(449 days)
Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
In addition, Tandry Locking Hip Plate System is in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, and basilar neck fracture.
Each plate is indicated to be used in the following anatomic regions:
- 1.5mm and 2.0mm locking plates Metacarpals, metatarsals, tarsals, and phalanges
- 2.4mm locking plates Radius, wrist, and ulna
- 3.5 mm locking plates Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia
- 5.0 mm locking plates Femur and tibia
The Tandry Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept locking, cortex, shaft and cancellous screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. The instruments are used for completing the surgery.
Based on the provided text, the device in question, the "Tandry Locking Plate System," is a bone fixation device seeking 510(k) clearance, which means it is determined to be substantially equivalent to legally marketed predicate devices. This type of device, being a physical implant, does not involve AI or algorithms, and therefore, the acceptance criteria and study data provided in the document are not related to AI/algorithm performance.
The document describes non-clinical (biomechanical) testing to demonstrate substantial equivalence, rather than studies typically performed for AI-driven medical devices.
Therefore, I cannot provide information for the following points as they are not applicable to this type of device and the information provided:
- A table of acceptance criteria and the reported device performance (in the context of AI/algorithms)
- Sample sizes used for the test set and data provenance (for AI/algorithms)
- Number of experts used to establish ground truth and qualifications (for AI/algorithms)
- Adjudication method (for AI/algorithms)
- MRMC comparative effectiveness study (for AI/algorithms)
- Standalone performance (for AI/algorithms)
- Type of ground truth used (for AI/algorithms)
- Sample size for the training set (for AI/algorithms)
- How ground truth for the training set was established (for AI/algorithms)
Instead, here is a summary of the acceptance criteria and study information provided in the document for the physical medical device:
The "Tandry Locking Plate System" is a bone fixation device, not an AI/algorithm-driven device. Its approval is based on demonstrating substantial equivalence to existing predicate devices through non-clinical testing, primarily biomechanical tests, rather than clinical studies or performance against AI-specific metrics.
Acceptance Criteria & Device Performance (Physical Device Context):
The acceptance criteria for this type of device are centered around demonstrating that its mechanical performance (strength, integrity) is comparable to that of legally marketed predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices in terms of mechanical properties (plate and screw performance). | "Results indicate that the subject plate and screw are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness." |
| Compliance with relevant ASTM standards for biomechanical testing. | "The biomechanical tests ASTM F543 and F382 were performed to determine substantial equivalence for the Tandry Locking Plate System including the performance of plate and screw." |
| Material compliance with specified international standards. | "The Tandry Locking Plate System is fabricated from stainless steel 316L per ASTM F139, titanium alloy per ASTM F136 and unalloyed titanium per ASTM F67." |
Study Details (for Physical Device):
- Sample sizes used for the test set and the data provenance: Not specified in terms of number of test articles beyond "biomechanical tests ASTM F543 and F382 were performed." The "data provenance" would be from laboratory biomechanical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For biomechanical testing, the "ground truth" is the established mechanical properties and performance data from predicate devices and the physical test results.
- Adjudication method: Not applicable. Biomechanical tests follow standardized protocols.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for diagnostic or AI-assisted devices where human readers interpret cases.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical device, not an algorithm.
- The type of ground truth used: For biomechanical testing, the ground truth is derived from the established mechanical properties and performance of predicate devices as measured through standardized laboratory tests.
- The sample size for the training set: Not applicable. There is no "training set" for a physical medical device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document pertains to a traditional medical device (bone plate system) cleared via the 510(k) pathway, which primarily relies on demonstrating substantial equivalence through non-clinical (biomechanical) testing rather than AI-specific performance metrics or clinical studies involving human readers and AI assistance.
§ 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.