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The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:
Shoulder: Rotator 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

The provided text is a 510(k) summary for the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by non-clinical testing. However, it does not contain information related to a study proving a device meets acceptance criteria for an AI/algorithm-based medical device performance.

Specifically, the document discusses a suture anchor (a physical medical device used in orthopedic surgery), not an image-based AI or algorithm. Therefore, the requested information (acceptance criteria for an AI, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) is not applicable to this document.

The "studies" mentioned in the document are non-clinical physical tests of the suture anchor and suture, such as:

• suture diameter
• knot tensile strength
• suture approximation force
• chemical characterization
• anchor fixation (in-vitro and in-vivo)
• torque testing
• biocompatibility
• sterility
• packaging
• shelf-life
• bacterial endotoxin testing

These tests are to demonstrate the physical properties and safety of the orthopedic implant and suture, not the performance of an AI algorithm.

Therefore, I cannot provide the requested table or details about an AI study based on the provided text.

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The Healix Ti Anchor is intended for:

• Shoulder: Rotator 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 Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Hip: Capsular Repair, Acetabular Labral Repair

The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. The Healix Ti Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device, nor does it provide specific numerical performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "Verification activities were performed on the implant and / or its predicates. Testing assessment includes pull out testing." However, it does not provide any details regarding the sample size used for these tests, nor the data provenance (country of origin, retrospective or prospective). Given the nature of a 510(k) summary, these granular details are often found in the full submission, not the publicly available summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this document. The device in question is a medical implant (suture anchor), not an AI or diagnostic device that requires expert review for ground truth establishment. The "ground truth" for this device would be its physical and mechanical performance characteristics.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above.

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 as the device is a medical implant, not an AI or diagnostic tool that would involve human readers.

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

This is not applicable as the device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering and mechanical testing data, primarily "pull out testing" to demonstrate its fixation strength in bone. It also relies on the established performance and safety record of its predicate devices.

8. The Sample Size for the Training Set

This is not applicable as the device is hardware (medical implant) and not an AI algorithm that would require a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as the device is hardware and does not have a training set or associated ground truth in the context of machine learning.

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Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

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.

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.

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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