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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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The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.

The SINEFIX is a PEEK implant which can be used to re-attach a ruptured rotator cuff tendon to the humerus of the shoulder. The implant can be used to re-attach complete or partially ruptured tendons up to 2 cm to facilitate the healing of the natural bone-tendon interface. The implant consists of a baseplate with a lateral and a medial anchor. The baseplate is placed over the tendon and attached to the humerus with the anchors. The medial anchor goes through the tendon, while the lateral anchor goes directly into the bone, lateral of the tendon.

The provided document is a 510(k) summary for a medical device called SINEFIX, a PEEK implant for soft tissue to bone reattachment in rotator cuff repairs. This document does not describe a study involving an AI/Machine Learning device or a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the non-clinical testing of a physical implant.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from this document. However, I can provide information based on the non-clinical testing for the physical SINEFIX device.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test and then provide the exact performance results in a consolidated table. Instead, it lists the types of tests performed and concludes that the results demonstrate substantial equivalence.

Implied Acceptance Criteria (based on the type of tests performed and the conclusion of substantial equivalence):

• Mechanical Performance: The device must perform comparably to predicate devices in terms of mechanical strength, pullout strength, and response to cyclic loading. This would imply meeting or exceeding the mechanical properties of the predicate devices or relevant ASTM/ISO standards.
• Biocompatibility: The device must be biocompatible, meaning it does not cause adverse biological reactions. The acceptance criterion is compliance with ISO 10993-1.
• Sterilization: The device must be able to be effectively sterilized to a sterility assurance level (SAL) of 10^-6. Acceptance criterion is compliance with ISO 11137-1/2.
• Packaging: The packaging must maintain sterility and product integrity for the stated shelf life. Acceptance criterion is compliance with ISO 11607-1/2.
• Reprocessing (for reusable instruments): Reusable instruments (if any are associated with the implant) must be able to be reprocessed effectively. Acceptance criterion is compliance with the FDA guidance on reprocessing medical devices.

Reported Device Performance:

The document states: "Results of the performed tests demonstrate that the SINEFIX are substantially equivalent to legally marketed predicate devices." This is the overarching reported performance. Specific numerical results are not provided in this summary.

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

For the non-clinical tests (insertion, pullout, cyclic loading, static tensile, dynamic testing, pyrogenicity, endotoxins, packaging, biological evaluation, sterilization validation, reprocessing validation), the sample sizes are not specified in this 510(k) summary. These tests are performed in a laboratory setting (not on human data), so terms like "country of origin of the data" or "retrospective/prospective" are not applicable.

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

This question is not applicable as the tests are non-clinical (mechanical, biological, sterility, etc.) and do not involve "ground truth" derived from expert interpretation of medical images or patient data. The interpretation of results would be done by laboratory personnel according to established scientific and engineering standards and protocols.

4. Adjudication method for the test set

Not applicable, as there is no "test set" in the context of human data or expert review. Non-clinical tests follow laboratory protocols and 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

Not applicable. This is for a non-AI/ML physical implant, not a diagnostic or prognostic AI tool.

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

Not applicable. This is for a non-AI/ML physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for a physical implant's mechanical or material performance. "Ground truth" for these types of tests refers to established physical properties, chemical composition, and performance against defined standards (e.g., maximum load at failure, sterility assurance level).

8. The sample size for the training set

Not applicable. This is for a non-AI/ML physical implant, so there is no "training set."

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

Not applicable. This is for a non-AI/ML physical implant, so there is no "training set" or "ground truth" in that context.

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The Citregen Tendon Interference Screw (TIS) and Citrelock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The Citregen TIS and Citrelock are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm to be used with reusable instruments. There are two designs for the system: 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock™) that is inserted into bone. The Citregen TIS and Citrelock system is intended to attach soft tissue to bone for procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist.

The Citregen TIS and Citrelock are made from Citregen biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxvapatite (HA) and 40 wt.-% polyester. Citregen's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.

The provided text focuses on the 510(k) premarket notification for the Citregen Tendon Interference Screw and Citrelock. This document primarily addresses the substantial equivalence of this medical device to a predicate device, rather than providing detailed acceptance criteria and study results in the context of an AI/ML powered medical device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment cannot be extracted from the provided text as it pertains to a traditional medical device (a physical screw) and not an AI/ML algorithm.

