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The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

In addition, the Tandry Locking Hip Plate System is indicated for fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, intertrochanteric, and basilar neck fracture.

Each plate is indicated for 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.

This document describes the Tandry Locking Plate System, a medical device for bone fixation. However, it does not include information about acceptance criteria and a study that proves the device meets those criteria in the way typically expected for an AI/ML powered device. This submission is for a traditional medical device (bone plates and screws), and its clearance is based on substantial equivalence to a predicate device, rather than a performance study against specific acceptance criteria for diagnostic or prognostic accuracy.

Therefore, many of the requested fields cannot be extracted or are not applicable.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics typically found for AI/ML devices. Instead, the "acceptance criteria" for clearance appear to revolve around demonstrating substantial equivalence to a predicate device through non-clinical testing (biomechanical, biocompatibility, reprocessing, and sterilization).

Since this is not a diagnostic device, there are no metrics like sensitivity or specificity.

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of diagnostic performance evaluation. The device undergone non-clinical testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for this type of device.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense. "Ground truth" for this device would refer to the successful demonstration of mechanical properties, biocompatibility, and sterilization effectiveness through standardized tests.
7. The sample size for the training set: Not applicable. This is not a machine learning device.
8. How the ground truth for the training set was established: Not applicable.

Summary from Document:

This device, the Tandry Locking Plate System, received FDA clearance (K230690) based on substantial equivalence to a predicate device (Tandry Locking Plate System, K171904). The evaluation focused on non-clinical tests including biomechanical, biocompatibility, and reprocessing/sterilization studies. The document explicitly states: "Clinical studies are not required to support substantially equivalent." The biomechanical and reprocessing/sterilization performance of the proposed device are deemed equivalent to the predicate device, thus utilizing the predicate's testing results. Biocompatibility testing was performed on representative samples according to ISO standards. The modifications to the device (material, anodization, and some length specifications) were deemed not to change its intended use, fundamental scientific technology, or biocompatibility requirements.

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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.

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.

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