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The KATOR Suture Anchor is 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 KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair suture tape within the implant.

The applicant is seeking 510(k) clearance for the KATOR Suture Anchor, a device designed to attach soft tissues to bone. The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics comparison and nonclinical testing.

Here's an analysis of the provided information, structured to address your questions:

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 sample sizes for the individual nonclinical tests (Insertion, Pullout Strength, Cyclic Displacement, Pyrogenicity). It only mentions that "All testing was performed on test units representative of finished devices."

Data provenance is not explicitly stated as retrospective or prospective, but considering it's nonclinical testing of a device, it would inherently be prospective testing performed in a controlled laboratory environment. There's no mention of country of origin for the data, but the manufacturer is based in Logan, Utah, USA, suggesting the testing was likely conducted in the US or by a US-affiliated lab.

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

This question is not applicable to this submission. The KATOR Suture Anchor is a physical medical device, and its performance is evaluated through mechanical and biocompatibility testing, not through interpretations requiring expert consensus or ground truth derived from expert opinions (as would be the case for AI/software devices or diagnostic tools). The "ground truth" here is defined by engineering and biological standards.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons above. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human experts when establishing ground truth, typically in the context of diagnostic or interpretive tasks. The nonclinical tests here have objective pass/fail criteria based on predefined 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

An MRMC study was not applicable and therefore not performed. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging or similar fields where human interpretation is a key component. The KATOR Suture Anchor is a physically implanted medical device, and its safety and effectiveness are determined by objective mechanical and biocompatibility tests, not by human reader performance.

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

This question is not applicable. The KATOR Suture Anchor is a physical medical device, not an algorithm or software. Therefore, there is no "standalone algorithm performance" to evaluate.

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

For the nonclinical tests conducted:

• Mechanical Tests (Insertion, Pullout Strength, Cyclic Displacement Testing): The ground truth is established by engineering specifications and industry standards. The device is subjected to forces and movements, and its response is measured against predefined thresholds for strength, displacement, and ease of insertion.
• Pyrogenicity (BET Test): The ground truth is established by biological safety standards for pyrogen limits. The test measures the presence of pyrogens, and the result is compared against a specified limit to determine if the device meets safety requirements.

8. The Sample Size for the Training Set

This question is not applicable. The KATOR Suture Anchor is a physical medical device, and its development and testing do not involve "training sets" in the context of machine learning. The design and manufacturing processes are based on engineering principles and material science, not data training.

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

This question is not applicable for the same reasons as #8. There is no training set for a physical medical device.

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The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

The modified KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair sutures or suture tape within the implant.

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study proving a device meets these criteria. The document is a 510(k) premarket notification for a medical device (KATOR Suture Anchor) and primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's what I can extract and why some parts of your request cannot be answered from this text:

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

The document states: "The results of this testing as summarized in the Design Control Activities Summary demonstrate that the modified KATOR Suture Anchor met the pre-determined acceptance criteria for the verification activities." However, it does not explicitly list the specific acceptance criteria or the numerical results of the performance tests. It only lists the types of tests performed.

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

This information is not provided in the document. The text mentions "verification tests" and "testing as summarized in the Design Control Activities Summary" but does not detail the sample sizes or the provenance of the test 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)

This is not applicable as the document describes mechanical testing of a medical implant (suture anchor), not an AI or diagnostic imaging device that would typically rely on expert-established ground truth.

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

This is not applicable for the same reason as point 3.

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 as the document is about a mechanical medical device, not an AI or diagnostic imaging system involving human readers.

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

This is not applicable as the device is a physical suture anchor, not an algorithm.

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

This is not applicable in the context of mechanical device testing. The "ground truth" for mechanical performance is typically defined by engineering specifications and standards.

8. The sample size for the training set

This is not applicable as the document describes a mechanical medical device, not a machine learning model that would have a training set.

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

This is not applicable for the same reason as point 8.

Summary of what can be extracted from the document:

• Device Name: KATOR Suture Anchor
• Purpose of Study: Verification testing to demonstrate that the modified KATOR Suture Anchor met pre-determined acceptance criteria and introduced no new issues of safety or effectiveness compared to its predicate device (K152236).
• Types of Tests Performed:
  • Static Performance Testing
  • Dynamic Performance Testing
  • Limulus Amebocyte Lysate (LAL) testing for endotoxin levels.
• Outcome of Testing: "The results of this testing as summarized in the Design Control Activities Summary demonstrate that the modified KATOR Suture Anchor met the pre-determined acceptance criteria for the verification activities."
• Ground Truth (Implicit): For mechanical tests, the ground truth would be defined by the engineering specifications and relevant ASTM or ISO standards for suture anchors. For endotoxin levels, it's defined by acceptable limits established using LAL testing.
• Data Provenance: Not specified, but generally, such testing for 510(k) submissions is performed in a controlled laboratory environment.

To provide the detailed information you requested (specific acceptance criteria, numerical performance data, sample sizes, etc.), you would need access to the "Design Control Activities Summary" mentioned in the document, which is not included in the provided text.

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The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

The KATOR Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone.

This document, a 510(k) premarket notification from the FDA, pertains to a medical device (KATOR Suture Anchor) and does not describe or contain information about a study proving that a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Instead, this document is a Traditional 510(k) approval for a physical medical device (suture anchor). The "tests" mentioned are nonclinical (mechanical) tests to ensure the device's physical performance, not diagnostic performance of an AI algorithm.

Therefore, I cannot provide the requested information for an AI/SaMD product based on this document. The document lists:

• Device Name: KATOR Suture Anchor
• Regulation Name: Smooth or threaded metallic bone fixation fastener
• Regulatory Class: Class II (physical device)
• Product Code: MBI (physical device)
• Predicate Device: Arthrex Corkscrew FT (K061665) - also a physical device.

The "Nonclinical Testing" section states:
"The device performance was characterized through the following tests:

• Static and Dynamic Performance
• Suture Knot Strength"

These are mechanical tests, not performance studies for a diagnostic AI.

To answer your request about acceptance criteria and a study for an AI/SaMD, I would need a document that describes the clinical performance evaluation of an AI or software device, typically involving a test set, ground truth establishment, and statistical analysis of diagnostic metrics. This document does not contain that information.

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