The SUMMIT™ Acetabular System is indicated for use in total hip replacement procedures for 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 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, where bone stock is inadequate for other reconstruction techniques.

All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.

Device Description

The SUMMIT™ Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, an outer shell composed of titanium alloy (Ti-6Al-4V) with a commercially pure titanium porous coating and a liner of ultrahigh molecular weight polyethylene (UHMWPE), which locks into the outer shell. The acetabular component articulates with a femoral head of an appropriate diameter.

The acetabular shell has a porous-coated surface and is provided No-Hole, Cluster Hole, Multi-Hole, Spiked and Deep Profile configurations that accept liners for 22.225, 26, 28 and 32mm femoral head sizes; as well as 0°, 10°, and 15° face angles.

Also available for use with the SUMMIT™ Acetabular System are an apical hole plug and a variety of bone screws, all composed of titanium alloy.

AI/ML Overview

This document is a 510(k) summary for the SUMMIT™ Acetabular System, a medical device for total hip replacement. It outlines the device's information, indications for use, and a statement of substantial equivalence to predicate devices. It does not describe acceptance criteria, performance data, or a study to prove the device meets acceptance criteria in the way typically expected for an AI/software as a medical device (SaMD).

Therefore, I cannot populate the requested table and answer many of the questions as the provided text pertains to a hardware medical device (an acetabular system) and its regulatory clearance as substantially equivalent to existing devices, not a software or AI-based device's performance study.

However, I can extract information related to the device and its regulatory clearance:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical device, not an AI/SaMD, specific "acceptance criteria" and "reported device performance" are not presented in the format of metrics like sensitivity, specificity, or accuracy. The "acceptance criteria" for regulatory clearance were met through demonstrating substantial equivalence to predicate devices. "Device performance" in this context refers to its mechanical integrity and biocompatibility, as demonstrated through materials and design.

Criterion Type	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as basis for substantial equivalence)
Intended Use	Must be the same or very similar to predicate devices.	"The SUMMIT™ Acetabular System is substantially equivalent in terms of intended use..." when compared to ZTT™ I and II Acetabular Cup (K951000), Arthopor™ I and II (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301).
Materials	Must be comparable to predicate devices in terms of biocompatibility and mechanical properties. (e.g., Titanium alloy (Ti-6Al-4V) for the shell, commercially pure titanium porous coating, UHMWPE for the liner, titanium alloy for screws/plugs)	"...materials..." were deemed substantially equivalent. Conformance with voluntary performance standards: ASTM F-67 (Standard Specification for Unalloyed Titanium for Surgical Implant Applications) and ASTM F136 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications).
Design	Must be comparable to predicate devices. (e.g., modular system with an outer shell and a liner, various head sizes and face angles, porous coating)	"...design..." was deemed substantially equivalent.
Sterilization Method	Must be a validated sterilization method commonly used for medical devices and comparable to predicate devices.	"...sterilization method..." was deemed substantially equivalent.
Packaging	Must be appropriate for maintaining sterility and device integrity, and comparable to predicate devices.	"...packaging..." was deemed substantially equivalent.
Performance Testing	Mechanical and material performance testing to ensure safety and effectiveness, conforming to relevant standards. (Though specific tests are not detailed, ASTM standards imply certain mechanical properties and biocompatibility requirements were met).	"performance testing" was conducted and contributed to the determination of substantial equivalence. Specifically mentioned: ASTM F1044 (Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Interfacially Attached to Metallic Substrates).

Regarding the remaining questions:

2. Sample sized used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" in the context of an AI/SaMD. The "data" here refers to device specifications, materials, design, and performance testing results which are compared to predicate devices and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established for this type of device submission. The "ground truth" for regulatory clearance is based on established engineering principles, material science, and the safety and effectiveness record of predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is for a mechanical implant, not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this medical device's clearance is adherence to recognized industry standards (e.g., ASTM F-67, ASTM F136, ASTM F1044), material specifications, and comparison to the known safety and efficacy profiles of legally marketed predicate devices through the 510(k) Substantial Equivalence pathway. It relies on scientific and engineering principles rather than clinical 'ground truth' in the sense of diagnostic accuracy.
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical hip implant. It demonstrates substantial equivalence to existing devices based on traditional engineering and material science evaluations, rather than a clinical performance study with "acceptance criteria" and "test sets" as understood for AI/SaMD.

Summary

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Exhibit I

510(k) Summary SUMMIT™ Acetabular System

K98 3014

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

A. Contact Person:

Janet G. Johnson, RAC Associate Regulatory Affairs Specialist (508) 828-3466

B. Device Information:

Proprietary Name:	SUMMIT™ Acetabular System
Common Name:	Acetabular Cup and Liner
Classification Name:	Hip joint metal/ polymer semi-constrained porous-coated uncemented prosthesis
Regulatory Class:	Class II, per 21 §CFR 888.3358
Product Code:	87 LPH

C. Indications for Use:

All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.

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D. Device Description:

Also available for use with the SUMMIT™ Acetabular System are an apical hole plug and a variety of bone screws, all composed of titanium alloy.

E. Substantial Equivalence:

The SUMMIT™ Acetabular System is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the ZTT™ I and II Acetabular Cup (K951000), Arthopor™ I and II (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301).

The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ASTM F-67, ASTM F136 and ASTM F1044.

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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. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1998

Janet G. Johnson, RAC Associate Requlatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K983014 Summit™ Acetabular System Trade Name: Regulatory Class: II Product Code: LPH Dated: August 27, 1998 Received: August 28, 1998

Dear Ms. Johnson:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੋ substantially equivalent determination assumes 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 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. 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.

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Paqe 2 - Janet G. Johnson, RAC

This letter will allow you to begin marketing your device as described in your 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 requlation (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 obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
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) Device Name

SUMMIT™ Acetabular System

Indications For Use

All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	Yes
(Per 21 CFR §801.109)

Over-the-Counter Use	No
	(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices

510(k) Number	K983014
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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.