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The Tigon Medical All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
• Elbow: Biceps Tendon Reattachment. Ulnar or Radial Collateral Liqament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
• Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carnal Ligament Reconstruction, Repair/ Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for all Digits, Digital Tendon Repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Tigon Medical All-Suture Anchors are soft-tissue fixation devices provided sterile, preloaded on an inserter. The anchor consists of different load configurations consisting of one or more working sutures. The inserters can be reprocessed after use and are made from stainless steel.

This document is a 510(k) premarket notification for a medical device (Tigon Medical All-Suture Anchors). It does not include information about AI/ML device performance or clinical studies with human readers. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, or expert qualifications for ground truth establishment.

The document discusses the substantial equivalence of the device to legally marketed predicate devices based on mechanical testing, specifically according to ASTM F543. The acceptance criteria and "performance" in this context relate to the physical and mechanical properties of the anchor itself, not the performance of an AI/ML algorithm.

Here's the information that can be extracted or inferred from the provided text, related to the device's assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
Not applicable for an AI/ML study. The "test set" here refers to the samples of the medical device used for mechanical testing. The specific sample size for the mechanical testing is not explicitly stated in this document. Data provenance would refer to the origin of the mechanical test results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as this is not an AI/ML study involving human interpretation of medical images or data. Ground truth in this context would be established by the mechanical testing protocols and measurements.

4. Adjudication method for the test set:
Not applicable as this is not an AI/ML study requiring expert adjudication of results. Mechanical testing results are typically evaluated against pre-defined engineering specifications.

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, an MRMC comparative effectiveness study was not done. This document pertains to the clearance of a physical medical device (all-suture anchors), not an AI/ML-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, standalone algorithm performance was not done. This document is not about an algorithm.

7. The type of ground truth used:
The "ground truth" for the device's performance is established through mechanical testing (per ASTM F543) comparing the device's physical properties (e.g., insertion strength, fixation strength) to those of predicate devices.

8. The sample size for the training set:
Not applicable, as this is not an AI/ML study.

9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML study.

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The Tigon Medical FIRE System is intended to provide the orthopedic surgeon with a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries.

• Bone Loss Deficiencies/Deformities
  • · Latariet
  • Free bone block
• Internal bone fixation for bone fractures, fusions, non-unions, and osteotomies in the foot, ankle, hand, and wrist.

The Tigon Medical Fractures, Instability, and Reconstruction (FIRE) System includes reconstruction devices that are designed to provide a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries. The system includes instruments that allow for the placement of the reconstruction device and screws. The reconstruction devices and screws are available in various sizes.

This is a 510(k) premarket notification for a medical device called the Tigon Medical Fractures, Instability, and Reconstruction (FIRE) System. This device is a metallic bone fixation fastener (screws and reconstruction devices) used for bone-to-bone fixation and reconstructive surgeries.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the sample size used for the mechanical testing (test set).
• The document does not specify the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "mechanical testing was performed."

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

• This information is not applicable to this type of submission. The "ground truth" for a mechanical fixation device is typically established through adherence to standardized mechanical testing methods and published performance criteria, not expert consensus on clinical cases.

4. Adjudication Method for the Test Set

• This information is not applicable as the evaluation is based on mechanical testing, not interpretation of clinical data by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic AI devices where human readers interpret medical images. The FIRE system is a physical implant, and performance is assessed through mechanical properties.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• This is not applicable as the FIRE system is a medical device (screws and reconstruction devices), not an algorithm or AI system. Its performance is inherent in its physical properties and design, not in a computational algorithm.

7. Type of Ground Truth Used

• The "ground truth" for validating the device's performance is based on established mechanical testing standards (ASTM F543 and ASTM F382) and FDA guidance documents ("Orthopedic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway"). These standards define acceptable physical properties for such devices.

8. Sample Size for the Training Set

• This information is not applicable. The FIRE system is a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.

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

• This information is not applicable as there is no training set for a physical medical device.

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The Tigon Medical Gryphon Anchor Line is made up of four families of soft tissue fixation devices: Tomahawk Anchor, Dual Anchor, Eye-Deal Anchor, and Tenodesis Anchors. The entirety of the gryphon anchor line 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), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff repairs, Bicep tenodesis.

