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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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DePuy 1 Gentamicin is 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 Bone Cement is a self curing cement, to which one gram of Gentamicin is added in 40 grams PMMA (Polymethyl methacrylate) cement for allowing the seating and securing of a metal or plastic prosthesis to living bone.

The provided text is a 510(k) summary for the DePuy 1 Gentamicin Bone Cement. It does not contain information about acceptance criteria, device performance metrics, or any studies using a test set of data with ground truth established by experts.

Here's what can be extracted from the document, though it doesn't directly answer your specific questions related to AI device evaluation:

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

This document does not provide a table of acceptance criteria or reported device performance in the context of diagnostic accuracy, sensitivity, specificity, etc., as one would expect for an AI/ML medical device. The "device performance" in this context refers to its physical and chemical properties.

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

Not applicable. This is a PMMA bone cement, not a data-driven device. The document mentions "product testing" and "conformance with voluntary performance standards" as part of the substantial equivalence determination, but no details on sample size, data provenance, or study design are provided for these tests.

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. There is no concept of "ground truth" or expert review in the context of this traditional medical device's 510(k) submission.

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. This is a bone cement, not an AI-assisted diagnostic device.

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):

Not applicable.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the machine learning sense.

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

Not applicable.

Summary of available information from the document:

• Device Name: DePuy 1 Gentamicin Bone Cement
• Indications for Use: For use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
• Substantial Equivalence Basis: Similarity in indications for use, design, materials, sterilization, and packaging to predicate devices (DePuy 1 Bone Cement, BACTISEAL Catheter, OrthoGuard AB Antimicrobial Sleeve).
• Testing Mentioned: "Product testing and conformance with voluntary performance standards" were used for the determination of substantial equivalence. However, no specific details about the nature of these tests, acceptance criteria, or results are provided in this summary. The tests would likely relate to the material properties, mechanical strength, gentamicin elution, and biocompatibility, as per relevant standards for bone cements.

In conclusion, the provided document is a 510(k) summary for a traditional medical device (bone cement) and therefore does not contain the specific information requested regarding acceptance criteria and studies for an AI/ML-driven device.

Ask a specific question about this device