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510(k) Data Aggregation
(475 days)
TAKARA BELMONT USA, INC.
The BelSensor GOLD is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The BelSensor GOLD shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The BelSensor GOLD can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.
The BelSensor GOLD is an indirect converting x-ray detector that converts incident xrays by a scintilator into visable light, which is coupled optically to a light detection imager based on CMOS technology. Incident x-rays are automatically detected to generate digital images for dental intra-oral applications.
The BelSensor GOLD supports USB 2.0 connectivity to personal computer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BelSensor GOLD:
The provided document describes a 510(k) summary for the BelSensor GOLD, a digital X-ray sensor for dental intra-oral applications. It is crucial to note that this document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone clinical study with detailed performance metrics against specific acceptance criteria.
Therefore, much of the requested information about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly present in this type of regulatory submission summary. The demonstration of safety and effectiveness relies on comparison to a predicate device and adherence to relevant standards.
Let's break down what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria (e.g., minimum sensitivity, spatial resolution targets) and their corresponding measured performance values are NOT explicitly stated in this 510(k) summary.
The primary "performance" discussed is in comparison to the predicate device in terms of technological characteristics.
| Characteristic | Acceptance Criterion (Implicitly, to be equivalent/similar to predicate) | Reported Device Performance (BelSensor GOLD) |
|---|---|---|
| Intended Use | Acquire dental intra-oral radiology images, operated by healthcare professionals, can use positioning devices or be handheld. | Same as predicate |
| Technology | CMOS | CMOS |
| Interface with PC | USB | USB |
| Dynamic Range | Similar or better than predicate (16,384:1) | 15,000:1 (Slightly lower than predicate, but within typical ranges for such devices and likely considered acceptable for substantial equivalence) |
| Sensor Cable Length | Similar or better than predicate (2.8m) | 3m (Slightly longer, which is generally a practical improvement) |
| Sensor Size | No direct criterion, but various sizes offered by predicate | 30 x 20 mm, 36 x 26 mm (Predicate has 30 x 39 mm, implying multiple sizes are acceptable) |
| Number of Sensors | Not applicable as a direct performance metric; design choice | 2 (Predicate has 1) |
| Safety | Adherence to IEC 60601-1 (2005) | Performed and compliant |
| EMC | Adherence to IEC 60601-1: 1988 + A1: 1991 + A2:1995, IEC 60601-1:2005, EN 60601-1: 2006, EN 60601-1-2: 2007 | Performed and compliant |
| Biocompatibility | Adherence to USP testing guidelines | Performed and compliant |
Missing: Specific quantitative performance metrics like spatial resolution (lp/mm), signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), DQE (Detective Quantum Efficiency), exposure latitude, etc., that would typically be associated with acceptance criteria for image quality.
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly stated for a clinical performance test set. The document primarily relies on non-clinical testing (electrical, mechanical, environmental safety, EMC, biocompatibility) and comparison to a predicate device. If human imaging tests were performed, the details are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not stated. This summary does not describe a clinical study where expert ground truth establishment would be required. The evaluation focuses on technical equivalence and compliance with standards.
4. Adjudication Method for the Test Set
Not applicable/Not stated. No clinical adjudication process is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study is not mentioned or described. This type of study is more common for diagnostic AI devices and involves evaluating how human performance changes with or without AI assistance. This device is an imaging sensor, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The BelSensor GOLD is an imaging sensor (hardware), not an algorithm or software-only device. Therefore, a "standalone" algorithm performance study is not relevant in this context. The standalone performance would be its physical performance characteristics, which are implicitly covered by the technical comparisons and standards compliance.
7. Type of Ground Truth Used
Not explicitly stated in terms of a clinical ground truth. For non-clinical testing, the "ground truth" would be the specifications of the tests and standards (e.g., a specific electrical property should measure within a certain range, or a material should not cause a toxic reaction).
8. Sample Size for the Training Set
Not applicable. The BelSensor GOLD is a hardware imaging sensor. It does not utilize machine learning or AI algorithms that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no "training set" for this device.
