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The VertiForm Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the VertiForm Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft to facilitate fusion.

The VertiForm Posterior Fixation System is a non-cervical spinal fixation system consisting of pedicle screws, set screws, rods and cross connectors. The pedicle screws are offered in a Polyaxial. Fixed or Uniplanar pedicle screw configuration and are available in a variety of geometries and sizes to accommodate patient anatomy. They are offered non-sterile and sterile. The VertiForm Posterior Fixation System is manufactured from titanium alloy (ASTM F136), medical-grade commercially pure titanium (ASTM F67) and medical-grade cobalt chrome (ASTM F1537). This Special 510(k) Premarket Notification seeks clearance to add variable cross connectors to the currently marketed VertiForm Posterior Fixation System.

The provided document is a 510(k) summary for a medical device called the "VertiForm Posterior Fixation System." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study or detailed acceptance criteria for an AI/algorithm.

Therefore, the information required to fill out the table and answer the study-related questions (points 1-9) about acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies is not present in this document.

Here's why and what information is available:

• Device Type: This is a physical spinal implant system (pedicle screws, rods, cross connectors), not an AI/algorithm-based diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This is often achieved through comparison of indications for use, technological characteristics, and sometimes non-clinical performance testing (e.g., mechanical tests for implants).
• Focus of the Document: The document explicitly states that it seeks clearance to add "variable cross connectors" to an already marketed VertiForm Posterior Fixation System. The main comparison is between the modified device and the predicate device (the previous version of the VertiForm system, K141291).

What is present in the document is a summary of non-clinical (mechanical) testing performed to demonstrate equivalence, not AI performance metrics:

• Non-Clinical Test Summary (Section 5):
  • Dynamic compression testing: Performed in accordance with ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, 2004."
  • Bacterial endotoxin testing: Performed in accordance with ANSI/AAMI ST72.
  • Results: "Testing results demonstrated that the VertiForm Posterior Fixation System with variable cross connectors performs comparable with the predicate device."

In summary, the request pertains to information typically found in submissions for AI/algorithm-enabled medical devices, which is not applicable to this 510(k) for a spinal implant system.

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The VertiForm Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the Vertiform Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and or allograft to facilitate fusion.

The VertiForm Posterior Fixation System consists of pedicle screw assemblies, set screw, rod and crosslink. The pedicle screw assemblies consist of Polyaxial Pedicle Screw, Fixed Pedicle Screw, and Uniplanar Pedicle Screw and are in a variety of geometries and sizes to accommodate patient anatomy. They will be provided non-sterile. The VertiForm Posterior Fixation System is manufactured from Titanium allov in accordance with ASTM F136, medical-grade commercially pure titanium per ASTM F67 and medical grade cobalt chrome per ASTM F-1537.

This document is a 510(k) summary for the VertiForm Posterior Fixation System, which is a pedicle screw spinal system. It describes the device, its intended use, and substantial equivalence to predicate devices. The document does not contain specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/ML medical device.

Based on the provided text, here's what can be extracted and what is missing:

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

The document provides the following information regarding performance testing:

Note: The acceptance criteria are implicitly stated as "equivalent to the predicate devices" rather than specific numerical thresholds. The reported performance is a general statement of equivalence.

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

This information is not provided. The document states "Performance testing has been conducted for the subject devices in accordance with the following guidance documents: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, ASTM F1717". This refers to non-clinical (mechanical) testing of the device hardware, not a clinical study on patient data.

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 information is not applicable/provided. The study described is a non-clinical, mechanical performance test of a physical device, not an AI/ML algorithm requiring expert-established ground truth from medical images or patient data.

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

This information is not applicable/provided for the same reasons as point 3.

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 information is not applicable/provided. No MRMC study or AI assistance is mentioned. The device is a physical spinal fixation system.

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

This information is not applicable/provided. The device is a physical medical implant, not an algorithm.

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

This information is not applicable/provided. The "ground truth" for the mechanical performance tests would be the measured physical properties (e.g., strength, stiffness, fatigue resistance) according to the ASTM standard, and comparison to predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no training set for a physical implant device.

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

This information is not applicable/provided. There is no training set for a physical implant device.

In summary:

The provided document describes a traditional medical device (a spinal implant). The "study" mentioned is non-clinical performance testing of the device's mechanical properties, not a clinical trial or an evaluation of an AI/ML algorithm. Therefore, many of the requested details, especially those related to AI/ML device evaluation, are not present or applicable to this document. The key information provided is that mechanical tests (Static Compression, Dynamic Compression, Static Torsion) were performed according to ASTM F1717, and the device was found to be "equivalent to the predicate devices" in terms of mechanical safety and performance.

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