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The Parcus Actiflip is used for fixation of bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repari (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.

The Parcus ActiFlip device consists of a titanium implantable button that is mounted onto an inserter shaft that allows for placement and deployment of the button. ActiFlip is available in three (3) configurations, with or without UHMWPE suture – Naked (without suture), CINCH, WHIP.

The provided text is a 510(k) summary for the Parcus ActiFlip device. It outlines the device's indications for use, its characteristics, and how its substantial equivalence to predicate devices was established. However, it explicitly states that "Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices" and that "Performance was established based on acceptance criteria with the rationale that the new specific indications...do not introduce a worst-case for mechanical performance of the subject device."

This type of submission for a medical device (a 510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance through a clinical trial with specific performance metrics and acceptance criteria for algorithm-based diagnostic or prognostic devices.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-driven diagnostic devices. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance: No such table or performance metrics are provided. The "performance" mentioned refers to mechanical performance, not diagnostic accuracy.
2. Sample size used for the test set and data provenance: No test dataset details are given.
3. Number of experts used to establish ground truth and qualifications: Not applicable as there's no clinical data or ground truth establishment for a diagnostic study.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was performed or is mentioned.
6. Standalone (algorithm-only) performance: Not applicable as this is a physical implant, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there's no algorithm training mentioned.
9. How ground truth for the training set was established: Not applicable.

The document describes a physical medical device (a fixation fastener), not an AI/ML-driven diagnostic or image analysis tool. The "performance" mentioned is mechanical validation (implicitly, by showing it's not a 'worst-case' scenario compared to predicates), not the type of performance evaluation relevant to AI diagnostics.

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The Parcus AcTiFlip is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

The Parcus AcTiFlip and GFS Ultimate Hip devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture and are provided sterile.

This FDA 510(k) summary provides limited information regarding the acceptance criteria and study data for the Parcus Medical AcTiFlip and GFS Ultimate Hip devices.

Here's an analysis based on the provided text, highlighting where information is available and where it's missing for your specific requests:

Summary of Acceptance Criteria and Device Performance (Limited Information):

Detailed Responses to Specific Questions:

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

   • See the table above. The document primarily states that the devices demonstrate "substantial equivalency" to predicate devices for mechanical properties (strength and elongation) and meet endotoxin specifications. Specific numerical acceptance criteria for strength and elongation are not
     provided in this summary, nor are the precise numerical results of the testing.

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

   • Sample Size: The document states that "testing was conducted on the worst case configurations," but does not specify the sample size (N) for these tests.
   • Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. It describes laboratory testing, not clinical studies.

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 is not applicable as the summary describes mechanical and biocompatibility laboratory testing of a medical device (fixation fasteners), not a diagnostic or AI-driven device requiring expert-established ground truth.

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

   • This is not applicable for mechanical and biocompatibility testing. Adjudication methods are typically used in clinical studies or studies involving human assessment of data.

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 is not applicable. The device (fixation fasteners) is not an AI/diagnostic device 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 is not applicable. The device is a physical medical implant, not an algorithm.

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

   • For the mechanical tests, the "ground truth" (or more accurately, the reference standard for comparison) was the performance of the predicate device. The testing aimed to show that the new device's performance was "substantially equivalent" to this established predicate.
   • For pyrogenicity, the "ground truth" was established based on endotoxin limit specifications, which are regulatory standards.

8. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is not an AI/machine learning device. The testing described is for physical properties and biocompatibility.

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

   • This is not applicable for the reasons stated above.

In summary, the provided FDA 510(k) letter and summary focus on demonstrating substantial equivalence of a physical medical device (bone/soft tissue fixation fasteners) to already cleared predicate devices through mechanical testing and biocompatibility assessments. It does not involve AI, diagnostic algorithms, or human interpretation studies.

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