Summary of Device Evaluation in the 510(k) Filing:
The safety and effectiveness of the BelSensor GOLD are primarily established through:
- Substantial Equivalence: Direct comparison of its intended use and technological characteristics to a legally marketed predicate device (Dexis Sensor K090458).
- Adherence to Standards: Compliance with recognized international standards for electrical, mechanical, environmental safety (IEC 60601-1 series), EMC (IEC 60601-1-2), and biocompatibility (USP testing guidelines).
The 510(k) process is less about presenting de novo clinical study data with specific acceptance criteria and more about demonstrating that a new device is as safe and effective as a previously cleared device.
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(127 days)
TAKARA BELMONT USA, INC.
Dental Unit and Accessories are intended for the Dentists, Hygienists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
The Belmont QUOLIS 5000 SERIES DENTAL UNIT is a modification of the existing Belmont Dental Unit, Model 2000 series and Model 6000 series. It is a Dental Operative Unit and Accessories.
The provided text is a 510(k) premarket notification for a dental operative unit and accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The device is a physical dental unit, not an AI algorithm or diagnostic tool that would typically involve a test set, ground truth, expert adjudication, or MRMC studies.
Here's an analysis based on the information provided, highlighting what is applicable and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units, which presumably meet these standards. |
| ISO-7494-2:2003 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units. |
| ISO-7494-1:2004 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units. |
| ISO 60601-1 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units. |
Explanation: The primary method for demonstrating that this device meets its performance "acceptance criteria" (which are outlined as specific international standards for medical electrical equipment and dental equipment) is by proving "Substantial Equivalence" to previously cleared predicate devices. The document states that a comparison (Attachment 2, not provided here) indicates the QUOLIS 5000 is substantially equivalent to the Belmont 2000 Series and Model 6000 Series Dental Units. This means that if the predicate devices meet these standards, then the new device, being substantially equivalent, is also considered to meet them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a substantial equivalence submission for a physical dental unit, not a study involving a test set of data for an algorithm. There is no "test set" in the context of an AI or diagnostic device performance evaluation. The "data provenance" would refer to the technical specifications and comparison data of the device itself and its predicate, not patient data.
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)
- Not Applicable. As above, there is no "test set" or "ground truth" to be established by experts in the context of a dental operative unit's substantial equivalence. The "experts" involved would be regulatory reviewers (FDA) and potentially engineers/designers from the manufacturer who performed the comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no "test set" or "adjudication method" as this is not a diagnostic or AI performance study.
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 a physical dental unit and does not involve AI assistance for human readers/clinicians, nor does it involve a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical dental unit, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. There is no "ground truth" in the sense of clinical reference standards for an AI or diagnostic device. The "truth" in this context is that the device, through its design and specifications, adheres to relevant safety and performance standards equivalent to predicate devices.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth in that context.
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(37 days)
TAKARA BELMONT USA, INC.
The BELMAX CM dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The BELMAX CM Model X168 X-Ray System is the next generation of the Takara Belmont digital dental X-ray systems. Similar to the prior Takara Belmont ANA-BEL, ANA-BEL CM equipped with the Takara Belmont ADR Plus SSXI, the BELMAX CM Model X168 X-Ray System offers digital imaging with panoramic and cephalometric imaging programs with the same exposure levels (KV/mA). Modifications resulting in the device include a new sized CCD sensor including three rather than two of the same sensor array grids mounted in a removable cartridge rather than bolted in place.
The provided document describes a 510(k) premarket notification for the BELMAX CM Model X168 X-Ray System. The study conducted for this device is a clinical trial comparing its performance to film images.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the clinical study in the form of a pre-defined threshold that the device needed to meet to be considered successful. Instead, it presents comparative performance metrics against film images, aiming to demonstrate that the BELMAX CM digital images are "better than" or "as good as" film.
| Acceptance Criteria (Implied) | Reported Device Performance (BELMAX CM Digital Images) | Comparator (Film Images) |
|---|---|---|
| Clear observation of skeletal hard tissue structures | 97% of subjects | 81% of subjects |
| Sufficient depiction of soft tissue structures | 87% of images | 43% of images |
| Overall image quality | Rated better than film images | - |
| Sufficient clarity for landmark identification | 93.6% average percentage | 81.6% average percentage |
2. Sample size used for the test set and the data provenance
- Sample Size: 30 patients
- Data Provenance: Retrospective, conducted in Japan at the Department of Oral Radiology, Asahi University School of Dentistry.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Five specialists
- Qualifications of Experts: Specialists in orthodontic dentistry. (Further details on experience level, e.g., years of experience, are not provided).
