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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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The Healix BR and Gryphon BR Anchors are intended for:
Shoulder: Rotor Cuff Repair, 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;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The Healix BR and Gryphon BR Anchors are absorbable threaded suture anchors manufactured of "Biocryl Rapide" material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Healix BR Anchor is provided in three sizes: one with an outer diameter of 4.5mm. another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The Gryphon BR Anchor is provided as size 3.0mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix BR and Gryphon BR Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.

1. Acceptance Criteria and Reported Device Performance:

The document provided does not specify explicit acceptance criteria for device performance based on quantitative metrics. Instead, the "Safety and Performance" section states: "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This implies that the acceptance criteria were met by demonstrating substantial equivalence to pre-existing, legally marketed devices.

Therefore, the table would reflect this:

2. Sample Size and Data Provenance:

The document does not provide details on the sample size used for any specific tests or studies. It also does not specify the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing. The statement is general, referring to "performance and safety testing."

3. Number and Qualifications of Experts for Ground Truth:

This information is not provided in the document. The substantial equivalence claim is against predicate devices, not based on expert-established ground truth on a new dataset.

4. Adjudication Method:

This information is not provided in the document. As no specific "test set" with ground truth established by experts is mentioned, adjudication methods like 2+1 or 3+1 are not applicable here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The submission focuses on substantial equivalence to predicate devices rather than direct comparative effectiveness with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable as the device is a physical bone anchor, not an algorithm or AI-based system. Therefore, an "algorithm only" performance study would not be relevant.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically applied in AI/software evaluation (e.g., expert consensus, pathology, outcome data) is not directly relevant here. The "ground truth" in this context is implicitly the established safety and performance profile of the predicate devices to which this device is compared for substantial equivalence.

8. Sample Size for the Training Set:

This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."

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

This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."

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