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The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

The Ellipse PRECICE Trauma Nail System is composed of the PRECICE Trauma Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Trauma Nail is supplied sterile by gamma radiation while the locking screws and accessories are supplied non-sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.

The provided document is a 510(k) premarket notification for the "PRECICE Trauma Nail System". The document states that the device is substantially equivalent to a previously cleared device (K141447) and relies on the testing and data from that predicate device. Therefore, a direct study proving the device meets new acceptance criteria is not presented, as the submission is based on demonstrating equivalence.

Here's an analysis of the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results for this specific 510(k) submission (K142599). Instead, it states that "all testing that was performed on the predicate PRECICE Trauma Nail System is applicable" because there are "no changes to the design of the PRECICE Trauma Nail being made as a result of this submission."

However, the document lists the types of tests performed on the predicate device, which can be inferred as satisfying the acceptance criteria for those tests:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for individual tests. It refers to "mechanical testing according to the methods outlined in the standard ASTM F1264-03." These standards typically define sample size requirements.

• Data Provenance: The data comes from tests performed on the predicate device (K141447). The document doesn't specify the country of origin of this data or if it was retrospective or prospective, but it's implied to be data collected during the development and clearance process of the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (experts for ground truth) is typically relevant for studies involving subjective human assessment (e.g., image interpretation for AI algorithms). For physical medical devices undergoing mechanical, sterilization, or biocompatibility testing, ground truth is established by the specified test standards and methodologies themselves (e.g., ASTM, ISO standards), not by human expert consensus in the same way. Therefore, this information is not applicable in this context and is not provided in the document.

4. Adjudication Method for the Test Set

As explained above, for physical device testing against established standards, adjudication methods like 2+1 or 3+1 (common in clinical trials or diagnostic studies) are not applicable. The "ground truth" and "adjudication" are inherent in the test method's specifications and the objective measurements obtained.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is specifically for evaluating the effectiveness of a diagnostic tool, often an AI algorithm, by comparing human reader performance with and without its assistance. The PRECICE Trauma Nail System is an intramedullary fixation rod, a physical implant, and therefore, an MRMC study is not applicable to its evaluation.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is also specific to AI/software as a medical device. The PRECICE Trauma Nail System is a physical device, and therefore this type of study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the predicate device's evaluation (and by extension, for this submission's substantial equivalence claim) is based on:

• Compliance with recognized industry standards: ASTM F1264-03 for mechanical testing, ANSI/AAMI/ISO 11137-2 for sterilization, and ISO 10993-1 for biocompatibility.
• Objective measurements and criteria: As defined within these standards for various performance parameters (e.g., strength, sterility assurance level, material compatibility).

8. The Sample Size for the Training Set

Not Applicable. The device is a physical medical implant, not an AI algorithm. Therefore, 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 there is no training set for an AI algorithm, there is no ground truth to establish for it.

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The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of:

• 1. The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue.
• 2. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
• 3. Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

The Precise SHP Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

The provided document is a 510(k) summary for the Precise SHP Diode Laser. It outlines the device's characteristics, intended uses, and claims of substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or details of a study that proves the device meets those criteria in the format of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or other quantitative measures of effectiveness).

Instead, the document focuses on demonstrating substantial equivalence based on:

• Similar intended uses: Both the proposed device and predicates are for dentistry and oral soft tissue procedures, temporary pain relief, and teeth whitening.
• Similar technological characteristics: Wavelength, operating controls, laser delivery method, control systems, safety features, and performance monitoring.
• Conformity to standards: Compliance with regulatory standards like 21 CFR 1040.10, 1040.11, IEC 60601-2-22, IEC 60825-1, IEC 60601-1 (3rd Edition), IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-1-6.
• Bench testing: A general statement about bench testing indicating the device met design criteria, satisfied performance requirements of 21 CFR 1010 and 21 CFR 1040, and that outputs were within requirements and safety features functioned correctly.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the requested format (e.g., sensitivity, specificity, accuracy) because this information is not present in the provided text. The document describes a bench testing study, but not a clinical study with detailed performance metrics.

