The indications for the use of the Osteonics® Primary Secur-Fit™ Plus Hip Stems , in keeping with those of other legally marketed 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.

Device Description

The Osteonics® Primary Secur-Fit™ Plus Hip Stems are currently marketed devices that are being modified. The modification involves the addition of two smaller sizes, 5 and 6, and elimination of the distal tri-slot on stems with a 9mm or 10mm distal diameter. All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged.

AI/ML Overview

The provided document is a 510(k) summary for a medical device modification, specifically for the Osteonics® Primary Secur-Fit™ Plus Hip Stems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness claims. As such, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as it would apply to a novel AI/software medical device is not directly applicable here.

However, I can interpret the request in the context of this 510(k) submission, focusing on how the manufacturer demonstrated equivalence and what evidence was presented.

Here's an analysis based on the provided text, addressing the points you raised, with explanations for why some are not applicable to this type of submission:

Acceptance Criteria and Study for Osteonics® Primary Secur-Fit™ Plus Hip Stems (Modified)

The core "acceptance criteria" for this 510(k) submission are that the modified device remains substantially equivalent in terms of safety and effectiveness to the predicate device, despite the modifications. The study performed aims to demonstrate this equivalence, particularly regarding mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence to Predicate)	Reported Device Performance against Criteria
Mechanical Equivalence: The modified device (with smaller sizes and without distal tri-slot on certain diameters) must maintain equivalent fatigue strength compared to the predicate device.	"Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics stem design to predicate stem designs in terms of its fatigue strength."
Material Equivalence: Must be manufactured from the same material type as the predicate.	"The Osteonics® Primary Secur-Fit™ Plus Hip Stems are manufactured from titanium alloy (ASTM F-620-96)," which implicitly matches the predicate (as the modification is not about material change).
Intended Use Equivalence: The modified device must share the same intended use as the predicate device.	The stated "Intended Use" for the modified device is identical to the predicate device.
Technological Characteristics Equivalence (beyond modification): All other aspects of the device not subject to this specific modification must remain unchanged.	"All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the document. For mechanical testing of implantable devices like hip stems, "sample size" typically refers to the number of individual stems tested for each configuration (e.g., each size, with/without tri-slot). This exact number is not provided.
Data Provenance: The document does not specify the country of origin for the mechanical testing data. It's implicitly (and standardly) generated by the manufacturer (Osteonics Corporation, based in Allendale, NJ, USA). The testing would be prospective in nature, as it involves newly manufactured devices being subjected to controlled mechanical loads.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This concept is not applicable to this 510(k) submission. "Ground truth" and "expert evaluation" are typically relevant for diagnostic or AI-driven devices where human experts establish the true condition (e.g., presence of disease in an image). For mechanical testing of a hip stem, the "ground truth" is established by the physical testing itself, measuring properties like fatigue strength against established engineering standards (e.g., ASTM standards).

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human experts when establishing ground truth. Mechanical testing involves repeatable measurements against objective standards, not subjective expert interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was NOT done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. This submission is for a mechanical orthopedic implant, not a diagnostic or AI-powered device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable in the context of typical AI/algorithm standalone studies. This device is a passive mechanical implant. The "standalone" performance here refers to the device's inherent mechanical properties (fatigue strength) as measured in a lab setting, without human interaction beyond the setup and execution of the tests. This is what the "Mechanical testing has been performed" statement refers to.

7. The Type of Ground Truth Used

Engineering/Mechanical Standards and Benchmarking against Predicate: The "ground truth" for this submission would be adherence to relevant ASTM (American Society for Testing and Materials) standards for orthopedic implants (e.g., for fatigue testing of metallic hip prostheses) and, crucially, demonstrating that the modified design performs equivalently to the previously cleared predicate device in those mechanical tests. It's based on quantitative physical measurements against established criteria.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (hip stem), not for an AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI model or training set, this question is not relevant.

