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The Securis Spinal Fixation system is intended for immobilization and stabilization of the thoraco-lumbar-sacral spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The subject Securis Spinal Fixation System consist of screws of various diameter and length, non-sterile, single use Cannulated Titanium (ASTM F136, Ti-6Al-4V) screws and set screws to be used in conjunction with 5.0 mm diameter Cobalt-Chrome-Molybdenum (CoCr, ASTM F1537) rods. The rods are provided in various lengths to form various configurations for the individual patients and surgical condition. Instruments and guide wires are made from various grades of stainless steel.

The provided text discusses a 510(k) premarket notification for a medical device called the SECURIS Spinal Fixation System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

Here's an analysis of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance" in this context refers to regulatory acceptance based on demonstrating substantial equivalence to predicate devices, primarily through bench testing and comparison of design, materials, and indications for use.

• Reported Device Performance: The document only mentions that "Bench testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance 'Guidance for Industry and FDA Staff: Spinal System 510(k)s.'" The specific tests performed were:

  • Static Compression Bending
  • Static Torsion
  • Dynamic Compression Bending
  • These tests were conducted in accordance with ASTM F1717.

  The actual quantitative results or direct comparison to predicate device performance values for these tests are not provided in the summary. The summary only states that documentation was provided to demonstrate substantial equivalence through these comparisons.

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

• Test set sample size: Not applicable, as this was a bench testing study, not a clinical study involving patients. The sample size would refer to the number of test articles (e.g., screws, rods) tested, which is not specified in the provided text.
• Data provenance: Not applicable in the context of clinical data. For bench testing, the data would originate from the testing laboratory.

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

• Not applicable. There was no clinical ground truth established for this device submission within the provided text. Bench testing relies on established engineering standards (ASTM F1717).

4. Adjudication method for the test set:

• Not applicable. There was no clinical test set requiring expert adjudication.

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 study was NOT done. This document pertains to a spinal fixation system, not an AI-powered diagnostic device, and thus, this type of study is irrelevant.

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

• No, a standalone algorithm performance study was NOT done. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• Not applicable / Engineering Standards. For the bench testing, the "ground truth" would be the established performance requirements and methods outlined in ASTM F1717 for spinal implant testing. There is no clinical or pathological "ground truth" in this context.

8. The sample size for the training set:

• Not applicable. There was no training set, as this is a physical medical device, not a machine learning algorithm.

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

• Not applicable. There was no training set.

In summary, the provided document is a 510(k) summary for a spinal fixation system, focusing on demonstrating substantial equivalence through bench testing against established engineering standards and comparison to predicate devices, rather than a clinical study with detailed acceptance criteria and expert-validated ground truth.

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The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

• Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis
• Fracture
• Spinal deformities such as scoliosis, kyphosis, lordosis
• Tumor
• Revision of failed fusion attempts
• Pseudarthrosis
• Spinal stenosis

When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.

The subject ISSYS LP Polyaxial Spinal Fixation System includes 5.5 mm diameter rods (preformed rod or straight rod configuration) in addition to the selection of the cleared 6.0 mm and 6.35 mm diameter rods. It is to be used with both the Polyaxial and Monoaxial screws.

This is a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, much of the requested information regarding AI device performance, such as sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies, is not applicable. The provided document focuses on demonstrating substantial equivalence to predicate devices through material, design, and performance data for a new component (5.5 mm diameter rod) of an existing spinal fixation system.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission is for a physical medical device (spinal fixation system component), not a diagnostic algorithm that uses a "test set" of data in the typical sense. The "testing" refers to mechanical and material characterization.
• Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance refers to materials testing and engineering analysis performed according to recognized standards (ASTM F-136, ASTM F 1717). This would typically be conducted in a laboratory setting by the manufacturer or contracted labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This is not an AI/ML device requiring expert-established ground truth from clinical data. The "ground truth" for this device relates to established engineering standards for material properties and mechanical performance.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication method" as would be used for clinical data interpretation. Compliance is assessed against engineering standards.

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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is based on:

• Established engineering and material standards: Specifically, ASTM F-136 for material composition (implant grade titanium alloy) and ASTM F 1717 for mechanical performance of spinal implant constructs.
• FDA Guidance: The device's design and testing adhered to the "FDA's Guidance For Spinal System 510(k) May 3, 2004."
• Predicate Device Characteristics: The core of a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices in terms of material, design, and indications for use. The characteristics of these predicate devices serve as a benchmark.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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