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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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K Number

K140324

Device Name

RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL

Manufacturer

DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY

Date Cleared

2014-07-07

(147 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K083070,K130033,K123362

Intended Use

The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.

Device Description

The proposed device is a cortical fixation system composed of titanium button, adjustable suture (Ultra-high molecular polyethylene (UHMWPE)), leading suture (UHMWPE and green Polyester (PET) co-braid) and training suture (green PET). Length of the suture loops is adjustable to the desired length. The proposed device provides a fixation in cruciate ligament reconstructive surgery. The device is provided as sterile for single patient use only.

AI/ML Overview

The provided text describes a medical device, the RIGIDLOOP™ Adjustable Cortical Fixation System, and its 510(k) summary for FDA clearance. This document type (510k summary) typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that proves the device meets them:

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

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance
Fixation Strength	Substantial equivalence to predicate device's fixation strength.	"Fixation strength testing (bench-top) was conducted. The testing demonstrated substantial equivalence of device performance."
Biocompatibility	Suitable for intended use without adverse biological reactions.	"The proposed device has been determined biocompatible for the intended use based on biocompatibility data."
Safety and Efficacy	Raise no new issues of safety and efficacy compared to predicate devices.	"The proposed device has raised no new issue of safety and efficacy."
Technological Characteristics	Substantial equivalence to predicate devices' technological characteristics (titanium button, non-absorbable sutures, adjustable suture).	"Technological characteristics and fixation strength are 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):

Sample Size: Not specified. The document only states "Fixation strength testing (bench-top) was conducted." This implies an engineering test, not a clinical study with human subjects.
Data Provenance: Not specified, but likely laboratory/bench testing data rather than human subject data.

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

This information is not applicable to the type of testing described. The "ground truth" for bench testing would be measured physical properties, not expert consensus on medical images or clinical outcomes.

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

This information is not applicable as the described testing is bench-top, not a clinical study requiring adjudication of expert interpretations.

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 information is not applicable. The RIGIDLOOP™ system is a medical device for orthopedic surgery, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this device's clearance.

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

This information is not applicable. The RIGIDLOOP™ system is a physical surgical device, not an algorithm.

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

For the fixation strength testing, the "ground truth" would be direct physical measurements of load, displacement, and failure points, consistent with engineering and biomechanical bench-top testing standards. For biocompatibility, it would be results from standardized biocompatibility assays.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training suture" mentioned in the description is for surgical training, not algorithm training.

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

This information is not applicable for the same reason as above (not an AI/machine learning device).

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