Summary in the Context of a 510(k):

The manufacturer demonstrated substantial equivalence by:

Clearly defining the modifications (smaller sizes, removal of distal tri-slot).
Stating that all other aspects remained unchanged (material, overall design principles).
Asserting that mechanical testing was performed to prove equivalent fatigue strength between the modified design(s) and the predicate device.
Confirming the intended use remains the same.

The FDA reviewed this information and concurred that the device is substantially equivalent, but placed specific labeling limitations related to "biological attachment" or "enhanced fixation" claims, indicating that equivalence was shown only for a "conventional press-fit hip prosthesis (i.e., mechanical interlock, only)."

Summary

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2/18/99

K990203

Special 510(k) - Device Modification Summary of Safety and Effectiveness for the Osteonics® Primary Secur-Fit™ Plus Hip Stems

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677
Contact Person:	Kate SuttonRegulatory Affairs Specialist
Date of Summary Preparation:	January 18, 1999
Device Identification
Proprietary Name:	Osteonics® Primary Secur-FitTM Plus HipStem Series
Common Name:	Hip Prosthesis
Classification Name and Reference:	Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained Cemented or Non-Porous

Predicate Device Identification

The modified features of the Osteonics® Primary Secur-Fit™ Plus Hip Stems are substantially equivalent to features of the following Osteonics predicate device, which has been cleared for marketing via the 510(k) process:

Uncemented Prosthesis 21 CFR §888.3353

Osteonics® Primary Secur-Fit™™ Plus Hip Stem Series .

Device Description

The Osteonics® Primary Secur-Fit™ Plus Hip Stems are currently marketed devices that are being modified. The modification involves the addition of two smaller sizes, 5 and 6, and elimination of

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the distal tri-slot on stems with a 9mm or 10mm distal diameter. All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged.

Intended Use:

The Osteonics® Primary Secur-Fit™ Plus Hip Stems are single use components. They are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. The modified and predicate hip stems are intended to be used in conjunction with any commercially available Osteonics C-Taper femoral bearing head. For use as a total hip replacement, the modified and predicate stems may be used in conjunction with any legally marketed Osteonics acetabular component. The Osteonics® Primary Secur-Fit™ Plus Hip Stems are manufactured from titanium alloy (ASTM F-620-96). The indications for the Osteonics® Primary Secur-Fit™ Plus Hip Stems include the following:

For Use as a Bipolar Hip Replacement:

Femoral head/neck fractures or non-unions. .
Aseptic necrosis of the femoral head.
. Osteo-, theumatoid, 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.

Performance Data:

Mechanical testing has been performed to demonstrate the substantial equivalence of this Osteonics stem design to predicate stem designs in terms of its fatigue strength.

Statement of Technological Comparison:

The modification involves the addition of two smaller sizes, 5 and 6, and elimination of the distal tri-slot on stems with a 9mm or 10mm distal diameter. All other aspects of the Osteonics® Primary Secur-Fit™ Plus Hip Stems will remain unchanged.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1999

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

Re : K990203 Osteonics® Primary Secur-Fit™ Plus Hip Stem Series Requlatory Class: II Product Code: MEH Dated: January 18, 1999 Received: January 21, 1999

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 fixation." The data presented support equivalence with 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 (QS) for Medical Devices: General regulation (21 CFR Part and that, through periodic (QS) inspections, the Food and 820) Druq Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this 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 regulation (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 Division of Billar (301) 443-6597 or at
at its toll-free number (800) 638-2041 or (301) 443-6597 or at at Its Coll-Iree number (600)- 650 2011-02-100, 100 1000 1000 1000 1000 1000 1000 1000 1000 100

Sincerely yours,

a M. Witten, Ph.D., M.D. L Celi 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): K_990 >0 }

Device Name: Osteonics® Primary Secur-Fit™ Plus Hip Stems

Indications For Use:

The indications for the use of the Osteonics® Primary Secur-Fit™ Plus Hip Stems , in keeping with those of other legally marketed 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.

(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 No

(Optional Format 1-2-96)

eral Restorative Device

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.