The ULTIMA® Acetabular Roof Reinforcement Ring 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 patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.

The Ultima® Acetabular Roof Reinforcement Ring is secured in the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide stabilization.

Device Description

The ULTIMA® Acetabular Roof Reinforcement Ring is a support component for the reconstruction of the acetabulum and is composed of commercially pure titanium (cp Ti). The ULTIMA® Acetabular Roof Reinforcement Ring is a hemispherical shell with a mesh of screw holes covering the shell to allow for use with cancellous screws for additional stabilization.

The ULTIMA® Acetabular Roof Reinforcement Ring is used in conjunction with the ULTIMA® UHMWPE Acetabular Cup and Augmented UHMWPE Cup, and is held into the prepared acetabulum using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide primary stabilization.

The ULTIMA® Acetabular Roof Reinforcement Rings will be available in a range of designated sizes from 40mm through 62mm in 2mm increments. The nominal outer diameter of the ULTIMA® Acetabular Roof Reinforcement Ring is the same as the designated size.

The instrumentation used for implanting the ULTIMA® Acetabular Roof Reinforcement Ring includes a drill guide, 70mm drill, flexible shaft, depth gauge, tap and screw clamp, hemispherical reamers and a universal screw driver.

AI/ML Overview

The provided text is a 510(k) summary for the ULTIMA® Acetabular Roof Reinforcement Ring, which is a medical device. This type of document is a premarket notification to the FDA, demonstrating that a new device is substantially equivalent to a legally marketed predicate device.

Therefore, the document does not describe "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of clinical performance or diagnostic accuracy studies for AI/ML devices.

Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device based on aspects like intended use, materials, design, sterilization, and packaging. The "acceptance criteria" in this context would be the FDA's regulatory requirements for 510(k) clearance, primarily demonstrating that the device is as safe and effective as a legally marketed predicate device.

Here's how to address the prompt based on the provided document:

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

This information is not directly available in the document in the format of a clinical performance study with specific metrics like sensitivity, specificity, or F1 score. The acceptance criteria for this 510(k) revolve around demonstrating substantial equivalence.

Acceptance Criteria (for 510(k) Clearance)	Reported Device Performance (as per 510(k) Submission)
Intended Use: Same as predicate device	The ULTIMA® Acetabular Roof Reinforcement Ring is indicated for total hip replacement procedures for various conditions (rheumatoid arthritis, osteoarthritis, etc.), similar to other existing devices.
Materials: Same or equivalent to predicate device	Composed of commercially pure titanium (cp Ti), a commonly used and accepted material in orthopedic implants.
Design: Same or equivalent to predicate device	Hemispherical shell with a mesh of screw holes, available in 40mm through 62mm sizes. This design is compared to the Protek Roof Reinforcement Ring (K953578).
Sterilization Method: Same or equivalent	(Not explicitly detailed in the provided text, but implied to be standard and equivalent for orthopedic implants.)
Packaging: Same or equivalent	(Not explicitly detailed in the provided text, but implied to be standard and equivalent for orthopedic implants.)
Performance Standards: Conformance to voluntary standards	Conformance with voluntary performance standards, e.g., ASTM F-67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). This implies the material meets established quality and performance benchmarks.

2. Sample size 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/provided. This 510(k) summary does not describe a clinical study with a test set of patient data to evaluate device performance in the way an AI/ML device would be evaluated for diagnostic accuracy. The basis for clearance is substantial equivalence to a predicate device.

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/provided. No ground truth for a test set is established in this summary, as it's not a clinical performance study.

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

This information is not applicable/provided. No adjudication method for a test set is described.

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/provided. This is a medical device (an acetabular roof reinforcement ring), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

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

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

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

This information is not applicable/provided. The concept of "ground truth" as it applies to clinical performance evaluation (e.g., for diagnostic accuracy) does not apply to this type of medical device submission. The "truth" for this submission is that it is substantially equivalent to a predicate device based on its technical characteristics and intended use.

8. The sample size for the training set

This information is not applicable/provided. This device is not an AI/ML model that requires a training set.

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

This information is not applicable/provided. This device is not an AI/ML model that requires a training set with established ground truth.

In summary: The provided document is a 510(k) premarket notification for a physical medical implant (an acetabular roof reinforcement ring). It establishes substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting clinical study data with acceptance criteria for diagnostic performance or AI algorithm accuracy. Therefore, most of the questions posed, which are highly relevant to AI/ML device evaluations, are not applicable to this document.

Summary

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Image /page/0/Picture/3 description: The image shows the text "K980286" in a handwritten style. Below this, the words "Exhibit I" are printed in a serif font. The text appears to be part of a document or label, possibly indicating an exhibit number or identification code.

APR 3 1998

510(k) Summary ULTIMA® Acetabular Roof Reinforcement Ring

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

1. Contact Person:

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

2. Device Information:

Proprietary Name:	ULTIMA® Acetabular Roof ReinforcementRing
Common Name:	Acetabular Roof Reinforcement Ring
Classification Name:	Hip joint metal/ polymer semi-constrainedcemented prosthesis
Regulatory Class:	Class II, per 21 §CFR 888.3350
Product Code:	87 IDI

3. Indications for Use:

The ULTIMA® Acetabular Roof Reinforcement Ring 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, posttraumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated 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 reconstructive techniques.

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4. Device Description:

5. Substantial Equivalence:

The ULTIMA® Acetabular Roof Reinforcement Ring is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the Protek Roof Reinforcement Ring (K953578).

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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized depiction of an eagle with its wings spread, symbolizing protection and service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 APR

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

Re: K980286 ULTIMA® Acetabular Roof Reinforcement Ring Trade Name: Regulatory Class: II Product Code: JDI Dated: January 23, 1998 Received: January 26, 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, Drug, 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 Requlations, Title 21, Parts 800 to 895. ಡಿ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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Page 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 regulation (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,

foiolesa

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

K980286 ULTIMA® Acetabular Roof Reinforcement Ring

Indications For Use

The ULTMA® Acetabular Roof Reinforcement Ring 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 patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.

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

bcooles

Prescription Use (Per 21 CFR §801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.