The SPA Porcus Coated Proximal Sleeve components of the S-ROM Total Hip System are indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from theumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonumion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

The SPA Porous Coated Proximal Sleeves are intended for cementless use.

Device Description

The SPA Poeous Coated Peoximal Sleeve is a composent of the S-ROM Total Hip Replacement System. It is a porous coated Titanium femoral component with an elliptical shape that matches the contour of the bone and a stepped exterior to maximize compressive stresses. Fixation of the proximal sleeve to the femur is achieved by biologic fixation via tissue in-growth into the porous onsung.

AI/ML Overview

This 510(k) premarket notification is for a medical device called "DePuy SPA™ Porous Coated Proximal Sleeves". It's a component of a total hip replacement system. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria for device performance as would be seen for a novel AI/software component.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. This document describes a traditional medical device (implant), not an AI/software device.

However, I can extract the information relevant to the concept of "acceptance criteria" and "proof" in the context of a 510(k) submission for a physical device.

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission of a physical orthopedic implant, "acceptance criteria" and "device performance" are typically framed in terms of mechanical properties, biocompatibility, and substantial equivalence to a predicate device. The document states:

Criterion Type (Implicit)	Acceptance Criteria (Implicit)	Reported Device Performance (Claimed)
Design Equivalence	The device's design is identical or substantially similar to a legally marketed predicate device.	The SPA Porous Coated Proximal Sleeve is identical in design to the S-ROM™ 135 Porous Coated Femoral Stem Collar (K860207). It has an elliptical shape that matches the contour of the bone and a stepped exterior to maximize compressive stresses.
Material Equivalence	The device's materials are identical or substantially similar to a legally marketed predicate device.	The SPA Porous Coated Proximal Sleeve uses identical materials to the S-ROM™ 135 Porous Coated Femoral Stem Collar (K860207). It is a porous coated Titanium femoral component.
Manufacturing Equivalence	The device's manufacturing method is identical or substantially similar to a legally marketed predicate device.	The SPA Porous Coated Proximal Sleeve uses an identical manufacturing method to the S-ROM™ 135 Porous Coated Femoral Stem Collar (K860207).
Porous Coating Equivalence	The porous coating is identical to one used on a predicate device cleared for cementless use.	The porous coating of the SPA Porous Coated Sleeve is identical to the porous coating used on the Coated ZT Proximal Sleeve (K934412), which was cleared for cementless use.
Intended Use Compatibility	The device's intended use falls within the scope of predicate devices or is a logical extension thereof based on equivalence.	The device is indicated for total hip replacement procedures for various conditions (rheumatoid arthritis, osteoarthritis, etc.) and for cementless use. This is presented as equivalent to the predicates.

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

This information is not applicable as this is not a study measuring performance of an AI/software device. The "proof" for this device relies on demonstrating substantial equivalence to existing, legally marketed predicate devices through a comparison of design, materials, manufacturing, and intended use. There is no "test set" in the sense of patient data or algorithm output.

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. Ground truth for a physical implant is typically established through engineering specifications, material standards, and clinical experience with similar devices, not through expert consensus on a test set of data.

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

This information is not applicable. There is no "adjudication method" for a test set in this kind of 510(k) 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. This is a physical implant, not an AI or software device that would involve human readers or AI assistance.

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

This information is not applicable. This is a physical implant, not an algorithm.

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

For this type of device, the "ground truth" is established by:

Engineering specifications and material standards: Ensuring the Titanium material meets biocompatibility and mechanical strength requirements.
Clinical experience and regulatory clearances of predicate devices: The "ground truth" for safety and effectiveness is largely derived from the long-standing use and prior FDA clearance of the S-ROM™ 135 Porous Coated Femoral Stem Collar (K860207) and the Coated ZT Proximal Sleeve (K934412). The company argues that because the new device is "identical" or uses "identical" components, it shares the same safety and effectiveness profile.

8. The sample size for the training set

This information is not applicable. There is no "training set" for a physical implant.

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

This information is not applicable. There is no "training set" for a physical implant.

Summary of the Study/Evidence Provided:

The document describes a 510(k) premarket notification where DePuy Orthopaedics, Inc. seeks to demonstrate the "substantial equivalence" of their DePuy SPA™ Porous Coated Proximal Sleeves to legally marketed predicate devices. This is the primary "study" or evidence a 510(k) package provides for a physical device.

