When used as a hemi-hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
When used as a total hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
In addition, the NexFlex Total Hip System is intended for cases where alternative modes of treatment appear less preferable and the associated risks of a total hip replacement are thought to be acceptable. It is intended for severely disabled joints, which could result from arthritis or late stages of avascular necrosis and revisions of unsuccessful acetabular cup arthroplasty and/or femoral procedure.

Device Description

The NexFlex™ Total Hip System is a sterile total or hemi-hip replacement system. It consists of a series of femoral and acetabular implants that are used to help restore patient range of motion and aid in the treatment of other deformities as histor in the Indications for Use. The purpose of this 510(k) is to provide for HA coated hip sterns and acetabular cups. This submission also includes additions / modifications to the and accedural under formal change control procedures.

AI/ML Overview

The provided text is a 510(k) summary for the NexFlex™ Total Hip System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing the results of a primary clinical or performance study with defined acceptance criteria and detailed statistical analysis as would be expected for a novel AI/software medical device.

Therefore, many of the requested elements for an AI/software device cannot be extracted directly from this document. However, I can provide the information that is present and explain why other sections are not applicable.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Internal/Implicit)	Reported Device Performance
Mechanical Performance: Performance comparable to or better than predicate devices during fatigue testing.	Demonstrated that the mechanical performance is at least comparable to, if not better than, those of the predicate device.
Biocompatibility: Characteristics comparable to or better than predicate devices.	Demonstrated that the biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device.
Substantial Equivalence: Device (including HA coated components) is substantially equivalent to legally marketed predicate devices.	FDA determined the device is substantially equivalent to legally marketed predicate devices.

Explanation: In a 510(k) submission, the primary "acceptance criterion" is often a demonstration of substantial equivalence to a predicate device. For mechanical components like hip implants, this is typically proven through bench testing (fatigue, wear, etc.) and material characterization (biocompatibility). Explicit numerical acceptance criteria and a detailed statistical comparison with a confidence interval, as common for AI devices, are not typically found in these types of summarized 510(k) documents.

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

Sample Size for Test Set: Not specified. The document mentions "Fatigue testing and microstructure examination" but does not detail the number of samples or specimens used in these tests.
Data Provenance: Not specified. These are likely bench test results, not human 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)

Not applicable. This document describes mechanical and biocompatibility testing of a physical medical device (hip implant components), not performance evaluation of an AI-based diagnostic or prognostic tool that would require expert-established ground truth.

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

Not applicable. This relates to expert consensus for ground truth establishment, which is not relevant to the type of testing described here.

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

Not applicable. This describes the evaluation of an AI/software device, which the NexFlex™ Total Hip System is not.

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

Not applicable. This describes the evaluation of an AI/software device, which the NexFlex™ Total Hip System is not.

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

Mechanical and Material Standards: The "ground truth" for the performance claims would be established by recognized engineering and material standards for orthopedic implants (e.g., ISO standards for fatigue testing, material properties, and biocompatibility). The document states that the test results "demonstrated that the mechanical performance and biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device," implying a comparison against established benchmarks or the predicate device's known performance.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" as this is not an AI/machine learning device.

Summary

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AUG - 5 2004

NexFlex™ Total Hip System 510(k) SUMMARY November 2003

K033580
page 1 of 7

l. Company: Nexmed, Inc. 6110 Corte Del Cedro Carlsbad. CA 92009 USA (760) 431-9286
II. Contact Person: Ellen Yarnall, Director of Regulatory Affairs
III. Trade/Proprietary Name: NexFlex™ Total Hip System with HA Coating

IV. Product Description:

The purpose of this 510(k) is to provide for HA coated hip sterns and acetabular cups. This submission also includes additions / modifications to the and accedural under formal change control procedures.

V. Indications for Use:

1. When used as a hemi-hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
1. When used as a total hip replacement system, it is intended for osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal involvement of the corresponding acetabulum, femoral head or neck fractures, aseptic necrosis of the femoral head, previous failed hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
1. In addition, the NexFlex Total Hip System is intended for cases where alternative modes of treatment appear less preferable and the associated risks of a total hip replacement are thought to be acceptable. It is intended for severely disabled joints, which could result from arthritis or late stages of avascular necrosis and revisions of unsuccessful acetabular cup arthroplasty and/or femoral procedure,

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NexFlex™ Total Hip System 510(k) SUMMARY November 2003

c 33586
page 2 of 2

VI. Substantial Equivalence:

The NexFlex Total Hip System with HA coated components is substantially equivalent to various total hip and hemi-hip systems commercially available.

VII. Performance Data:

Fatigue testing and microstructure examination the NexFlex Total Hip System was previously submitted. The test results demonstrated that the mechanical performance and biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2004

Ms. Ellen A. Yarnall Director of Regulatory Affairs Nexmed, Inc. 6110 Corte Del Cedro Carlsbad, California 92009

Re: K033580

Trade/Device Name: Nexflex Total Hip System Trade Dovice Name: 21 CFR 888.3358; 21 CFR 888.3350; 21 CFR 888.3390 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis; Hip joint metal/polymer semi-constrained cemented prosthesis; Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis

Regulatory Class: II Product Code: LPH, JDI, KWY Dated: July 5, 2004 Received: July 7, 2004

Dear Ms. Yarnall:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Incrisiate commerce prior to has ray, been reclassified in accordance with the provisions of Amendinents, or to do rough that nortic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include Controls provisions of the 1100 Justing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (111), it hay of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be actised that the a determination that your device complies with other requirements mean that 127 was Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Ms. Ellen A. Yarnall

You must comply with all the Act's requirements, including, but not limited to: registration 1 ou intest compry with and 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirelate as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I rais reter notification. The FDA finding of substantial equivalence of your device to a premiurker notification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division may ordain onufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N. Milkin

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

Enclosure

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Indications for Use

K033580 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: NexFlex™ Total Hip System

Indications for Use:

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1. When used as a total hip replacement system, it is intended for osteo-, rheumatoid, with as ou a tetal hittis of the hip with minimal involvement of the corresponding and post tradinatio arthatio a neck fractures, aseptic necrosis of the femoral head, abotabulari, to hip arthroplasty where there is evidence of sufficient bone quality to adequately set the implant.
1. In addition, the NexFlex Total Hip System is intended for cases where alternative in addition, the Noxt Topear less preferable and the associated risks of a total hip modes of treatment are thought to be acceptable. It is intended for severely disabled joints, ropidoomerit and the arthritis or late stages of avascular necrosis and revisions of unsuccessful acetabular cup arthroplasty and/or

plasty and/or femoral procedure.
Muhle n Millikun

ral. Restorative, and Neurological Devices

Prescription Use (Part 21 CFR 801 Subpart D)

510(k) Number__

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.