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The Parcus Miti Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

The Parcus V-lox™ Titanium Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Hip: Acetabular Labral Repair

The Parcus Miti and V-lox Titanium Suture Anchors are a family of threaded, tapered fasteners for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136). It comes preloaded with either one, two, or three strands of sutures between 3-0 and #2 in size or suture tape between 1.4mm and 2.0mm wide. The suture and suture tape is available either with or without attached needles, and is provided sterile and attached to a driver. The Miti Suture Anchor is available in diameters of 2.0mm, 2.5mm and the V-lox Titanium Suture Anchor is available in diameters of 4.5mm, 5.0mm, 5.5mm and 6.5mm.

The provided text describes a 510(k) premarket notification for Parcus V-lox Titanium Suture Anchors and Parcus Miti Suture Anchors. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically associated with a new AI/software device. Instead, this document is a regulatory submission demonstrating substantial equivalence to previously cleared devices.

Here's an analysis of why the requested information cannot be fully provided based on the input:

• Type of Device: The devices are physical implants (suture anchors), not an AI or software device. The "performance data" section focuses on MR (Magnetic Resonance) compatibility, which is a safety evaluation for implanted medical devices, not an evaluation of diagnostic or treatment efficacy based on AI algorithms.
• Regulatory Pathway: A 510(k) submission primarily aims to demonstrate "substantial equivalence" to a predicate device, meaning it is as safe and effective as a device already on the market. This often involves comparing device specifications, materials, and intended use, and sometimes includes performance testing for specific safety attributes (like MR compatibility here), rather than clinical efficacy studies against acceptance criteria for a new mode of action.

Given this context, I will address the requested points as much as possible, clarifying where the information is not present due to the nature of the submission.

Acceptance Criteria and Device Performance

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

The document does not provide a table of acceptance criteria for diagnostic performance or treatment efficacy. The only performance data presented relates to MR compatibility.

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

The document mentions "worst-case devices were selected for testing" for MR compatibility. However, it does not specify the exact sample size (number of devices tested) for the MR evaluation. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) as this was a laboratory-based physical test on the device itself, not a clinical data study.

• 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 point is not applicable. The MR compatibility testing is a physical measurement of the device's interaction with an MR environment, not a diagnostic or clinical assessment requiring expert consensus or ground truth in the medical sense.

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

This point is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for physical performance testing like MR compatibility.

• 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 point is not applicable. The device is a physical medical implant (suture anchor), not an AI or software system that would involve human readers or AI assistance.

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

This point is not applicable. The device is a physical medical implant, not an algorithm.

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

For the MR compatibility testing, the "ground truth" would be the scientifically established physical limits and behaviors for MR safety as defined by FDA guidance and ASTM standards. It's a technical standard, not a medical "ground truth" derived from patient data.

• 8. The sample size for the training set

This point is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

This point is not applicable. There is no training set.

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