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The Stryker Anchorage 2 CP System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients.

Indications include:

Replantation
Joint fusions
Corrective osteotomies
Osteopenic bone

Device Description

This Traditional 510(k) submission is being supplied to the U.S. FDA to seek clearance to market the new Anchorage 2 CP System. The Anchorage 2 CP System is an internal fixation device that consists of various plates used with compatible screws to treat different types of corrective osteotomies and fractures in the foot and ankle. The subject plates comprise of a new countersunk screw interface that is only compatible with the new inter-fragmentary partially threaded Cross-Plate (CP) lag screws. The subject components will be available sterile and non sterile. The plates will be available in sizes ranging from 23-49mm in length. The Anchorage 2 CP System is introducing Ø3.6mm and Ø4.1mm inter-fragmentary partially threaded Cross-Plate (CP) lag screws. The Anchorage 2 CP Ø3.6mm CP lag screws will be available in sizes ranging from 20-44mm in length and the Anchorage 2 CP Ø4.1mm CP lag screws will be available in sizes ranging from 20-70mm. The Anchorage 2 CP System includes holes that are only compatible with the existing VariAx 2 System screws that were previously cleared in the VariAx 2 System (K132502).

Apart from the CP Lag screws, the associated accessories include:

CP Reamer
CP Drill Guide for T8 Ø3.6mm CP lag screws
CP Drill Guide for T10 Ø4.1mm CP lag screws
CP Templates

AI/ML Overview

This document describes the Anchorage 2 CP System, a medical device for internal fixation in foot and ankle. The information provided outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to predicate devices, rather than a study proving it meets specific acceptance criteria in the typical sense of AI/diagnostic device performance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size, etc.) are not applicable to this type of device and submission. This is a 510(k) premarket notification for a bone fixation system, relying on non-clinical performance testing and comparison to legally marketed predicate devices to establish substantial equivalence. Clinical studies, AI algorithm development, and human reader performance are not relevant to this submission.

Here's a breakdown of the available information based on your request, with an emphasis on what is and isn't provided or applicable:

Section of Request	Information from Document	Analysis/Explanation
1. Table of acceptance criteria and reported device performance	The document doesn't explicitly state "acceptance criteria" in the format of specific numerical thresholds for accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" can be inferred as the device demonstrating substantial equivalence to predicate devices through successful completion of non-clinical biomechanical and biocompatibility testing.	The reported device performance is that it met the requirements of the listed ASTM standards in biomechanical testing and passed biocompatibility tests.
2. Sample size used for the test set and data provenance	Not applicable for this type of device/submission. This is a physical implant device, not a diagnostic or AI device that uses patient data for a test set in the traditional sense. The "test set" refers to physical samples of the device components.	The document does not specify a "sample size" of patients or data points. It refers to the number of device components tested for biomechanical and biocompatibility properties. No data provenance in terms of country of origin or retrospective/prospective is relevant here.
3. Number of experts used to establish ground truth for test set and qualifications	Not applicable. Ground truth in the context of diagnostic/AI devices refers to a definitive diagnosis. For this physical device, "ground truth" relates to the established standards for mechanical performance and biocompatibility. Experts are involved in setting these standards (e.g., ASTM committees) rather than adjudicating individual cases.	No "experts" were used to establish ground truth for a diagnostic test set. The "ground truth" for the device's performance is adherence to established engineering and material standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set	Not applicable. Adjudication methods are used in diagnostic/AI studies to resolve discrepancies in expert interpretations of data. This is not relevant for the biomechanical and biocompatibility testing of a physical medical implant.	No adjudication method was used as there's no diagnostic task or expert interpretation of patient cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size	No, an MRMC study was not done. This is not relevant for a bone fixation system. MRMC studies are typically used for diagnostic imaging or AI devices to assess human reader performance with and without AI assistance.	The document explicitly states "Clinical testing was not required for this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done	Not applicable. This device is a bone plate and screw system, not an algorithm.	No standalone algorithm performance was assessed.
7. The type of ground truth used	For biomechanical testing: Compliance with ASTM F382-14 and ASTM F543-13 standards.
For biocompatibility testing: Compliance with ISO 10993-1 as recognized by FDA.	The "ground truth" is established by recognized international and federal standards for medical device performance and safety.
8. The sample size for the training set	Not applicable. This device does not involve a "training set" in the context of machine learning or AI.	No training set was used.
9. How the ground truth for the training set was established	Not applicable.	No ground truth for a training set was established.

Summary of the Study that Proves the Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" conducted for the Anchorage 2 CP System was a series of non-clinical performance tests designed to demonstrate that the device is as safe and effective as its predicate devices.

Type of Study: Non-clinical (benchtop) biomechanical testing and biocompatibility testing. No human or animal clinical studies were required or performed.
Biomechanical Testing Performed:
- Construct Fatigue Strength Testing as per ASTM F382-14 (Plates and CP Screws)
- Insertion Torque Testing as per ASTM F543-13 (CP Screws)
- Shear-off Testing as per ASTM F543-13 (CP Screws)
- Pull-out Testing as per ASTM F543-13 (CP Screws)
Biocompatibility Testing Performed:
- Cytotoxicity
- Sensitization
- Irritation
- Conducted in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993-1," which is recognized by FDA.
Ground Truth for Testing: Adherence to the specified ASTM standards for mechanical performance and ISO 10993-1 for biocompatibility.
Conclusion: "Testing demonstrated that the Anchorage 2 CP System is substantially equivalent to the predicate devices currently cleared for marketing." The non-clinical data supported the safety of the system and demonstrated that it should perform as intended, thereby meeting the requirement for substantial equivalence.

In essence, for this Class II bone fixation device, "acceptance criteria" are met by demonstrating through standardized non-clinical testing that the device functions comparably to already approved predicate devices and is biocompatible. The nature of the device (a physical implant) means that many of the typical AI/diagnostic study metrics are not relevant.

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