Here's what can be extracted based on the nature of the submission:

• Device Type: The device is a traditional medical implant (tendon interference screw).
• Study Purpose: The studies were conducted to demonstrate substantial equivalence to a predicate device, primarily focusing on safety and performance characteristics relevant to an orthopedic implant.

Here's a breakdown of what could be extracted related to performance data, even though it's not in the context of AI/ML acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance: This type of table is not present for acceptance criteria in the AI/ML sense. However, the document states that "performance characteristics... were established via comprehensive studies" and that results of these studies "demonstrated that the Citregen TIS performance was substantially equivalently to the predicate device."

   • Acceptance Criteria (Implied for a physical implant): Substantial equivalence to the predicate device in terms of "imaging, histological, histomorphometry, and biomechanical data."
   • Reported Device Performance: "The Citregen TIS performance was substantially equivalently to the predicate device."

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

   • Test Set (for in-vivo animal studies): Ovine (sheep) model of ACL reconstruction.
   • Sample Size: Not explicitly stated as a number, but mentioned as a "GLP functional ovine model."
   • Data Provenance: Not specified, but likely from a laboratory conducting GLP (Good Laboratory Practice) studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an orthopedic implant's performance in animal models would typically be established through pathological examination, imaging analysis, and biomechanical testing by specialized researchers/veterinarians, not "experts" in the AI/ML sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to this type of device and study.

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: Not applicable. This device is not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Ground Truth: Based on "imaging, histological, histomorphometry, and biomechanical data" from the ovine model, evaluated at 0, 3, 6, 12, and 24 months.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

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

Summary of Relevant Information from the Text:

The provided document describes a traditional medical device (Citregen Tendon Interference Screw and Citrelock) and its 510(k) submission to the FDA, demonstrating substantial equivalence to a predicate device. The performance data presented refers to bench testing, biocompatibility tests, and animal studies (GLP ovine model) to assess the device's physical and biological performance over time, not the performance of an AI/ML algorithm. Therefore, the questions tailored for AI/ML device evaluations are largely not addressable from this document.

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The Tenodesis Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically: Shoulder: Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization Medial Stabilization Achilles Tendon Repair Hallux Valgus Reconstruction Midfoot Reconstruction Metatarsal Ligament Repair Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction. Knee: Anterior Cruciate Ligament Repair Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair Illiotibial Band Tenodesis Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) Carpal Ligament Reconstructions and repairs Ligament Reconstruction and Tendon Interposition.

The Tenodesis Screw System is composed of a screw manufactured from polyetheretherketone (PEEK). They are fully threaded, cannulated anchors with a flat head. The screws are provided in multiple lengths and sizes to accommodate variations in patient anatomy.

The provided text is a 510(k) summary for a medical device called the "Tenodesis Screw System." It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence.

Based on the nature of this document (510(k) summary for a mechanical orthopedic implant), the information requested in your prompt regarding acceptance criteria and study design for an AI/Software as a Medical Device (SaMD) is largely not applicable. This document details the mechanical, material, and performance testing for a physical implant, not an AI-driven diagnostic or assistive tool.

Therefore, for aspects related to AI/SaMD studies (like sample size for test sets, expert consensus, MRMC studies, training set details, etc.), the answer will be that this information is not relevant or not present in the provided document, as it deals with a different type of medical device.

I will address each point of your query based on the information available in the provided text.

Acceptance Criteria and Study for the Tenodesis Screw System

The "Tenodesis Screw System" is a mechanical implant designed for soft tissue reattachment, primarily fixation of ligament and tendon graft tissue. Its performance is evaluated through mechanical testing, not clinical studies involving AI or human interpretation of images.

1. A table of acceptance criteria and the reported device performance

The document states:
"All necessary testing has been performed on representative Tenodesis Screw System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished Tenodesis Screw System implants. The device performance was characterized via Static Torsion, Static Insertion and Removal Torque, and Static Axial Pullout Testing per ASTM F543. Clinical data are not needed to support the safety and effectiveness of the subject devices."

The specifics of acceptance criteria (e.g., minimum torque values, maximum displacement) and reported device performance (e.g., actual measured values) are not explicitly provided in this 510(k) summary table. This summary states that the device meets the criteria (by demonstrating substantial equivalence) but does not list the numerical targets or results. The testing was conducted according to ASTM F543, which is a standard specification for metallic medical bone screws. Compliance with this standard implies that specific mechanical properties were tested and met, but the precise numbers are proprietary and typically found in the full submission, not the public summary.