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

Knee: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquus advancement), Iliotibial 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

In addition to these indications, the Tenodesis Anchors, a sub family of the gryphon anchor line will also be indicated for:

Foot and Ankle: Flexor hallucis longus for Achilles tendon reconstructions, tendon transfers in the foot and Ankle

Knee: ACL Repair

Hand/Wrist: Carpometacarpal joint arthroplasty, carpal ligament reconstructions and repairs, tendon transfer in hand/wrist

The Tigon Medical Gryphon Anchor Line consists of four sub-families of suture anchors: Tomahawk anchors, Dual anchors, Tenodesis anchors, and Eye-Deal anchors. It consists of a range of anchors sizes between 3.75 mm diameter and 6 mm length to 10.5 mm diameter and 23 mm length. The Tomahawk Anchors, Dual Anchors, and Tenodesis anchors are made from VESTAKEEP® i4R PEEK per ASTM F2026 while the Eye-Deal Anchors are made from Ti6Al4V ELI per ASTM F136.

The anchors are available with many configurations of sutures and suture tapes or without suture. All the anchors in this system may be loaded with a combination of USP #2 suture cables and/or tape equivalent while the Dual Anchors and Tenodesis anchors may be loaded with a combination of USP 2 and USP 5 suture cables and/or tape equivalent.

All anchors are inserted with stainless steel inserters per ASTM F899. The shafts that are used with the Tomahawk anchors may be reprocessed and will be available sterile packed and attached to the anchor and suture.

The provided document describes the predicate device and the new device for a 510(k) submission, confirming substantial equivalence through non-clinical testing. However, it does not include the detailed acceptance criteria and a study proving the device meets those criteria in the format requested. Specifically, the document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, indicating the new device performs "as well as or better than" the predicate. It lacks explicit numerical acceptance criteria for performance metrics beyond a comparative statement with the predicate.

Therefore, for aspects requiring quantitative acceptance criteria, specific study details (sample size for test set, data provenance, number and qualifications of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set), the information is not present in the provided text.

Based on the available information:

Acceptance Criteria and Reported Device Performance

Missing Information Specifics:

The provided text focuses on demonstrating substantial equivalence to existing predicate devices through mechanical and other non-clinical testing. It explicitly states: "Mechanical testing has been done, including cyclical loading and tensile strength which demonstrated the proposed products met the acceptance criteria for the proposed indications." and "The device was found to be substantially equivalent to the predicate for maximum pullout strength per ASTM F543."

However, the document does not provide the following information from the input request:

1. Sample size used for the test set and the data provenance: Not specified for any of the tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a medical device, not an AI/diagnostic software. The ground truth refers to performance against established engineering standards and predicate devices.
3. Adjudication method for the test set: Not applicable for performance testing against engineering standards.
4. 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: Not applicable. This device is a physical medical implant (suture anchors), not an AI diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical tests, the ground truth is typically defined by established engineering standards (e.g., ASTM F543) and the performance of legally marketed predicate devices. For biocompatibility, it's ISO 10993-1.
7. The sample size for the training set: Not applicable as this is a physical medical device and not an AI/ML model.
8. How the ground truth for the training set was established: Not applicable.

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Indications for Use: The Tigon Medical Button System implants are intended to facilitate fixation of bone or soft tissue to bone. Shoulder: Proximal Biceps Tendon Repair Minor Pectoralis Repair Major Pectoralis Repair Elbow: Distal Biceps Tendon Repair Ulnar Collateral Ligament Reconstruction Knee: Anterior Cruciate Ligament Repair Posterior Cruciate Ligament Repair

The Tigon Medical Button System is comprised of reusable instrumentation and button implants designed to interface together in order to secure soft tissue to bone and fixate bone to bone. The reusable instrumentation is designed to operate with any grouping of available buttons within the system. Each button is made of fitanium and designed to be used with #2 suture cable or 1.4 mm to 2 mm sufure tapes. Each button is made up of very similar eyelet geometry and a thickness of 2 mm. The button widths vary from 2.25 mm to 2.7 mm. The lengths of the buttons vary from 6.65 mm to 8 mm. The buttons are designed to function against a single cortex by resting in the intramedullary cavity or against the cortex on the opposite side of the fixation site.

The Tigon Medical Button System is compared to the Arthrex Biceps Button for demonstrating substantial equivalence. The following criteria and results were reported:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document indicates that "Mechanical testing has been done, including cyclical loading and tensile strength," but does not explicitly state the sample sizes (number of devices tested) for the pull-out strength or fatigue testing. The data provenance is not mentioned, but it can be inferred that these were laboratory-based non-clinical tests rather than human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the study involved non-clinical mechanical testing, not a medical imaging or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable as the study involved non-clinical mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The study focused on mechanical performance comparison of the device itself, not on human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not done as this is a mechanical fixation device, not a software or AI product.

7. The type of ground truth used

For mechanical strength and fatigue testing, the "ground truth" was established by measured physical properties (e.g., maximum pullout strength in Newtons, number of cycles to failure) observed under controlled laboratory conditions, compared against the reported performance of a legally marketed predicate device.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not a machine learning model.

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

This information is not applicable as there is no "training set."

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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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