Here's an analysis of what is provided, based on your requested categories:

1. A table of acceptance criteria and the reported device performance

Note: This table is an interpretation based on the provided text, which states the device "met the design criteria for essential performance, and satisfied the performance requirements indicated in 21 CFR 1010 and 21 CFR 1040. Device outputs were within performance requirements and all safety features and functions were operating correctly." Specific numerical or qualitative performance metrics beyond these general statements are not given.

2. Sample size used for the test set and the data provenance

• Sample Size: "an evaluation sample of the current device." The exact number of devices in this sample is not specified.
• Data Provenance: Not specified, but generally, bench testing for a 510(k) submission would be conducted by the manufacturer (CAO Group, Inc.) in a controlled lab environment. It is not patient or human data, so "country of origin" and "retrospective/prospective" are not applicable in a clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. The study was bench testing, not a clinical study involving human assessment or ground truth established by experts. The "ground truth" would be the engineering specifications and regulatory requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This refers to clinical studies where different experts might disagree on an assessment. Bench testing typically involves objective measurements against predefined specifications.

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. This was a bench test of a laser device, not an AI-based diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is not an algorithm, but a physical medical device (laser). The bench testing described essentially represents the "standalone" performance of the device against its specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the bench testing would be the engineering specifications and performance requirements defined by the manufacturer and relevant regulatory standards (e.g., maximum power output, wavelength accuracy, safety feature functionality).

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no training set in the machine learning sense. The "training" for the device would be its design and manufacturing process.

9. How the ground truth for the training set was established

• Not applicable for the same reason as above.

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The Precise SHP Diode Laser is indicated for the removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, freeectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.

The Precise SHP Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

The provided 510(k) summary for the "Precise SHP Diode Laser" does not contain information about acceptance criteria and a study proving those criteria are met in the way a diagnostic device approval would. This device is a surgical instrument (a diode laser), not a diagnostic algorithm. For such devices, the assessment criteria focus on manufacturing, safety, and performance specifications rather than diagnostic accuracy metrics.

Therefore, many of the requested points cannot be answered from the provided text, as they are not applicable to the type of device and regulatory submission presented.

Here's an analysis based on the information provided, and where information is missing for a diagnostic device context:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in a quantitative table format with corresponding performance results similar to a diagnostic device. Instead, it refers to compliance with regulatory standards and general functional performance.

2. Sample Size for Test Set and Data Provenance

Not applicable in the context of a diagnostic test on patient data. The "test set" here refers to the device itself.

• Sample size: "Bench testing on an evaluation sample of the current device" - implies at least one device was tested.
• Data provenance: N/A (bench testing of the physical device).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Ground truth for a diagnostic device would involve independent clinical review or pathological confirmation. For a surgical laser, experts might design the testing protocols, but they aren't establishing a "ground truth" diagnosis.

4. Adjudication Method

Not applicable for a device performance test of a surgical laser.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic imaging device where human readers interact with AI.

6. Standalone Performance Study

Yes, in a sense. The "bench testing" described is a standalone evaluation of the device's physical and functional performance without human interaction beyond operating the device.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is adherence to:

• Engineering design specifications.
• Performance requirements outlined in 21 CFR 1010 and 21 CFR 1040.
• Relevant international safety and performance standards (e.g., IEC 60601 series, IEC 60825-1).

8. Sample Size for Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

Not applicable. This device is not an AI/ML algorithm.

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The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.

The PreciseCore™ Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The stylet of the device is stationary, therefore acquiring tissue without an advancement of the needle set beyond the visualized tip.

This 510(k) submission (K093399) for the PreciseCore™ Biopsy Device primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing. However, it does not provide detailed acceptance criteria, specific performance metrics in a tabular format, or a comprehensive study report with the kind of information typically requested (e.g., sample sizes for different sets, ground truth establishment details, expert qualifications, MRMC studies).

Here's an analysis based on the provided text, highlighting what is and is not present:

Acceptance Criteria and Device Performance (Based on available information)

The document states: "Performance testing confirms that the quality of samples obtained with the PreciseCore™ Biopsy Device is equivalent to that of the predicate device." This implies the acceptance criterion was "equivalence in sample quality" to the predicate, but no specific metrics or thresholds are provided.

