The DePuy S-ROM® Hip Stem Prosthesis is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the component.

The DePuy S-ROM® Hip Stem Prosthesis is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicted for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

Device Description

The subject DePuy S-ROM® Hip Stem is a line extension to the 36mm S-ROM® titanium stems previously cleared in K961939 and K851422. The line extension adds a +12L option to the previously cleared standard stem sizes 19 x 24 x 175 w/36mm neck and 21 x 26 x 175 w/36mm neck. These two new stems will provide greater lateralization (+12 mm) to the standard stem of comparable diameters. The increased lateralization assists in restoring anatomical biomechanics through adjusting off-set without effecting leg length.

AI/ML Overview

This document describes a 510(k) premarket notification for a hip stem prosthesis, which is a medical device. The information provided is not a study that proves a device meets acceptance criteria in the way one would conduct a clinical trial or algorithm performance study for AI/software. Instead, it's a regulatory submission for substantial equivalence to a previously cleared device. Therefore, the questions about acceptance criteria, performance tables, sample sizes, experts, MRMC studies, standalone performance, and ground truth are not directly applicable in the typical sense of a study proving performance for a software algorithm.

However, I can reframe the information provided to address your questions in the context of a 510(k) submission for a medical device line extension.

Here's how I'll interpret and answer your questions:

Acceptance Criteria & Reported Device Performance: For a 510(k) submission, "acceptance criteria" generally refers to demonstrating that the new device is as safe and effective as a legally marketed predicate device. "Reported device performance" would relate to how the new device compares to the predicate.
Study: In a 510(k) for a line extension, the "study" is often an analysis of design, materials, manufacturing, and intended use to show substantial equivalence. It's not usually a clinical performance study with human trial data unless there are significant changes.
Ground Truth: For device mechanical properties, the "ground truth" would be established through engineering specifications, material testing standards, and design principles.

Reframed Acceptance Criteria and "Study" for a 510(k) for a Hip Stem Prosthesis Line Extension

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

For a 510(k) submission like this, the primary "acceptance criterion" is Substantial Equivalence to a predicate device. The "reported device performance" is the demonstration that the new device shares fundamental characteristics with the predicate.

Acceptance Criterion (for Substantial Equivalence)	Reported Device "Performance" (demonstration of equivalence)
Criterion 1: Same Intended Use The new device must have the same intended use as the predicate device.	Demonstrated: The DePuy S-ROM® Hip Stem Prosthesis is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation, which is consistent with the general intended use of hip stem prostheses and implicitly, the predicate DePuy S-ROM® Hip Stem (K961939).
Criterion 2: Same Indications for Use The new device must have the same indications for use as the predicate device.	Demonstrated: The DePuy S-ROM® Hip Stem Prosthesis is indicated for uncemented use as the femoral component in THA for replacing hip joints due to various conditions (rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, etc.), revision, congenital hip dysplasia, etc. The submission explicitly states: "The fundamental scientific technologies of the subject DePuy S-ROM® Hip Prosthesis have not changed from the FDA-cleared DePuy S-ROM® Hip Stem (K961939). They have the same intended use, indications..."
Criterion 3: Same Technological Characteristics If technological characteristics differ, they must not raise new questions of safety or effectiveness.	Demonstrated: The submission states, "The fundamental scientific technologies... have not changed from the FDA-cleared DePuy S-ROM® Hip Stem (K961939). They have the same... sterilization method, packaging, materials, method of manufacture and design." The specific change is a "line extension adds a +12L option to the previously cleared standard stem sizes," providing "greater lateralization (+12 mm)." This type of modification (a dimensional variation within an existing design and material framework) is generally considered to not raise new questions of safety or effectiveness as long as mechanical integrity (e.g., fatigue, strength) is maintained, likely demonstrated through bench testing (though not explicitly detailed in this summary).
Criterion 4: Performance Data Any performance data (e.g., bench, non-clinical, clinical) provided must support substantial equivalence.	Demonstrated: While specific detailed study data (like fatigue testing results) are not included in this summary, the assertion of "same intended use, indications, sterilization method, packaging, materials, method of manufacture and design" implies that engineering analyses and testing (e.g., mechanical, materials, biocompatibility) would have been performed to confirm that the +12L line extension performs equivalently to the predicate devices and meets relevant standards. Such documentation would be part of the full 510(k) submission, substantiating that the dimensional change for increased lateralization does not compromise the device's safety or efficacy. The clearance letter confirms that Substantial Equivalence was found based on the provided information.

