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The TopLock Anchor System is intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation, Rotator Cuff Repair, Capsule Repair, Biceps Tenodesis. Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction, Bicep Tendon Reconstruction, Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction, Ulnar / Radial Collateral Ligament Reconstruction, Extensor Tendon Repair, Flexor Tendon Repair
The Knee:
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Tendon Repair
The Ankle and Foot:
Lateral Ligament Stabilization Repair, Medial Ligament Stabilization Repair.
Achilles Tendon Repair / Reconstruction, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Mid and Rear Foot Reconstruction

The TopLock Anchor System consists of a collection of barbed suture anchors, manufactured from medical grade Polyetheretherketone or PEEK (ASTM F2026). The anchors are offered from diameters of 3.5mm to 5.0mm with each size offering two eyelet size options to accommodate suture and suture tape. The size range and configurations are offered for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).

This document is a 510(k) premarket notification for a medical device (TopLock Anchor System). It describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence.

Crucially, this document explicitly states that no clinical studies were performed to prove the device meets acceptance criteria. Instead, non-clinical tests (mechanical testing, cleaning, packaging, sterilization, pyrogenicity) were conducted to demonstrate design equivalence to predicate devices.

Therefore, I cannot provide the detailed information requested in the prompt regarding acceptance criteria, study design, ground truth, or expert involvement for clinical performance. The information provided in the document pertains to non-clinical acceptance criteria and testing for mechanical and material equivalence.

Based on the provided text, here's what can be extracted regarding the device's validation:

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Regarding the specific questions about clinical performance and AI-related studies:

1. A table of acceptance criteria and the reported device performance: Covered above for non-clinical aspects. No clinical performance criteria or data are provided.
2. Sample size used for the test set and the data provenance: Not applicable to clinical performance as no clinical studies were performed. For non-clinical tests, specific sample sizes are not detailed, but standard validation protocols would have been followed for mechanical and material testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical outcomes was not established as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical performance. For non-clinical testing, the "ground truth" would be established engineering and material specifications, and regulatory standards.
8. The sample size for the training set: Not applicable. No training set for an AI/algorithm was used.
9. How the ground truth for the training set was established: Not applicable.

In summary, the TopLock Anchor System received 510(k) clearance based on demonstrating "substantial equivalence" to existing predicate devices through non-clinical testing (mechanical, material, and sterility validations), rather than through clinical performance studies. The document explicitly states: "No clinical studies were performed."

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The Parcus Knotless PEEK and PEEK CF Push-In 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, lliotibial 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 Knotless PEEK and PEEK CF Push-In Suture Anchors are tapered fasteners with an eyelet at the distal tip and circumferential barbs used to secure the implant in bone and provide suture fixation without the need for knot tying. After passing through the target tissue, sutures are passed through the distal eyelet of the anchor, it is pounded into place which secures both the anchor and the suture in place. This is the same design and insertion technique as the predicate Knotless PEEK CF Push-In Suture Anchors. The predicate device was originally provided in 3.5mm and 4.5mm diameters and this 510(k) will expand that size range to include 2.8mm and 5.5mm options. The Knotless PEEK Push-In Suture Anchor is made from polyetheretherketone (PEEK) and the Knotless PEEK CF Push-In Suture Anchors are made from carbon fiber polyetheretherketone (PEEK CF). The Parcus predicate device is comprised of carbon fiber polyetheretherketone (PEEK CF). The Parcus reference devices consist of devices comprised of either PEEK or PEEK CF. The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are provided sterile with a single use suture passer and either with or without a single use inserter.

This document describes the Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors. The provided text is a 510(k) summary for a medical device and, as such, does not contain information about acceptance criteria or a detailed study proving the device meets those criteria in the context of diagnostic performance or AI model evaluation.

The "Summary Performance Data" section briefly mentions that the device was evaluated for "strength and elongation under cycle loading and ultimate failure conditions" and that "Results were compared with test data for the predicate device and demonstrated substantial equivalency." This indicates mechanical testing was performed to demonstrate that the new device performs comparably to an existing, legally marketed device (the predicate).

However, the document does not provide specific numerical acceptance criteria for these mechanical tests, nor does it detail the specific results. It also does not involve any AI, image analysis, or human reader performance evaluation, and therefore, many of the requested points are not applicable.

