(129 days)
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- . Femoral neck and trochanteric fractures of the proximal femur;
- Osteonecrosis of the femoral head;
- Revision procedures where other devices or treatments for these indications have failed.
The Apex Hip System Bipolar Head consists of a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell and UHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have an inner diameter that mates with a 28 mm diameter femoral head. The Apex Hip System Bipolar Head may be used in conjunction with an Apex Hip System femoral stem (K060072) for hemiarthroplasty.
The provided document does not describe a study involving an AI or algorithmic device, nor does it include acceptance criteria and performance data in the typical sense of a software-based medical device.
Instead, the document is a 510(k) Premarket Notification for a medical implant: the OMNI life science Apex Hip System Bipolar Head. This submission demonstrates substantial equivalence to a predicate device, as required by the FDA for certain medical devices.
Therefore, many of the requested categories are not applicable to the information contained in this document.
Here's an analysis based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test Type) | Reported Device Performance |
|---|---|
| Push-out and lever-out testing | Conducted (details not provided on specific criteria or results, only that the test was done). The conclusion implies satisfactory performance for substantial equivalence. |
| Locking ring spring storage heat tolerance test (150°F) | Conducted (details not provided on specific criteria or results, only that the test was done). The conclusion implies satisfactory performance for substantial equivalence. |
| ETO sterilization validation, SAL 106 | Conducted (details not provided on specific criteria or results, only that the test was done). The conclusion implies satisfactory performance for substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in the document for the non-clinical tests. These would typically be a small number of physical samples for mechanical testing.
- Data Provenance: Not explicitly stated, but assumed to be from OMNI life science, Inc.'s internal testing labs or contracted labs. The document indicates the submitter's location as E. Taunton, MA, USA, and the contact's location as Raynham, MA, USA, suggesting testing was conducted in the US.
- Retrospective or Prospective: Not applicable as these are bench tests on physical devices, not data analysis.
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. This document describes non-clinical bench testing of a physical implant, not a study requiring expert-established ground truth for data. The "ground truth" here is the physical performance of the device against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is relevant for the described non-clinical bench tests. The results of these tests are objective measurements.
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 comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This is a device for physical implantation, not an AI or imaging diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical implant, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by engineering specifications and established test methods (e.g., ASTM standards for UHMWPE, internal specifications for push-out/lever-out forces, and sterilization standards).
8. The sample size for the training set
- Not applicable. This is a physical medical implant, not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical implant, not an AI device.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.