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The Tigon Medical Tissue Anchor System is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions). Acromnioclavicular separation repairs, Rotator cuff repairs, Bicep tenodesis;

Elbow, Wrist, and Hand: Biceps tendon reattachmnent, Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair;

Knee: Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medials obliquous advancement), Illiotibial band tenodesis;

Foot and Ankle: Hallux valgus repairs. Medial or Lateral instability repairs/reconstructions. Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy

The Tigon Medical Tissue Anchor System consists of multiple-sized medial, lateral tissue anchors, and a single sized labral anchor. The medial anchors are threaded and are offered in 5.5 and 6.5 mm outer diameter sizes. The lateral anchors are conically barbed and are offered in 4.8 and 6 mm outer diameter sizes. The lateral anchors also offer unique angled locking slits to eliminate the need for knotting to secure the suture. The labral anchors are also barbed, and are offered in a 2.9 mm outer diameter, and are available with grooves, and two groove-less, knotless varieties (with and without locking slit). Tigon Tissue Anchors can be used with Tigon 2mm CuffTape and Tigon #2CuffCable (sold separately). Each tissue anchor will have a similar inserter.

The provided text describes the 510(k) summary for the Tigon Medical Tissue Anchors, specifically addressing its substantial equivalence to predicate devices. It outlines the device's indications for use, description, and technological characteristics. Crucially, it details the non-clinical and clinical performance data, but does not describe a study that uses AI/algorithm-based outcomes or human-in-the-loop performance.

The document discusses acceptance criteria and device performance in the context of mechanical, material, and sterilization testing for a medical device (tissue anchors), not a software or AI-based diagnostic/assessment tool. Therefore, many of the specific questions related to AI/algorithm performance (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth for training set) are not applicable to this submission.

However, based on the provided text, I can infer the following about the acceptance criteria and proof of substantial equivalence for this mechanical device:

Acceptance Criteria and Device Performance (for Tigon Medical Tissue Anchors - a physical medical device)

This submission focuses on demonstrating substantial equivalence to predicate devices through physical and material testing, rather than an AI/algorithm-based performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that tests were completed and results concluded that the device "passed all pre-determined acceptance criteria." It implies that the acceptance criteria were defined by relevant ASTM and ISO standards for medical devices.

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

• The document does not specify a "test set" in the context of an AI/algorithm.
• For the non-clinical performance data (mechanical, material, packaging, sterilization), typical sample sizes are used as defined by the respective ASTM/ISO standards. This is not explicitly stated but is an industry standard.
• The data provenance is from in-vitro laboratory testing conducted by the manufacturer (Tigon Medical and/or its testing partners) to meet regulatory requirements for a physical medical device. This is prospective testing of the manufactured device.

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

• This is not applicable. Ground truth, in the context of AI/algorithm performance, refers to expertly labeled data. For a physical medical device, "ground truth" is established by the physical and chemical properties of the device and its performance against established engineering and safety standards. The "experts" would be the engineers, material scientists, and quality assurance personnel conducting and verifying the tests according to the standards.

4. Adjudication Method for the Test Set:

• This is not applicable. Adjudication is relevant for resolving discrepancies in expert labeling of data for AI. For physical device testing, results are quantitative and compared directly to predetermined acceptance criteria defined by standards.

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:

• This is not applicable. This submission is for a physical tissue anchor, not an AI-assisted diagnostic or treatment planning system. There are no "human readers" to assist or improve.

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

• This is not applicable. The device is a physical tissue anchor, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's performance is based on established engineering standards, material science principles, and regulatory requirements for the physical properties, mechanical strength, biocompatibility, and sterility of medical implants. Performance is validated against these objective standards.

8. The Sample Size for the Training Set:

• This is not applicable. There is no AI/algorithm training set for this physical device.

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

• This is not applicable.

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The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. It is intended to be implanted using the Compasso surgical instruments.

Compasso is a series of surgical instruments intended for use for the implantation of the Elite SPK or the Sharc-FT bone anchor.