Below is an attempt to address the request based only on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the mechanical performance tests. The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from internal testing conducted by Parcus Medical, LLC. The testing is for a new device attempting to prove substantial equivalence to a predicate, so it is a prospective evaluation of the new device's performance against existing data or concurrent testing of the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device performance study, not a study requiring expert interpretation of diagnostic data.

4. Adjudication method for the test set
Not applicable. This is a mechanical device performance study.

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
Not applicable. This document pertains to a physical medical device (suture anchors) and does not involve AI, image analysis, or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical device.

7. The type of ground truth used
For the mechanical tests, the "ground truth" (or reference) was the performance data of the predicate device (Parcus Knotless PEEK CF Suture Anchors, K113730) for "strength and elongation under cycle loading and ultimate failure conditions." For biocompatibility, the ground truth was based on the known materials and manufacturing processes of the predicate and reference devices. For pyrogenicity, it was an endotoxin limit specification.

8. The sample size for the training set
Not applicable. This document describes the testing of a physical medical device and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established
Not applicable. This document describes the testing of a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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The Parcus Twist AP Suture Anchors are indicated for the attachment of soft tissue to bone. This product is intended for the following indications:

The Parcus Twist AP Suture Anchors consist of fully threaded anchor bodies in 4.5. 5.5, and 6.5mm diameters. The anchor body is comprised of a β-TCP and PLGA biocomposite that has a proven record as a safe and effective absorbable material that has been used in the industry for over 10 years. The anchor bodies feature an internal bar over which strands of UHMWPE suture and/or suture tape are suspended. This allows for free movement of the suture or suture tape in order to assist with the passing and securing of soft tissue. The anchor body material has been designed such that it will maintain the necessary strength to insert successfully and provide the necessary resistance to pull-out long enough for the body to heal and then, over time, break down, be absorbed into the body and eventually replaced by bone. While the UHMWPE suture and suture tape are non-absorbable, this does not create any problems and may remain implanted indefinitely. The presence of the osteoconductive ß-TCP will allow for boney replacement at the insertion site as the anchor is absorbed.

Suture anchors are assembled with suture and/or suture tape provided with or without needles assembled on single use drivers and provided to the end user individually packaged and sterile.

This is a 510(k) premarket notification for the Parcus Twist AP Suture Anchors, a medical device used for the attachment of soft tissue to bone. The document focuses on demonstrating the substantial equivalence of the new device to existing predicate devices. Consequently, it does not detail a study proving the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy. Instead, the "acceptance criteria" discussed relate to biocompatibility and mechanical performance for demonstrating substantial equivalence.

Here's the information extracted from the provided text regarding the testing performed:

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

The document does not provide a specific table of detailed acceptance criteria with numerical values and reported performance for each mechanical test. Instead, it states:

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 states, "The entire scope of the proposed Twist AP Suture Anchor product family was considered and worst-case scenarios for various concerns were identified." However, it does not specify the sample size for any of the tests (biocompatibility, pull-out strength, cyclic loading, insertion torque testing, in-vitro degradation, or animal implantation studies).
The data provenance is not specified beyond indicating that the data were generated to support a US FDA 510(k) submission. It's implicitly prospective in the sense that the testing was conducted for this specific submission to demonstrate equivalence.

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 section is not applicable to this document. The testing performed is for mechanical and biological properties of a physical medical device, not related to expert interpretation of data or images to establish ground truth.

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

This section is not applicable to this document for the same reasons 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 section is not applicable to this document. This is not an AI/software device or an imaging device requiring human reader interpretation.

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

This section is not applicable to this document. This is not an algorithm or software device.

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

The "ground truth" in this context refers to established standards and performance of predicate devices:

• For Pyrogenicity: "acceptance criteria described in the FDA recognized standard"
• For Biocompatibility, Mechanical, In-vitro Degradation, and Animal Implantation: "comparison with the performance of the predicate devices or published acceptance criteria"

8. The sample size for the training set

This section is not applicable to this document. This is not a device based on machine learning or AI that requires a training set.

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

This section is not applicable to this document for the same reasons as point 8.

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