(239 days)
Ideal® locking plate system is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.
Ideal® locking plate system contains locking plates with various specifications, cortical and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery.
The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The cortical and locking screws are made of Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.
The provided document is a 510(k) premarket notification for a medical device called the "Ideal® Locking Plate System." It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical (bench) testing.
However, the document does not contain information about a study that would involve acceptance criteria related to device performance in a clinical setting, such as a study with human readers, AI assistance, or the establishment of ground truth by medical experts.
Therefore, many of the requested items cannot be extracted from this document as they are not applicable to the type of submission described. This is a submission for a metallic bone fixation appliance, and the evidence provided focuses on mechanical and material properties through bench testing, not clinical performance metrics typically associated with AI-driven or diagnostic devices.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test Standards) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates: | Complies with standards. |
| - Static four point bending | (Details not provided, but compliance stated) |
| - Dynamic four point bending | (Details not provided, but compliance stated) |
| ASTM F 543-07, Standard Specification and Test Metallic Medical Bone Screws: | Complies with standards. |
| - Torsional properties | (Details not provided, but compliance stated) |
| - Driving torque | (Details not provided, but compliance stated) |
| - Pull out test | (Details not provided, but compliance stated) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document for any of the bench tests.
- Data Provenance: The tests were conducted to demonstrate compliance with ASTM standards, which are international standards. The device manufacturer is Jiangsu Ideal Medical Science & Technology Co., Ltd. in China. The specific location where the bench tests were performed is not mentioned within the text, but it can be inferred that they were part of the submission process from a Chinese manufacturer. The tests are non-clinical, so "retrospective or prospective" does not apply in the clinical sense.
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 submission relies on engineering bench tests, not clinical evaluation requiring expert ground truth for interpretation of images or other clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for clinical studies, especially those involving human interpretation of data. This submission is based on physical and mechanical testing against recognized standards.
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 device is a metallic bone fixation system, not a diagnostic or AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve algorithms or AI. It is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: The "ground truth" for the bench tests would be the specifications and performance requirements defined by the ASTM standards (ASTM F 382-99 and ASTM F 543-07). The device's performance is compared directly against these established engineering criteria, not against biological or clinical "ground truth" like pathology or expert consensus.
8. The sample size for the training set
- Not applicable. This submission evaluates a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or AI model is involved.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.