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The Smith & Nephew BIORAPTOR◊ Suture Anchor is indicated for the reattachment of soft tissue to bone for the following indications:

Hip:

• Hip Capsule Repair
• Acetabular labrum reattachment/reconstruction

Shoulder:

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff tear repairs
• Biceps 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

Elbow, Wrist, and Hand:

• Biceps tendon reattachment
• Ulnar or radial collateral ligament reconstructions
• Lateral epicondylitis repair

Knee:

• Extra-capsular repairs:
  • Medial collateral ligament
  • Lateral collateral ligament
  • Posterior oblique ligament
• Patellar realignment and tendon repairs
• Vastus medialis obliquous advancement
• Iliotibial band tenodesis

Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchors are indicated 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 tear repairs
• Biceps 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

Elbow, Wrist, and Hand:

• Biceps tendon reattachment
• Ulnar or radial collateral ligament reconstructions
• Lateral epicondylitis repair

Knee:

• Extra-capsular repairs:
  • Medial collateral ligament
  • Lateral collateral ligament
  • Posterior oblique ligament
• Patellar realignment and tendon repairs
• Vastus medialis obliquous advancement
• Iliotibial band tenodesis

The Smith & Nephew BIORAPTOR◊ Suture Anchor is intended for the reattachment of soft tissue to bone.

The Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone.

The Smith & Nephew BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchors are fixation devices intended to provide secure attachment of soft tissue to bone. The devices consist of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. The BIORAPTOR Curved 2.3 PK Suture Anchors are preassembled to a flexible insertion device.

The provided FDA 510(k) clearance letter and summary for the BIORAPTOR Suture Anchors primarily focus on demonstrating substantial equivalence to a predicate device, particularly concerning a packaging modification. As such, the document does not contain the typical acceptance criteria and detailed study data (like sample size, expert consensus, MRMC studies, etc.) that would be found in a submission for a novel or significantly modified AI/medical imaging device.

The "Performance Data" section specifically mentions non-clinical testing related to the packaging modification. Therefore, I will extract information related to these non-clinical tests and frame them as 'acceptance criteria' and 'reported performance' for the device's packaging.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for BIORAPTOR Suture Anchors (Packaging Modification)

The described study proves that the modified packaging for the BIORAPTOR Suture Anchors meets the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "Non-clinical testing was completed on the subject device for the proposed packaging modification," but does not specify the exact sample size used for these tests.
• Data Provenance: The tests are non-clinical, conducted by the manufacturer (Smith & Nephew, Inc.). The document does not specify the country of origin for the data beyond the company's US headquarters (Andover, MA). These were likely prospective tests performed on the new packaging design.

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

• This information is not applicable to the type of non-clinical, packaging-related testing described. There is no 'ground truth' in the clinical sense (e.g., diagnosis, pathology) that requires expert consensus. The "ground truth" here is the adherence to engineering specifications and performance standards for packaging.

4. Adjudication Method for the Test Set

• This information is not applicable as the testing is engineering/laboratory-based for packaging performance, not clinical interpretation of data that would require adjudication.

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

• No, an MRMC study was not done. This type of study is relevant for AI/imaging devices where human readers interpret diagnostic images, often with and without AI assistance. The device in question is a physical suture anchor, and the described studies are non-clinical evaluations of its packaging.

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

• Not applicable. This concept applies to AI algorithms. The described studies are physical tests of a medical device's packaging.

7. The Type of Ground Truth Used

• The "ground truth" for these non-clinical tests is based on pre-defined engineering specifications and performance standards for medical device packaging (e.g., ISO or ASTM standards for sterile barrier systems, shelf life, and shipping integrity). It is not clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This concept applies to machine learning models. The tests performed are physical, non-clinical evaluations related to manufacturing and packaging.

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

• Not applicable. This concept applies to machine learning models.

Summary of Limitations Based on Document Content:

The provided document details a 510(k) submission for a suture anchor with a packaging modification. The testing described is therefore focused on demonstrating that this packaging change does not compromise the device's safety, effectiveness, or equivalence to its predicate. The detailed information typically requested for AI/software devices (like expert consensus, MRMC studies, training data details) is not relevant or present in this type of submission for a physical, mechanical device's packaging.

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The subject device can be used with the TRIGEN META-TAN Trochanteric Antegrade Nailing System, TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System, and the TRIGEN META-NAIL Retrograde Femoral Nail System therefore the indications for use for all three systems are applicable to the subject TRIGEN Stable Lock Nut & Washer.

