "extensive clinical validation for the indicated use" and "a validation report for Cerebral Tissue Oxygen Saturation (StO2%) in Adult and Transitional Adolescent Subjects." However, it does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This document describes an oximeter, which is a measurement device for physiological parameters (blood oxygen saturation). It is not an AI-assisted diagnostic imaging device for which MRMC comparative effectiveness studies involving human readers and AI assistance would typically be conducted. Therefore, this question is not applicable in the context of the provided device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an oximeter with an algorithm to determine StO2 values. The "accuracy" or "performance" of such a device is inherently its standalone measurement capability. The document states: "The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics." It also mentions "extensive performance... testing" and "clinical validation." This implies standalone performance was evaluated, but specific metrics are not provided.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For an oximeter, the ground truth would typically be established against a reference standard method for blood oxygen saturation measurement (e.g., arterial blood gas analysis, co-oximetry). The document does not explicitly state the "type of ground truth" used for its clinical validation studies, but for physiological measurements, it is usually a recognized clinical gold standard.
8. The Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This type of information is typically relevant for machine learning or AI models that require distinct training and testing phases. While the device uses an "algorithm," the document doesn't explicitly refer to its development structure in terms of training sets.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" and its ground truth establishment are not discussed, this information is not provided.
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(120 days)
FORE-SIGHT ABSOLUTE TISSUE OXIMETER
The noninyasive FORE-SIGHT® Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows:
When used with Large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and children over 40 Kg.
When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg.
When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg.
The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.
The FORE-SIGHT Absolute Tissue Oximeter measures a single parameter of oxygenated hemoglobin under the Sensor, allowing the clinican to continuously and accurately determine absolute levels of blood oxygenation in the tissue.
The Oximeter monitor features a LASER-SIGHT® Optical Technology generating 4 precise wavelenglis to optimize measurement of targeted hemoglobin states. COOL-LIGHT™ sensor technology ensures zero risk of patient burns. 3 sizes of sensors are available. The Oximeter is for continuous or spot checking use in a variety of hospital settings. A rechargeable battery pack permits the monitor to be used independently from an AC power source.
This request refers to the CASMED FORE-SIGHT Absolute Tissue Oximeter (K112820). However, the provided text does not contain acceptance criteria for the device, nor a study proving it meets such criteria.
The document discusses the device's intended use, comparison to predicate devices, and general statements about performance, safety, and clinical testing. It states that "The FORE-SIGHT Absolute Tissue Oximeter has successfully undergone extensive clinical study for the expanded indications for use especially for neonatal subjects." and cites a validation report: "Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects". However, the details of this study, including specific acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics, are not present.
Therefore, I cannot fulfill the request with the information provided. The missing information includes:
- A table of acceptance criteria and the reported device performance: This is entirely absent.
- Sample size used for the test set and the data provenance: Not specified for the cited clinical study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method for the test set: Not specified.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is an oximeter, not an AI diagnostic device for image analysis.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an oximeter, typically used for continuous monitoring by clinicians, so the concept of "standalone performance" in the AI sense might not directly apply here without further context on how "performance" is measured.
- The type of ground truth used: Not specified, although an oximeter's ground truth would typically be invasive blood gas analysis or other established direct oxygen measurement methods.
- The sample size for the training set: Not applicable, as this isn't an AI model with a distinct "training set" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
To answer your request, you would need to provide the "Validation of the CASMED FORE-SIGHT® Tissue Oximeter for Skeletal Muscle and Abdominal Tissue Oxygen Saturation (StO2%) in Pediatric and Neonatal Subjects" report or similar detailed clinical study documentation.
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(288 days)
ABSOLUTE WHITE LIGHT
The Absolute White Light emits visible blue light in the 400 nanometer spectrum and is intended to provide a light source for bleaching teeth.
The Absolute White Light is intended for use by the end consumer. The Absolute White Light is a battery operated, hand held device that contains a hun vosible light in the 400 nanometer spectrum, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. Built in safety features include automatic light shut off after two minutes and "Light Guard" that prevents light exposure to the user's eyes.
The provided document describes the Absolute White Light, a device intended to provide a light source for bleaching teeth. However, it does not include a study that proves the device meets specific acceptance criteria in terms of efficacy or performance on human subjects for tooth whitening. Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety standards.
Here's a breakdown based on your request, highlighting what is present and what is absent:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., a specific percentage improvement in tooth shade) for the Absolute White Light. Instead, it relies on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device (Dentovations Luster Whitening System) in terms of its intended use and technical characteristics.
The "performance data" section primarily refers to compliance with quality system regulations and safety standards, not clinical efficacy data.
Table of Comparison with Predicate Device (acting as the basis for "performance" as substantial equivalence):
| Feature | Absolute White Light | Dentovations Luster Light (Predicate) | Acceptance Criteria Implied by Equivalence | Reported Device Performance (Absolute White Light) |
|---|---|---|---|---|
| Intended Use | Light source, Teeth Bleaching | Light source, Teeth Bleaching | Same as Predicate | Light source, Teeth Bleaching |
| Method of Use | Hand Held | Hand Held | Same as Predicate | Hand Held |
| Treatment Time | 2 minutes | 2 minutes | Same as Predicate | 2 minutes |
| Treatment(s) | As Needed | As Needed | Same as Predicate | As Needed |
| Area of Use | Oral Cavity | Oral Cavity | Same as Predicate | Oral Cavity |
| Light Source | LED | LED | Same as Predicate | LED |
| Wavelength of Light | 400 nm | 350 – 700 nm | Within (or close to) Predicate's range | 400 nm (within predicate range) |
| Color of Light | Blue | Blue | Same as Predicate | Blue |
| Presentation | Non-Sterile | Non-Sterile | Same as Predicate | Non-Sterile |
Additional "Performance Data" (Compliance, not clinical efficacy):
The device is manufactured in compliance with:
- Quality System Regulations (21 CFR 820)
- DIN EN ISO13485:2003
- DIN EN ISO 9001:2000
- EN 61000-6-1 Electromagnetic compatibility (EMC) Part 6-1: Immunity standard for residential, commercial and light-industrial environments
- EN61000-6-3 Electromagnetic compatibility (EMC) Part 6-3: Emission standard for residential, commercial and light-industrial environments
Study Details (or lack thereof)
Based on the provided text, there is no specific clinical study or performance study presented that directly proves the device's efficacy in terms of tooth whitening (e.g., changes in shade). The submission relies on demonstrating substantial equivalence to a predicate device, implying that since the predicate device is already cleared for use, a device with similar characteristics and intended use is also safe and effective.
Therefore, the following points cannot be addressed with the provided text, as no such study is described:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no clinical test set described for efficacy.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set described for efficacy.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no clinical test set described for efficacy.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, this is not an AI/imaging diagnostic device. No MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an AI/imaging diagnostic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth for efficacy was established or reported. The "ground truth" for regulatory clearance was the substantial equivalence to the predicate device based on technical specifications and safety standards.
- The sample size for the training set: Not applicable, no machine learning model or training set is described.
- How the ground truth for the training set was established: Not applicable, no machine learning model or training set is described.
Conclusion from the document:
The regulatory approval (K110888) was granted based on the determination of "substantial equivalence" of the Absolute White Light to the predicate device (Dentify Luster Whitening System, K042153). This means the FDA concluded that the new device has the same intended use and similar technological characteristics to a device already on the market and does not raise different questions of safety and effectiveness. The "performance data" provided focuses on manufacturing quality systems and adherence to electromagnetic compatibility (EMC) standards, not on clinical performance demonstrating tooth whitening efficacy in human subjects.
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