The Ensemble CMC is intended to replace the first metacarpal and the trapezium in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

Device Description

The Ensemble CMC implant is a single use, uncemented, one-piece interpositional joint prosthesis designed to fit in the space between the trapezium and first metacarpal for patients with early stage arthritis of the carpometacarpal joint (CMC). The Ensemble CMC is not intended to interact with other devices. It has upper and lower surfaces that are saddle (toroidal) shaped to match the anatomy of the base of the first metacarpal and the trapezium. The design of the Ensemble CMC allows for flexion-extension, abduction-adduction, and circumduction motions. The implant is manufactured with an On-X® PyroCarbon (pyrocarbon) layer encasing a graphite core and comes in three sizes. Each device is provided sterile in packaging containing a single implant, Instructions for Use, and patient chart labels.

A series of non-powered, hand-held manual surgical instruments can be used to prepare the joint space before implantation of the Ensemble CMC.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary:

This device (Ensemble CMC) is a medical implant, not an AI/ML algorithm or a diagnostic tool. Therefore, the concept of a "test set," "ground truth," "expert consensus," "MRMC study," or "standalone algorithm performance" as described in the prompt's context for AI/ML devices is not directly applicable to this submission. The "study" here refers to non-clinical mechanical testing, not a clinical trial or performance evaluation against a diagnostic standard.

Here's an analysis of the provided text in the requested format, interpreting "acceptance criteria" as the performance aspects evaluated for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Aspects Evaluated)	Reported Device Performance
Material Characteristics	Demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing.
Joint Biomechanics	Demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing.
Static Testing	Demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing.
Endurance Testing	Demonstrated substantial equivalence to predicate devices through non-clinical mechanical testing.
Allowable Range of Motion	Confirmed through cadaveric testing.
Prevention of Impingement	Confirmed through cadaveric testing.

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

Sample Size:
- The document mentions "cadaveric testing" for range of motion and impingement, but does not specify the sample size (i.e., number of cadavers or samples tested).
- For the other mechanical tests (material, joint biomechanics, static, endurance), the document refers to "non-clinical mechanical testing" but does not specify sample sizes of implants tested.
Data Provenance: The cadaveric testing implies biological samples, but the country of origin is not specified. Given it's an FDA submission, it's likely conducted in or for the US market, but this is an inference. The other mechanical testing is laboratory-based; provenance is not applicable in the same way as clinical data.
Retrospective or Prospective: Not applicable as this is not a study on clinical data.

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

Not applicable in the context of AI/ML ground truth. For an implant, "ground truth" would relate to accepted engineering and biomechanical principles, as well as the physical properties of the materials. No "experts" are noted in the role of establishing diagnostic ground truth or labeling data. The engineers and scientists conducting the mechanical tests would be qualified in their respective fields.

4. Adjudication Method

Not applicable. This relates to diagnostic interpretation consensus, which is not relevant for an orthopedic implant's mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI/ML device for diagnostic assistance, so an MRMC study comparing human readers with and without AI assistance was not conducted.

6. Standalone (Algorithm Only) Performance

No. This is a physical medical device (an implant), not an algorithm.

7. Type of Ground Truth Used

For the mechanical and cadaveric testing, the "ground truth" is defined by:
- Engineering specifications and standards: For material, static, and endurance testing.
- Biomechanical principles and anatomical observation: For joint biomechanics, range of motion, and impingement confirmed through cadaveric studies.
- Comparison to predicate devices: The overall goal was to demonstrate "substantial equivalence" to established, legally marketed predicate devices, meaning performance characteristics were compared to these existing devices.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The device itself is manufactured, not "trained."

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm.

Summary

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December 2, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ensemble Orthopedics, LLC Sandie Roth VP, Regulatory Affairs 107 Redbud Trail, Suite 11 Austin, Texas 78746

Re: K201072

Trade/Device Name: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist Joint Carpal Trapezium Polymer Prosthesis Regulatory Class: Class II Product Code: KYI Dated: October 30, 2020 Received: November 2, 2020

Dear Sandie Roth:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vesa Vuniqi Assistant Director DHT6A2: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201072

Device Name ENSEMBLE CMC

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Ensemble Orthopedics LLC. The word "ENSEMBLE" is written in a large, sans-serif font, with each letter outlined in black. Below the word "ENSEMBLE" is the text "ORTHOPEDICS LLC", written in a smaller, bold, sans-serif font.

510(k) Summary Ensemble CMC

July 24, 2020

Submitter:

Ensemble Orthopedics, LLC 107 Redbud Trail, Suite 11 Austin, TX 78746 Tel: (512) 364-3830 Contact: Sandie Roth, VP of Regulatory Email: sroth@ensembleortho.com

Establishment Registration Number: TBD

Name and Classification:

Trade Name:	ENSEMBLE CMC
Common Name:	Carpometacarpal implant
Regulation Name:	Wrist joint carpal trapezium polymer prosthesis
Classification:	21 CFR 888.3770
Product Code:	KYI
Regulatory Class:	Class II

Predicate Devices:

K042690	Ascension PyroSphere, Cleared December 13, 2004
K061451	Ascension CMC, Cleared August 11, 2006
K092548	Extremity Medical Trapezium, December 15, 2009
K111068	Stablyx CMC Arthroplasty, Cleared December 30, 2011
K033529	Tie-In Trapezium, Cleared December 3, 2003

Description of the Device:

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On-X® PyroCarbon (pyrocarbon) layer encasing a graphite core and comes in three sizes. Each device is provided sterile in packaging containing a single implant, Instructions for Use, and patient chart labels.

A series of non-powered, hand-held manual surgical instruments can be used to prepare the joint space before implantation of the Ensemble CMC.

Intended Use:

The Ensemble CMC is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

Technological Characteristics:

The substantial equivalence of the Ensemble CMC to the predicate device is demonstrated by similarities in indications for use, device design, materials, manufacturing process, anatomical site, principles of operation, and sterility status. A comparison of technological characteristics of the Ensemble CMC and the predicate devices do not raise any new questions of safety or effectiveness.

Non-Clinical Testing:

Non-clinical mechanical testing was performed to demonstrate that the Ensemble CMC is substantially equivalent to the performance characteristics of the predicate devices currently marketed with respect to material characteristics, joint biomechanics, static and endurance testing. Cadaveric testing was performed to demonstrate the allowable range of motion and to confirm that the device does not cause impingement. Based on the results of the non-clinical testing, it can be concluded that the subject device is as safe and effective as legally marketed predicate devices.

Clinical Performance:

No clinical performance data were needed to support substantial equivalence of this implant to the predicate device.

Conclusion:

The Ensemble CMC is substantially equivalent to the predicate device identified in this premarket submission.

Regulation Number and Section

§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.

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