(80 days)
The Osteonics® X Cemented Hip Stems Series are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® X Cemented Hip Stem Series are intended to provide a variety of options as a means for the Orthopaedic Surgeon to obtain an implant-to-patient match designed to provide reproducible cemented hip arthroplasty when used in conjunction with the Osteonics® Femoral Bearings with C-Taper geometry specified in this submission.
Indications:
For use as a Bipolar or Hemi-Hip 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 Hip Replacement:
- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis, theumatoid 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® X Cemented Hip Stem Series of cemented hip stems designed to meet requirements of a wide range of patients requiring cemented hip arthroplasty. All components are manufactured from ASTM F-799 Cobalt chromium alloy. The Osteonics® Omnifit®-X Cemented Hip Stems and the Osteonics® Omnifit®-X Plus Cemented Hip Stems have a 132 degree neck and 127 degree neck angle respectively. They employ a satin was and finish, polished neck, forged proximal centralizer, and distal flutes and are available in sizes 4 through 11. The Osteonics® ODC™-X Cemented Hip Stems and the Osteonics® ODC™-X Plus Cemented Hip Stems have a 132 degree neck angle and 127 degree neck angle respectively. They employ a satin finish, forged proximal centralizer, and distal hole for use with optional cement spacer and are available in sizes 5 through 11.
The provided text is a 510(k) Premarket Notification Summary for a medical device, the Osteonics® X Cemented Hip Stem Series. It details the device's identification, predicate devices, description, intended use, and a statement of technological comparison.
However, it does not contain any information regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or performance data for the device. The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for lower-risk medical devices in the US.
In this context, "Performance Data" is mentioned but without any specifics. The FDA's letter (pages 2-3 of the provided text) indicates that the device has been cleared based on this submission, implying that the provided information (or other information not included in this summary) was sufficient to demonstrate substantial equivalence.
Therefore, many of the requested details cannot be extracted from the provided input.
Here's a breakdown of what can and cannot be answered based on the input:
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A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states "Performance data for the Osteonics® X Cemented Hip Stem Series provided in this submission demonstrates the substantial equivalence to predicate devices," but no specific performance metrics, acceptance criteria, or results are detailed in the summary.
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Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided. No test set or data provenance information is mentioned.
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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):
- Cannot be provided. No ground truth establishment related to a test set is discussed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication method is discussed.
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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:
- Cannot be provided. This device is a hip stem (a physical implant), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This is not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. No ground truth for performance evaluation is described. For a physical implant like this, "ground truth" would typically refer to clinical outcomes, mechanical testing results, or material properties compliance, none of which are detailed here.
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The sample size for the training set:
- Cannot be provided. There is no mention of a "training set" as this is a physical device, not an AI model.
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How the ground truth for the training set was established:
- Cannot be provided. Not applicable due to the nature of the device.
In summary, the provided document is a regulatory submission focused on demonstrating "substantial equivalence" by comparing the new device's design, materials, and intended use to existing predicate devices. It does not contain the detailed performance study information typically associated with establishing acceptance criteria and proving performance through a clinical or technical study as might be seen for a novel diagnostic or AI device.
§ 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.