The core of the argument is built on direct comparisons:

S-ROM™ 135 Porous Coated Femoral Stem Collar (K860207): The SPA Porous Coated Proximal Sleeve is claimed to be identical in design, materials, and manufacturing method to this predicate device. This predicate was cleared for cemented use.
Coated ZT Proximal Sleeve (K934412): The porous coating of the SPA device is claimed to be identical to the porous coating used on this predicate, which was cleared for cementless use.

By combining the design/material/manufacturing equivalence from one predicate with the porous coating (and thus cementless use) equivalence from another, DePuy argues their new device is substantially equivalent to existing approved devices, therefore demonstrating its safety and effectiveness. The FDA's letter concurs with this assessment, stating the device is "substantially equivalent" for the stated indications for use.

Summary

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K071059

510(k) SUMMARY

NAME OF FIRM:	DePuy Orthopaedics Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Establishment Registration Number: 1818910
510(K) CONTACT:	Kathy HarrisDirector, Regulatory AffairsTel: (574) 372-7082Fax: (574) 371-4987
DATE PREPARED:	October 20, 2007
TRADE NAME:	DePuy SPA™ Porous Coated Proximal Sleeves
COMMON NAME:	Femoral Proximal Sleeve
CLASSIFICATIONS:	21 CFR 888.3330: Hip joint metal/metal semi-constrained,with an uncemented acetabular component, prosthesis, Class III
	21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis,Class II
	21 CFR 888.3358: Hip joint metal/polymer semi-constrainedporous coated uncemented prosthesis, Class II
	21 CFR 888.3310: Hip joint metal/polymer constrainedcemented or uncemented prosthesis, Class II
DEVICE PRODUCT CODES:	KWA, LZO, MEH, LPH, KWZ.
SUBSTANTIALLY

EQUIVALENT DEVICES: S-ROM™ 135 Porous Coated Femotal Stem Collar, K860207 cleared August 6, 1986

Coated ZT=14 Prosimal Sleeve, K934412 cleared June 3, 1994

DEVICE DESCRIPTION:

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INDICATIONS AND INTENDED USE:

The SPA Porcus Coated Proximal Sleeve components of the S-ROM Total Hp System are indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheatuatoid arthritis, ostecarthritis, post-traumatic arthritis, collages disorders, avascular necessis, and nominion of femoral fractures. Use of the prosthesis is also indicated for revision of premous hip arthroplasty and for patients with congenital hip dysplasia. protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

The SPA Porous Coated Proximal Sleeves are intended for cementless use.

and the contract and consistence of the country and the country and the con-

and and the commend of the

SUBSTANTIAL EQUIVALENCE:

The SPA Porous Coated Proximal Sleeve is identical in design, materials and manufacturing method to the S-ROM 135 Porcous Coated Femoral Stem Collar, cleared in K860207 for cemented use only. The porous coating of the SPA Porcous Coated Sleeve is identical to the porcus coating used on the Coated ZT Proximal Sleeve, cleared in K934412 for cemendess use. Based on these samilatines, DePuy believes that the SPA Porous Coated Proximal Sleeve is substantially equivalent to the referenced predicate devices.

0000026

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing segments, oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

DuPuy Orthopaedics, Inc. % Ms. Kathy Harris Director, Regulatory Affairs 700 Orthopaedic Drive Warsaw, IN 46581-0988

Re: K071059

Trade/Device Name: DePuy SPA™ Porous Coated Proximal Sleeves Regulation Number: 21 CFR 888.3330 Regulation Name: Single/multiple component metallic bone Fixation appliances and accessories Regulatory Class: Class III Product Code: LPH, MEH, LZO, and KWZ Dated: October 23, 2007 Received: October 24, 2007

Dear Ms. Harris:

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. Iisting 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 (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.

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Page 2 - Ms. Kathy Harris

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehlm

Mark N. Melk 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

510(k) Number (if known): K071059

Device Name: DePuy SPA Porous Coated Proximal Sleeves

Indications for Use:

The SPA Porous Coated Proximal Sleeves are intended for cementless use.

Prescription Use ানুষ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart Of

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buell

(Division Sign-Off Division of General, Restorative, and Neurological Devices

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510(k) Number K071059
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Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”