(376 days)
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.
§ 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.”