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2.4mm Wise-Lock Distal Radius System:
2.4mm Wise-Lock Distal Radius System are used for displaced extra-articular distal radius fractures and corrective osteotomies of the distal radius.

2.4mm Wise-Lock Proximal Radius System:
2.4mm Wise-Lock Proximal Radius System are used for extra-articular fractures of Proximal radius and multifragmented radial neck fractures.

2.4mm Variable Angle Distal Radius System:
2.4mm Variable Angle Distal Radius System are used for displaced extra-articular and intra-articular distal radius fractures and corrective osteotomies of the distal radius.

The 2.4mm Radius System consists of various types of bone plates, screws for implantation in the radius bone to treat the radius bone fracture.

The provided text describes a 510(k) premarket notification for a medical device called the "2.4mm Radius System." This is a submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device, and thus does not require approval of a premarket approval application (PMA).

Crucially, this document focuses on demonstrating substantial equivalence based on design, materials, and mechanical performance tests against recognized standards, rather than clinical performance or diagnostic accuracy. Therefore, the concepts of acceptance criteria for diagnostic performance, test set characteristics, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of regulatory submission.

The "acceptance criteria" in this context refer to compliance with material standards, mechanical performance standards, and sterilization/packaging standards. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing conducted against these standards.

Here's a breakdown of the requested information based on the provided text, noting where certain categories are not applicable:

Acceptance Criteria and Study Details for the 2.4mm Radius System (K211324)

1. Table of Acceptance Criteria and Reported Device Performance

• ASTM F899-12: Standard Specification for Wrought Stainless Steels for surgical instruments.
• ASTM F138/ISO 5832-1: Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants. | - Compliance verified with Titanium Alloy (Ti-6Al-4V) Grade 5 as per ISO 5832-1/ASTM F136 for Titanium Implants.
• Compliance verified with Stainless Steel (Grade 316L) as per ISO 5832-3/ASTM F138 for Stainless Steel Implants.
• Compliance verified with Grade 304 of Stainless steel (SS 304) Material for instruments as per ASTM F899-12b. |
  | Mechanical Performance | - ASTM F382: Standard Specification and Test Method for Metallic Bone Plates.
• ASTM F543: Standard Specification and Test Method for Metallic Medical Bone Screws. | Plate Testing:
• 4-Point Static Test: Conforms
• 4-Point Fatigue Test: Conforms
  Screw Testing:
• Driving Torque Test: Conforms
• Torsion Test: Conforms
• Axial Pull-out Test: Conforms |
  | Biocompatibility | - ISO 10993-3 (General evaluation for raw materials) | Raw materials evaluated and found to comply with ISO 10993-3. |
  | Sterilization & Packaging | - ISO 11137-1, -2, -3 (Radiation sterilization)
• ISO 17665-1, -2, -3 (Moist heat sterilization)
• ISO 11140-1 (Chemical indicators)
• ISO 11737-1, -2 (Microbiological methods)
• ISO 11607-1, -2 (Packaging for sterile medical devices)
• ASTM F1980 (Accelerated Aging of Sterile Barrier Systems)
• ASTM F88/F88M (Seal strength)
• ASTM F1929 (Seal leaks by dye penetration) | Subject device and packaging validated against these standards for both Gamma Sterilization and non-sterile products. |
  | Bacterial Endotoxin | - USP Bacterial Endotoxin Test.
• USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests. | Compliance with USP and for bacterial endotoxin and pyrogen tests. |
  | Dimensional Verification | Comparison to predicate device dimensions. | Same dimension as of Predicate device. |
  | Shelf-life | 5 Years | 5 Years (Same as predicate device) |
  | Use Type | Single Use | Single Use (Same as predicate device) |

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

• Sample Size for Test Set: The document describes bench testing for mechanical integrity and material compliance, not clinical or diagnostic performance on human or animal subjects. The "sample size" would refer to the number of test coupons or devices subjected to mechanical tests (e.g., how many plates for 4-point static test, how many screws for torsion test). This specific number is not explicitly stated in the provided text, but it is implied that a sufficient number was tested to meet the requirements of the ASTM standards.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): The data provenance here refers to the origin of the bench test results. These tests were conducted as part of the manufacturer's (Auxein Medical Private Limited, India) submission to the FDA. The tests likely involved physical samples of the manufactured devices. The data itself is prospective in the sense that the tests were performed specifically for this submission against established standards.

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

• Not Applicable. This device is a bone fixation system (medical hardware), not a diagnostic algorithm that requires expert interpretation to establish a ground truth. The "ground truth" for this device relates to its material properties and mechanical performance, which are established by standardized laboratory testing methods and engineering specifications, not expert consensus on medical images or diagnoses.

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

• Not Applicable. As this is not a diagnostic performance study, there's no need for an adjudication method for establishing ground truth. The compliance with standards is determined by objective measurements during bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a bone fixation device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant to this submission.

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

• Not Applicable. This is a physical medical device (bone plate and screws), not an algorithm.

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

• The "ground truth" for this device is defined by established engineering and material standards (e.g., ASTM F382, ASTM F543, various ISO and ASTM material standards). Compliance with these standards confirms the device's functional and material integrity.

8. The sample size for the training set

• Not Applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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