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S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Epikut PTG Surgical Kit and associated instruments is 632 grams.

The weight of the empty Epikut PTG Surgical Kit is 353 grams.

The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device tray is to be used to organize and protect the instruments that are sterilized by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior components during sterilization. The tray is perforated to allow for penetration of the sterilant, is to be used with moist heat (steam) and requires the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone (PSU), and holders of various geometries to position instruments in the kits are manufactured from silicone.

The provided text is a 510(k) Premarket Notification for a medical device (S.I.N. Instrument Kits, an instrument sterilization tray). This document describes the nonclinical testing and acceptance criteria for mechanical and sterilization performance of the device itself, rather than the performance of an AI/ML algorithm.

Therefore, the specific information requested in your prompt regarding acceptance criteria and study design for an AI/ML device (e.g., sample sizes, expert ground truth, MRMC studies, standalone algorithm performance, training set details) cannot be extracted from this document. This document describes a traditional medical device, not an AI/ML enabled one.

However, I can extract the acceptance criteria and performance data for the device itself based on the provided "Summary of Nonclinical Testing" table.

Acceptance Criteria and Device Performance (Non-AI/ML)

The S.I.N. Instrument Kits are sterilization trays. The studies performed are to ensure the trays can be properly cleaned, sterilized, and maintain their integrity over a specified lifespan.

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

Since this document does not pertain to an AI/ML device, the following points typical for AI/ML device evaluations are not applicable and thus, no information can be extracted for them:

• 2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable (for AI/ML, but for a physical device, the "ground truth" is established through standardized testing procedures and specified acceptance criteria, as shown in the table).
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Epikut Long Surgical Kit and the associated instruments is 422 grams.

The weight of the empty Epikut Long Surgical Kit is 310 grams.

The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device tray is to be used to organize and protect the instruments that are sterilized by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior components during sterilization. The tray is perforated to allow for penetration of the sterilant, is to be used with moist heat (steam), and requires the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone (PSU), and holders of various geometries to position instruments in the kits are manufactured from silicone.

The subject device is provided in one (1) size and one (1) configuration; the primary predicate device K201688 is provided in 5 sizes and 14 configurations. The subject device and the predicate device have similar overall dimensions, enclose similar volumes, and have similar vent to volume ratios. Differences in the dimensions and vent to volume ratios between the subject device and the predicate device are mitigated by the sterilization validation performed.

The provided document details the nonclinical testing performed for the S.I.N. Instrument Kits to demonstrate that they meet the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test. However, it indicates that the tests were nonclinical, implying that the data provenance is likely from laboratory testing rather than human subjects or a specific country of origin for patient data. The tests are described as validations, which typically involve testing multiple units of the device under specified conditions. The provenance for the referenced standards (K201688 and K212404 for predicate devices) would apply to the methodologies but not necessarily the data for the subject device.

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

Not applicable. The tests performed are nonclinical and involve validation against established industry standards and regulatory guidance, not expert interpretation of medical images or patient data. The "ground truth" for these tests is defined by the acceptance criteria set forth in the referenced standards and FDA guidance.

4. Adjudication method for the test set:

Not applicable. As the tests are nonclinical validations against predefined criteria, there is no need for expert adjudication. The results are determined by whether the device's performance meets the quantitative or qualitative requirements of the standard/guidance.

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. The S.I.N. Instrument Kits are sterilization trays, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm or AI system, so standalone algorithm performance is irrelevant. The tests performed are for the physical sterilization kit itself.

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

The "ground truth" for these nonclinical tests is established by industry standards (e.g., ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, USP , ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) and FDA guidance documents (e.g., "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"). These standards and guidance define the acceptable performance parameters and methodologies for ensuring the safety and effectiveness of medical devices like sterilization kits. For example, for bacterial endotoxin testing, the ground truth for "Pass" is a level ≤ 20 EU/device.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI, and therefore does not have a training set.

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

Not applicable. As there is no training set for this device.

