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The Arthrex Corkscrew Family of Suture Anchors has been previously cleared in 510(k) K003817, K003227, K043337, and K050358. These suture anchors are intended for fixation of suture(soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis in, but not limited to, 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, Midfoot Reconstruction, Metatarsal Ligament /Tendon Repair, Bunionectomy . .
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Arthrex PushLock™, previously cleared under 510(k) K051219, is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, hip, and pelvis in the following procedures:

Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: 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, Illiotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Elbow: collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Arthrex Tak™ Family, previously cleared under 510(k)s K971723, K000506, and K050749, is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:

Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone. mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction. soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal 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 transfers

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, Illiotibial Band Tenodesis

Bladder Neck Suspension for female urinary incontinence due to Pelvis: urethral hypermobility or intrinsic sphincter deficiency.

Hip: Capsular repair, acetabular labral repair.

The Arthrex Families which are part of this expanded indications submission are as follows: Arthrex Bio-Corkscrew and Corkscrew Arthrex Bio-Corkscrew FT and Corkscrew FT Arthrex PushLock Arthrex Tak Family

These implants are comprised of titanium alloy, poly (L-lactide) or PLLA, poly (Llactide-Co-D, L-lactide) or PLDLA, and Polyaryletherketone or (PEEK). They are offered in several different shapes and sizes. They are offered sterile.

This 510(k) premarket notification is for an expanded indication for the Arthrex PushLock, Tak, and Corkscrew products. Therefore, the information provided focuses on demonstrating substantial equivalence to predicate devices for the new indications rather than establishing new acceptance criteria and conducting studies against them.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance for the Arthrex PushLock, Tak, and Corkscrew products in the provided 510(k) summary (K061863). This submission is for an expanded indication for already cleared devices. The acceptance criteria for these devices would have been established during their original 510(k) clearances (K003817, K003227, K043337, K050358 for Corkscrew; K051219 for PushLock; K971723, K000506, K050749 for Tak Family).

The current submission hinges on demonstrating substantial equivalence to existing predicate devices for the new indications of hip capsular repair and acetabular labral repair. The performance criteria for these new indications are implicitly met by showing equivalence to the predicate devices, which are already deemed safe and effective for similar uses.

The predicate device for the hip labral repair indication is identified as K053344, Smith & Nephew BioRaptor 2.9 mm and TwinFix Ti 2.8 & 3.5 mm implants. The performance of the Arthrex devices for these new indications would be considered acceptable if they are deemed substantially equivalent to the Smith & Nephew devices.

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

The provided document does not mention any sample sizes used for a test set or data provenance because this is a 510(k) submission for new indications based on substantial equivalence to predicate devices, not a de novo submission requiring extensive new clinical trial data. Instead, the focus is on comparing the characteristics of the Arthrex devices to the predicate devices, particularly for the new hip indications. This typically involves:

• Dimensional comparisons: Ensuring the sizes and designs are comparable.
• Material comparisons: Confirming the materials (titanium alloy, PLLA, PLDLA, PEEK) are acceptable and similar to the predicate.
• Mechanical testing data (if any was submitted): To demonstrate comparable strength, pull-out strength, or other relevant biomechanical properties for the intended use, although the document does not explicitly detail such testing for this particular submission.

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

Not applicable. As this is a substantial equivalence submission, there is no "test set" in the context of clinical studies requiring expert ground truth establishment for performance evaluation. The "ground truth" for the predicate devices' safety and effectiveness has already been established through their prior clearances and clinical use.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is mentioned.

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

Not applicable. This is not a study involving human readers or AI assistance. It's a regulatory submission for expanded indications of medical devices based on substantial equivalence.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This is not a study of an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" for this submission is the established safety and effectiveness of the predicate devices (Smith & Nephew BioRaptor and TwinFix Ti implants for hip labral repair), as determined by their previous 510(k) clearances and accepted clinical performance. The Arthrex devices are being presented as having sufficiently similar characteristics and intended use to the predicates for the new indications.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. As there is no training set.

In summary, the provided document K061863 is a 510(k) premarket notification seeking clearance for expanded indications for existing Arthrex medical devices (suture anchors). It operates on the principle of "substantial equivalence" to predicate devices already on the market. Therefore, it does not involve the type of acceptance criteria, clinical studies, or data provenance usually associated with proving performance for novel devices or AI algorithms. The "proof" is the detailed comparison of the new indications' intended use and the device characteristics to those of the legally marketed predicate devices.

