(13 days)
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.
| Acceptance Criterion (Implicitly based on Predicate) | Reported Device "Performance" / Justification for Equivalence |
|---|---|
| Intended Use: Second stage revision for total joint arthroplasty after initial infection cleared. | Same: "have the same basic design and the same intended use as the originally cleared bone cements." (K041656 / K023103, K033382, K033563) |
| Technological Characteristics: |
- 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.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”