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S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The subject device includes a total of three (3) instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner trays, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior components during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone (PSU), and holders of various geometries to position instruments in the kits are manufactured from silicone. The subject device includes two (2) sizes (lid, base, and enclosed volume), and a total of three (3) tray configurations.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the S.I.N. Instrument Kits.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size for Test Set: The document mentions "3 consecutive half-cycles performed for each of 3 sizes of trays" for Sterilization Validation. For Biocompatibility, it states "L-929 cells exposed to extract of device." The exact number of units or iterations per test beyond what is explicitly stated (e.g., how many trays were tested for cleaning, how many units for biocompatibility extract) is not explicitly detailed in the provided text.
   • Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only lists the standards followed (e.g., FDA Guidance, USP, ANSI/AAMI/ISO).

2. 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 tests performed are laboratory-based and follow established standards, implying no human expert consensus was required to establish ground truth for these specific performance criteria.

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

   • This information is not applicable as the tests are non-clinical, objective validations against predetermined criteria, not assessments requiring expert adjudication of subjective findings.

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:

   • No MRMC comparative effectiveness study was done. This device (S.I.N. Instrument Kits, which are instrument sterilization trays) is a physical medical device, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.

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

   • No standalone (algorithm-only) performance study was done. As mentioned above, this is a physical medical device, not an algorithm.

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

   • The ground truth for these non-clinical tests is based on objective measurements and adherence to established regulatory standards and protocols (e.g., protein residue levels, endotoxin levels, sterility assurance level (SAL), weight change, visual inspection, dimensional verification, cell viability).

7. The sample size for the training set:

   • There is no training set as this is a physical medical device validation, not a machine learning model.

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

   • This question is not applicable as there is no training set.

Ask a specific question about this device

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time. S.I.N. Instrument Kits are intended for sterilization of non-porous loads. S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The subject device includes a total of 4 instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner travs, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior components during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone (PSU), and holders of various geometries to position instrument in the kits are manufactured from silicone. The subject device includes a total of 3 sizes (same lid, base, and enclosed volume), and a total of 4 tray configurations.

The document provides information on the nonclinical testing performed for the S.I.N. Instrument Kits to demonstrate they meet acceptance criteria.

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

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

• Sterilization Validation: 3 consecutive half-cycles were performed for each of the 3 sizes of trays. This indicates a sample size of at least 9 sterilization cycles in total (3 sizes * 3 half-cycles).
• Other tests: The exact sample sizes for Manual Cleaning Validation, Bacterial Endotoxin Testing, Dry Time, Life Cycle / Simulated Use Life Validation, and Biocompatibility are not explicitly stated by number, but the results indicate that sufficient samples were tested to meet the acceptance criteria.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the manufacturer is S.I.N. - Sistema de Implante Nacional S.A. from Brazil, it is likely the testing was conducted in Brazil or at an international testing facility. The nature of the tests (laboratory testing of medical devices) implies a prospective test setup.

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

This section is not applicable. The tests performed are laboratory-based performances of a medical device (instrument kits for sterilization) against established regulatory standards and guidance, not diagnostic evaluations requiring expert consensus on "ground truth."

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

This section is not applicable for this type of nonclinical, laboratory-based device performance testing. Ground truth is established by the predefined acceptance criteria of the test methodologies.

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 type of study is not applicable as the device is a medical instrument kit for sterilization, not an AI-based diagnostic tool.

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

No. This concept is not applicable as the device is a physical medical instrument kit.

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

The "ground truth" for this device's performance is based on established scientific and regulatory standards and methods for medical device sterilization, cleaning, biocompatibility, and durability. These include:

• Predefined acceptance criteria based on standard test methods (e.g., absence of protein residue, endotoxin levels, sterility assurance level (SAL), weight gain after drying, visual inspection for integrity, cytotoxicity).
• Compliance with recognized standards such as USP , ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 10993-5, and ANSI/AAMI/ISO 10993-12.
• FDA Guidance documents (e.g., "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling").

8. The sample size for the training set

This section is not applicable as the device is a physical medical instrument kit, not an AI/machine learning model that requires training data.

