(24 days)
The indications for the use of the Howmedica Osteonics® Restoration™ HA Stems, in keeping with those of other legally marketed Howmedica Osteonics femoral components, are as follows:
For Use as a Bipolar 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:
- 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, 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.
Additional Indication for Howmedica Osteonics Head/Neck Stems:
- Clinical circumstances which require an altered femoral resection level due to a proximal fracture, bone loss or calcar lysis.
The Osteonics® Restoration™ HA Hip Stems are currently marketed devices that are being modified (and titled Howmedica Osteonics® Restoration™ HA Hip Stems). The modification involves introducing two new stem sizes, size 5 and size 6, each with two distal diameters, 9mm and 11mm for the size 5, and 10mm and 12mm for the size 6. Additionally, the stem length will be reduced by 10mm (from 155mm to 145mm) for 6512-xxxx and by 30mm (from 205mm to 175mm) for 6513-xxxx. All other aspects of the Restoration™ HA Hip Stems will remain unchanged.
The provided document, K993077, describes a Special 510(k) submission for modifications to the Howmedica Osteonics® Restoration™ HA Hip Stems. The device in question is a hip prosthesis.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate stem designs in terms of fatigue strength. | "Mechanical testing has been performed to demonstrate the substantial equivalence of this Howmedica Osteonics stem design to predicate stem designs in terms of its fatigue strength." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The performance evaluation was based on mechanical testing. The specific sample size for this mechanical testing is not provided in the document. The data provenance is also not explicitly stated beyond being "Mechanical testing." It implies laboratory testing rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the evaluation was based on mechanical testing, not a clinical test set requiring expert ground truth establishment.
4. Adjudication method for the test set
This section is not applicable as the evaluation was based on mechanical testing, not a clinical test set requiring adjudication.
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
This section is not applicable. The device is a physical hip prosthesis, and the study was mechanical testing, not an AI-assisted diagnostic or imaging device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical hip prosthesis, and the study was mechanical testing, not an algorithm.
7. The type of ground truth used
The "ground truth" for the mechanical testing was the fatigue strength of the predicate stem designs. The acceptance criterion was that the modified stem designs demonstrate "substantial equivalence" to this established characteristic of the predicate devices.
8. The sample size for the training set
This section is not applicable. The device is a physical hip prosthesis, and the study was mechanical testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This section is not applicable as there was no training set. The "ground truth" for the mechanical performance comparison was the fatigue strength of the predicate devices, which would have been established through prior mechanical testing for those original devices.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.