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The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocryl® RapideTM (composite of β-TCP and PLGA copolymer). Size #1 blue Permacord™ suture (UHMWPE braided suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The Permacord suture is a non-absorbable suture that conforms to USP except for oversized diameter. The device is provided as sterile; the device is for single patient use only.

AI/ML Overview

The provided document describes a 510(k) submission for a medical device, the GRYPHON™ ANCHOR w/PROKNOT™ Technology. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through a clinical or performance study with a test set, ground truth experts, and MRMC studies as typically seen in AI/Software as a Medical Device (SaMD) submissions.

The "study" in this context is the non-clinical testing performed to show the new device performs similarly to the predicate device.

Here's how to interpret the information based on the provided text, addressing your points where possible, and noting when the information is not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an orthopedic anchor), the "acceptance criteria" are typically related to mechanical performance characteristics that demonstrate equivalence to the predicate.

Acceptance Criteria (What was tested)	Reported Device Performance (How the GRYPHON™ ANCHOR w/PROKNOT™ Technology performed)
Fixation Strength Testing (To ensure substantial equivalence of device performance compared to predicate devices)	Data demonstrated substantial equivalence of product performance when compared to predicate devices (GRYPHON™ Anchor w/PROKNOTT™ Technology (K132241), GRYPHON BR Anchor (K100012, K090124), GRYPHON PEEK Anchor (K103712), and Healix Advance Anchor w/Permacord suture (K133794)).
Suture Knot Strength Testing (To ensure substantial equivalence of device performance compared to predicate devices)	Data demonstrated substantial equivalence of product performance when compared to predicate devices. Specific values and thresholds are not provided in this summary but were presumably met.
Suture Fray Testing (To ensure substantial equivalence of device performance compared to predicate devices)	Data demonstrated substantial equivalence of product performance when compared to predicate devices. Specific values and thresholds are not provided in this summary but were presumably met.
Suture per USP (United States Pharmacopeia) Standards (For the Permacord suture)	Suture testing on the Permacord suture was conducted per USP standards. (It's implied it met these standards, though specific results are not detailed).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated. For mechanical testing of medical devices like this, the "sample size" refers to the number of physical anchors and sutures tested. This is typically determined by engineering standards and statistical power calculations to demonstrate a certain level of confidence in the performance. The document only states "Fixation strength testing, suture knot strength testing and suture fray testing were conducted."
Data Provenance: The testing was "conducted" by DePuy Mitek. The provenance of the "data" itself (e.g., patient data, country of origin, retrospective/prospective) is not applicable here as this is mechanical testing of the device itself, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable for this type of device submission. Ground truth, in the context of expert review, is relevant for diagnostic devices or AI/SaMD where human interpretation or clinical outcomes are the gold standard. For an orthopedic anchor, the "truth" is established by physical measurements and engineering specifications, not expert consensus.

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

Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes to resolve discrepancies in ground truth labeling. For mechanical testing, the "adjudication" is based on objective measurements and established thresholds.

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. MRMC studies are specific to diagnostic imaging devices, particularly those involving AI. This device is a surgical implant (an anchor), not an imaging or diagnostic tool.

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

Not applicable. This device does not have an algorithm component.

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

The "ground truth" for this device's performance relies on engineering specifications, standardized test methods (e.g., ASTM standards, USP for sutures), and direct physical measurements (e.g., force required for fixation failure, suture break strength, degree of fraying). The "truth" is objective, measurable, and compared against established performance criteria from the predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are established through engineering principles, not data-driven training.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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