TRIGEN META-TAN Trochanteric Antegrade Nailing System

The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures.

In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures.

TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; and nonunions. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures and intertrochanteric fractures.

TRIGEN META-NAIL Retrograde Femoral Nail System

The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures.

The device in scope of this submission is the TRIGEN Stable Lock Nut & Washer.

The TRIGEN Stable Lock Nut & Washer is intended to be used as an aid to normal fracture healing for fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures; simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; nonunions; for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated; and for fractures of the femur that include stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures. The TRIGEN Stable Lock Nut & Washer is made from Ti-6Al-4V material. The device is Gamma sterilized and intended for single-use only.

The provided FDA 510(k) Clearance Letter for the TRIGEN Stable Lock Nut & Washer does not pertain to an Artificial Intelligence (AI) or machine learning (ML) device. Instead, it describes a mechanical bone fixation appliance.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training and test sets) cannot be extracted or inferred from this document.

The clearance letter focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical bench testing:

• Acceptance Criteria and Reported Device Performance: This document does not present quantitative acceptance criteria or performance metrics in a table format that would be typical for an AI/ML device validating its inferential accuracy (e.g., sensitivity, specificity, AUC). Instead, for this mechanical device, the performance is implicitly demonstrated by the successful completion of the following non-clinical tests:

  • Theoretical Failure Analysis
  • Torque to Failure/Insertion/Extraction Torque Testing and Analysis
  • MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013)

• Study That Proves the Device Meets Acceptance Criteria: The study that proves the device meets acceptance criteria consists of the non-clinical bench tests listed above. The conclusion states: "The results of the equivalence testing demonstrate that the differences in design of the subject device does not raise any difference in safety or effectiveness as compared to the predicate devices." This implies that the 'acceptance criteria' were met if these tests demonstrated performance comparable to, or better than, the predicate devices without compromising safety or effectiveness.

In summary, as this is a traditional mechanical medical device, the concepts of acceptance criteria, test sets, ground truth, and study methodologies related to AI/ML device validation are not applicable here.

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• Rheumatoid arthritis;
• Post-traumatic arthritis, osteoarthritis, or degenerative arthritis;
• Posterior stabilized and constrained knee systems are also indicated for the treatment of unicompartmental replacement or total knee replacement;
• Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
• Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.

The subject insert is a line addition to the LEGION Inserts with JOURNEY Lock (K200407) and has undergone design modifications to provide a new articulating surface that incorporates a flatter lateral plateau and extended medial geometry to match the asymmetry of the tibial baseplate, while maintaining the JOURNEY locking mechanism. The subject LEGION Medial Stabilized Inserts with JOURNEY Lock have a size range of 1-2, 3-4, 5-6, and 7-8mm with thicknesses of 9, 10, 11, 12, 13, 15, 18mm, and come in both left (LT) and right (RT) configurations. The LEGION Medial Stabilized XLPE Inserts with JOURNEY Lock are provided sterile via Ethylene Oxide sterilization and are intended for single use only. The subject inserts are intended to be used with compatible knee systems for total knee arthroplasty in skeletally mature patients with or without bone cement.

I am sorry, but based on the provided FDA 510(k) clearance letter for the LEGION Total Knee System, the document does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria, especially in the context of an AI/human-in-the-loop performance study.

Here's why the requested information cannot be found in the provided text:

• Device Type: The cleared device, the "LEGION Total Knee System," is a physical medical device (a knee joint prosthesis), not an AI/software device. The 510(k) is for a hardware modification (a new articulating surface for an insert).
• Study Type: The document states, "No clinical testing was performed to support safety and effectiveness of the subject device." The testing mentioned is "bench testing" (Tibiofemoral Constraint Testing and Tibiofemoral Contact Area Testing) which applies to the physical properties of the knee implant.
• AI/Human-in-the-loop: There is no mention of AI, human readers, ground truth establishment by experts, or MRMC studies, as the device is not an AI diagnostic or assistance tool.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer questions about sample sizes for AI test sets, expert numbers, adjudication methods, MRMC studies, standalone AI performance, or training set details, as these concepts are not applicable to the cleared device as described.

The document focuses on demonstrating substantial equivalence of a new knee implant component to existing, legally marketed predicate devices through material and mechanical performance testing.