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The MILAGRO Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

The MILAGRO Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The device is made from a copolymer of absorbable Poly(lactide-co-glycolide) (PLA PGA) compounded with beta-Tricalcium Phosphate (beta-TCP) and is available in several sizes and varied lengths.

The provided text describes a 510(k) summary for the MILAGRO Interference Screw. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on the safety and performance of the device through non-clinical laboratory testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that "Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate devices for the proposed new intended uses." However, it does not provide a specific table of acceptance criteria or detailed reported device performance metrics (e.g., tensile strength, degradation rates, biocompatibility test results, etc.). It only mentions that the device is made from a copolymer of absorbable Poly(lactide-co-glycolide) (PLA PGA) compounded with beta-Tricalcium Phosphate (β-TCP).

Therefore, a table cannot be constructed from the provided text as the specific criteria and corresponding performance values are not detailed.

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

The document mentions "Non-clinical laboratory testing" but does not specify the sample sizes used for these tests. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective) as it pertains to laboratory testing data, not human patient data.

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

Since the testing described is "non-clinical laboratory testing" and not related to clinical image interpretation or diagnosis, the concept of "experts establishing ground truth" in the traditional sense of medical image analysis does not apply here. The document does not mention any experts or their qualifications for establishing ground truth.

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

As this is non-clinical laboratory testing and not a clinical study involving interpretation or diagnosis, an adjudication method for a "test set" is not relevant and is not mentioned in the document.

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

No, an MRMC comparative effectiveness study was not done or mentioned. The safety and performance were based on "non-clinical laboratory testing."

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

This question is not applicable. The device is a physical interference screw, not an algorithm or AI. Therefore, a "standalone algorithm performance" study was not conducted.

7. The type of ground truth used:

For "non-clinical laboratory testing," the ground truth would be established by physical measurements and analytical results according to established scientific and engineering standards (e.g., material properties testing, mechanical strength testing, degradation studies, biocompatibility assays). The document does not specify the exact type of physical or chemical ground truth used beyond stating "non-clinical laboratory testing."

8. The sample size for the training set:

As this is non-clinical laboratory testing for a physical medical device, there is no concept of a "training set" as would be used in machine learning or AI.

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

This question is not applicable due to the reasons stated in point 8.

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The Arthrex Bio-Corkscrew FT Suture Anchor is intended for fixation of suture in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:

Shoulder: Rotator Cuff Repair, 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.

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

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

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The Arthrex Bio-Corkscrew Suture Anchor is a 5.5 x 15mm fully threading anchor configured with suture or with suture and needles.

This K043337 submission for the Arthrex Bio-Corkscrew Suture Anchor is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device). For devices cleared via 510(k), especially for general orthopedic fixation devices like suture anchors, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through comparison to a predicate device's performance, rather than through a rigorous, AI-specific performance study with pre-defined acceptance criteria and ground truth validation. This clearance relies on the established safety and effectiveness of the predicate.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in a 510(k) submission for this type of device, as it does not involve an AI/ML algorithm or a new performance claim that requires such a study design.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (General to 510(k) process):

• Same Intended Use: The new device must have the same intended use as a legally marketed predicate device.
• Same Technological Characteristics: The new device must have the same technological characteristics as the predicate, OR different technological characteristics must not raise new questions of safety and effectiveness.
• No New Questions of Safety and Effectiveness: Any differences in technological characteristics must be demonstrated to be as safe and effective as the predicate.

Reported Device Performance (as per the 510(k) Summary):

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

• Not applicable: This 510(k) submission does not describe a clinical study with a "test set" in the context of an AI/ML algorithm or a performance study requiring such a sample size. The substantial equivalence relies on comparison to a predicate device and potentially non-clinical bench testing (but details of such testing are not provided in the summary).

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

• Not applicable: No "ground truth" was established for a test set in the context of an AI/ML or diagnostic performance study as described in the provided document.

4. Adjudication Method for the Test Set

• Not applicable: There was no test set requiring adjudication in this 510(k) submission.

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

• No: An MRMC comparative effectiveness study was not done, as this is a medical device for physical fixation, not an image analysis or diagnostic AI 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 device is a physical suture anchor, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable: No "ground truth" data of the type requested (expert consensus, pathology, outcomes data) was used in this 510(k) submission for the purpose of validating an AI/ML model or a new diagnostic claim. The "ground truth" for substantial equivalence is effectively the performance and safety profile of the predicate device.

8. The Sample Size for the Training Set

• Not applicable: This submission does not involve a "training set" for an AI/ML model.

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

• Not applicable: This submission does not involve an AI/ML model or a training set requiring ground truth establishment.

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