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The F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal stenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinal tumor, Schuermann's disease, and failed previous fusion.

The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The F1-MPS is also intended for posterior, non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

The F1-Modular Pedicle Screw System is composed of cannulated and non-cannulated pedicle screws which are designed to accept a 5.5mm rod and are available in various sizes. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 or cobalt-chromium-molybdenum per ASTM F1537.

This document is a 510(k) premarket notification for a medical device called the "F1-Modular Pedicle Screw System". It's not a study proving device performance against acceptance criteria in the way you're asking about for an AI/software device. This document is for a mechanical implant, and the "acceptance criteria" and "study" described are for non-clinical mechanical testing to demonstrate substantial equivalence to existing devices.

Therefore, many of your requested points (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the non-clinical performance testing and substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this mechanical device, "acceptance criteria" are typically defined by recognized standards such as ASTM F1717 and ASTM F543, and the performance is demonstrated by meeting or exceeding the performance of predicate devices. Specific quantitative acceptance criteria are not provided in this summary, but the conclusion states the device meets or exceeds the performance of predicate devices.

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

• Sample Size: Not explicitly stated in this summary. For mechanical testing per ASTM standards, specific sample sizes are prescribed, but the exact number of screws/constructs tested is not given here.
• Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical testing.

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 this context refers to established mechanical testing standards and the comparison to predicate devices, not expert human interpretation of data for an AI.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical testing against engineering standards.

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

No. This is not an AI/diagnostic imaging device.

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

Not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established ASTM mechanical testing standards (F1717, F543) and the performance of existing, legally marketed predicate devices. The goal is to show substantial equivalence, meaning it performs at least as well as, if not better than, comparable devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this type of mechanical device.

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

Not applicable. There is no "training set."

Summary for this specific document related to your request:

This document describes a non-clinical performance testing study for a mechanical pedicle screw system. The purpose of the study was to demonstrate substantial equivalence to existing predicate devices based on recognized ASTM standards for mechanical testing. The "acceptance criteria" are implied by these standards and the performance of the predicate devices, which the subject device was found to meet or exceed. There are no elements related to AI, software performance, human reader studies, or ground truth derived from expert consensus on clinical data.

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