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The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The CATALYSTEM Femoral Stems are intended for use without bone cement.

The purpose of this Special 510(k) is to notify the FDA of Smith & Nephew's intent to market the CATALYSTEM Femoral Stems with additional femoral head compatibility. The CATALYSTEM Femoral Stems were previously cleared by the FDA under K240381.

The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

This document is a 510(k) clearance letter for the CATALYSTEM Femoral Stems. It primarily addresses the regulatory approval process rather than detailing a study proving the device meets specific acceptance criteria in the context of an AI/software device.

The provided text does not contain information related to AI/software device performance or studies proving such a device meets acceptance criteria. It describes a medical device (femoral stems for hip replacement) and its regulatory clearance based on substantial equivalence to a predicate device.

Specifically, it states:

• "No clinical tests were performed to support safety and efficacy of the subject device."
• Bench testing was performed for mechanical properties (e.g., fatigue, range of motion, impingement), which are relevant to orthopedic implants, not AI performance.
• The clearance is a "Special 510(k)" primarily for "additional femoral head compatibility."

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI device meets them from this document. The concepts of ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and test sets are not applicable to the information provided in this 510(k) clearance letter for a mechanical implant.

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The EVOS Pelvic and Acetabular System is indicated for fixation of fractures and/or disruptions of the pelvis and acetabulum in skeletally mature patients.

The subject EVOS Pelvic and Acetabular System consists of Class II bone plate and screw implants. The subject bone plates are available in a variety of shapes and sizes. The subject screws consist of locking screws as well as cannulated screws. The subject plates are also compatible with the previously cleared EVOS locking screws, and partially and fully threaded osteopenia screws (K140814 S.E. 5/7/2014 and K162078 S.E. 7/27/2016). The proposed plates and screws are manufactured from implant-grade 316L Stainless Steel material and will be available in a sterile packaged condition.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) clearance letter from the FDA for the "EVOS Pelvic and Acetabular System," which is a metallic bone fixation appliance. The clearance is based on substantial equivalence to legally marketed predicate devices, not on the performance of a software algorithm or AI model.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that "No clinical testing was performed on the subject devices." The tests conducted are mechanical and materials testing for the implants (e.g., Finite Element Analysis, fatigue testing, static evaluation of screws, MRI compatibility, and packaging verification), which are standard for orthopedic hardware, not for AI performance.

Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance (for an AI/ML device)
• Sample size used for the test set and data provenance (for an AI/ML device)
• Number of experts and qualifications (for establishing ground truth for an AI/ML device)
• Adjudication method (for an AI/ML device)
• Multi-reader multi-case comparative effectiveness study (for an AI/ML device)
• Standalone performance (for an AI/ML device)
• Type of ground truth used (for an AI/ML device)
• Sample size for the training set (for an AI/ML device)
• How ground truth for the training set was established (for an AI/ML device)

The document is about a traditional medical device (surgical implants) and does not contain the information requested about AI/ML device performance or studies.

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The RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are intended to be used in conjunction with Smith + Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS system.

The Smith + Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Sub-Acute and dehisced wounds
• Ulcers (such as pressure or diabetic)
• Partial-thickness burns
• Flaps
• Grafts

RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are accessories intended for use in conjunction with RENASYS TOUCH, RENASYS GO and RENASYS EDGE Negative Pressure Wound Therapy systems.

Based on the provided text, the document is a 510(k) summary from the FDA for a medical device called "RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port." This document does not describe an AI/ML device or its performance criteria. It pertains to a physical medical device used for negative pressure wound therapy.

Therefore, I cannot provide the requested information as the document does not contain details regarding acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets those criteria. The original text only mentions non-clinical tests (simulated wound model tests, human factors validation, biological evaluation) and explicitly states "No clinical performance data was necessary" for this particular device.

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BIOBRANE Dressings are indicated for:

• Covering clean partial thickness burn wounds
• Split thickness donor sites

BIOBRANE Glove is indicated for:

• Covering clean partial thickness burn wounds of the hand.

BIOBRANE Dressing and BIOBRANE Glove are wound dressings made from an ultrathin, semipermeable, perforated silicone membrane that is mechanically bonded to a flexible knitted tri-filament nylon fabric. Denatured porcine dermal collagen is bonded to the silicone-nylon membrane to provide a flexible and conformable dressing with adherence properties and a hydrophilic surface.

