(224 days)
Tandry Compression Screw System is intended for the treatment of fractures, and fusions of bone with the appropriate screw size.
Tandry Compression Screw System consists of 2.8mm, 4.1mm, 4.7mm, 5.5, and 7.5mm cannulated compression screw, 2.0mm compressions screw and 2.0mm compression pin. The 2.0mm compression pin features a beak-off groove between a shaft and compression screw body, the shaft can be separated from the compression screw body by bending it back and forth. The screw system has multiple lengths depending on the diameter of the screws and pins are fabricated from Ti-6Al-4V and anodized.
The provided FDA 510(k) K220359 summary for the Tandry Compression Screw System does not describe an AI/ML medical device. It pertains to a physical medical device (bone fixation screws). Therefore, many of the requested elements for describing the acceptance criteria and study of an AI/ML device are not applicable or cannot be extracted from this document.
However, I can extract information related to the non-clinical performance testing of the physical device, including the acceptance criteria and the study that demonstrated compliance.
Here's the breakdown of the information that can be extracted, and where the requested AI/ML specific information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Defined in FDA guidance document "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway". This guidance document specifies performance criteria for various biomechanical tests (e.g., torsional strength, bending strength, fatigue life, screw pull-out). | The testing results and assessment indicated that the Tandry Compression Screw System meets the acceptance criteria defined in the FDA guidance document. (Specific numerical results are not provided in this summary but are indicated to have met the criteria.) |
| Biocompatibility requirements per ISO 10993-1. | The proposed device meets biocompatibility requirements. |
| Reprocessing and sterilization effectiveness, using predicate device data (K171904). | Performance and testing results of the predicate device (Tandry Locking Plate System K171904) regarding reprocessing and sterilization were utilized and deemed applicable, indicating the proposed device is expected to meet these criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated in this summary. Biomechanical testing would typically involve a specific number of screws for each test (e.g., 5-10 samples per test arm).
- Data Provenance: Not explicitly stated. Non-clinical (bench) testing is typically conducted in controlled laboratory environments, possibly by the manufacturer or a contract testing organization.
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)
- Not Applicable. This is a physical device, and its performance is evaluated through objective biomechanical and material testing, not through expert reading of images or data. Ground truth here refers to actual physical properties and performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert review of images/data. Biomechanical testing relies on measurable physical parameters.
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
- Not Applicable. This is a physical device, not an AI/ML system that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biomechanical performance: Direct measurement of physical properties and mechanical performance (e.g., torsion, bending, fatigue) against established engineering standards (ASTM F-543-17) and FDA guidance documents.
- For biocompatibility: Laboratory testing results according to ISO 10993-1.
- For reprocessing/sterilization: Laboratory testing results, leveraging prior data from a substantially equivalent predicate device (K171904).
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" as this is not an AI/ML device.
Additional Study Information Extracted:
- Study Type: Non-clinical (bench) testing, including biomechanical tests, biocompatibility assessments, and reprocessing/sterilization validation.
- Standards Utilized:
- ASTM F-543-17: Standard Specification and Test Methods for Metallic Medical Bone Screws
- Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (FDA guidance)
- ANSI/AAMI/ISO 10993-1: 2018: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
- AAMI TIR30: 2011(R2016): A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
- ANSI/AAMI/ISO 17665-1: 2006/(R)2013: Sterilization of health care products – Moist heat – Part1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
- ANSI/AAMI/ISO 14937: 2009(R)2013: Sterilization of healthcare products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.