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The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments that can accept a device construct up to 80mm in length 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 including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

The PressON Spinal Fixation System is composed of pedicle screws and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. Components are made from Ti-6Al-4V ELI (ASTM F-136).

Here's a breakdown of the acceptance criteria and study information based on the provided document:

The document describes the PressON Spinal Fixation System, a Class II pedicle screw spinal system (21 CFR 888.3070 (b) (1)). It highlights its substantial equivalence to predicate devices in terms of materials, design, indications for use, and operational principles.

Acceptance Criteria and Device Performance:

The acceptance criteria for the PressON Spinal Fixation System are based on its substantial equivalence to legally marketed predicate devices through performance testing. The reported device performance indicates that the system meets these criteria.

Study Details:

• Sample Size for the Test Set and Data Provenance:

  • The document does not specify a sample size for a "test set" in the context of clinical data for AI or diagnostic purposes. The studies mentioned are mechanical and material performance tests (static and dynamic loading) conducted on the device itself.
  • The data provenance is from mechanical testing labs (implied, not explicitly stated as country of origin, but generally conducted in a controlled lab environment). These are prospective mechanical tests conducted on the device components.

• Number of Experts and Qualifications for Ground Truth of Test Set:

  • This information is not applicable (N/A) as the study is a mechanical performance verification and not a clinical study requiring expert assessment for diagnostic ground truth.

• Adjudication Method for the Test Set:

  • This information is not applicable (N/A) for mechanical performance testing.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • No, an MRMC comparative effectiveness study was not done. This type of study is for comparing human readers with and without AI assistance in diagnostic tasks, which is not relevant for this device.

• Standalone (Algorithm Only) Performance Study:

  • No, a standalone algorithm performance study was not done. This device is a physical medical implant (spinal fixation system), not a software algorithm or AI-based diagnostic tool.

• Type of Ground Truth Used:

  • The "ground truth" for the mechanical performance studies is the established performance standards and criteria defined by the ASTM F1798-97(2008) and F1717-13 standards, and the comparative performance of the predicate devices. The device's ability to withstand these defined forces and loads, and perform comparably, establishes its "truth" of efficacy in this context.

• Sample Size for the Training Set:

  • This information is not applicable (N/A). There is no training set mentioned in the context of AI or machine learning for this physical product.

• How Ground Truth for the Training Set Was Established:

  • This information is not applicable (N/A) for the same reason as above.

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The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).

When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

This document describes a medical device, the MonoPoly Pedicle Screw System, and its regulatory filing, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the provided text is a 510(k) summary and associated FDA correspondence, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. This means the manufacturer is asserting their device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and performance studies. The "Performance Testing" section explicitly states: "The pre-clinical testing performed indicated that the MonoPoly Pedicle Screw System is substantially equivalent to predicate devices." This implies the testing was comparative in nature against existing devices, not against a predefined set of acceptance criteria for a new device.

Here's a breakdown of what is and is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not present. The document does not define specific performance acceptance criteria (e.g., in terms of strength, fatigue life, or other biomechanical properties). It also does not report specific quantitative performance data for the device against such criteria. The "Performance Testing" section only states that the testing indicated substantial equivalence to predicate devices.

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

• Not present. The document does not describe a clinical "test set" for performance evaluation in the way you're asking. The testing mentioned is "pre-clinical," likely referring to mechanical or biomechanical bench testing. No sample sizes for any test sets are provided, nor is any information about data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. Ground truth is generally relevant for diagnostic or AI-driven devices where a human expert's judgment is used to label data. This document describes a mechanical implant, not a diagnostic device.

4. Adjudication Method:

• Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This type of study is used for diagnostic imaging devices to assess human reader performance with and without AI assistance. The MonoPoly Pedicle Screw System is a surgical implant.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This is a mechanical implant, not an algorithm or AI system.

7. Type of Ground Truth Used:

• Not applicable. See point 3.

8. Sample Size for the Training Set:

• Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a physical medical device.

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

• Not applicable. See point 8.

Summary from the provided text:

The MonoPoly Pedicle Screw System is a Class III spinal implant comprising various screws, rods, and connectors made from titanium alloy. It is intended to aid in spinal segment immobilization and stabilization as an adjunct to fusion for various spinal conditions. The pre-clinical testing indicated substantial equivalence to four predicate devices: Cross Medical Synergy VLS System (K974749), U&I Optima Xia System (K031585), GSS Medical GS System (K053573), and Signus Medical OvalTwist System (K061577). The document does not provide details of specific performance criteria or a study demonstrating the device meets such criteria, as its 510(k) clearance path relies on equivalence to existing devices.

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