(118 days)
Locking Screw,CoCrMo is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.
Locking Screw, CoCrMo is used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Locking Screw, CoCrMo consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw shall be used in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Locking Screw,CoCrMo is made of CoCrMo following ASTM F1537. Locking Screw,CoCrMo is provided as sterile and non-sterile. The implants are intended for single-use only.
This submission describes a medical device, the "Locking Screw, CoCrMo," and its substantial equivalence to predicate devices, not an AI/ML powered device. Therefore, the information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.
The document provides details for a traditional medical device submission, focusing on material, design, and mechanical performance. Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with explicit acceptance criteria and reported device performance in the manner expected for an AI/ML device. Instead, it states that the device was tested to demonstrate substantial equivalence to the predicate device based on specific mechanical tests. The acceptance is implied by the FDA's substantial equivalence determination.
| Acceptance Criteria Category | Specific Test/Type of Evaluation | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | Evaluation per FDA Guidance "Use of International Standard ISO 10993-1" | The biocompatibility evaluation was conducted successfully, implying the device meets relevant safety standards for biological interaction. (Specific results like cytotoxicity scores are not provided in this summary but would be in the full submission). |
| Mechanical Performance | Torsion Test (per ASTM F543-17) | Performed to demonstrate safety and efficacy substantially equivalent to the predicate device. (Specific torque values, failure modes, or comparison data are not provided in this summary but would be in the full submission for comparison against the predicate/standards). |
| Insertion/Removal Test (per ASTM F543-17) | Performed to demonstrate safety and efficacy substantially equivalent to the predicate device. (Specific forces, cycles, or comparison data are not provided in this summary but would be in the full submission). | |
| Pullout Test (per ASTM F543-17) | Performed to demonstrate safety and efficacy substantially equivalent to the predicate device. (Specific forces, displacement, or comparison data are not provided in this summary but would be in the full submission). | |
| Material Composition | CoCrMo following ASTM F1537 | The device is made from CoCrMo following ASTM F1537, which is a recognized standard for medical implant materials. This implicitly means it meets the material specifications for this type of implant. |
| Sterility | Provided as sterile and non-sterile | Not a performance metric in this context, but a manufacturing and packaging standard. The manufacturer provides both options, implying compliance with sterilization standards as needed. |
| Single-Use | Intended for single-use only | Not a performance metric, but a critical design/usage specification to prevent reuse and associated risks. |
| Substantial Equivalence | Comparison of Regulatory Classification, Indications for Use, Materials, Design Features with predicate devices. | The device is determined to be substantially equivalent (SE) to the predicate devices in terms of safety and effectiveness, based on the non-clinical performance data and comparison of characteristics. This is the overarching "acceptance criterion" met for 510(k) clearance. Full details of the comparison would be in the complete 510(k) submission. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical performance data" and mechanical tests (Torsion, Insertion/removal, Pullout). It does not specify the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is not applicable as these are laboratory mechanical tests, not clinical studies with patient data.
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 is not applicable as this is a submission for a physical medical device (locking screw), not an AI/ML diagnostic or predictive tool. Ground truth in this context typically refers to objective measurements and compliance with established ASTM standards for mechanical properties and biocompatibility, not expert consensus on interpretations of medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device undergoing a diagnostic performance study requiring adjudication of expert interpretations.
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 not an AI/ML device. No MRMC study was performed. The product is a physical implant, not a software tool assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for non-clinical testing refers to:
- Established ASTM Standards: The mechanical tests (Torsion, Insertion/removal, Pullout) are performed according to ASTM F543-17. The acceptance criteria for these tests are derived from these industry standards, often with comparative data to the predicate device to show equivalence.
- Biocompatibility Standards: The biocompatibility evaluation follows ISO 10993-1, with acceptance based on meeting the requirements of this international standard.
- Material Specifications: The material (CoCrMo) must conform to ASTM F1537.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.