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Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair.
Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Device Description

The In2Bones Hercules™ Suture Anchor System is a bone implant device intended for the fixation of soft tissue to bone. This system consists of two anchor styles manufactured from ASTM F 2026 Poly Ether Ether Ketone (PEEK) - Fully threaded anchor and Knotless anchor - that are available in five sizes ranging from 2.0mm to 5.5mm and 4 sizes ranging from 2.5mm to 5.5mm respectively, for use in a range of fixation applications.

AI/ML Overview

This document is a 510(k) summary for the Hercules™ Suture Anchor System. It details the device's indications for use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the mechanical performance tests in an easily digestible table format with reported performance. Instead, it states that "mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." This implies that the acceptance criteria are met if the device's performance is comparable to or better than previously cleared predicate devices, as assessed against the standards of ASTM F543-07.

To extract acceptance criteria and reported performance, we infer from what is mentioned:

Test	Acceptance Criteria (Inferred)	Reported Device Performance
Anchor Insertion Torque and Torque to Failure	Performance comparable to or better than predicate devices, as per ASTM F543-07.	"mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." (Implies satisfactory performance relative to predicates via this standard).
Tensile Pullout	Performance comparable to or better than predicate devices, as per ASTM F543-07.	"mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." (Implies satisfactory performance relative to predicates via this standard).
Cyclic Load	Performance comparable to or better than predicate devices, as per ASTM F543-07.	"mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." (Implies satisfactory performance relative to predicates via this standard).
Post-Fatigue Pullout	Performance comparable to or better than predicate devices, as per ASTM F543-07.	"mechanical testing was done in accordance with ASTM F543-07 to evaluate the anchors and establish substantial equivalence." (Implies satisfactory performance relative to predicates via this standard).
Bacterial Endotoxin Testing (LAL)	Meet requirements of ANSI/AAMI ST72.	"Bacterial endotoxin testing (LAL) was done per ANSI/AAMI ST72." (Implies successful completion and meeting the standard).
Sterility Validations (EO sterilization)	Meet requirements of ISO 11135.	"Sterility validations for EO sterilization per ISO 11135 for the implants... were conducted and shelf-life validations were completed and determined to be 5 years." (Implies successful validation for sterility and shelf-life).
Sterility Validations (gamma sterilization)	Meet requirements of ISO 11137-2.	"Sterility validations... for gamma sterilization per ISO 11137-2 for the instruments were conducted and shelf-life validations were completed and determined to be 5 years." (Implies successful validation for sterility and shelf-life).
Biocompatibility Assessment	Meet requirements of ISO 10993-1, with all required testing done per ISO 10993 standard.	"A biocompatibility assessment was done per ISO 10993-1 and any required testing was done per the ISO 10993 standard." (Implies successful assessment and testing).
Packaging Validations	Meet requirements of ISO 11607-1.	"Packaging validations were completed in accordance with ISO 11607-1." (Implies successful validation).

Note: The document focuses on demonstrating substantial equivalence rather than defining specific acceptance criteria for a new, novel product. Therefore, the "reported device performance" is often a statement that the relevant standard was met, implying that the performance was acceptable relative to the predicate devices.

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

Sample Size for Test Set: The document does not specify the exact sample size (number of anchors) used for each mechanical test (Anchor Insertion Torque, Torque to Failure, Tensile Pullout, Cyclic Load, Post-Fatigue Pullout). It only mentions that "mechanical testing was done."
Data Provenance: The studies were bench tests (non-clinical performance mechanical testing). This means the data is not from human subjects. The location where the tests were performed is not specified, but it would have been in a laboratory or testing facility. The data is prospective in the sense that these tests were conducted specifically for this submission, although they are based on established standards.

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

This section is not applicable as the studies are mechanical bench tests, not involving human interpretation or expert evaluation of data to establish a ground truth. The "ground truth" for these tests is defined by the physical properties and performance characteristics measured against industry standards (ASTM, ISO).

4. Adjudication Method for the Test Set

This section is not applicable as the studies are mechanical bench tests. Adjudication methods (like 2+1, 3+1) are typically used for studies involving multiple human readers assessing medical images or patient data where disagreements may arise.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers, and the provided information pertains to the mechanical performance of a medical device (suture anchors), not an AI algorithm for diagnostic purposes.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. The device is a physical medical implant (suture anchor system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance tests is based on established engineering standards and specifications (e.g., ASTM F543-07, ANSI/AAMI ST72, ISO 11135, ISO 11137-2, ISO 10993-1, ISO 11607-1). The device's performance is compared against these objective, quantifiable standards and against the performance of predicate devices as measured under these standards.

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As stated above, there is no training set for a physical medical device.

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