(12 days)
The InterSpace GV Hip Spacer is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).
The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The InterSpace GV Hip Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).
The InterSpace GV Hip Spacer is manufactured from PMMA with gentamicin and vancomycin and includes a stainless-steel core as well as a tapered wedge design. The InterSpace GV Hip Spacer is single-use, disposable, and provided sterile. The InterSpace GV Hip Spacer is inserted into the femoral medullary canal and acetabular cavity following the removal of the existing femoral and acetabular implants and debridement as part of a two-stage procedure due to a septic process. The device is protected from bacterial colonization due to the presence of gentamicin and vancomycin.
The provided text is a 510(k) clearance letter for a medical device called the "InterSpace GV Hip Spacer." This type of document is a regulatory approval and outlines the device's intended use, regulatory classification, and a summary of the reasons for its clearance (often by showing substantial equivalence to a predicate device).
However, this document does not contain the specific information required to answer your detailed questions about acceptance criteria and the study that proves the device meets those criteria, particularly regarding AI/algorithm performance and clinical validation.
The document states that "The information summarized in the Design Control Activities Summary demonstrates that the subject InterSpace GV Hip Spacer met the pre-determined acceptance criteria for the verification activities." It then lists the types of performance tests conducted (Mechanical Testing, Analysis of Antibiotic Content, Biocompatibility Assessment, Sterilization Validation, Shelf-Life Validation, Packaging Validation).
These tests are standard for a physical medical device (a hip spacer) to ensure its mechanical integrity, material compatibility, and sterile delivery, which are critical for its safety and function. They are not related to the performance of an AI/algorithm.
Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance, ground truth establishment, sample sizes for AI training/testing, or MRMC studies, as the provided text does not describe a study involving an AI or algorithm.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Mechanical Performance | "met the pre-determined acceptance criteria for the verification activities" through "Mechanical Testing" |
| Antibiotic Release/Content | "met the pre-determined acceptance criteria for the verification activities" through "Analysis of Antibiotic Content" |
| Biocompatibility | "met the pre-determined acceptance criteria for the verification activities" through "Biocompatibility Assessment" |
| Sterilization Efficacy | "met the pre-determined acceptance criteria for the verification activities" through "Sterilization Validation" |
| Shelf-Life Stability | "met the pre-determined acceptance criteria for the verification activities" through "Shelf-Life Validation" |
| Packaging Integrity | "met the pre-determined acceptance criteria for the verification activities" through "Packaging Validation" |
Note: The document only generically states that "pre-determined acceptance criteria" were met for these categories. It does not provide the specific numerical or qualitative criteria themselves, nor the detailed results for each test.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This document does not describe a study involving a "test set" in the context of an AI/algorithm. The "tests" mentioned are physical and chemical characterizations of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No AI/algorithm study is described where ground truth would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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, an MRMC study was not done for this device. This is a physical hip spacer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. The "ground truth" for this device's performance would be engineering specifications, material science standards, and in-vitro or in-vivo testing results to confirm physical and biological properties.
8. The sample size for the training set:
- Not applicable / Not provided. No AI/algorithm training set is mentioned.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. No AI/algorithm training set is mentioned.
In summary: The provided FDA clearance letter pertains to a conventional medical device (a hip spacer) and its physical and material properties, not a software or AI-driven device. Therefore, the questions related to AI/algorithm performance and clinical validation through sophisticated study designs (like MRMC) are not relevant to this document.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.