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The MLP Special Locking Bone Plate System is indicated for use in internal fixation for bone fractures, fusions, osteotomies, pseudoarthroses, and non-unions of the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal in pediatrics and adult populations.

Device Description

The MLP Special Locking Bone Plate System consists of Bone Plates and locking screw components that are intended to be used in various bone fixation procedures. The MLP Special Locking Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium (Ti-6Al-4V) in conformance with ASTM F136. Plates and screws are provided non-sterile.

AI/ML Overview

This is a 510(k) premarket notification for the MLP Special Locking Bone Plate System. This type of submission rarely contains the kind of detailed performance data and study information you're asking for, as the primary goal is to demonstrate "substantial equivalence" to a predicate device.

Based on the provided document, here's what can and cannot be answered regarding acceptance criteria and a study proving those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Description	Acceptance Criteria	Reported Device Performance
Material Conformity	Device materials should conform to ASTM F136 (titanium).	All plates and screws are manufactured from titanium (Ti-6Al-4V) in conformance with ASTM F136.
Static and Dynamic 4-Point Plate Bending Tests (ASTM F382-17, Annex 1, 2 and 3)	Performance should demonstrate equivalence to predicate devices.	The results of these evaluations indicate that the MLP Special Locking Plate System is equivalent to the predicate devices.
Screw Pull-Out Tests (ASTM F543-17)	Performance should demonstrate equivalence to predicate devices.	The results of these evaluations indicate that the MLP Special Locking Plate System is equivalent to the predicate devices.
Screw Torque Tests (ASTM F543-17)	Performance should demonstrate equivalence to predicate devices.	The results of these evaluations indicate that the MLP Special Locking Plate System is equivalent to the predicate devices.
Screw Torsion Tests (ASTM F543-17)	Performance should demonstrate equivalence to predicate devices.	The results of these evaluations indicate that the MLP Special Locking Plate System is equivalent to the predicate devices.

Important Note: The document states that the MLP Special Locking Plate System is equivalent to the predicate devices based on these tests, but it does not provide specific numerical acceptance criteria or detailed numerical results for any of these tests. For instance, it doesn't say "bending strength must be > X MPa" and then report "our device achieved Y MPa." It only states that the results "indicate equivalence."

Regarding "the study that proves the device meets the acceptance criteria":

The document describes non-clinical mechanical testing as the study that supports the substantial equivalence claim.

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

Sample Size for Test Set: Not specified in the document. The tests performed are ASTM F382-17 and ASTM F543-17, but the number of devices or components tested is not mentioned.
Data Provenance: The document does not specify the country of origin of the data. It's an in-vitro non-clinical test conducted by the manufacturer or a contracted lab. It is a retrospective analysis in the sense that the tests were performed to support the 510(k) submission, not as part of an ongoing clinical trial.

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

This question is not applicable to this submission. The "ground truth" here is established by standardized mechanical testing protocols (ASTM). It's not a diagnostic device where expert interpretation of data generates a ground truth.

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

This question is not applicable to this submission. Mechanical tests don't involve adjudication in this manner.

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, an MRMC comparative effectiveness study was not done. This is a bone plate system, not an AI-powered diagnostic device.

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

No, a standalone (algorithm only) performance study was not done. This is a mechanical device, not an algorithm.

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

The "ground truth" for the non-clinical tests is the specified performance requirements and methods defined by the ASTM standards (ASTM F382-17 and ASTM F543-17). These standards define how the mechanical properties should be measured and likely include performance benchmarks (though the specific benchmarks are not reported in this document). The comparative aspect is against the performance of the predicate device(s).

8. The sample size for the training set

This question is not applicable to this submission. There is no "training set" as this is not an AI/machine learning device. The design and validation of the device rely on engineering principles, material science, and mechanical testing.

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

This question is not applicable as there is no training set for this type of device.

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