This document is a 510(k) K242146 premarket notification for the BIOBRANE Dressing and BIOBRANE Glove. It asserts substantial equivalence to the predicate device BIOBRANE II (K901369).

Here's an analysis of the provided information relating to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table of acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or any quantitative measures for the device's diagnostic or predictive capabilities. This is likely because the device is a wound dressing, not a diagnostic AI/ML device.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and verification tests. The "acceptance criteria" can be inferred as successful completion of these tests and demonstration that the device's characteristics are similar to the predicate.

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

The document explicitly states: "No clinical data is relied upon in this submission to determine substantial equivalence."

Therefore:

• Sample size for the test set: Not applicable, as no clinical test set was used for substantial equivalence determination.
• Data provenance: Not applicable. The evaluation was based on non-clinical (bench) testing and comparison of technological characteristics.

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

Not applicable, as no clinical test set with a ground truth established by experts was used. The substantial equivalence was based on non-clinical data and direct comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used requiring adjudication.

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 performed or relied upon. This is a wound dressing, not an AI/ML diagnostic device where such studies are typical.

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

Not applicable. This device is a wound dressing, not an algorithm or software-only device.

7. The Type of Ground Truth Used

Not applicable, as no clinical data or ground truth in the context of diagnostic performance was used. The "ground truth" for this submission is implicitly the established safety and efficacy profile of the legally marketed predicate device (BIOBRANE II, K901369) and the physical/chemical properties assessed through bench testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth for training.

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The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures.

In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures.

The device in scope of this submission is the TRIGEN META-TAN Trochanteric Antegrade Nail.

TRIGEN META-TAN Trochanteric Antegrade Nails are intended to be used as aids to normal fracture healing of the femur. They are made from Ti-6Al-4V material and available in a nail size range of 30 to 50 cm in 2 cm increments. They are Gamma sterlized and intended for single-use only.

The provided text is a 510(k) summary for the TRIGEN META-TAN Trochanteric Antegrade Nail. This document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical performance testing. It is not a study that proves the device meets specific performance acceptance criteria related to AI/ML or diagnostic accuracy.

Therefore, many of the requested fields cannot be filled from the provided text, as they pertain to clinical studies, human reader performance, or AI/ML algorithm evaluation, which are not present in this regulatory document.

However, based on the information available, I can extract the following:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical outcomes or AI/ML algorithm metrics. Instead, it refers to non-clinical bench tests demonstrating acceptable outcomes for design, materials, and technological characteristics to establish substantial equivalence.

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

Not applicable. The document explicitly states: "No clinical tests were performed to support safety and efficacy of the subject device." The testing mentioned is non-clinical bench testing.

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. No clinical test set or ground truth established by experts is mentioned.

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

Not applicable. No clinical test set or adjudication method is mentioned.

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 MRMC study was done, as explicitly stated: "No clinical tests were performed to support safety and efficacy of the subject device." This device is a physical intramedullary nail, not an AI-powered diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. Ground truth, in the context of clinical or diagnostic performance, is not discussed as "No clinical tests were performed." The device's "acceptance" is based on meeting non-clinical engineering and material specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device.

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The REGENETEN™ Bioinductive* Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue. * Bioinductivity has been demonstrated for tendon only.

The REGENETEN Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN Bioinductive Implant.

The REGENETEN™ Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons or ligaments. The implant is designed to provide a layer of collagen between a tendon or ligament and the surrounding tissue. After hydration, the implant is an easy-tohandle, pliable, nonfriable, porous collagen sheet. The REGENETEN Bioinductive Implant is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, in a dual sterile seal.

The provided text is a 510(k) summary for the REGENETEN™ Bioinductive Implant, focusing on demonstrating substantial equivalence to a predicate device for an expanded indication for use (inclusion of extra-articular ligament injuries). It does not describe an AI/ML device or its performance against acceptance criteria in the manner requested (e.g., sensitivity, specificity, MRMC study, expert ground truth adjudication).

Therefore, it is not possible to extract the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or details of MRMC studies and ground truth establishment, as this documentation pertains to a medical device (bioinductive implant) rather than a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The document details the device's physical characteristics, intended use, and the rationale for expanding its indications based on an animal study, not an AI model's performance.

To answer your request, I would need a 510(k) summary or similar regulatory document describing the validation of an AI/ML-powered medical device.

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