Missing Information (Based on the provided text):

The provided 510(k) summary does not contain the following details:

1. Sample sizes used for the test set and the data provenance: There is no mention of a specific clinical "test set" in terms of patient or tissue samples. The performance testing appears to be functional or mechanical, comparing the device's output (sample quality) to a predicate.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there isn't a described "test set" requiring expert ground truth establishment in the context of clinical images or diagnostic outcomes. The "quality of samples" likely refers to characteristics like length, integrity, or cellularity, evaluated by laboratory personnel or pathologists, but no specifics are given.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the reasons above.
4. 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 is not applicable. The device is a physical biopsy instrument, not an AI-powered diagnostic or imaging tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable, as it is a physical biopsy device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While the "quality of samples" would likely refer to histopathological evaluation, the specific method of establishing this ground truth for the comparison is not detailed.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Study (Based on provided text):

The submission relies on a "Performance Testing Summary" to demonstrate substantial equivalence.

• Study Design/Purpose: To confirm that the quality of samples obtained with the PreciseCore™ Biopsy Device is equivalent to that of the predicate device (K994272 – Promex Automated Core Biopsy Device, Inrad® AccuCore Single Action Core Biopsy Device, and US Biopsy SABD).
• Methodology (General): "Performance testing" was conducted. While no specifics are given, for a biopsy device, this typically involves mechanical testing (e.g., penetration force, firing reliability) and potentially benchtop testing on tissue phantoms or ex vivo tissue to assess core length, integrity, and cellular yield when compared to the predicate device.
• Data Provenance: Not specified, but likely laboratory/benchtop testing rather than clinical data from a specific country.
• Result: The testing "confirms that the quality of samples obtained with the PreciseCore™ Biopsy Device is equivalent to that of the predicate device."

Conclusion:

The K093399 submission successfully demonstrated substantial equivalence for the PreciseCore™ Biopsy Device by asserting that its performance testing confirmed sample quality equivalent to its predicate. However, it lacks the detailed breakdown of acceptance criteria, specific performance metrics, and clinical study information (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies) that would be expected for an AI/ML device or a device requiring detailed clinical validation data. This is typical for 510(k)s for predicate-based medical devices where the equivalence is often shown through functional, mechanical, and benchtop testing rather than extensive clinical efficacy trials.

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The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Roche Preciset DAT Plus I calibrators contain a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine and propoxyphene. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture.

Roche Preciset DAT Plus II calibrators contain a mixture of 4 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, benzodiazepines. cannabinoids, and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multianalyte mixture.

Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture.

This 510(k) premarket notification is for calibrators used with drug abuse assays, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, many of the requested categories (e.g., expert consensus, MRMC studies, standalone performance) are not applicable in the traditional sense for this type of device.

This submission focuses on demonstrating substantial equivalence to already marketed calibrators by Roche. The "acceptance criteria" here are implicitly meeting the performance characteristics and intended use of the legally marketed predicate devices.

Here's an attempt to structure the available information according to your request, with significant caveats for the non-applicability of certain criteria:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• N/A (for traditional diagnostic device testing): This submission is for calibrators, not a diagnostic test that processes patient samples to generate a "test set" in the conventional sense. The "test" here involves comparing the composition and intended use of the new calibrators to existing, cleared predicate calibrators.
• Data Provenance: The calibrators themselves are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This suggests an in-house manufacturing process rather than external data provenance like country of origin or clinical data collection. The submission doesn't specify any external "testing" data from a large population.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable: For calibrators, "ground truth" isn't established by expert consensus on clinical images or patient data. The "ground truth" concerning the calibrators' composition is established by the manufacturing process – the quantitative addition of specified drug concentrations to drug-free human urine. Analytical techniques would verify these concentrations during manufacturing and quality control.

4. Adjudication Method for the Test Set

• Not Applicable: There is no clinical "test set" and thus no need for an adjudication method for disagreements among experts, as would be common in diagnostic imaging or clinical assessment studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: MRMC studies are used to assess the impact of a diagnostic device (often AI-based) on human reader performance. This submission is for calibrators, which are reagents used to set the measurement scale for an assay, not a diagnostic tool read by humans.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable: Calibrators do not have an "algorithm" or standalone "performance" in the way an AI diagnostic device would. Their function is to provide known reference points for an assay. Their performance is related to their stability, accuracy of stated concentrations, and ability to correctly calibrate the associated assays, which would be validated during manufacturing and quality control, not as a standalone "algorithm."

