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Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

Spinal inner fixation system consists of a variety of shapes and sizes of pedicle screws, rods, hooks, transverse linking pole assembly, and connecting components (side, domino, and axial), which can be rigidly locked into a variety of configurations. These components are made of titanium alloy per ASTM F136.

This document is a 510(k) premarket notification for a medical device, the "Spinal Inner Fixation System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets a specific set of acceptance criteria for diagnostic performance or treatment efficacy in the way an AI/ML device would.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance for AI/ML systems is not applicable or present in this document.

However, I can extract the information relevant to the mechanical performance testing conducted for this orthopedic device.

Here's the breakdown of the available information:

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

The document does not explicitly state numerical acceptance criteria for mechanical tests. Instead, it compares the proposed device's performance to that of the predicate device within the context of the testing standard ASTM F1717. The acceptance is based on the results showing no statistically significant difference between the proposed device and the predicate device for various mechanical properties.

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

The document refers to "two samples groups" for the mechanical testing, but the specific numerical sample sizes are not provided. The data provenance is testing conducted by the applicant, Changzhou Dingjian Medical Appliance Co., Ltd., likely in China, as it is the country of origin for the submitter. This is a bench test, not clinical data, so the concepts of retrospective or prospective data as typically applied to patient studies are not applicable.

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)

This is not applicable as this is a mechanical testing study, not a study involving human interpretation or ground truth establishment by experts in the context of diagnostic performance.

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

This is not applicable for mechanical testing.

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

This is not applicable as this is a mechanical orthopedic device, not an AI/ML diagnostic or assistive device.

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

This is not applicable as this is a mechanical orthopedic device.

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

For mechanical testing, the "ground truth" or reference standard would be the established testing methodology and performance characteristics defined by the ASTM F1717 standard and the performance of the legally marketed predicate device. The comparison is made against the predicate device's measured performance in these standardized tests.

8. The sample size for the training set

This is not applicable as this is a mechanical testing study, not an AI/ML study involving a training set.

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

This is not applicable as this is a mechanical testing study.

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The Metallic Locking Bone Plate and Screw System are intents with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

The proposed device, Metallic Locking Bone Plate and Screw System consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is made of Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67.
The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.

The provided document is a 510(k) Premarket Notification Submission for the "Metallic Locking Bone Plate and Screw System." It details the device's characteristics, intended use, and comparison to predicate devices to establish substantial equivalence.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device meets design specifications and is substantially equivalent to the predicate device based on bench testing. The acceptance criteria are defined by industry standards for metallic bone fixation devices.

Note: The document explicitly states "No clinical performance testing" and "No clinical studies to support substantial equivalence." The "Reported Device Performance" column indicates that these tests were conducted and the conclusion is that the device "should perform as intended." Specific numerical results or statistical analyses from these tests are not provided in this summary document. The acceptance criteria for these tests are the requirements outlined in the ASTM standards themselves.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the sample size used for the bench tests (e.g., how many plates or screws were tested for each performance metric).
• Data Provenance: The tests are bench tests, not clinical studies. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the same way it would be for patient data. The tests were likely conducted by the manufacturer, Changzhou Dingjian Medical Appliance Co., Ltd., in China.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This question is not applicable to the context of this document. The "ground truth" for material and mechanical performance is established by the specifications in the ASTM standards and the physical properties of the device, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set:

This is not applicable as the test set involves bench testing against predefined engineering standards, not human interpretation or clinical adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing" and "The subject of this premarket submission, metallic locking bone plate system, does not require clinical studies to support substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device is a physical medical implant (bone plate and screw system), not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation in this submission is the mechanical and material specifications outlined in the referenced ASTM F382 (for plates) and ASTM F543 (for screws) standards. Compliance with these established engineering standards serves as the basis for performance evaluation for non-clinical aspects.

8. The Sample Size for the Training Set:

This question is not applicable. There is no concept of a "training set" for a physical medical device in this type of premarket notification for substantial equivalence based on bench testing.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the reasons stated above.

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