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Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions.

One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand.

Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius)

Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required.

The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures.

The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius.

One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus

Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula.

Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia.

The Clavicle Superior Plates 3.5 are indicated for:

• Fractures of the clavicle shaft
• Fractures of the lateral clavicle
• Malunions of the clavicle
• Non-unions of the clavicle

The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus.

The Tibia Proximal Lateral Plates 3.5 are indicated for:

• Split-type fractures of the lateral tibial plateau
• Lateral split fractures with associated depressions
• Pure central depression fractures
• Split or depression fractures of the medial plateau

The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for

• Intraarticular fractures of the distal humerus
• Supracondylar fractures of the distal humerus
• Non-unions of the distal humerus

The Humerus Distal Medial Plates 2.7/3.5 are indicated for

• Intraarticular fractures of the distal humerus
• Supracondylar fractures of the distal humerus
• Non-unions of the distal humerus

The Ulna Proximal Olecranon Plates 3.5 are indicated for

• Complex extra- and intra-articular olecranon fractures
• Non-unions of the proximal ulna
• Osteotomies
• Simple olecranon fractures

Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia.

T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur

Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.

The Genostis Osteosynthesis System comprises of fracture fixation plates, corresponding screws and required surgical instruments. Different shapes and sizes are available to accommodate for different anatomical regions and locations of fractures. The plate screw interface is either locking, non-locking or, for some plates, realized by a combination hole offering both options (locking and non-locking).

All plates and screws are made of titanium alloy (Ti 6Al 4V ELI) according to ASTM F136 and ISO 5832-3.

The implants of the Genostis Osteosynthesis System are sterilized by radiation and are delivered sterile.

The provided FDA 510(k) clearance letter for the Genostis Osteosynthesis System does not describe a study involving an AI/software device or human readers. Instead, it describes a traditional medical device (bone fixation plates and screws) and primarily references non-clinical (biomechanical and biocompatibility) testing to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested criteria related to AI/software performance, human reader studies, and ground truth establishment in a diagnostic context are not applicable to this document.

However, I can extract and structure the information that is relevant to the device's acceptance criteria based on the provided text, particularly concerning non-clinical testing.

Here's the breakdown based on the information available:

Acceptance Criteria and Study for Genostis Osteosynthesis System

The Genostis Osteosynthesis System is a traditional medical device (bone fixation plates and screws), not an AI/software diagnostic device. As such, the "acceptance criteria" and "study" proving it meets them are primarily based on non-clinical engineering and biological tests, not AI performance metrics or human-in-the-loop diagnostic studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All results were satisfactory" for all tests, indicating the device met the pre-defined acceptance criteria for each test.

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

• Sample Size: The document does not specify the exact number of units or samples used for each biomechanical or biocompatibility test. It generally states that testing was "performed" and "conducted on final sterile product."
• Data Provenance: Not explicitly stated as "country of origin," but testing would be performed in a controlled laboratory environment. The tests are non-clinical (biomechanical and biocompatibility), not data from patients. The study is by nature prospective in that new manufactured devices were tested to meet the standards, not a retrospective analysis of existing data.

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

• Not Applicable. This is a medical device (hardware) clearance, not an AI/software diagnostic device that requires expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" here is the adherence to established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical mechanical and biocompatibility testing, there is no "adjudication" in the sense of reconciling expert opinions on diagnostic findings. The results are quantitative and objective measurements against established standard thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not Applicable. MRMC studies are for evaluating clinical interpretation of diagnostic results, typically with AI assistance. This device is a physical implant, not a diagnostic tool or AI.

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

• Not Applicable. This pertains to AI algorithm performance. The device is a bone fixation system and does not rely on an algorithm for its primary function.

7. The Type of Ground Truth Used

• Pre-defined Standards and Controls: The "ground truth" for this device's performance is established by well-defined, internationally recognized (ISO) and American (ASTM) standards for material properties, mechanical strength, and biocompatibility. The device must perform within the specified parameters of these standards. For example, screws must meet certain torque resistance (ASTM F543), and plates must meet specific load-sharing characteristics (ASTM F382).

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.

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

• Not Applicable. There is no "training set" for this type of medical device clearance. The design and manufacturing processes are established based on engineering principles and existing predicate device designs, with performance validated against the standards mentioned above.

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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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