The indications for use of the Ascension Silicone PIP are for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.

Device Description

The Ascension® Silicone PIP is a single component silicone spacer consisting of a proximal and distal intramedullary stem and a central flexible hinge. The central flexible hinge has a pre-flexed angle of 15 degrees. The Ascension Silicone PIP is available in 6 sizes for use in left or right applications. Device components are provided sterile in individual packaging.

AI/ML Overview

This 510(k) summary (K082231) describes a medical device rather than a software algorithm or AI. Therefore, the concepts of "acceptance criteria," "study," "test set," "ground truth," "MRMC," and "standalone performance" as they relate to software performance evaluation are not applicable in this context.

The document discusses the Ascension® Silicone PIP, a finger joint prosthesis. For such devices, the "acceptance criteria" and "study" typically refer to bench testing, material characterization, biocompatibility testing, mechanical performance testing, and comparison to legally marketed predicate devices to demonstrate substantial equivalence.

Here's how the provided information relates to the typical evaluation of a medical device like this:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present a table of specific numerical acceptance criteria (e.g., accuracy thresholds) and reported device performance metrics in the way one would for a software algorithm. Instead, the "acceptance criteria" for a physical medical device are inherently met through the demonstration of substantial equivalence to predicate devices and adherence to relevant standards.

The "reported device performance" is inferred from its similarity to the predicate devices and the physical characteristics described.

Criterion Category (Inferred)	Acceptance Criteria (Inferred)	Reported Device Performance
Material Composition	Similar to predicate devices	Silicone
Design Features	Similar to predicate devices	Single component silicone spacer, proximal and distal intramedullary stem, central flexible hinge, 15-degree pre-flexed angle.
Intended Use	Replacement of PIP joint for advanced osteoarthritis, post-traumatic arthritis, rheumatoid arthritis.	Matches the predicate devices' intended use.
Surgical Technique	Similar to predicate devices	Implied to be similar to predicate devices.
Biocompatibility	Compliant with relevant standards for silicone implants (implied by 510k process).	Not explicitly stated but assumed to be met through standard regulatory pathways for implantable materials.
Mechanical Performance	Sufficient strength and durability for indicated use (implied by 510k process and similarity to predicates).	Not explicitly stated, but assumed to be comparable to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

This is irrelevant for a physical medical device. There isn't a "test set" of data in the sense of patient images or clinical records for an AI algorithm. The "test" for a physical device involves various forms of engineering and biocompatibility evaluations.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This is irrelevant for a physical medical device. "Ground truth" for a device like this would involve:

Material specifications: Established by material science experts and standards organizations.
Design specifications: Established by biomedical engineers.
Clinical effectiveness (long-term): Established by clinical trials and post-market surveillance (not part of initial 510k for substantial equivalence).

4. Adjudication Method for the Test Set:

This is irrelevant for a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

This is irrelevant. MRMC studies are used to evaluate the diagnostic accuracy of imaging systems or AI algorithms with multiple readers and cases. The Ascension® Silicone PIP is a prosthetic implant, not a diagnostic tool.

6. If a Standalone Performance Study was Done:

This concept doesn't directly apply. The "standalone performance" of a physical device refers to its ability to perform its intended function (e.g., the flexibility and articulation of the joint, material durability). This is typically assessed through bench testing (mechanical, wear, fatigue) and biocompatibility testing, rather than a "standalone study" akin to an algorithm. The 510(k) summary implies that these tests were conducted or that the shared characteristics with predicate devices negate the need for novel extensive testing for this specific submission.

7. The Type of Ground Truth Used:

For a physical medical device submitted via a 510(k), the "ground truth" for substantial equivalence is primarily based on:

Predicate Device Data: Evidence that the new device is as safe and effective as a legally marketed predicate device. This includes comparing materials, design, intended use, and performance characteristics.
Engineering Standards: Compliance with recognized national and international consensus standards for medical device design, manufacturing, and materials.
Biocompatibility Standards: Evidence that the materials used are safe for implantation in the human body.

8. Sample Size for the Training Set:

This is irrelevant for a physical medical device. There is no "training set" in the context of an AI algorithm.

9. How the Ground Truth for the Training Set was Established:

This is irrelevant for a physical medical device.

In summary, the provided 510(k) document is for a medical device (a joint prosthesis) and not a software algorithm. Therefore, the questions posed, which are designed for evaluating AI/software performance, are not directly applicable.

The "study that proves the device meets the acceptance criteria" for a physical device in a 510(k) submission generally refers to:

Non-clinical testing: Benchtop mechanical testing (fatigue, wear, tensile strength, etc.), material characterization, and biocompatibility testing.
Comparison to predicate devices: Demonstrating that the new device is substantially equivalent in terms of materials, design, intended use, and performance to one or more legally marketed predicate devices.

The document states: "A comparison of the Ascension Silicone PIP and the DePuy NeuFlex PIP Finger Implant (K001922) and Ascension Silicone MCP (K022892) show similar material, design features, surgical technique and indications." This statement is the core of the "study" described, demonstrating substantial equivalence rather than presenting specific performance metrics from a clinical trial or algorithm test.

Summary

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K08223i.

6	510(k) Summary	JAN 12 2009
	SUBMITTER NAME:	Ascension Orthopedics, Inc.8700 Cameron Road, #100Austin, TX 78754-3832
	510(k) CONTACT:	Debbie StearnsPhone: (512) 836-5001 x1548
	TRADE NAME:	Ascension® Silicone PIP
	COMMON NAME:	Prosthesis, finger, constrained, polymer
	CLASSIFICATION:	21 CFR 888.3230
	PRODUCT CODE:	KYJ
	PANEL:	Orthopedic

PREDICATE DEVICES:

K022892 - Ascension Silicone MCP K001922 - DePuy Neuflex PIP Finger

DEVICE DESCRIPTION:

INTENDED USE:

The indications for use of the Ascensions Silicone PIP are for replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, posttraumatic arthritis and rheumatoid arthritis.

BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of the Ascension Silicone PIP and the DePuy NeuFlex PIP Finger Implant (K001922) and Ascension Silicone MCP (K022892) show similar material, design features, surgical technique and indications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper half of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ascension Orthopedics, Inc. % Ms. Debbie Stearns 8700 Cameron Road, Suite 100 Austin, Texas 78754-3832

JAN 12 2009

Re: K082231

Trade/Device Name: Ascension Silicone PIP Regulation Number: 21 CFR 888.3230 Regulation Name: Finger joint polymer constrained prosthesis Regulatory Class: II Product Code: KYJ Dated: December 23, 2008 Received: December 29, 2008

Dear Ms. Stearns:

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 (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

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Page 2 - Ms. Debbie Stearns

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,

Mark M Mulkerson

Mark N. Melkerson - 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 Statement

510(K) Number. K082231

Device Name:

Ascension® Silicone PIP

Indications for Use:

Prescription Use	X
(Part 21 CFR 801Subpart B) C

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

L 082231

Regulation Number and Section

§ 888.3230 Finger joint polymer constrained prosthesis.

(a)
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.(b)
Classification. Class II.