Additionally, a "Bacterial Endotoxin Test has been conducted on the subject device and it meets the specified 20 EU/Device limit." This is an acceptance criterion for biocompatibility.

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Milagro Interference Screw (5x12, 6x12, 7x15, 8x15)

The MILAGRO BR Interference Screws are designed to attach soft tissues to bone in Orthopedic surgical procedures for the following indications:

Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair

Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair

Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)

Milagro Advance Interference Screw (7x23, 8x23, 9x23)

The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial and lateral ligament repart, medial patellofemoral ligament reconstruction (femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

The proposed devices are interference screws used for attachment of soft tissue to bone in Orthopedic surgeries. The proposed devices are cannulated, threaded interference screws, made of absorbable Biocryl® Rapide™ (composite of β-TCP and PLGA copolymer). The devices are provided as sterile (EtO), and are for single patient use only.

There is no accessory accompanied with the devices. Manual Orthopedic instruments such as tap and driver are used for screw insertion. Instruments are classified as LXH: Orthopedic Manual Surgical Instruments, Class I Exempt device, regulated per 21 CFR 888.4540. No new instrumentation is developed for the purpose of this submission.

This document is a 510(k) Premarket Notification from the FDA regarding the Milagro / Milagro Advance Interference Screw. It focuses on establishing substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with specific acceptance criteria related to accuracy or performance metrics.

Therefore, the requested information components related to acceptance criteria, ground truth, expert adjudication, and comparative effectiveness studies typical for AI/CAD devices are not applicable in this context. The device is a bone fixation appliance, not an AI or diagnostic device.

Here's a breakdown of the available information based on your request, highlighting why certain sections are not applicable:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Not explicitly defined in terms of numerical performance thresholds as this is a medical implant seeking substantial equivalence, not a diagnostic or AI device with performance metrics like sensitivity/specificity. The implicit "acceptance criterion" is demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness for the stated indications for use.
   • Reported Device Performance:
     | Performance Metric | Reported Performance |
     | :----------------- | :------------------- |
     | Fixation Strength | Demonstrated substantial equivalence to the predicate device. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified in the provided document. The study was "bench-top mechanical testing," implying lab-based material or device samples, not patient data.
   • Data Provenance: Not applicable. This was a physical bench-top test, not a study involving human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. The ground truth for mechanical testing is typically established by engineering standards and measurement accuracy, not expert consensus as in diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is not a human-readable diagnostic test; it's mechanical performance assessment.

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:

   • Not applicable. This is a medical implant, not an AI or diagnostic tool that would involve human readers.

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

   • Not applicable. This is a medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for the mechanical testing would be defined by engineering standards and measured physical properties (e.g., force required for failure, displacement under load) obtained through controlled laboratory experiments. It's not clinical data like pathology or outcomes.

8. The 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 above, this is not an AI device.

Summary of the Study:

The study conducted was bench-top mechanical testing to assess the fixation strength of the Milagro / Milagro Advance Interference Screw. The primary goal was to demonstrate that its fixation performance was substantially equivalent to that of the predicate device (Bioraptor Knotless Anchor and BioTenodesis Interference Screw). The document explicitly states: "The data demonstrated substantial equivalence of fixation performance." There were no changes to the material, packaging system, or sterilization, further supporting the substantial equivalence claim.

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The MedShape PEEK Interference Screw is intended for soft tissue to bone reattachment in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically;

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (Basal Thumb Joint Arthroplasty), Carpal Ligament Reconstructions and Repairs, Tendon Transfer in the Hand/Wrist

The proposed Helical Ridge Bone Anchor is a sterile, single use, orthopedic implant intended to be used for fixation of soft tissue to bone.

The Helical Ridge Bone Anchor is comprised of PEEK. The anchor is provided sterile and pre-loaded on a disposable driver handle.

The provided document is a 510(k) premarket notification for the MedShape Helical Ridge Bone Anchor (also referred to as MedShape PEEK Interference Screw). This type of submission is for medical devices and does not typically involve AI/ML components or software. Therefore, the questions related to AI/ML study design, such as sample size for test and training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are primarily bench testing (e.g., in Sawbone® models) rather than clinical studies with human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of AI/ML or clinical expert review is not relevant here. The "ground truth" for this device's performance would be the physical properties and mechanical strength of the anchor, measured objectively.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or expert review for AI/ML performance, not for bench testing of physical devices.

