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The Unity Beta Anchor System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

The Unity Beta Anchor System is designed for the fixation of tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLLA) implant materials are ultrasonically joined to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall, suture management.

The provided text is a 510(k) premarket notification for the Unity Beta Anchor System. This type of document outlines the technical specifications and intended use of a medical device and seeks to demonstrate its substantial equivalence to a legally marketed predicate device.

After reviewing the document, I can say that it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of performance metrics, sample sizes, expert involvement, or statistical analysis typically found in clinical or laboratory performance studies.

Here's why and what information is present:

1. Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in a table format with specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical thresholds with acceptance limits). The document mentions "Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Beta Anchor System to predicate devices." However, it does not provide the results, specific acceptance criteria for these comparisons (e.g., "tensile strength must be within X% of the predicate device"), or reported performance values.

2. Sample Size used for the test set and data provenance: Not mentioned.

3. Number of experts used and their qualifications for establishing ground truth: Not applicable, as this is a mechanical fixation device, not one that requires expert interpretation of diagnostic images or data for ground truth.

4. Adjudication method for the test set: Not applicable.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical data. This device is a surgical fixation device.

6. Standalone (algorithm only) performance: Not applicable, as this is a mechanical device, not an algorithm.

7. Type of ground truth used: For a mechanical device, "ground truth" would typically refer to validated mechanical testing methods (e.g., ASTM standards for tensile strength, pull-out strength). The document only generally states that "Design verification testing... compared the mechanical strengths and failure modes." Specifics are absent.

8. Sample size for the training set: Not applicable. This document refers to a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what is in the document:

• Device Name: Unity Beta Anchor System
• Manufacturer: Bonutti Research, Inc.
• Contact Information: Patrick Balsmann, MBA, MS, RAC
• Date Prepared: September 29, 2008
• Common Name: Fixation Device
• Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.
• Device Description: Absorbable poly-L-lactic acid (PLLA) implants ultrasonically joined for the fixation of tissue, ligament, tendon, and bone. It uses an electrical generator to provide ultrasonic energy to weld the implant materials.
• Indications for Use: Fixation of tissue, ligament, tendon, and bone as fasteners (anchors), indicated in general soft tissue approximation/ligation.
• Predicate Device(s): Existing Bonutti Research, Inc., fixation products and various other suture anchors determined to be substantially equivalent.
• Predicate Comparison: "Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Beta Anchor System to predicate devices." (No specific results or acceptance criteria provided)
• Regulatory Information:
  • 510(k) Number: K082906
  • Regulation Number: 21 CFR 888.3040
  • Regulation Name: Smooth or threaded metallic bone fixation fastener (Note: The product is PLLA, not metallic, but falls under this classification for regulatory purposes).
  • Regulatory Class: Class II

In conclusion, the document serves as a regulatory submission demonstrating substantial equivalence based on design and intended use, and general mechanical comparison to predicate devices, but it does not provide the detailed performance study results and acceptance criteria as outlined in your request.

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