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DePuy 1 Gentamicin Bone Cement and SmartSet GMV Endurance Gentamicin Bone Cement are indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements are self-curing coments, containing one gram of Gentamicin in 40 grams PMMA (Polymethyl methacrylate, and Polymethy) methacrylate and styrene co-polymer). The cements allow the seating and securing of a metal or plastic prosthesis to living bone.

This submission is a 510(k) for a medical device (bone cement), and as such, it does not typically contain "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI/ML device performance evaluation.

510(k) submissions focus on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study with a test set, ground truth, and expert adjudication as described in your request. The "proof" in a 510(k) comes from showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as a predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested data points (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable to this type of regulatory submission for this device.

However, I can interpret the available information in the context of your request to the best extent possible for a 510(k).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, there are no explicit quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC that would be typical for an AI/ML device. The "acceptance criteria" here are implicitly the characteristics of the predicate device, and the "reported device performance" is the claim of substantial equivalence.

• Composition (PMMA bone cement with antibiotic)
• Gentamicin as antibiotic
• Self-curing | Similar (with change):
• "self-curing cements, containing one gram of Gentamicin in 40 grams PMMA"
• Change: Gentamicin Sulphate changed from micronised to non-micronised particles. |
  | Performance (Safety & Effectiveness): No new questions of safety or effectiveness raised by changes. | Justification: "Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin manufactured with non-micronised are substantially equivalent to the previously cleared antibiotic bone cements manufactured with micronised Gentamicin." |

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

• Sample Size for Test Set: Not applicable. There is no "test set" in the context of an AI/ML performance study as this is a material change to an existing device. Substantial equivalence is based on comparison to predicate devices, not on a new clinical study with a specific test cohort to generate performance metrics.
• Data Provenance: Not applicable. The "data" here refers to the characteristics of the predicate device and the new device. The information is derived from the device's design, materials, and manufacturing process.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. There is no "ground truth" establishment by experts in the context of an AI/ML performance study for this type of submission. The safety and effectiveness of the predicate device would have been established through its original clearance, and the current submission relies on comparisons to that.

4. Adjudication Method

• Not applicable. No adjudication method is mentioned or relevant to this type of medical device submission.

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

• Not applicable. No MRMC study was done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k).

6. Standalone (Algorithm Only) Performance Study

• Not applicable. There is no AI algorithm involved with this medical device (bone cement).

7. Type of Ground Truth Used

• Not applicable. There is no "ground truth" as a clinical reference standard in the context of an AI/ML study. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices, which implicitly means the predicate devices' safety and effectiveness were already established.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. See point 8.

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Smartset GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

SmartSet GMV Endurance Gentamicin Bone cement is a self-curing cement, containing one seating and securing of seating and securing of a metal or plastic prosthesis to I ving bone.

This document is a 510(k) summary for a medical device called "SmartSet GMV Endurance Gentamicin Bone Cement." It details the device's information, indications for use, and a claim of substantial equivalence to previously marketed predicate devices.

However, the provided text does not contain information about specific acceptance criteria or an associated study that proves the device meets those criteria.

Generally, for a 510(k) submission, the "study" would be a series of tests demonstrating that the new device performs as safely and effectively as a predicate device. These tests often include:

• Mechanical Property Testing: To ensure the cement has adequate strength, fatigue resistance, and other physical characteristics suitable for its intended use.
• Biocompatibility Testing: To confirm that the materials are not harmful to the body.
• Leaching Studies: To assess the release rate of the antibiotic (Gentamicin) and ensure it's effective without being toxic.
• Sterilization Validation: To confirm the sterilization process is effective.

The FDA's review letter confirms that the device was found substantially equivalent, implying that the submitted data (which is not fully included here) demonstrated this equivalence.

Therefore, with the provided text, I cannot complete the table or answer most of your specific questions as the detailed study information is absent.

Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:

1. Table of acceptance criteria and the reported device performance

• Cannot be provided. The document states that "The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards." However, it does not specify what those "voluntary performance standards" were, what the acceptance criteria within those standards were, or the explicit results of the product testing against those criteria.

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

• Cannot be provided. The document mentions "product testing" but provides no details on sample sizes, types of tests (e.g., in-vitro, in-vivo), origins of data, 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)

• Not applicable for this type of device/submission. This question typically applies to AI/ML or diagnostic devices where human expert interpretation is used to establish a "ground truth" for evaluating algorithm performance. For bone cement, performance is usually assessed through objective physical, chemical, and biological tests, not expert consensus on image interpretation.

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

• Not applicable. As above, this pertains to expert review and consensus, which is not described or typically used for evaluating the performance of bone cement.

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 question is specific to AI-assisted diagnostic or interpretation devices. The SmartSet GMV Endurance Gentamicin Bone Cement is a therapeutic material, not a diagnostic tool, and does not involve human readers interpreting cases or AI assistance in that context.

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

• Not applicable. This device is bone cement, it does not involve an algorithm.

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

• Not explicitly stated, but inferred. For bone cement, "ground truth" would generally be established by:
  • Mechanical Engineering Standards: Established benchmarks for strength, fatigue, working time, setting time, etc.
  • Biocompatibility Standards: ISO standards for cytotoxicity, sensitization, irritation, etc.
  • Pharmacological Standards: For antibiotic release profile and efficacy, likely in-vitro elution studies.
  • These are based on scientific evidence and established testing methodologies, not typically "expert consensus" in the way it's used for diagnostic accuracy studies.

8. The sample size for the training set

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

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

• Not applicable. As above, no training set for an algorithm is involved.

Conclusion:

The provided 510(k) summary is a high-level document stating intent and claiming substantial equivalence. It does not include the detailed technical reports, test protocols, specific acceptance criteria, or raw performance data that would be part of a full 510(k) submission. Therefore, it's impossible to fully answer your questions based only on this text. The FDA's letter simply confirms that the submitted information (which is not provided here) was sufficient to demonstrate substantial equivalence.

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