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

This section is not applicable as the device is a physical medical instrument kit and does not involve a training set or AI model.

Ask a specific question about this device

S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time. S.I.N. Instrument Kits are intended for sterilization of non-porous loads. S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The subject device includes a total of 14 instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner trays, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior components during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone (PSU), and holders of various geometries to position instrument in the kits are manufactured from silicone. The subject device includes a total of 5 sizes (same lid, base, and enclosed volume), and a total of 14 tray configurations.

The provided text describes the acceptance criteria and a non-clinical study to prove that the S.I.N. Instrument Kits meet these criteria for their intended use as sterilization wraps/containers.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set:
  • For Sterilization Validation, the test set involved "3 sizes of trays". The document lists 5 overall tray dimensions and 14 configurations, suggesting that not all configurations were tested for sterilization, but rather representative sizes.
  • For Life Cycle / Simulated Use Life Validation, the testing involved simulating 250 use cycles.
  • Specific quantities for other tests (Manual Cleaning, Bacterial Endotoxin, Biocompatibility) are not explicitly stated, but the "Pass" results imply adequate testing was performed.
• Data Provenance: The document states the manufacturer is S.I.N. - Sistema de Implante Nacional S.A. based in São Paulo, Brazil. The testing described is non-clinical, implying laboratory-based studies rather than patient data. The document does not specify if the testing was performed retrospectively or prospectively, but standard validation studies like these are typically conducted prospectively.

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

This information is not applicable to this study. The study involves non-clinical performance testing of a medical device (sterilization instrument kits), not an AI algorithm or diagnostic device that requires human expert review to establish ground truth from patient data. The "ground truth" here is based on objective, quantifiable measures against established industry standards for sterility, cleanliness, and material properties.

4. Adjudication Method for the Test Set:

This information is not applicable as the study involves objective, non-clinical laboratory testing, not subjective human-in-the-loop performance evaluation that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices (especially AI-assisted models) where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This submission describes the non-clinical performance of a sterilization instrument kit, which does not involve human interpretation in the same way. The document explicitly states: "No clinical data were included in this submission."

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

This question is not applicable as the device is a physical instrument kit for sterilization, not an AI algorithm or software. The testing performed is to validate the physical and functional aspects of the kit itself.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective, quantifiable measurements and adherence to established industry standards for medical device reprocessing and biocompatibility. Specifically:

• Sterility: Sterility Assurance Level (SAL) of 10^-6, complete inactivation of all biologic indicators.
• Cleanliness: Absence of protein residue (no color change in protein assay), Total Organic Carbon (TOC) assay results below limit of quantification.
• Endotoxin Levels: Endotoxin results ≤ 20 EU/device.
• Dryness: Weight gain after drying ≤ 3%.
• Physical integrity and functionality: Visual inspection, component dimensional fit verification, and functional closure/latch verification after simulated use cycles.
• Biocompatibility: Non-cytotoxic according to L-929 cell exposure.

These are not "expert consensus", "pathology", or "outcomes data" in the typical sense applied to diagnostic AI models.

8. The Sample Size for the Training Set:

This information is not applicable. This is a physical medical device, not an AI model that requires a training set of data.

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

This information is not applicable as there is no AI model or training set involved.

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Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kits require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minute dry time

Gravity displacement - Exposure at 132 °C for 15 minutes, 20 minute dry time

Neodent Instrument Kits are intended for sterilization of non-porous loads.

The GM/WS Surgical Kit Case maximum load weight is 125 grams.

The GM Surgical Kit Case maximum load weight is 113 grams.

Neodent Instrument Kits are recommended not to be stacked during sterilization.

The subject device kits are reusable rigid containers, comprising a case bottom (or base), a removable inner tray base (tray), and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject includes two (2) kits in one size and two (2) inner tray configurations. The lids are manufactured from injection molded polyphenylsulfone, the tray base and case bottoms are manufactured from injection molded polysulfone, and holders of various geometries to position items in the trays are manufactured from molded silicone. The subject device kits are provided nonsterile to the end-user.

