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510(k) Data Aggregation
(92 days)
SMV Scientific 4.5 mm Bone Screws
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
| Test Mode | Standard Applied | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Static Torsion | ASTM F543 | Not explicitly stated in the provided text, but implies performance comparable to the predicate device. | The strength of the SMV Scientific 4.5mm Bone Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. |
| Driving Torque | ASTM F543 | Not explicitly stated in the provided text, but implies performance comparable to the predicate device. | The strength of the SMV Scientific 4.5mm Bone Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. |
| Pullout Testing | ASTM F543 | Not explicitly stated in the provided text, but implies performance comparable to the predicate device. | The strength of the SMV Scientific 4.5mm Bone Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. |
| Removal Torque | ASTM F543 | Not explicitly stated in the provided text, but implies performance comparable to the predicate device. | The strength of the SMV Scientific 4.5mm Bone Screw is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. |
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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