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: This document does not describe a clinical trial or algorithm performance study with a "test set" in the common sense. For a device like a hip stem, a "test set" would typically refer to the number of devices or components tested during bench testing (e.g., fatigue testing, static load testing). This summary does not provide these specific numbers.
Data Provenance: Not applicable in this summary. The data would primarily be engineering and design specifications, and potentially results from in-house lab testing, not patient-derived data in the typical sense.

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)

Experts: Not applicable for this type of submission summary. The "ground truth" for hip stem design and performance is established by engineering standards, material science, biomechanical principles, and regulatory requirements, not by expert consensus on interpretive data (like radiology images). Design engineers, materials scientists, and quality assurance personnel would be involved.

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

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-interpreted data (e.g., clinical endpoint events, imaging studies). This submission is about a mechanical device.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging algorithms with human interpretation. This submission is for a physical medical implant (hip stem).

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

Standalone Performance: No, this is not applicable. This is for a physical medical device, not a software algorithm.

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

Type of Ground Truth: For a hip stem line extension, the "ground truth" for demonstrating substantial equivalence rests on:
- Engineering Specifications and Design Principles: The device must meet established biomechanical and material science principles for an orthopedic implant.
- Material Standards: The materials used must conform to accepted standards for biocompatibility and mechanical properties (e.g., ASTM, ISO standards for titanium alloys).
- Bench Testing Results: Mechanical performance (e.g., fatigue strength, torsional strength, corrosion resistance) would be compared to predicate devices and/or established performance standards through laboratory testing.
- Clinical Outcomes of Predicate Device: The predicate devices (K961939 and K851422) have a history of safe and effective use, and the new device is demonstrated to be structurally and functionally similar enough not to introduce new risks.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is not a machine learning or AI algorithm development; there is no "training set."

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

Training Set Ground Truth: Not applicable, as there is no training set for this type of device submission.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy Orthopaedics Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988EST REG No.: 1818910
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	AUG 2 8 2006
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510(K) CONTACT:	Anne SchulerSr. Regulatory Affairs SpecialistTel: (574) 372-7098Fax: (574) 371-4987
DATED PREPARED:	June 22, 2006
TRADE NAME:	DePuy S-ROM® STD Hip Stem Prosthesis
COMMON NAME:	Cementless Hip Stem Prosthesis
CLASSIFICATION:	21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis,Class II
	21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis,Class II
	21 CFR 888.3330 Hip joint metal/metal semi-constrained,with an uncemented acetabular component prosthesis,Class III
DEVICE PRODUCT CODES:	LPH, LZO, KWA
SUBSTANTIALLYEQUIVALENT DEVICES:	DePuy S-ROM® Femoral Hip Stem (K961939, clearedAugust 13, 1996)
	DePuy S-ROM® STD Hip Stem Prostheses (K851422,cleared July 9, 1985 with additional modifications

DEVICE DESCRIPTION:

cleared through internal documentation)

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INTENDED USE AND INDICATIONS:

INTENDED USE:

INDICATIONS FOR USE:

SUBSTANTIAL EQUIVALENCE:

The fundamental scientific technologies of the subject DePuy S-ROM® Hip Prosthesis have not changed from the FDA-cleared DePuy S-ROM® Hip Stem (K961939). They have the same intended use, indications, sterilization method, packaging, materials, method of manufacture and design. DePuy believes that the subject DePuy S-ROM® Hip Prosthesis is substantially equivalent to the FDAcleared DePuy S-ROM® Hip Stem (K961939).

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo features the HHS symbol, which is a stylized representation of a human figure embracing a globe. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2006

Ms. Anne Schuler Senior Regulatory Affairs Specialist DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K061221 Re.

Trade/Device Name: S-ROM STD Hip Stem Prosthesis Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA, LZO, LPH Dated: August 16, 2006 Received: August 17, 2006

Dear Ms. Schuler:

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

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Page 2 - Ms. Anne Schuler

CFR Part 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 applicable, the 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) 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), please contact the Office of Compliance at (240) 276-0120. 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 of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Oaibaie Buellm

Mark N. Melkerson, M.S 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

15061221 510(k) Number (if known): Device Name: DePuy S-ROM® Hip Stem Prosthesis

Indications for Use:

Prescription Use	X (Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use	(21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

	Kaubare BuchelD
	for MKM

0000COG

510(k) Number	K061221
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Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.