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The PolyLock System is indicated for use in the treatment of bone fractures, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand, foot, and ankle, including the distal tibia, talus, and calcaneus. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 3rd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.

The PolyLock Plating System consists of various shapes and sizes of plates for the management of orthopedic osteotomies, reconstruction, and trauma of the foot, ankle, and hand. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm, 2.7mm, 3.5mm and 4.0mm with lengths from 8mm to 60mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.

This document is a 510(k) premarket notification for a medical device (PolyLock Plating System). It does not contain any information about an AI/ML-based medical device study, acceptance criteria, or performance data related to AI/ML.

Instead, it's about a metallic bone fixation appliance. The "Non-clinical Test Summary" and "Clinical Test Summary" explicitly state:

• "Engineering rational was performed to show substantial performance equivalence."
• "No clinical studies were performed."

Therefore, I cannot provide details on the requested points because the provided text does not describe an AI/ML study. It details the submission of a physical medical device.

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The PolyLock System is indicated for use in the treatment of bone fractures, arthrodesis, osteochondritis, and interfragmentary indications in the small bones of the hand and foot. Including, fusions of the forefoot and midfoot, stabilization of 1st, 2nd, 4th, and 5th tarsometatarsal fusions, intercuneiform, navicular-cuneiform, talo-navicular, calcaneo-cuboid, and medial column fusions, first metatarsal osteotomies for hallux valgus/rigidus correction, first metatarsal fracture fixation, arthrodesis of the first metatarsal cuneiform joint, and arthrodesis/fusion of the first metatarsophalangeal joint.

The PolyLock Plating System consists of various shapes and sizes of plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact plate capable of dynamic/manual compression, with threaded screw holes accepting both poly-axial and locking screws. The system also consists of poly-axial and locking screws with diameters consisting of 2.0mm, 2.4mm, 2.7mm, 3.5mm and 4.0mm with lengths from 8mm to 60mm. System instrumentation includes: drill bits, countersinks, K-wires, olive wires, depth gauges, reamers, driver shafts, guides, plate benders, clamps, and driver handles to facilitate the placement of the screws. The implants are intended for single use only. Instruments designed for bone removal are intended for single use only, such as: drill bits, countersinks, reamers, K-wires, and olive wires.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device meets acceptance criteria:

Based on the provided FDA 510(k) summary for the PolyLock Plating System, it's crucial to understand that this submission does not involve an AI/ML powered device. The device is a traditional orthopedic implant (plating system). Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI, standalone performance, ground truth establishment for training set, etc.) are not applicable here.

The "acceptance criteria" in this context refer to demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than performance metrics for an AI algorithm.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Not applicable in the context of an AI/ML device. For this traditional medical device (orthopedic plating system), the "test set" refers to the specific implant designs and materials subjected to non-clinical testing (e.g., sterilization tests, mechanical property tests).
• The document does not specify exact "sample sizes" for each non-clinical test (e.g., how many plates were sterilized, how many screws were tested for torque). However, engineering rationales and validation protocols typically involve statistically relevant sample sizes for specific tests.
• Data provenance: Not explicitly stated beyond "non-clinical tests were performed." These would generally be performed in a laboratory setting by the manufacturer or a third-party testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. "Ground truth" in the context of expert consensus is specific to AI/ML performance evaluation. For a traditional medical device, the "ground truth" for material properties or mechanical performance is established through standardized engineering tests and specifications (e.g., ASTM standards for materials).
• The "experts" would be the engineers and quality assurance professionals conducting and verifying the non-clinical tests, following recognized standards and protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts when establishing ground truth for AI/ML performance studies.
• For non-clinical device testing, results are typically objective (e.g., passing a specific mechanical load, achieving a certain sterility assurance level) and validated against established standards. Data analysis and interpretation would be reviewed by internal quality and regulatory personnel.

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

• No. A Multi-Reader Multi-Case (MRMC) study is specifically for evaluating the performance of AI-assisted diagnostic devices with human readers. This device is an orthopedic implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This device does not have an algorithm or AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable in the AI/ML sense. For this device, the "ground truth" is defined by:
  • Material Standards: Adherence to ASTM F899 (Stainless steel) and ASTM F136 (Ti-6Al-4V) specifications.
  • Engineering Standards: Meeting predefined mechanical performance criteria (e.g., strength, stiffness, fatigue resistance) typically derived from industry standards or comparison with predicate devices.
  • Validation Standards: Compliance with validated cleaning, packaging, and sterilization protocols (e.g., ISO or AAMI standards).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable. This device is not an AI/ML model, so there is no "training set" or ground truth established for one.

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