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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 in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The PressON Spinal Fixation System is composed of pedicle screws, cortical screws, couplers, 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 F136).

This document is a 510(k) premarket notification for the "PressON Spinal Fixation System." It is a regulatory document from the FDA, and as such, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document describes a spinal fixation system, which is a physical implant used in spinal surgery, not a software or AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, ground truth establishment, MRMC studies, or standalone performance, are not applicable to this submission.

The "Performance Testing" section explicitly states: "Mechanical testing was not performed as the additional parts for the PressON system did not create a new worst case scenario. All previously submitted testing for the PressON system (K223529) is applicable to the subject device." This indicates that the device's performance is established through mechanical testing (which is standard for spinal implants), but that testing was already performed and submitted under a previous 510(k) (K223529) for a very similar device.

Therefore, I cannot provide the requested information for an AI/ML device based on this document.

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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 in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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. The system is composed of pedicle screws, cortical screws, and a variety of couplers. All components of the PressON Spinal Fixation System are made from Ti-6Al-4V ELI (ASTM F-136).

I am sorry, but the provided text does not contain any information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria. The document is an FDA 510(k) clearance letter for the "PressON Spinal Fixation System," stating it is substantially equivalent to a previously cleared predicate device.

The information primarily concerns:

• The device's name and classification.
• Its intended use (indications for use).
• Details about the manufacturer and regulatory contacts.
• A list of mechanical performance tests performed (ASTM F1717 and ASTM F1798), but without reporting any specific results, acceptance criteria, or details of a study setup (like sample size, ground truth establishment, expert qualifications, etc.). The document only states that "Performance testing was performed, and results demonstrated that the subject device is substantially equivalent to the predicate device."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC study details or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

This document pertains to the regulatory clearance of a physical medical device (spinal fixation system), not a software or AI/ML device that would typically involve the type of performance studies you are asking about (e.g., studies involving "human readers improve with AI vs without AI assistance").

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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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