SBI ULNAR HEAD IMPLANT by SMALL BONE INNOVATIONS INC.

The SBI Ulnar Head Implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.

Device Description

The uHead™ Ulnar Head Replacement prosthesis is currently approved under 510(k) K010786 and marketed by Small Bone Innovations. This device is used to treat patients with rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection. The sigmoid notch component is used in conjunction with the uHead™ device. Dependent upon the severity of degenerative joint disease and forearm stability, the sigmoid notch component can be used to restore stabile wrist function and improve forearm kinematics that is not always obtainable with the uHead™ prosthesis alone.

AI/ML Overview

This 510(k) summary for the SBI Ulnar Head Implant primarily focuses on establishing substantial equivalence to previously marketed devices. It does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Information on a specific study conducted for this 510(k) submission to demonstrate performance against acceptance criteria. Instead, it refers to documentation showing substantial equivalence.
Details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The provided text is a regulatory submission for premarket notification (510(k)) for a medical device. A 510(k) typically demonstrates substantial equivalence to existing devices rather than requiring an extensive de novo clinical trial with defined acceptance criteria for performance in the same way a PMA submission might.

Therefore, many of your requested points cannot be answered from the provided text.

Here's what can be extracted from the document:

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

Not Available. The document does not provide specific performance acceptance criteria or a "reported device performance" table as if from a study designed to meet specific metrics. It states, "Documentation is provided which demonstrated the SBI Ulnar Head Implant to be substantially equivalent to other legally marketed devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. There is no mention of a "test set" or a study in this context that would involve a sample size for performance evaluation. The substantial equivalence argument likely relies on design, material, and intended use comparison to predicate devices, rather than a new performance study.

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)

Not Applicable / Not Available. This information is not relevant to a 510(k) substantial equivalence submission for this type of device. There is no mention of a "ground truth" establishment process within this document.

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

Not Applicable / Not Available. No test set or adjudication method 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

No. This is a physical implant device, not an AI diagnostic tool. Therefore, an MRMC study and AI assistance are not applicable.

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

No. This is a physical implant device.

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

Not Applicable / Not Available. The concept of "ground truth" as typically applied to diagnostic algorithms or imaging interpretation is not relevant for this device's 510(k) submission.

8. The sample size for the training set

Not Applicable / Not Available. This is a physical implant device, not an AI algorithm. Therefore, there is no "training set."

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

Not Applicable / Not Available. As above, no training set exists for this device.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states: "Documentation is provided which demonstrated the SBI Ulnar Head Implant to be substantially equivalent to other legally marketed devices."

This indicates that the "study" proving the device meets acceptance criteria (which, in a 510(k), are generally met by demonstrating equivalence to a predicate device) is a comparison against legally marketed predicate devices. The specific details of that "documentation" are not elaborated on in this summary but would typically include:

Comparison of Intended Use: Showing the new device has the same intended use as predicate devices. (The document explicitly lists the intended use).
Comparison of Technological Characteristics: Demonstrating that the new device has substantially similar technological characteristics (e.g., materials, design principles, operating principles) to predicate devices. (The document mentions material: "implantable grades of cobalt chrome (ASTM 1537-94), with CpTi coating.").
Performance Data (if necessary): For an implant, this would primarily involve non-clinical testing (e.g., mechanical testing, biocompatibility testing) to ensure it performs safely and effectively in a similar manner to the predicate, or that any differences do not raise new questions of safety and effectiveness. This summary does not detail these non-clinical tests, but they would be part of the "documentation."

In summary, the provided text is a high-level summary for a 510(k) premarket notification. It asserts substantial equivalence to predicate devices as the basis for marketing clearance, rather than detailing a specific clinical performance study against pre-defined acceptance criteria.

Summary

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K061146 (pg 1 of 2)

510(k) Summary

JUL 1 9 2006

Manufacturer:	Small Bone Innovations1711 South Pennsylvania AveMorrisville, PA 19067215-428-1791
Submitted By:	Small Bone InnovationsJames O' Connor505 Park Avenue, 14th FloorNew York, NY 10022joconnor@totalsmallbone.com215-428-1791 - Office212-750-2112 - Fax
Proprietary Name:	SBI Ulnar Head Implant
Classification name:	Class II, 888.3810 - Prosthesis, Wrist, Hemi-, Ulnar
Common/Usual Name:	Ulnar Head Implant
Substantial Equivalence:	Documentation is provided which demonstrated the SBIUlnar Head Implant to be substantially equivalent to otherlegally marketed devices.
Device Description:	The uHead™ Ulnar Head Replacement prosthesis iscurrently approved under 510(k) K010786 and marketed bySmall Bone Innovations. This device is used to treatpatients with rheumatoid, degenerative, or post-traumaticdisabilities presenting the following; pain and weakness ofthe wrist joint not improved by conservative treatment,instability of the ulnar head with x-ray evidence of dorsalsubluxation and erosive changes, and failed ulnar headresection. The sigmoid notch component is used inconjunction with the uHead™ device. Dependent upon theseverity of degenerative joint disease and forearm stability,the sigmoid notch component can be used to restore stabilewrist function and improve forearm kinematics that is notalways obtainable with the uHead™ prosthesis alone.
Intended Use:	The SBI Ulnar Head Implant is intended for replacement ofthe distal radioulnar joint following ulnar head resectionarthroplasty: Replacement of the distal ulnar head forrheumatoid, degenerative, or post-traumatic disabilitiespresenting the following; pain and weakness of the wristjoint not improved by conservative treatment, instability ofthe ulnar head with x-ray evidence of dorsal subluxationand erosive changes, and failed ulnar head resection.
Material:	The SBI Ulnar Head Implant is designed from implantablegrades of cobalt chrome (ASTM 1537-94), with CpTicoating.

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KO61146 ( pg.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a caduceus, which is often associated with healthcare. The overall design is simple and professional, reflecting the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2006

Small Bone Innovations % Mr. James O'Connor VP, QA/QC & Regulatory Affairs 505 Park Avenue, 14th Floor New York, New York 10022

Re: K061146

Trade/Device Name: SBI Ulnar Head Implant Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: Class II Product Code: KXE Dated: June 13, 2006 Received: June 19, 2006

Dear Mr. O'Connor:

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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Indications for Use

510(k) Number:

Device Name: SBI Ulnar Head Implant

Indications For Use:

The SBI Ulnar Head Implant is intended for replacement of the distal radiouinar joint following unar The SBI Unial Head Infont is intended for reprosition of the distal ulnar head for rheumatoid, degencrative, or posttraumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by and or traumatic disabilities presenting the introwing, pain and with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Ambare Buchup

Division of General, Restorative, and Neurological Devices

510(k) Number K061146.

Regulation Number and Section

§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.