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Devices (K-Wires and Steinmann Pins) are intended to be used as:

• · Guide wires for osteosynthesis implants
• · Accessories for external fixation (Steinmann Pins)
• · Implants according to principles of fracture management

The SMV Scientific K-Wire and Pin consists of K-Wire and Pins in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided nonsterile. All devices are manufactured from medical grade Stainless Steel or Titanium alloys.

This document is a 510(k) clearance letter for the "SMV Scientific K-Wire and Pins." It does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML device. The device described here is a physical medical device (K-wires and Steinmann pins), and its clearance is based on substantial equivalence to a predicate device, not on a performance study with acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states:

"Testing, therefore, was not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices."

This indicates that the clearance was based on engineering analysis and comparison to a predicate device, not on a performance study that would generate the kind of data requested (acceptance criteria, reported device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.).

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The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

The SMV Scientific 4.5mm Solid Bone Screws consist of cortical screws in a variety of lengths to accommodate different anatomic sizes of patients. The screws are provided non-sterile and are self-tapping. Screws are manufactured from stainless steel.

The SMV Scientific 4.5mm Bone Screws are subject to acceptance criteria derived from mechanical performance tests, as outlined in the 510(k) summary (K150188).

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the mechanical performance tests, nor does it provide information on data provenance (country of origin or retrospective/prospective nature). The tests are described as "non-clinical testing," suggesting a in vitro laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a bone screw, and its performance is evaluated through mechanical testing against engineering standards, not through expert-based assessment of clinical images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts, which is not the nature of this mechanical testing.

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 information is not applicable. The device is a bone screw and its evaluation does not involve AI assistance or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a bone screw and mechanical testing is performed on the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance tests is established by the specifications and requirements of the ASTM F543 standard. The performance of the SMV Scientific 4.5mm Bone Screw is compared directly against the predicate device's performance under these same mechanical tests, aiming for substantial equivalence.

8. The sample size for the training set
This information is not applicable as this is a medical device (bone screw) undergoing mechanical testing, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device evaluation.

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