The Osteonics® Anteverted Neck HA Hip Stems are intended for single use in patients requiring either bipolar, hemior total hip replacement. The Osteonics® Anteverted Neck HA Hip Stems are intended to be implanted in a cementless application. These devices feature an Osteonics® C-Taper trunnion, and are therefore compatible with any Osteonics® component which features the mating Osteonics® C-Taper geometry. The Osteonics® Anteverted Neck HA Hip Stems, when used with any commercially available Osteonics® C-Taper femoral bearing head, may be used with any commercially available Osteonics® acetabular component. The use of the Osteonics® Anteverted Neck HA Hip Stems, in keeping with those of other legally marketed Class II hip stems, are as follows:

For use as a Bipolar/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:

Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
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.

Device Description

The Osteonics® Anteverted Neck HA Hip Stems are fabricated from forged Titanium 6AI-4V ELI alloy and have a surface coating of arc deposited commercially pure (CP) Titanium on the proximal third of the femoral stem, and an HA coating on the full length of the stem. The basic design characteristics of the Osteonics® Anteverted Neck HA Hip Stems include proportional stem sizes, maximized projected proximal area, proximal anterior and posterior normalizations, Osteonics® C-Taper trunnion, reduced anterior/posterior collar, rounded configuration for the length of the stem's lateral aspect, cylindrical distal cross-section, left and right configurations, and 15° anteverted neck angle.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for a medical device (Osteonics® Anteverted Neck HA Hip Stems), not a study report detailing acceptance criteria and performance data. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is largely absent or not directly applicable in the format requested.

The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval. It does not contain a study design, performance metrics, or statistical analysis typically found in a clinical or validation study.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

This document does not present a formal table of acceptance criteria with corresponding device performance data as would be found in a study report. The "acceptance criteria" for this regulatory submission are implicitly based on demonstrating substantial equivalence to predicate devices, which means sharing similar materials, indications, intended use, surgical techniques, basic design features, and manufacturing methods.

Acceptance Criteria (Implied)	Reported Device Performance (Implied from Substantial Equivalence Claim)
Material Equivalence: Fabricated from same/equivalent materials as predicate devices.	"The Osteonics® Anteverted Neck HA Hip Stems share the same materials... of their predicate devices." (Forged Titanium 6AI-4V ELI alloy with CP Titanium and HA coating.)
Indications for Use Equivalence: Same indications as predicate devices.	"The Osteonics® Anteverted Neck HA Hip Stems... share the same... indications and intended use... of their predicate devices." (For bipolar, hemi-, or total hip replacement, specifically for femoral head/neck fractures, aseptic necrosis, arthritis, or revision procedures.)
Intended Use Equivalence: Same intended use (cementless application).	"The Osteonics® Anteverted Neck HA Hip Stems... share the same... intended use... of their predicate devices." (Intended for cementless application.)
Design Feature Equivalence: Similar basic design features to predicate devices.	"The Osteonics® Anteverted Neck HA Hip Stems... share the same... basic design features... and basic manufacturing methods of their predicate devices." (Includes proportional stem sizes, maximized proximal area, normalizations, C-Taper trunnion, reduced collar, etc.)
Manufacturing Method Equivalence: Similar manufacturing methods to predicate devices.	"The Osteonics® Anteverted Neck HA Hip Stems... share the same... basic manufacturing methods of their predicate devices."
Performance Equivalence: Applicable performance testing demonstrates no significant difference from predicate devices.	"Applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs." (Specific test data not provided in this summary.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not provide information on a specific test set sample size or data provenance because it is a regulatory submission for substantial equivalence rather than a report of a clinical trial or performance study. The "performance testing" mentioned is likely mechanical or in-vitro testing to support the equivalence claim, not a human clinical trial with patient data.

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)

This information is not applicable and not present in the document. The device is a hip implant, and its "ground truth" for regulatory approval is based on its physical and mechanical properties, as well as its similarity to previously approved devices, rather than expert interpretation of medical images or outcomes in a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not present. "Adjudication method" is typically relevant for studies involving human interpretation or subjective endpoints, which is not the primary focus of this regulatory submission.

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 information is not applicable and not present. This submission is for a hip implant, not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies and AI-related effect sizes are irrelevant to this document.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not present. As stated above, this is not an AI-driven device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device, in the context of a 510(k) submission, is based on:

Engineering specifications and material science: Verification of material composition and mechanical properties.
Design similarities: Comparison of basic design features with predicate devices.
Performance testing (likely mechanical/in-vitro): Demonstrating that physical performance (e.g., strength, fatigue) is equivalent to predicate devices.
Established clinical use of predicate devices: The safety and effectiveness of the type of device (hip stem) and its predicate versions are already well-established.

8. The sample size for the training set

This information is not applicable and not present. This document pertains to a physical medical device, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable and not present.

Summary

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MAY 2 7 1998

Osteonics" Anteverted Neck HA Hip Stems

510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® ANTEVERTED NECK HA HIP STEMS

Submission Information Name and Address of the Sponsor of the 510(k) Submission:

Contact Person:

Date Summary Prepared:

Device Identification Proprietary Name:

Common Name:

Classification Name and Reference:

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900

Donna S. Wilson Regulatory Affairs Specialist

February 27, 1998

Osteonics® Anteverted Neck HA Hip Stems

Hip Prosthesis

Hip Joint. Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Non-Porous Uncemented Prosthesis; 21 CFR §888.3353

Predicate Device Identification

The Osteonics® Anteverted Neck HA Hip Stems are substantially equivalent to the Osteonics® Anteverted Neck Hip Stems and the Osteonics® Secur-Fit HA Plus Hip Stem Series.

Device Description

Intended Use

The Osteonics® Anteverted Neck HA Hip Stem is intended for single use in patients requiring either bipolar, hemi- or total hip replacement. The Osteonics® Anteverted Neck HA Hip Stem is intended

K980766 510(k) Premarket Notification

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510(k) Premarket Notification

Osteonics" Anteverted Neck HA Hip Stems

to be implanted in a cementless application. The indications for the use of the Osteonics® Anteverted Neck HA Hip Stem, in keeping with those of other legally marketed Class II hip stems, are as follows:

For use as a Bipolar/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:

Pathological conditions or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.

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.

Statement of Technological Comparison

The Osteonics® Anteverted Neck HA Hip Stems share the same materials, indications and intended use, surgical techniques, basic design features, and basic manufacturing methods of their predicate devices. Applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three horizontal lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 1998

Ms. Elizabeth A. Staub Director Quality Assurance and Regulatory Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re : K980766 Anteverted Neck HA Hip Stem Trade Name: Requlatory Class: II Product Code: MEH Dated: February 27, 1998 February 27, 1998 Received:

Dear Ms. Staub:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable The data presented support equivalence with fixation." no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only).

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Ms. Elizabeth A. Staub

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation General regulation (21 CFR Part (QS) for Medical Devices: 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning this your device in the Federal Register. Please note: response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be

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Page 3 - Ms. Elizabeth A. Staub

obtained from the Division of Small Manufacturers Assistance Obtained from the Bivibion of 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

G. Celia M. Witten, Ph.D., M

Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K980766

Device Name: Osteonics® Anteverted Neck HA Hip Stems

Indications For Use:

For use as a Bipolar/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:

Pathological conditions or age considerations which indicate a more conservative acetabular . procedure and an avoidance of the use of bone cement in the acetabulum.
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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)

of General Restorative Devices 510(k) Number

Regulation Number and Section

§ 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.