The Elite SPK is an implantable bone anchor device designed to ensure the fixation of soft tissues (especially tendons) to bone, during the repair of injuries to the shoulder performed with open or arthroscopic technique. The implantable anchor is made of polyether ether ketone (PEEK), and allows the surgeon to attach the injured tendon to the humerus using a transosseous "double row" technique. The ELITE SPK anchor is suitable for a 3 mm in diameter hole, and is provided sterile for single use.

The Compasso is a series of manual surgical instruments to implant the Elite SPK. Instruments in contact with human body are made of Stainless Steel in conformity with ISO 5832-1, while other components not in contact with the patient are made of stainless steel, aluminum and laser sintering polyamide.

The Elite SPK may be provided in a kit form with sutures for physician convenience. The sutures are provided in their final, sterile form in the original packaging from the manufacturer. FDA has previously cleared the provided sutures in 510(k) application K100006; specifically, the kit includes the HS Fiber Sutures.

This document is a 510(k) Pre-market Notification for the Elite SPK, Compasso, and Elite SPK Kit, seeking clearance from the U.S. Food and Drug Administration (FDA). This notification declares the substantial equivalence of the new device to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Sterilization	The sterilization cycles have been validated following international standards. (Implied acceptance: device is terminally sterilized and meets sterility assurance level standards).
   Shelf Life	The shelf life of the devices has been established through stability studies. (Implied acceptance: device maintains its properties and safety over its declared shelf life).
   Biocompatibility	Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" have been taken into account. (Implied acceptance: materials are non-toxic, non-irritating, non-sensitizing, etc., as per ISO 10993 standards for medical devices in contact with tissue).
   Fixation Strength (Elite SPK)	Performance testing was performed to evaluate the fixation strength of the Elite SPK compared to the predicate device. These tests showed that the Elite SPK has adequate fixation strength and is comparable to the predicate devices. (Implied acceptance: fixation strength is non-inferior to or demonstrably equivalent to the predicate device, meeting clinically relevant biomechanical requirements for soft tissue to bone attachment).
   Functional Equivalence (Compasso instruments)	Implied (but not explicitly stated as a quantified acceptance criterion): The Compasso instruments are intended for use with the Elite SPK or Sharc-FT bone anchor, suggesting functionality and usability for their intended purpose. The substantial equivalence argument relies on their ability to implant the Elite SPK similar to how instruments implant the predicate.

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

   The document does not specify the sample size used for any of the performance tests (sterilization, shelf life, biocompatibility, or fixation strength). The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned. These details would typically be found in the technical reports for each test, which are summarized here.

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

   This type of information is not applicable to the performance tests described for this device. The tests are primarily engineering, materials science, and biological safety evaluations, not diagnostic accuracy studies that require expert-established ground truth.

4. Adjudication Method for the Test Set

   Not applicable for the engineering and biological safety tests performed.

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

   No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. The Elite SPK and Compasso are surgical implants and instruments, respectively, and thus do not involve human readers interpreting cases.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

   Not applicable. This device is not an algorithm or AI-driven system. Its performance is related to its physical and material properties and its function in a surgical context, with a human surgeon always in the loop.

7. Type of Ground Truth Used

   The "ground truth" for the tests mentioned would be based on:

   • Sterilization: Established international standards (e.g., ISO 11137 series for radiation sterilization, ISO 17665 series for moist heat sterilization).
   • Shelf Life: Real-time or accelerated aging studies with defined acceptance criteria for physical, chemical, and functional properties over time.
   • Biocompatibility: In vitro and in vivo testing endpoints defined by ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation effects).
   • Fixation Strength: Biomechanical testing protocols (e.g., cyclic loading, pull-out strength, stiffness) with acceptance criteria often established relative to predicate devices or clinically accepted performance benchmarks.

8. Sample Size for the Training Set

   Not applicable. This is not a machine learning or AI device that requires a training set.

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

   Not applicable. As mentioned above, this is not an AI/ML device.

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