The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentially the same shape as the native lunate bone. The Lunate implant acts as an articulating spacer to maintain the relationship of adjacent carpal bones after excision and to maintain mobility of the wrist. The articular concavity that captures the capitate is more exaggerated to enhance stability. The Lunate implant has two suture holes that allow fixation of the implant to the adjacent scaphoid and triquetrium bones to provide temporary postoperative stability while a capsuloligamentous system forms around the implant. The Ascension Pyrocarbon Lunate is constructed of a high strength On-X® PyroCarbon layer deposited on a graphite substrate. The graphite is impregnated with tungsten making the Lunate implant radiopaque. The Ascension Pyrocarbon Lunate is available in 5 sizes for use in left or right applications. Device components are provided sterile in individual packaging.

AI/ML Overview

The provided text describes the 510(k) summary for the Ascension® PyroCarbon Lunate, focusing on its substantial equivalence to predicate devices rather than a detailed study evaluating specific acceptance criteria for performance.

Therefore, many of the requested details about acceptance criteria, device performance metrics, study design, and ground truth establishment are not available in the provided document. The 510(k) process primarily relies on demonstrating substantial equivalence, often through comparison of design, materials, and intended use, along with basic performance testing to ensure safety.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria (Inferred from 510(k) Summary)	Reported Device Performance (as stated in the document)
Maintain relationship of adjacent carpal bones after excision	Acts as an articulating spacer to maintain the relationship of adjacent carpal bones after excision. (Device Description)
Maintain mobility of the wrist	Maintains mobility of the wrist. (Device Description)
Enhanced stability (articulation with capitate)	The articular concavity that captures the capitate is more exaggerated to enhance stability. (Device Description)
Temporary postoperative stability (suture holes)	Two suture holes that allow fixation of the implant to the adjacent scaphoid and triquetrium bones to provide temporary postoperative stability. (Device Description)
Strength and endurance adequate to ensure device safety	"Performance testing was performed on the Pyrocarbon Lunate. These test results demonstrate that the Ascension Lunate's strength and endurance are adequate to ensure device safety." (Basis of Substantial Equivalence)
Biocompatibility and material properties similar to predicate	Made of "a high strength On-X® PyroCarbon layer deposited on a graphite substrate." (Device Description) "The Ascension Lunate and the Ascension CMC (K061451) are made of the same material." (Basis of Substantial Equivalence)
Radiopacity (visibility on imaging)	The graphite is impregnated with tungsten making the Lunate implant radiopaque. (Device Description)

Note: The acceptance criteria for "strength and endurance" are not explicitly quantified in terms of specific thresholds (e.g., specific load, cycles, or failure rates). The document only states that the testing demonstrated they were "adequate to ensure device safety."

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 available in the provided text. The document refers to "performance testing" but does not detail the nature of these tests (e.g., in vitro, animal, human clinical), the number of samples tested, or any patient data provenance.

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 available. Given that the performance testing mentioned likely refers to mechanical/material testing for safety and endurance, there wouldn't typically be a "ground truth" established by clinical experts in the same way there would be for a diagnostic AI device.

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

This information is not available. Adjudication methods are typically relevant for clinical studies, especially those involving expert interpretation or subjective outcomes. The provided text does not describe clinical studies that would necessitate such methods.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied. This type of study is specific to evaluating diagnostic or assistive AI devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Ascension® PyroCarbon Lunate is a medical implant, not a diagnostic AI device.

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

This question is not applicable as the device is a medical implant, not an algorithm or AI-powered system designed for standalone performance.

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

The "ground truth" for the performance testing mentioned in the document would likely be engineering standards and specifications for mechanical properties (e.g., strength, endurance limits, material integrity) rather than clinical ground truth (like pathology or outcomes data). The document explicitly states, "These test results demonstrate that the Ascension Lunate's strength and endurance are adequate to ensure device safety." This suggests a comparison against predefined safety thresholds or benchmarks for the material and design.

8. The sample size for the training set

This information is not applicable as there is no "training set" in the context of this device. A training set is used for machine learning models, which is not relevant for this medical implant.

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

This information is not applicable for the same reason as above; there is no training set for this device.

Summary

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6	510(k) Summary	K080997 pg 1
SUBMITTER NAME:	Ascension Orthopedics, Inc.8700 Cameron Road, #100Austin, TX 78754-3832
510(k) CONTACT:	Debbie Stearns	JUN 17 2008

510(k) CONTACT: Debbie Stearns Phone: (512) 836-5001 x1548
Ascension® PyroCarbon Lunate TRADE NAME:

Prosthesis, Wrist Carpal Lunate COMMON NAME:

CLASSIFICATION: 21 CFR 888.3750

PRODUCT CODE: KWN

Orthopedic PANEL:

PREDICATE DEVICES:

K864491 - Swanson Titanium Carpal Lunate Implant K061451 - Ascension PyroCarbon CMC

DEVICE DESCRIPTION:

INTENDED USE:

The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of:

Avascular necrosis (Kienboch's disease) .
Localized osteoarthritic changes �
Long-Standing dislocations .

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510(k) Premarket Notification Device: Ascension® Lunate

K080947 pg 2 of 2 Page 13 of 141

BASIS OF SUBSTANTIAL EQUIVALENCE:

A comparison of the Ascension Lunate and the Swanson Titanium Carpal Implant (K864491) show similar design features, surgical technique and indications. The Ascension Lunate and the Ascension CMC (K061451) are made of the same material and both are intended to articulate with carpal bone.

Performance testing was performed on the Pyrocarbon Lunate These test results demonstrate that the Ascension Lunate's strength and endurance are adequate to ensure device safety.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2008

Director, Clinical Affairs 8700 Cameron Road, #100 Austin, Texas 78754-3832

Ascension Orthopedics, Inc.

% Ms. Debbie Steams

Re:

K080997 Trade/Device Name: Ascension PyroCarbon Lunate Regulation Number: 21 CFR 888.3750 Regulation Name: Wrist joint carpal lunate polymer prosthesis Regulatory Class: Class II Product Code: KWN Dated: April 4, 2008 Received: April 16, 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.

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Page 2 – Ms. Debbie Stearns

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.

Mark N. Milliman

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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5 Indications for Use Statement

KO80997 510(K) Number.

Device Name:

Ascension® PyroCarbon Lunate

Indications for Use:

The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of:

Avascular necrosis (Kienboch's disease)
Localized osteoarthritic changes
Long-Standing dislocations

OR Prescription Use × Over-The-Counter Use (Part 21 CFR 801Subpart B) (Part 21 CFR 801Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Re al for mkm

Division Sig Division of General, Restorative, and Neurological Devices

510(k) Number K080997

Regulation Number and Section

§ 888.3750 Wrist joint carpal lunate polymer prosthesis.

(a)
Identification. A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.(b)
Classification. Class II.