7. The Type of Ground Truth Used

• Manufacturing Specifications / Quantitative Addition: The "ground truth" for these calibrators is their precisely defined chemical composition. They are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This means the concentration of each drug in each level of the calibrator is precisely known and controlled during the manufacturing process.

8. The Sample Size for the Training Set

• Not Applicable: Calibrators are physical reference materials, not algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As above, there is no training set for this type of device.

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The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The device description of the Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is as follows:
• Delivery system profile in the area of stent housing is .069" (1.75mm) for stent diameters ranging from 5 - 7mm and .079" (2.0mm) for stent diameters ranging from 8 - 10mm.
• The stent will be delivered to the stricture site via the Rapid Exchange Stent Delivery System
• Guidewire lumen - 0.014"
• Stent delivery system useable length - 135cm
• Stent length - 20, 30, and 40mm
• Stent diameters - 5, 6, 7, 8, 9, and 10mm

The provided text describes a 510(k) premarket notification for a medical device, the Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies with detailed acceptance criteria for performance in the same way a de novo or PMA submission might.

Therefore, the requested information about acceptance criteria, study design, sample size, expert involvement, and ground truth establishment is not explicitly contained within the provided document. The 510(k) process primarily relies on demonstrating that the new device has "similar technological characteristics" and "is as safe and effective as" a legally marketed predicate device.

However, I can extract information related to the device description and what would typically be considered performance characteristics for such a device, and connect it to the concept of substantial equivalence as the "acceptance criteria" here.

Here's how I can address the request based on the provided text, while also noting the limitations:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are generally that the new device is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" would be presented through a comparison to the predicate device.

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 (N/A) / Not provided. A 510(k) submission typically does not involve a new clinical "test set" in the sense of a prospective clinical trial. The justification relies on comparison to a predicate device, which would have its own historical data. The document does not describe a new clinical study.

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)

N/A / Not provided. Since there's no new clinical test set described, there's no mention of experts establishing ground truth for a new study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A / Not provided. No new clinical test set 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

N/A / Not provided. This device is a physical medical stent, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A / Not provided. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A / Not provided. For a 510(k) submission of a physical device like a stent, "ground truth" typically refers to the established performance characteristics and safety profile of the predicate device, which would have been determined through prior clinical studies, literature, and real-world experience (often including pathology or patient outcomes data from those predicate studies). The current document does not detail how the predicate's ground truth was established, as it assumes the predicate is well-understood.

8. The sample size for the training set

N/A / Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

N/A / Not provided. There is no training set for this device.

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The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Roche Preciset DAT Plus II calibrators contain a mixture of 2 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are benzodiazepines and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture. Drug or drug metabolite and their respective levels included are as follows: Benzodiazepines: 0, 50, 100, 200, 400 ng/ml (no 6th level) Opiates: 0, 150, 300, 600, 1000, 2000 ng/ml. Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 7 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug mixture. Drugs or drug metabolites and their respective levels included are as follows: Barbiturates: 200 ng/ml Benzodiazepines: 300 ng/ml Cocaine: 150 ng/ml Methadone: 300 ng/ml Opiates: 2000 ng/ml Phencyclidine: 25 ng/ml Propoxyphene: 300 ng/ml

The provided text describes a 510(k) summary for Roche Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators, which are devices used for calibrating drug of abuse assays in human urine on automated clinical chemistry analyzers. As such, the information does not contain acceptance criteria or study results in the typical sense of measuring device performance against a predefined clinical or technical threshold.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device. This regulatory pathway does not require new efficacy studies if the new device is sufficiently similar to a previously cleared one.

Therefore, many of the requested elements for describing acceptance criteria and study results are not applicable to this type of regulatory submission and the provided documentation.

Here's an assessment based on the available information:

1. Table of acceptance criteria and the reported device performance:

• Not applicable. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its own performance. Instead, it aims to show substantial equivalence to a predicate device.