4. Adjudication method for the test set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It mentions that "Readings were performed by five specialists in orthodontic dentistry." It's implied that these experts performed the evaluations that led to the reported percentages, but the method for resolving discrepancies among their readings, if any, is not detailed.
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: A comparative study was done between digital images and film images, and human readers (specialists) were involved in reading both. However, this was not a study on AI assistance for human readers. It was a comparison between different imaging modalities (digital X-ray vs. film X-ray).
- Effect Size of Human Readers with AI vs. without AI assistance: Not applicable, as the device is an X-ray system, not an AI-powered assistant for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. The study specifically involved human readers (specialists) evaluating both digital and film images. The device itself is an imaging system, not an independent diagnostic algorithm.
7. The type of ground truth used
- Expert Consensus/Expert Reading: The "ground truth" for evaluating image quality and clarity was established through the readings and ratings performed by five specialists in orthodontic dentistry. The document uses phrases like "rated as sufficient" and "rated better than," indicating subjective expert assessment. No objective pathology or outcomes data is mentioned as ground truth.
8. The sample size for the training set
The document does not mention a "training set" or any machine learning components for which a training set would be required. The BELMAX CM Model X168 is an X-ray imaging system, not an AI-driven diagnostic tool. Therefore, the concept of a training set as used in AI/ML is not directly applicable here. The focus of the study was on the image quality produced by the device for human interpretation, not on training an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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(149 days)
TAKARA BELMONT USA, INC.
The ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM, a Solid State X-Ray Imaging Device is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended to replace conventional radiographic film for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Solid State X-Ray Imaging Device
This document is a 510(k) clearance letter from the FDA for a medical device called the "ADR Plus SSXI Imaging Device for X-ray Systems." It indicates that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter itself is a notice of clearance, confirming that the device can be legally marketed based on its substantial equivalence to predicate devices, but it does not detail the specific performance testing or clinical studies typically associated with demonstrating acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To answer your questions, I would need a document specifically describing the performance study, its methodology, results, and predefined acceptance criteria.
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(15 days)
TAKARA BELMONT USA, INC.
PHOT-X II MODEL 303 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor . The design, function and positioning of the x-ray unit is similar to most all other x-ray machines manufactured for this specific purpose over the past thirty years.
PHOT-X II, MODEL 303 dental x-ray contains; control box, wall mounting, adjustable support arm and x-ray generating tubehead. Package includes Operators Manual, Installation Manual and Warrantee.
The provided document is a 510(k) premarket notification for a dental X-ray device (PHOT-X II, MODEL 303). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness or diagnostic accuracy through a traditional clinical study with acceptance criteria for device performance. It's a regulatory filing, not an efficacy study report.
Therefore, many of the requested items related to clinical performance studies (such as acceptance criteria, sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance) are not applicable in this context.
The document does not describe an acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or clinical outcomes. Instead, it demonstrates that the new device has similar technical specifications and characteristics to previously cleared devices.