The provided text is a 510(k) summary for the Neodent Instrument Kits (K171713), which are sterilization containers. The document does not describe a study that uses AI or reports on acceptance criteria and performance data in the context of an AI-powered device.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (sterilization kits) and not an AI/ML medical device.

However, I can provide available information regarding the non-clinical performance data and acceptance relevant to the sterilization kits themselves:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the format typically used for AI/ML device evaluations (e.g., accuracy, sensitivity, specificity). Instead, it states that various validations were performed to demonstrate substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes validation studies for a physical sterilization device, not an AI/ML algorithm with a "test set" of data. The studies performed were laboratory-based validations of cleaning, sterilization, durability, and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to the successful execution of validation protocols by qualified personnel, rather than expert consensus on diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical performance studies would be defined by the results of standardized testing methods and international standards:
* Cleaning: Successful removal of biological and chemical contaminants per established assays.
* Sterilization: Achievement of sterility assurance level (SAL) and proper drying per AAMI/ANSI/ISO 17665-1 and ISO TS 17665-2.
* Life Cycle: Maintenance of functional and structural integrity after simulated use cycles.
* Biocompatibility: Absence of adverse biological reactions per AAMI/ANSI/ISO 10993-5 and ISO 10993-12.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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The instrument kits are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.

The cycle of sterilization is:

Pre-vacuum steam: 134 °C during 3 minutes with 16 minutes drying time

Anthogyr does not make any lumen claims for the instrument kits.

The Axiom range surgery kit represents the worst case validated load due to the number of components (34 instruments).

The cassettes are not intended to be stacked during sterilization process.

Instrument kits are cassettes used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage. The cassettes by themselves do not maintain sterility. They are to be used with an FDA cleared steam sterilizable pouch.

The cassette is available in only one size (129x156x47.5 mm) marketed in different variations, including different number of tools.

The tools included in the kits are class I exempt or already have class II pre-market notification clearance.

The cassettes are reusable and made of the same materials as the predicate device (Radel R-5000 and R-5100 for tray and lid and medical grade silicone for circular brackets holding the tools).

The provided document is a 510(k) premarket notification for "Instrument Kits" by Anthogyr. It details performance testing related to cleaning, sterilization, and material compatibility, but it does not describe a study involving acceptance criteria for device performance in terms of clinical or algorithmic outcomes. Instead, it focuses on the device's ability to be cleaned and sterilized effectively.

Here's an analysis of the information, tailored to the request but acknowledging the different nature of this medical device (sterilization kits vs. a performance-based device like AI):

1. Table of Acceptance Criteria and Reported Device Performance

The device is an instrument kit designed for sterilization of dental tools. The "performance" in this context relates to its ability to be effectively cleaned and sterilized, and its material safety. There are no clinical performance metrics like sensitivity, specificity, or accuracy for this type of device.

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

This is not applicable in the traditional sense for this device. The "test sets" would be the actual instrument kits subjected to cleaning and sterilization validation.

• Test Set Description: The "Axiom range surgery kit" was identified as the "worst case validated load" due to having the highest number of components (34 instruments). This indicates the most challenging configuration for sterilization was tested.
• Sample Size: The document does not specify a numerical sample size (e.g., how many kits were tested, or how many cycles were performed). It states "Sterilization validation was performed [...] on the most complete instrument kit".
• Data Provenance: The studies were conducted as part of the regulatory submission process, implying they are prospective studies performed by the manufacturer/authorized labs. The manufacturer's location is France (Sallanches, France).