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 document does not describe a performance study with a test set in the way you might expect for a diagnostic device measuring patient outcomes. The "data" here refers to the quantitative addition of drug or drug metabolite to drug-free human urine for calibrator preparation.

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. Ground truth in this context would relate to the precise concentration of drugs in the calibrators, which is established by the manufacturer through quantitative addition, not by expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No adjudication method is described as this is not a study assessing diagnostic performance against a clinical ground truth.

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:

• Definitely Not applicable. This device is a calibrator for laboratory assays, not an AI-powered diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm, but a physical calibrator product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the calibrators is the known, quantitatively added concentration of drug or drug metabolite in drug-free human urine. This is an engineered "truth" rather than a discovery-based one (like pathology).

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this device. The calibrators are manufactured to precise specifications.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for this product. The "ground truth" for the calibrators themselves is established by the quantitative addition process during manufacturing.

Summary of what the document DOES provide regarding comparison:

The core of the submission is to establish substantial equivalence to the predicate device: "Abuscreen OnLine Preciset DAT I Calibrators" (K951595).

The comparison focuses on:

• Intended Use: Both the new device and the predicate are designed for the calibration of Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
• Device Description (Composition):
  • Preciset DAT Plus II: Contains Benzodiazepines (0, 50, 100, 200, 400 ng/ml) and Opiates (0, 150, 300, 600, 1000, 2000 ng/ml). Up to six levels.
  • Cfas DAT Qualitative Plus: Contains Barbiturates (200 ng/ml), Benzodiazepines (300 ng/ml), Cocaine (150 ng/ml), Methadone (300 ng/ml), Opiates (2000 ng/ml), Phencyclidine (25 ng/ml), Propoxyphene (300 ng/ml). Single level.
  • Predicate Device (Abuscreen OnLine Preciset DAT I): Contains a mixture of 9 different drugs (amphetamines, barbiturates, benzodiazepines, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene). Four levels for each drug.
• All calibrators are prepared by the quantitative addition of drug or drug metabolite to drug-free human urine.

The primary argument for substantial equivalence rests on the similar intended use and the fact that both the new and predicate devices are calibrators for drug of abuse assays, even though the specific drug mixtures and number of levels differ. The regulatory approval letter confirms that the FDA determined the device to be substantially equivalent to legally marketed predicate devices.

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The Preciset DAT THC calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers.
The Preciset DAT THC 20 calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers.

Roche Preciset DAT THC calibrators contain 6 levels of cannabinoids, prepared by the quantitative addition of △'-THC-COOH to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains six levels of cannabinoids in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of cannabinoids. The respective target concentrations of cannabinoids included is as follows:
Δ -THC-COOH: 0, 20, 50, 100, 200, 300 ng/ml
Roche Preciset DAT THC 20 calibrators contain 5 levels of cannabinoids, prepared by the quantitative addition of A -THC-COOH to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains five levels of cannabinoids in bottles 1-5. Bottle 1 is negative (drug free) human urine, followed by bottles 2-5 containing increasing amounts of cannabinoids. The respective target concentrations of cannabinoids included is as follows:
△3-THC-COOH: 0, 10, 20, 40, 100 ng/ml

The provided document is a 510(k) summary for calibrators, not a study describing the performance of an AI or medical device with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

The document describes the Preciset DAT THC and Preciset DAT THC 20 Calibrators, which are used to calibrate Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers. The focus is on demonstrating substantial equivalence to a predicate device (Abuscreen OnLine THC Calibration Pack 20), not on proving performance against specific acceptance criteria in the way an AI or diagnostic device would typically be evaluated.

Here's what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance:

This document does not contain a table of acceptance criteria or reported device performance in the context of an AI or diagnostic study. The "performance" described is the chemical composition and intended use of the calibrators, and their verification by GC/MS.

2. Sample size used for the test set and the data provenance:

Not applicable. This is a description of calibrator products, not a study involving a test set of patient data. The calibrators themselves are prepared by adding known concentrations of Δ⁹-THC-COOH to drug-free human urine.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for the calibrators is established by the quantitative addition of Δ⁹-THC-COOH and verified by GC/MS, which is a chemical analytical method, not expert interpretation.

