Search Results

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.

Device Description

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.

AI/ML Overview

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:

Test Type	Acceptance Criteria / Performance
Pyrogenicity Testing	"The results of this testing met the acceptance criteria described in the FDA recognized standard and therefore it was concluded that the Twist AP Suture Anchors do not raise any additional concerns regarding pyrogenicity."
Biocompatibility	"Extensive biocompatibility... testing has been conducted and has demonstrated substantial equivalence between the Parcus Twist AP Suture anchors and the predicate devices."
Mechanical Testing	"Devices were subjected to biocompatibility and benchtop testing such as pull-out strength, cyclic loading, insertion torque testing, in-vitro degradation, and animal implantation studies. Based on the results of this testing and comparison with the performance of the predicate devices or published acceptance criteria, the Parcus Twist AP Suture Anchors are determined by Parcus Medical to be substantially equivalent to the predicate devices."
In-vitro Degradation	"Devices were subjected to... in-vitro degradation... Based on the results of this testing and comparison with the performance of the predicate devices or published acceptance criteria, the Parcus Twist AP Suture Anchors are determined by Parcus Medical to be substantially equivalent to the predicate devices."
Animal Implantation	"Devices were subjected to... animal implantation studies. Based on the results of this testing and comparison with the performance of the predicate devices or published acceptance criteria, the Parcus Twist AP Suture Anchors are determined by Parcus Medical to be substantially equivalent to the predicate devices."

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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