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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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GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The system is indicated for use in adult patients only. All implants are for single use only.

GPC Variable Angle Locking Two Column Volar Distal Radius Plates are machined metal plates designed for fixation of various fracture modes of the distal portion of the Variable Angle Locking Two Column Volar Distal Radius Plates allow fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. The variable angle locking mechanism improves the plate-screw construct stability. GPC Variable Angle Locking Two Column Volar Distal Radius Plates are manufactured using titanium material for surgical implant applications.

Following are the types of the GPC Variable Angle Locking Two Column Volar Distal Radius Plates:

• Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 22 mm, 6 Head Holes (with option of Left and Right Variants)
• Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 25.5 mm, 7 Head Holes (with option of left and right variants)
• Variable Angle Locking Two Column Volar Distal Radius Plate- Narrow, Width 19.5 mm, 6 Head Holes (with option of left and right variants)

Corresponding Screws for fixation:

• Variable Angle Locking Screw 2.4 mm, Star drive Lengths: 6mm to 30mm in 2mm increments
• FixLOCK Self-Tapping Screw 2.4 mm, Star drive Length 6mm to 30mm in 2mm increments
• Self-Tapping Cortex Screw 2.7 mm, Star drive Length: 12mm to 24mm

These implants are supplied non-sterile, the products have to be sterilized prior to use.

The provided document describes a 510(k) premarket notification for the GPC 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plates. This notification aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness. Therefore, the information provided focuses on the comparison to the predicate device and non-clinical testing against established standards, not on a study proving the device meets specific acceptance criteria in a clinical context with human users or AI.

However, based on the provided text, we can extract details related to the "device performance" as demonstrated through non-clinical testing.

Here's an analysis based on the information provided, framed as if the non-clinical tests are the acceptance criteria for substantial equivalence:

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

The document does not explicitly state "acceptance criteria" with numerical targets for the mechanical tests. Instead, it states that the device "Conforms" to the specified ASTM standards, implying successful performance according to the methodology and requirements of those standards.

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

• Sample Size: The document does not specify the sample size (number of plates or screws) used for each mechanical test.
• Data Provenance: The tests are non-clinical, conducted by the manufacturer, GPC Medical Ltd. The country of origin of the data would be India, where the manufacturer is located. The tests are prospective in the sense that they were conducted specifically for this submission.

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

This question is not applicable to the provided context as the "ground truth" here is established by engineering standards and direct physical measurement of mechanical properties, not by human expert interpretation. There were no human readers or expert consensus involved in determining if the device "conforms" to a bending fatigue test.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies with expert reviewers establishing ground truth, which is not the case here. The "adjudication" for mechanical tests involves comparing measured values against specified thresholds within the ASTM standards.

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 question is not applicable. The device is a physical medical implant (bone plate and screws), not an AI software/algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This question is not applicable, as the device is not an algorithm or AI.

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

For the non-clinical performance tests, the "ground truth" is defined by the specifications and methodologies of the applicable ASTM standards (ASTM F382 for plates and ASTM F543 for screws). The device's performance is compared directly against these engineering standards. For the comparison of characteristics, the "ground truth" is the specifications and characteristics of the identified predicate devices.

8. The sample size for the training set

This question is not applicable. This is a medical implant, not a machine learning model, so there is no "training set."

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

This question is not applicable, as the device is not a machine learning model.

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OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.

OsteoMed Wrist Plating System implants are intended for single use only.

The OsteoMed Wrist Plating System is a rigid fixation and fusion system , consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification, implantation, or removal of the implants. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking or non-locking head in various lengths. These screws are either solid core or cannulated and can be used with or without plates.

Plates and screws are supplied in a variety of configurations. The plates and screws are made of titanium alloy (ASTM F136). K-wires are made of titanium alloy (ASTM F136) or stainless steel (ASTM F138). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The provided text describes a 510(k) summary for the OsteoMed Wrist Plating System. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than conducting a de novo clinical study with specific acceptance criteria, sample sizes, and ground truth establishment for novel device performance.

Therefore, the requested information regarding acceptance criteria, a study proving device meeting these criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set is not applicable or available within this 510(k) submission.

The document states:

• "Analyses of plate and screw strength were conducted to compare the OsteoMed Wrist Plating system components to predicate devices." This implies mechanical bench testing for equivalence, not a clinical study with performance metrics like sensitivity, specificity, or accuracy.
• "Equivalence for OsteoMed Wrist Plating system is based on similarities in intended use, design and operational principle to the referenced predicates. Based on the similarities, we believe that the OsteoMed Wrist Plating System does not raise any new safety or effectiveness issues." This is the core argument for a 510(k) submission.

Without a clinical study explicitly designed to measure performance against predefined acceptance criteria, it's impossible to populate the requested table and answer many of the questions.

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