4. Adjudication method for the test set:

Not applicable. No test set 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 document is not about an AI device or a comparative effectiveness study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

For the calibrators, the "ground truth" for the concentration of Δ⁹-THC-COOH is established by quantitative addition of the substance to drug-free human urine and verified by GC/MS (Gas Chromatography/Mass Spectrometry). This is an objective chemical measurement.

8. The sample size for the training set:

Not applicable. This document does not describe a training set for an algorithm.

9. How the ground truth for the training set was established:

Not applicable. This document does not describe a training set.

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The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

The Cfas DAT Qualitative Amphetamine calibrator is designed for the qualitative calibration of the Roche Abuscreen OnLine assay for Amphetamines and the cassette COBAS Integra Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

Roche Preciset DAT Amphetamine calibrators contain 6 levels of amphetamines, prepared by the quantitative addition of d-amphetamine to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains six levels of amphetamines in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of amphetamines. The respective target concentrations of amphetamines included is as follows:

Amphetamines: 0, 250, 500, 1000, 1500, 2000 ng/ml

Roche Cfas DAT Qualitative Amphetamine calibrators contain a single level of amphetamines at a target concentration of 1000 ng/ml, prepared by the quantitative addition of d-amphetamine to drug-free human urine. Drug concentrations are verified by GC/MS. The calibrator set contains 3 bottles of the single level amphetamines at 5 ml each.

The provided text describes a 510(k) summary for Roche Preciset DAT Amphetamine and Cfas DAT Qualitative Amphetamine Calibrators. It details the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory submission for substantial equivalence based on comparison to an existing device, rather than a performance study report.

Therefore, I cannot provide the requested table and study details.

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External beam radiation therapy is typically delivered from a linear accelerator with either photon or electron beams, or from a radioactive source (high and low dose rate variants) to patients in the prone or supine position, lying on a patient support assembly (also known as the treatment couch). AKTINA Medical Physics Corporation has designed and manufactured a replacement table top of carbon fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

AKTINA Medical Phvsics Corporation has designed and manufactured a replacement table top of Carbon Fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber is provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

The provided document (K032248) is a 510(k) premarket notification for a medical device: "Precise Carbon Fiber Table Top". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies to prove effectiveness with specific performance metrics against acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC or standalone AI performance) is not applicable to this type of regulatory submission. The document explicitly states that "The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product," which further indicates that specific, predefined acceptance criteria and a detailed study proving performance against them are not required or provided in this context.

The summary emphasizes substantial equivalence to predicate devices (Elekta AB, K983678 and AKTINA Medical Physics Corporation, K991546), focusing on similar design, intended use, and performance characteristics, and asserting that "No new issues of safety or effectiveness are introduced by using this device." The demonstration of safety and effectiveness for such a device would primarily revolve around material properties (biocompatibility, structural integrity, radiolucency) and compatibility with existing patient support systems, rather than diagnostic accuracy or human performance improvement.

Given these limitations, here's a breakdown of what can be extracted and what is not available from the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The document does not provide specific quantitative acceptance criteria (e.g., maximum deflection under load, specific radiolucency percentages) or quantitative performance data, but rather states qualitative claims of compliance and equivalence.

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 / Not provided. This type of device (a patient support table top) does not typically involve a "test set" or "training set" in the context of diagnostic or AI performance evaluation. The "evaluation of product testing" mentioned for biocompatibility and "field experience for equivalent applications" would likely refer to engineering tests and general clinical usage knowledge for similar devices, not a formal study with a defined patient sample size.

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 / Not provided. Ground truth establishment by experts is relevant for diagnostic devices (e.g., image analysis algorithms). This device is a component of a radiation therapy system, and its evaluation would not involve expert ground truthing in that manner.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. See point 3.

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 done. MRMC studies are used for evaluating diagnostic performance, often related to AI applications. This device is not an AI-driven diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not done. See point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. The "ground truth" for this device would be established through engineering specifications, material science evaluations, and compatibility testing with the Elekta Precise Patient Support System, rather than clinical ground truth methods like pathology or outcomes data.

8. The sample size for the training set

• Not applicable / Not provided. See point 2.

9. How the ground truth for the training set was established

• Not applicable / Not provided. See point 2 and 7.

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