Here's the information that can be extracted from the document based on your request:
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) submission focused on substantial equivalence based on technical specifications rather than diagnostic performance, explicit "acceptance criteria" and "reported device performance" in the typical sense of a clinical study are not provided. The comparison provided is between the new device and predicate devices on various electrical and radiation parameters. The "acceptance criteria" here is implicitly that the new device's specifications should be comparable to or within acceptable ranges of the predicate devices.
| Parameter | Predicate Device (MODEL 2001CP) (K874238) | Predicate Device (HELIODENT DS) (K960819) | Predicate Device (PROSTYLE INTRA) (K970975) | Proposed Device (MODEL 303) |
|---|---|---|---|---|
| X-RAY WAVE FORM | DC Constant wave | N/A | N/A | DC Constant wave |
| FILAMENT | Pre-heating system | N/A | N/A | Pre-heating system |
| CONTROL PANEL LOCATION | At arm mounting bracket | N/A | N/A | Separable from power board |
| PRE-HEATING TIME | Manually adjusted | N/A | N/A | Automatically adjusted |
| HIGH VOLTAGE GENERATOR | 75 kHz high frequency inverter | N/A | N/A | 80 kHz high frequency inverter |
| FILAMENT CIRCUIT | 50 kHz high frequency inverter | N/A | N/A | 25 kHz high frequency inverter |
| Focal Point Measurement | 0.8mm×0.8mm | 0.7mm×0.7mm | 0.7mm×0.7mm | 0.7mm×0.7mm |
| Rated tube potential | 60kV, 70kV | 60kV | 50,53,55,57,60,63,66,70 kV | 60kV, 70kV |
| Rated tube current | 10mA | 7mA | 8mA | 4mA, 7mA |
| Maximum rated tube potential | 70kV | 60kV | 70kV | 70kV |
| Rated line voltage | 120VAC | 100VAC-125VAC | 110VAC-115VAC | 120VAC |
| Line voltage range | 105VAC-130VAC | 90VAC-137.5VAC | 99VAC-126VAC | 108VAC-132VAC |
| Range of line voltage regulation | 2-5% | 2.5% | 10% | 2-5% |
| Rated line current | 14A at 70KV,10mA | N/A | N/A | 10.8A at 70KV,7mA |
| Maximum line current | 17A at 70KV,10mA | 11A | 9.0A | 12A at 70KV,7mA |
| Exposure time | 0.01-2.0sec., 27steps | 0.01-3.2sec., 23steps | 0.01-3.2sec., 23steps | 0.01-3.2sec., 23steps |
| Timer accuracy | ±10% or ±10msec, whichever is greater | ±10% | ±10% | ±5msec (below 0.1sec), ±10msec (0.1sec & up) |
| Inherent filtration | 1.3mmAl Equivalent | 0.55mmAl Equivalent | 1.0mmAl Equivalent at 70KV | 1.7mmAl Equivalent |
| Added filtration | 2.0mmAl | N/A | N/A | 0.3mmAl |
| Minimum filtration permanently in useful beam | 3.3mmAl Equivalent at 70KV | 2.0mmAl Equivalent | 2.0mmAl Equivalent at 70KV | 2.0mmAl Equivalent at 70kV |
| Nominal roentgen output (Regular cone) | 6.3mGy/s±40% (60kV,10mA) | 10mGy/s±30% | N/A | 5.4mGy/s±40% (60kV,4mA), 9.4mGy/s±40% (60kV,7mA) |
| Nominal roentgen output (Long cone) | 2.2mGy/s±40% (60kV,10mA), 2.9mGy/s±40% (70kV,10mA) | N/A | N/A | 2.4mGy/s±40% (60kV,4mA), 4.2mGy/s±40% (60kV,7mA), 3.1mGy/s±40% (70kV,4mA), 5.5mGy/s±40% (70kV,7mA) |
| Source to skin distance (Regular cone) | 203mm | 203mm | 200mm | 203mm |
| Source to skin distance (Long cone) | 350mm | 305mm | 300mm | 305mm |
| Leaking technique factor | 70kV/0.48mA | 0.12mA | N/A | 70kV/0.14mA |
| Duty cycle | 1:20 | 1:60 | 1:15 | 1:50 |
| Maximum deviation of tube potential and tube current | ±10kV,±5mA (0.01-0.05sec); ±5kV,±2mA (0.06-2.0sec) | ±6.0kV (tube potential), ±0.7mA (tube current) | ±2.0kV (tube potential), ±10% (tube current) | ±10kV,±2mA (below 0.1sec); ±5kV,±1mA (0.1sec & up) |
| Intended Use | For diagnostic purposes of teeth, jaw, oral structures | For diagnostic purposes of teeth, jaw, oral structures | N/A | For diagnostic purposes of teeth, jaw, oral structures |
2. Sample size used for the test set and the data provenance
Not applicable. This document is a 510(k) submission, not a study report. It focuses on comparing technical specifications of a new device to existing predicate devices. No test set of patient data is mentioned or used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth is described in this regulatory filing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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 device is a dental X-ray unit, which is a hardware device for image acquisition, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This relates to an AI algorithm's performance, which is not relevant for a dental X-ray hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As no clinical performance study for diagnostic accuracy is presented, no ground truth is established or used. The "ground truth" in this context is the technical specifications and safety standards met by the predicate devices, against which the new device is compared for substantial equivalence.
