(184 days)
The Osteonics® Offset Hip Steans are intended for single use in patients requiring either a Total Hip Replacement or a Hemi- or Bipolar Hip Replacement. The Osteonics® Offset Hip Stems are intended to be implanted in cemented or cementless applications.
For use as a Binolor or Hemi-Hin Replacement:
- Femoral head/neck fractures or non-unions. .
- Aseptic necrosis of the femoral head. .
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal . acetabular involvement or distortion.
Other considerations for use as a Bipolar or Hemi-Hip Replacement:
- Pathological conditions or age considerations which indicate a more . conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty. ◆
For use as a Total Hin Replacement:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, ● rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty . or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
The Osteonics @ Offset Hip Stems are intended to be placed within the prepared femurs of patients requiring total or hemi- hip arthroplasty. These hip steans may be implanted either with or without the use of bone cement. The Ostconics® Offset Hip Stems are forged from cobalt chromium alloy, and are characterized by proportional stem sizing, proximal projected area, proximal grit-blasting, Osteonics® C-Taper femoral neck, enhanced offse, and a 127 neck angle. The stems gel available in collared and collarless versions, and in a full range of sizes.
This 510(k) summary does not contain the information requested to fully describe the acceptance criteria or a study proving the device meets those criteria.
The document states: "Comparison of the subject hip stem series with a predicate hip stem series demonstrated that fatigue testing results for the prodicate hip stem series can be relied upon to qualify the performance characteristics of the subject hip stem series." This indicates that the device's performance is being established by claiming substantial equivalence to a previously approved device, rather than through new, independent testing with explicit acceptance criteria for the new device.
Therefore, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement.
Here's what I can infer from the provided text, and what remains unanswered:
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be created. The document explicitly states that the performance characteristics of the subject hip stem series are qualified by relying on the fatigue testing results of a predicate hip stem series. There are no specific acceptance criteria or reported performance metrics for the subject device presented in this summary.
2. Sample size used for the test set and the data provenance
Cannot be determined. No new test set was used for the subject device. The reliance is on predicate device data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A (Not Applicable). No new test set, no ground truth established by experts for this submission.
4. Adjudication method for the test set
N/A (Not Applicable). No new test set.
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
N/A (Not Applicable). This device is a hip stem, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A (Not Applicable). This device is a hip stem, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Cannot be determined for the subject device. The ground truth (or performance validation) for the predicate device's fatigue testing would likely have involved standardized mechanical testing protocols and failure analysis, rather than expert consensus or pathology in a clinical sense.
8. The sample size for the training set
N/A (Not Applicable). This device is a hip stem. There is no "training set" in the context of device validation for this type of medical product.
9. How the ground truth for the training set was established
N/A (Not Applicable). No training set.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.