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The MedShape, Inc., Porous Morphix® Suture Anchor with Force Fibere is intended for fixation of suture to bone in the shoulder, footlankle, knee, hand/wrist and elbow in the following procedures:

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

The proposed Porous Morphix® Suture Anchor with Force Fiber® Suture is a line extension to our Morphix® product family and is substantially equivalent to the Morphix® Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, in which the features and intended uses are the same. In addition, the technological characteristics of the Morphix® and the Porous Morphix® Suture Anchor are equivalent. Differences between the Porous Morphix® Suture Anchor and the MedShape predicate Morphix® Suture Anchor include an extruded porous layer on the top surface of the device and a change in the preferred suture supplier (suture supplier CP Medical, previously cleared under K041894, was switched to suture supplier Teleflex Medical, previously cleared under K033654). This porous surface is derived directly from the implant body and is not a sintered coating.

The provided text describes a 510(k) submission for a medical device, the Porous Morphix® Suture Anchor with Force Fiber® Suture. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically associated with AI/ML device performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MedShape, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture - now referred to as Morphix®, K091202) based on:

• Same Intended Uses: The new device has the same indications for use as the predicate.
• Equivalent Technological Characteristics: Analysis of non-clinical test results (monotonic and post cyclic suture fixation strength in Sawbone® bone analogue [pull-to-failure], dimensional verification, and material safety data [both bio and MRI compatibility]) supports this equivalence.
• Minor Differences: The differences are an extruded porous layer on the top surface of the device and a change in suture supplier. These differences were determined not to raise questions concerning safety and effectiveness.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These points are relevant to AI/ML device validation, which is a different regulatory pathway and type of study than what is presented in this 510(k) summary for a physical medical device (suture anchor).

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CP-Fiber is indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries.

CP-Fiber is a synthetic non-absorbable suture composed of a braided polyblend. As with all surgical sutures, CP-Fiber is a single-use device. This submission expands the indications for use to include orthopedic surgeries.

The provided document is a 510(k) summary for a medical device (CP-Fiber suture). While it describes the device's intended use and substantial equivalence to predicate devices, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

This document focuses on regulatory approval based on demonstrating equivalence to existing products rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, nor its data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document states: "Testing activities demonstrate that the product complies with USP requirements for nonabsorbable sutures." This is a general statement about compliance with a standard, but it doesn't provide the detailed acceptance criteria or study results that you're asking for.

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The MedShape Solutions, Inc., WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis in the following procedures:

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

The proposed WedgeLoc™ Suture Anchor is a sterile, single use, two piece "push-in" bone anchor. The suture anchor is designed to use the principles of compression to force the eyelet, pre-loaded with non-absorbable suture, into a hole created in the bone. The suture anchor body is comprised of a crosslinked Methyl methacrylate (MMA) polymer (comprised of Memori™ 7111. refer to MAF #1533) and PEEK eyelet (comprised of PEEK-OPTIMA® by Invibio®, refer to MAF #1209).

Each suture anchor is preloaded with two non-absorbable USP No. 2 sutures. The polyblend surgical suture provided with the proposed WedgeLoc™ Suture Anchor is provided by CP Medical, and has previously been cleared for market under K041894. In addition, these sutures meet USP requirements as described in the USP monograph for non-absorbable surgical sutures. Opti-Fiber™ non-absorbable polyblend surgical sutures are made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover and are identical to the CP-Fiber™ USP No. 2 sutures described in K041894.

This is a 510(k) summary for a medical device called the WedgeLoc™ Suture Anchor with Opti-Fiber™ Sutures. This document aims to demonstrate substantial equivalence to predicate devices, rather than establishing primary safety and effectiveness through a traditional clinical study with defined acceptance criteria and performance reporting as one might expect for a novel device.

The "study" referenced in this document is an in-vitro functional performance testing to show the new device performs at least as well as the predicate.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a quantitative table for "device performance." Instead, it relies on demonstrating that the proposed device performs "as well as or better than" the predicate device in functional performance testing.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "functional performance testing," but the number of samples or tests conducted is not provided.
• Data Provenance: In-vitro (laboratory testing, not human or animal data).

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

Not applicable. The ground truth for this type of test is typically based on engineering specifications and direct measurement of mechanical properties, rather than expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. This was an in-vitro functional test, not a study requiring adjudication of expert opinions or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

No MRMC comparative effectiveness study was done. This document describes the 510(k) submission for a medical device (suture anchor), not an AI or imaging device that would typically involve MRMC studies.

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

Not applicable. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used

The ground truth for the in-vitro functional performance testing would be the measured mechanical properties of the suture anchor and its fixation strength in bone analogues, compared against the known performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this type of device submission.

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