8. The sample size for the training set
Not applicable. No machine learning or AI component is described, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. No machine learning or AI component is described, so there is no training set or ground truth for it.
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(71 days)
TAKARA BELMONT USA, INC.
The ANA-BEL and ANA-BEL CM dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
ANA-BEL and ANA-BEL CM, Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray all employ X-ray tube with maximum rated peak tube potential of 90 kV.
The provided document describes a 510(k) submission for the ANA-BEL and ANA-BEL CM X-ray systems, seeking substantial equivalence to predicate devices (Takara X-Caliber and X-Caliber CM, and PLANMECA 2002 CC Proline Panoramic X-ray).
The document does not contain detailed information about specific acceptance criteria or a dedicated study report proving the device meets those criteria in a quantitative sense. Instead, the equivalence is established by comparing the new device's indications for use and technological characteristics to those of the predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document uses the concept of "substantial equivalence" as its acceptance overarching criterion. The performance is assessed by confirming that the new device shares the same intended use and similar technological characteristics with existing legally marketed devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (ANA-BEL and ANA-BEL CM) |
|---|---|
| Same Indications for Use | Yes, "Generation of radiographic images of the dento-maxilofacial region for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures." This matches the predicate devices. |
| Same Technological Characteristics (Design, Materials, etc.) | Yes, employs an X-ray tube with a maximum rated peak tube potential of 90 kV, similar to predicate devices. (A detailed comparison table is referenced but not provided in the excerpt). |
| New characteristics do not affect safety and effectiveness | No, asserted that new characteristics do not affect safety and effectiveness. |
| New characteristics do not raise new types of safety or effectiveness questions | No, asserted that new characteristics do not raise new questions. |
| Acceptable scientific methods exist for assessing effects of new characteristics | Yes, asserted. |
| Performance data available to assess effects of new characteristics | Yes, asserted. |
| Performance data demonstrate equivalence | Yes, asserted. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" or provide details on data provenance (e.g., country of origin, retrospective/prospective) for a performance study. The basis for clearance is demonstrating equivalence to predicate devices, not through a separate clinical performance study with a distinct test set in the traditional sense. The phrase "performance data available to assess effects of new characteristics" is generic and not further elaborated on to describe specific testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the use of experts or the establishment of ground truth for a test set. The regulatory decision is based on a review of the device's specifications and comparison to predicates by the FDA, not on a human-readability study or expert consensus for image interpretation.
4. Adjudication Method for the Test Set:
Since there is no described test set or expert evaluation, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or at least not described in this document. The submission is for substantial equivalence, which often relies on technical specifications and functional comparisons rather than comparative clinical performance trials.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study (e.g., for an AI algorithm) was not done. This document pertains to an X-ray imaging device, which is hardware, not an AI algorithm.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically used in AI or diagnostic accuracy studies is not applicable or mentioned in this context. The basis for equivalence relies on comparing the device's functional and design characteristics to those of predicate devices, and its ability to "Generate radiographic images" for diagnosis, rather than the accuracy of image interpretation against a definitive ground truth.
8. Sample Size for the Training Set:
Not applicable. This document describes an X-ray imaging device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set mentioned, this information is not provided.
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