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The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following:

1. Spondylolisthesis.
2. Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies.
3. Degeneration of the facets with instability.

The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:

1. Pseudoarthrosis and failed previous fusion;
2. Spondylolisthesis; and
3. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.

The Facet-Link Stabilization Platform consists of a series of devices designed to stabilize the spine. The Platform includes the MINI and HEMI devices. The devices are secured to the bone using Facet-Link trans-articular (facet) screws. The MINI device utilizes an adjustable monorail to crossconnect the Facet Screws, while the HEMI device uses a small, fixed plate as a cross-connector. The implants are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes. The devices are provided non-sterile and for single patient use.

The Facet-Link Stabilization Platform requires several purpose manual orthopedic instruments for implantation, including a variety of k-wires, gauges, inserters, drills, and drivers.

The provided text describes the Facet-Link Stabilization Platform, a medical device intended to stabilize the spine. However, the document does not contain the specific information required to complete the table and answer all questions regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system. The document focuses on regulatory approval (510(k)) based on substantial equivalence to predicate devices, and the performance data presented is for mechanical and biocompatibility testing, not clinical performance or AI diagnostic accuracy.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Available:

• Acceptance Criteria (Implicit - based on predicate device testing): The document states that the device was evaluated to demonstrate substantial equivalence to predicate devices through various bench tests and functional cadaver tests. These tests are primarily focused on mechanical performance and biocompatibility.
  • Static Axial Compression Bending
  • Static Torsion
  • Dynamic Axial Compression Bending
  • Biocompatibility (ISO 10993)
  • MR Conditional (ASTM F2052-06)
• Reported Device Performance:
  • "Performance of the subject constructs was substantially equivalent to that of legally marketed screw constructs."
  • "Results demonstrated that repeatable and proper seating of the devices was achieved."
  • "The materials of the Stabilization Platform are biocompatible for the indicated use in accordance with ISO 10993."
  • "Testing demonstrated that the Stabilization Platform is MR Conditional, in accordance with ASTM F2052-06."

Information NOT Available (and thus cannot be filled in for your request):

• Specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy).
• Detailed quantitative results of the bench tests (e.g., actual force values, displacement).
• Any information regarding an AI component, human-in-the-loop performance, diagnostic accuracy, or clinical outcomes that would typically be evaluated with a test set of patient data, experts, and ground truth.
• Sample sizes for test sets related to human or AI performance.
• Data provenance for clinical studies (country, retrospective/prospective).
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• MRMC study details or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used for clinical validation (pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

Based on the provided document, here's how the information would be organized, with unknowns explicitly stated:

Acceptance Criteria and Study Proving Device Meets Criteria

The Facet-Link Stabilization Platform underwent a series of bench tests and functional cadaver tests to demonstrate substantial equivalence to its predicate devices, as required for 510(k) clearance. The performance data primarily focused on mechanical stability, material biocompatibility, and MR compatibility. There is no information in the provided document about an AI component, clinical diagnostic performance metrics, or a study involving human readers or a test set with established ground truth related to diagnostic outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. The document describes bench tests and functional cadaver tests. No "test set" of patient data for diagnostic evaluation is mentioned.
• Data Provenance: Not applicable. The tests involved cadaveric specimens and laboratory equipment.

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)

• Not applicable. There is no mention of experts establishing ground truth for a diagnostic test set. The cadaver implantation testing assessed the ability of "users" to perform surgical techniques, but no specific number or qualifications are provided, and this is not establishing ground truth for a diagnostic outcome.

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

• Not applicable. No diagnostic test set or adjudication method is described.

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, and this device is not presented as an AI-assisted diagnostic tool.

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

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

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

• Not applicable. The "ground truth" for the performance described is based on established engineering standards (ASTM, ISO) for mechanical stability, biocompatibility, and MR compatibility, and the observable success of surgical implantation in cadavers, rather than clinical diagnostic outcomes.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

• Not applicable.

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The PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.

The PSG 5.5mm Cannulated Pedicle Screw System is a non-cervical spinal fixation system. Pedicle screw fixation is limited to skeletally mature patients.

The PSG 5.5mm Cannulated Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.

The provided document is a 510(k) premarket notification for a medical device called the "PSG 5.5mm Cannulated Pedicle Screw System." This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance rather than clinical efficacy studies in the context of AI/software-as-a-medical-device (SaMD). Therefore, many of the requested details about acceptance criteria, clinical study design, and AI performance metrics are not applicable or available in this submission.

However, I can extract the information relevant to the device's mechanical performance and what the submission provides in place of clinical study details.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices such as pedicle screw systems, "acceptance criteria" and "reported device performance" are typically defined by engineering standards to ensure mechanical integrity and safety. In this context, the device's performance is compared against these standards and to predicate devices.

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

The document does not specify the exact sample sizes (number of devices or test repetitions) used for the mechanical tests. It only states that the device "has been tested" according to the ASTM standards.

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

This is not applicable as the device is a mechanical implant, not an AI/SaMD that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM F1717-13).

4. Adjudication method for the test set

Not applicable. Mechanical testing is objective and relies on measurements and adherence to specified test protocols, not human adjudication of results.

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

Not applicable. This device is a pedicle screw system, not an AI/SaMD for diagnostic imaging or decision support. No MRMC study was performed.

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

Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this type of device is defined by engineering standards and established mechanical performance characteristics relevant to spinal implants. Specifically, the ASTM F1717-13 standard dictates the methodologies and expected performance metrics for static and dynamic mechanical integrity. Comparison to legally marketed predicate devices also serves as a benchmark for "ground truth" in terms of acceptable clinical performance and safety.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a mechanical device, not a machine learning algorithm.

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

Not applicable.

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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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