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The Surgical Dynamics ' S•D sorb • E-Z Tac' is indicated for use in soft tissue to bone fixation for rotator cuff repairs and reattachment of the glenoid labrum and/or inferior glenohumeral ligament.

The Surgical Dynamics* S.D sorb* E-Z Tac* is an absorbable implant to be used for affixing soft tissue to bone.

This section of the 510(k) lacks specific acceptance criteria and detailed study information that would allow for a complete table of acceptance criteria and device performance, or a comprehensive description of a study proving the device meets acceptance criteria. The provided text is a summary of safety and effectiveness for a medical device (Surgical Dynamics SD sorb E-Z Tac, a bone anchor) and the FDA's clearance letter.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical or qualitative acceptance criteria for mechanical properties, biocompatibility, degradation, or clinical efficacy.
• Actual test results or performance metrics from any studies.

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

This information is not provided in the document. The text does not describe any specific test set for evaluation, nor does it mention sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature of data).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The document primarily focuses on regulatory clearance based on substantial equivalence, not on specific clinical studies involving expert adjudication for ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided in the document. MRMC studies are typically for imaging or diagnostic devices to assess reader performance with/without AI assistance, which is not relevant to this type of mechanical implant device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided and is not applicable. This is a physical, absorbable surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

This information is not explicitly stated as part of a formal "ground truth" establishment for a study in the provided text. The regulatory clearance is based on the device being "substantially equivalent" to predicate devices. This implies that the device design, materials, and intended use are similar enough to already approved devices, which would have had their own evidence of safety and efficacy (their "ground truth" or clinical validity) established prior to their market entry. For this specific 510(k), the "ground truth" for showing safety and effectiveness is implicitly tied to that of the predicate devices and general biocompatibility standards (e.g., ISO 10993-1 compliance).

8. The Sample Size for the Training Set

This information is not provided and is not applicable. This is a physical medical device, not an AI/ML algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable, as there is no "training set" for this type of device.

Summary of the Study (Based on Provided Text):

The provided document describes a 510(k) Premarket Notification for the Surgical Dynamics* S.D sorb* E-Z Tac* device. This is a regulatory submission process in the U.S. for medical devices.

• Type of Study: This is not a classic "study" in the sense of a clinical trial or performance evaluation with specific acceptance criteria beyond regulatory compliance. Instead, it's a demonstration of "substantial equivalence" to legally marketed predicate devices.
• Purpose: To show that the new device is as safe and effective as existing predicate devices and does not raise new questions of safety and effectiveness.
• Methodology (implied): The submission likely included:
  • Comparison to Predicate Devices: Detailed comparison of the device's design, materials, indications for use, and technological characteristics to the predicate devices (Surgical Dynamics* S.D sorb* E-Z Tac* (K961585), Surgical Dynamics* S.D sorb* Suture Anchor (K961578), Mitek GII Bone Anchor (K953877)).
  • Biocompatibility Testing: The text explicitly mentions "composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile." This indicates that biocompatibility studies were conducted, likely in accordance with this standard, to ensure the materials are safe for human implantation.
  • Mechanical/Performance Testing (implied): While not detailed, a substantial equivalence submission for an implantable device like a bone anchor would typically include non-clinical performance data (e.g., mechanical strength, degradation properties, fixation strength) to show that it performs similarly to the predicate devices and meets design specifications. These tests would be in vitro or ex vivo.
• Outcome: The FDA determined that the device is "substantially equivalent" to the predicate devices, allowing it to be marketed.

In essence, this document is a regulatory approval notice, not a detailed research paper describing a specific performance study with explicit acceptance criteria and results. The "proof" the device meets acceptance criteria comes from its successful comparison to predicate devices, which are already considered safe and effective, and its compliance with general biocompatibility standards.

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