ULNAR HEAD IMPLANT

• K Number: K982268
• Device Name: ULNAR HEAD IMPLANT
• Manufacturer: AVANTA ORTHOPAEDICS, INC.
• Date Cleared: 1998-12-04 ( 158 days)
• Product Code: KXE , PRE
• Regulation Number: 888.3810
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Avanta Orthopaedics 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
  • Failed ulnar head resection

Device Description

The ulnar head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the distal ulnar head.

AI/ML Overview

The provided text is a 510(k) Summary for the Avanta Orthopaedics Ulnar Head implant. This document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device for marketing purposes. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical trial reports or performance studies for AI/medical device software.

The document focuses on comparing the Avanta Ulnar Head implant to a predicate device (Silastic Swanson Ulnar Head Implant) in terms of design, materials, indications for use, and other characteristics to establish substantial equivalence for regulatory approval.

Therefore, I cannot provide the requested information from the given text.

To address your request fully, a document detailing performance testing, clinical studies, or verification and validation activities specific to the Avanta Ulnar Head Implant would be required. Such a document would typically include:

1. Acceptance Criteria and Reported Device Performance: Usually presented for mechanical properties (e.g., tensile strength, fatigue life), biocompatibility, or sterility, and compared against predefined thresholds.
2. Sample Size and Data Provenance: For material testing, it would be the number of test articles. For any human-related data (e.g., historical clinical outcomes for a previous version or similar device if used as supportive data), it would specify the source.
3. Number of Experts/Qualifications: Not applicable for a purely mechanical or material device performance study. This is relevant for diagnostic devices where ground truth is established by clinical experts.
4. Adjudication Method: Not applicable for the type of device described here.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: Not applicable as this is a physical medical implant, not an AI or diagnostic imaging device.
6. Standalone Performance: For an implant, this would refer to its inherent material and mechanical properties, not an "algorithm."
7. Type of Ground Truth: For an implant, "ground truth" relates to material specifications, engineering standards, biocompatibility testing results (e.g., ISO standards), and clinical outcomes from long-term use of similar devices.
8. Sample Size for Training Set: Not applicable as this is not an AI/ML device.
9. How Ground Truth for Training Set was Established: Not applicable as this is not an AI/ML device.

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.