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: Not applicable. This device is a physical bone anchor, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical bone anchor.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing (e.g., monotonic soft tissue fixation strength, dimensional verification, material safety), the "ground truth" refers to objective measurements and established standards for mechanical properties and material safety.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The MedShape, Inc., Eclipse™ Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbowing procedures:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
• Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Liqament Reconstructions and Repairs and Tendon Transfers
• Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction

The proposed Eclipse™ Soft Tissue Fastener is a sterile, single use, orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. The Eclipse™ Soft Tissue Fastener is designed to use the principles of interference fit to reattach soft tissue intended for insertion into a hole created in bone.

The Eclipse™ Soft Tissue Fastener body is comprised of an implant grade PEEK sleeve and implant grade PEEK insert. The outer sleeve is expanded into the bone hole, compressing the soft tissue aqainst the bone wall; fastening it into place.

The provided text describes a medical device, the Eclipse™ Soft Tissue Fastener, and its 510(k) summary for FDA clearance. However, it does not contain the information requested about acceptance criteria for a study proving device performance in the context of an AI/ML device.

Here's why and what information is missing:

• Device Type: The Eclipse™ Soft Tissue Fastener is an orthopedic implant for tissue fixation to bone. It's a physical medical device, not an AI/ML software device. The questions about "test set," "ground truth," "experts," "MRMC study," and "training set" are specific to AI/ML device validation.
• Study Details: The document mentions "functional performance testing has been conducted in Sawbone® bone analogue. This testing included monotonic soft tissue fixation strength (pull-to-failure) and other dimensional verification and material safety testing (both bio and MRI compatibility)." This describes physical performance testing relevant to an orthopedic implant, not a study for an AI/ML algorithm.
• Acceptance Criteria: While specific performance metrics like "pull-to-failure" strength are mentioned, the document does not present them as a formal table of acceptance criteria with corresponding reported performance values, as would be expected for an AI/ML device's validation.

Therefore, I cannot provide the requested information for acceptance criteria and the study proving the device meets them because the provided text describes a physical orthopedic implant, not an AI/ML device, and lacks the specific validation study details pertinent to AI/ML systems.

If you have a document describing an AI/ML device and its validation study, I would be able to extract the requested information.

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The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, acetabular labral repair

The SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. FiberWire suture may also be provided with the device.

The provided 510(k) summary (K101823) describes the Arthrex SwiveLock Anchors, a medical device intended for fixing suture (soft tissue) to bone in various anatomical regions. The device is seeking substantial equivalence to previously marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the Arthrex SwiveLock Anchors are based on demonstrating substantial equivalence to existing predicate devices. Since this is an equivalence submission, specific quantitative acceptance criteria for absolute performance metrics are not explicitly stated in the summary. Instead, the performance is compared against the known performance of the predicate devices.

The study aimed to demonstrate that the SwiveLock Anchors perform comparably to the predicate devices in terms of:

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

The document does not explicitly state the specific sample sizes for each test mentioned (degradation, mechanical pull-out, insertion, animal testing). It only refers to "data" for each category.

The data provenance is not specified. It is an industry standard to conduct these tests in a controlled laboratory environment or animal models. Neither the country of origin nor whether the data is retrospective or prospective is mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this type of 510(k) submission. Establishing "ground truth" by experts is typically relevant for diagnostic or AI-driven devices where human interpretation is involved. For a mechanical device like a suture anchor, the "truth" is established through physical and biological testing against established standards or predicate device performance.

4. Adjudication Method:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts in diagnostic studies, which is not relevant for the mechanical and biological testing of a suture anchor.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is evaluated.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through physical and biological testing methodologies. This includes:

• Degradation data: Measuring the breakdown of biomaterials over time.
• Mechanical pull-out (tensile) testing data: Quantifying the force required to pull the anchor out of bone, adhering to engineering standards.
• Insertion testing data: Assessing the ease and characteristics of device insertion.
• Animal testing data: Observing the biological response (histology), in-vivo pull-out strength, and imaging of the device in a living system.

The "truth" is rooted in the physical and biological properties and performance of the device as measured by these tests, compared against the known performance of predicate devices.

8. Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The Arthrex SwiveLock Anchor is a mechanical device, not an AI or algorithm-driven system.

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

This information is not applicable for the reasons stated above.

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