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.

Device Description

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.

AI/ML Overview

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.

Summary

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K954598

Osteonics® Offset Hip Stem Series

510(k) Summary

510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Offset Hip Stem Series

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677
Contact Person:	Terry JaroszRegulatory Affairs Specialist
Date of Summary Preparation:	October 2, 1995
Device Identification
Proprietary Name:	Osteonics® Offset Hip Stem Series
Common Name:	Artificial Hip Component
Classification Name and Reference:	Hip Joint, Metal/Polymer, Semi-Constrained, Cemented Prosthesis21 CFR §888.3350

Predicate Device Identification

The Osteonics offset Hip Stems are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

Osteonics® Omnifit® Plus Cemented Hip Stems Osteonics Corp.
Osteonics® ODC Hip Stems Osteonics Corp. .
Osteonics® Restoration Cemented Hip Stems Osteonics Corp. .

Device Description

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Intended Use:

The specific intended uses of the Osteonics® Offset Hip Stems include the following:

Indications

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.

Statement of Technological Comparison:

The subject devices, essentially, are the predicate Osteonics® ODC Femoral Stems from the collar area down (except that the subject devices are made from forged rather than from cast CoCr alloy), and the predicate Osteonics® Omnifit® Plus Cemented Hip Stems from the collar area up. A more detailed comparison between the subject and predicate devices, in terms of design, materials and intended uses, follows.

Design:

As previously stated, the subject devices are nearly identical in design - from the collar area and up - to the predicate Osteonics® Omnifit® Plus Cemented Hip Stems. Both hip stem series feature Osteonics® C-Taper neck, a 127" neck angle, and extended head offsets.

Distal to the collar location, the subject hip stems are identical in design to the predicate Osteonics® ODC Femoral Stems. Both the subject and the predicate hip stem series are gritblasted proximally (but distal to the collar). Both the predicate and the subject hip stem series share the same dimensions distal to the collar location. Both hip stem series feature a distal ? ? hole for use with an optional cement spacer.

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Materials:

The subject devices, like the predicate Osteonics® Omnifit® Plus Cemented Hip Stems, are forged from ASTM F-799 cobalt chromium alloy.

Intended Use:

The subject devices share the same indications for use as one or more of the predicate devices identified above. In addition, both the subject devices and the predicate Osteonics® ODC Hip Stems are intended for cemented and cementless indications.

Performance Data:

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.

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Regulation Number and Section

§ 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.