Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed hip arthroplasty.

Device Description

The MS-30 Lateral Femoral Stem intended for cemented use, is a highly polished, collarless femoral component manufactured from forged stainless steel (Protasul S-30, ISO 5832-9). The lateral version offers the surgeon 12% more offset than with the standard version. The stem features a three dimensional conical wedge shape with rounded edges to aid in rotational stability, self-centering in the femoral canal and creation of a favorable cement mantle. The proximal portion of the stem has a male 12/14 taper for attachment of a Sulzer Orthopedics metallic or ceramic femoral head with a neck that accepts an optional Proximal Positioner, The distal portion is designed to accept the optional existing and new Distal Centralizer. It is available in six sizes.

The optional new distal centralizer manufactured from Sulene -PMMA (poly-methyl-methacrylate/poly-styrene, ISO 5833-1), is intended for use with the MS-30 Standard and Lateral Femoral Stems. The centralizer is conically shaped and designed with four wings for better centering of the stem within the diaphysis of the femur providing a favorable cement mantle. One of the wings is longer than the others indicating its position on the lateral side of the stem. It is offered in two sizes for each of the six stem sizes.

The MS-30 also features an optional proximal positioner which is manufactured from Sulene -PMMA. The proximal positioner, intended for cemented use, centers the femoral stem in the anterior/posterior plane. It inserts into the extraction hole and snaps onto the neck of the stem. Once the bone cement has polymerized, the upper portion of the positioner is removed leaving the cemented U-shaped portion creating a favorable cement mantle.

AI/ML Overview

This submission describes a medical device, the Sulzer Orthopedics MS-30 Lateral Femoral Stem, which is a hip joint prosthesis. The document is a 510(k) summary for premarket notification to the FDA, indicating that the device demonstrates substantial equivalence to previously marketed devices. Therefore, this document does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against specific quantitative acceptance criteria through a clinical study with detailed statistical analysis and ground truth establishment.

However, based on the provided text, I can infer some aspects relevant to the concepts requested, even if direct answers are not present:

Key Takeaways from the Provided Document:

Device Type: This is a cemented femoral stem component for hip replacement surgery.
Approval Type: 510(k) premarket notification. This pathway relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy and safety through de novo clinical trials with rigorous performance metrics.
No Performance Acceptance Criteria or Study: The document explicitly states "Analysis indicated that the device would survive physiologic loading." This is the closest mention to any 'performance' assessment, but it's not presented as a formal study with acceptance criteria and results in the format requested.
Focus on Substantial Equivalence: The primary aim of this submission is to show that the MS-30 Lateral Femoral Stem is similar in intended use, materials, and general design to existing, legally marketed devices.

Given this context, I cannot populate the requested table or answer most of your detailed questions about acceptance criteria and study design because the provided text does not describe such a study or criteria for this specific device.

Here's a breakdown of why each numbered point cannot be fully addressed by the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document confirms the device "would survive physiologic loading," which is a general statement about its mechanical integrity, not a specific performance metric against a defined acceptance criterion.
Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical study is described. The "analysis" of physiologic loading likely refers to bench testing or simulation, not human data.
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. No test set or ground truth establishment is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process is described.
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 device is a mechanical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established for device performance in the context of a clinical study.
The sample size for the training set: Not applicable. No training set is implied for this type of device submission.
How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided document is a 510(k) summary for a medical device (femoral stem). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria and associated results. Therefore, the specific information requested about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in the given text.

The "analysis" that indicated the device would "survive physiologic loading" is the extent of performance information provided, and it lacks the detailed structure of a study report with acceptance criteria.

Summary

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MAY 1 4 2002

020713

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510 k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the in a securities with a lot of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics MS-30 Lateral Femoral Stem.

Manufacturer:	Sulzer Orthopedics Ltd.Grabenstrasse 25CH 6341 Baar, Switzerland
US Designated Agent:	Sulzer Orthopedics Inc.9900 Spectrum DriveAustin, Texas 78717(512) 432-9900
Date:	April 15, 2002
Contact Person:	Frances E. Harrison, RACManager, Regulatory Projects
Classification Name:	21 CFR Part 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Common/Usual Name:	Cemented Femoral Stem Component
Trade/Proprietary Name:	Sulzer Orthopedics MS-30 Lateral Femoral Stem

PRODUCT DESCRIPTION

MS-30 Lateral Femoral Stem

Distal Centalizer

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K020713

Proximal Positioner (Centralizer)

2 of 2

SPECIFIC DIAGNOSTIC INDICATIONS

The MS-30 Lateral Femoral Stem is intended for cemented use in treatment of the following:

Patient conditions of noninflammatory degenerative joint disease (NIDJD), 1. e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Those patients with failed previous surgery where pain, deformity, or 2. dysfunction persists.
Revision of previously failed hip arthroplasty. ಳ

SUBSTANTIAL EQUIVALENCE

The MS-30 Lateral Femoral Stem is similar to the following commercially available devices in terms of intended use, materials and general design:

MS-30 Femoral Stem, Centralizer .
Howmedica Osteonics Exeter Hip Stem, Centralizer .
Howmedica Osteonics Definitions Stem .
Zimmer VerSys Hip Cemented CT Hip Stem, Centralizer .

Analysis indicated that the device would survive physiologic loading.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles an abstract human figure or a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2002

Ms. Frances E. Harrison, RAC Manager, Regulatory Projects Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, TX 78717

Re: K020713

Trade/Device Name: MS-30 Lateral Femoral Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: II Product Code: LZO Dated: March 1, 2002 Received: March 5, 2002

Dear Ms. Harrison:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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 your device can be found 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 mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Frances Harrison, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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 H. Millman

Celia M. 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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510(k) Number (K020713):

Device Name: MS-30™ Lateral Femoral Stem

Indications For Use:

The MS-30 Lateral Femoral Stem is intended for cemented use in treatment of the following:

Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., 1. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Those patients with failed previous surgery where pain, deformity, or 2. dysfunction persists.
Revision of previously failed hip arthroplasty. 3.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

Mark A. Millman

ral, Restorative nd Neurologi

510(k) Number K02713
K02713

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.