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

This concept is not applicable here as the "ground truth" is based on objective scientific standards for cleaning, sterilization, and material safety, not expert interpretation of outputs. The standards themselves (e.g., ISO 17665, AAMI TIR 30) are established by experts in the field of medical device sterilization.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" is determined by established physical and biological testing standards and results, not by human adjudication of nuanced 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

Not applicable. This is a physical medical device (instrument kit), not an AI algorithm or a diagnostic tool that involves human readers.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The ground truth is based on:

• Scientific Standards: Adherence to recognized national and international standards for cleaning (AAMI TIR 30, AAMI TIR 12), sterilization (ISO 17665), and biocompatibility (ISO 10993-5).
• Biological Endpoints: Sterilization validation typically involves sterility testing (e.g., absence of microbial growth), while cleaning validation may involve residual soil detection.
• Material Properties: Technical data sheets for the materials (Radel) providing evidence of their properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device requiring a "training set."

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

Not applicable.

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The Biomet JuggerLoc™ Bone system is intended for repair in the foot and ankle including indications for: Midfoot repair including but not limited to Lisfranc repair, ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.

The new JuggerLoc Bone to Bone system is a suture based construct intended to stabilize fractures. The construct consists of a JuggerKnot Soft Anchor with ZipLoop Technology, featuring combinations of suture and metal button fixation.

The provided text describes a medical device called the "JuggerLoc Bone to Bone System," a suture-based construct intended to stabilize fractures. The submission is a 510(k) for a new device construct, claiming substantial equivalence to predicate devices (K130033 - Biomet ToggleLoc System, K110145 - Biomet JuggerKnot Soft Anchors, K133275 - Arthrex Mini-Tightrope).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state acceptance criteria in a quantitative or numerical format (e.g., a specific tensile strength in Newtons, or a particular displacement under load). Instead, it refers to "Preclinical performance tests are provided to address the subject construct's strength." The general acceptance is that "Results indicate that the subject construct is substantially equivalent to legally marketed devices."

Therefore, a table cannot be fully constructed with explicit numerical criteria. However, based on the text, the performance goal is implicitly to meet or exceed the performance of the predicate device(s) in terms of strength.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Preclinical performance tests" but does not specify the sample size used for these tests. It also does not specify the data provenance beyond stating they are "Preclinical performance tests," implying laboratory testing rather than human subject data. There is no information on country of origin or whether it was retrospective or prospective.

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)

This section is not applicable as the study described is a preclinical performance test (likely mechanical and material testing), not a study requiring human expert assessment of a test set, like in imaging or diagnostic device evaluations. There is no "ground truth" to be established by experts in the context of this submission.

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

This is not applicable for the same reasons as point 3. No human expert adjudication was involved in these preclinical performance 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, not for mechanical fixation systems like the JuggerLoc Bone to Bone System. There is no mention of AI assistance.

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

This is not applicable. The device is a physical medical implant, not an algorithm or software. Therefore, an algorithm-only standalone performance evaluation is not relevant.

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

For the preclinical performance tests, the "ground truth" would be objective physical measurements of the device's mechanical properties (e.g., tensile strength, displacement, fatigue resistance), compared against established industry standards or the performance of predicate devices. The document does not specify the exact parameters measured, but implies mechanical strength testing as the basis for evaluation.

8. The sample size for the training set

This is not applicable. There is no mention of a "training set" as this device is a physical construct, not a learning algorithm or AI.

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

This is not applicable for the same reason as point 8.

Ask a specific question about this device

The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics intended to examine media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.

The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics.

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific acceptance criteria. The document is an FDA 510(k) clearance letter for "Ophthalmoscopes Diagnostic Instrument Kits." It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.

The document does not contain details regarding:

• A table of acceptance criteria and reported device performance
• Sample sizes or data provenance for any test sets
• Number or qualifications of experts for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
• Standalone algorithm performance studies
• Type of ground truth used
• Sample size for training sets
• How ground truth for training sets was established

The letter primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence.

Ask a specific question about this device

The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.

The ophthalmoscope kits described in this submission include a battery handle and attachments which serve the intended use below. The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, expert numbers/qualifications, adjudication methods), or study types (MRMC, standalone). The document is a 510(k) clearance letter from the FDA for an Ophthalmoscope Diagnostic Instrument Kit, primarily confirming substantial equivalence and outlining regulatory compliance requirements. It does not include a performance study summary.

Ask a specific question about this device