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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 r or peareliar assort when matients, these systems are indicated for one or more of the following: decenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis).

In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with m automory wollisthesis (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.

The ISSYS LP Spinal Fixation System is also intended to provide immobilization and stabilization of the spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion of degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grade 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurological impairment.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation System, 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 .
• Pseudoarthrosis .
• Spinal Stenosis .

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

The subject ISSYS LP Spinal Fixation System includes will include auxiliary connectors in the form of side to side, axial connectors, and offset connectors with various length arms up to 35mm. Additionally, pre bent 6.0 mm diameter rods, in various lengths, will be provided to be used with the side to side connectors, if required. These connectors are intended to be used with 5.5 mm, 6.0 mm, and 6.35 mm diameter rods. These additional components are to be used in the posterior non-cervical spine (T1-S1). The indications for use are not affected by the addition of these components.

This is a 510(k) premarket notification for a medical device, the ISSYS LP Spinal Fixation System. It is not an AI/ML device, and therefore the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable in the context of an AI/ML device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a modified spinal fixation system. The "performance data" referred to here are mechanical tests, not clinical performance or AI algorithm performance.

Here's the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Performance data per ASTM F1717 and F1798 were submitted to characterize the subject ISSYS LP Spinal Fixation system components in this notification." It further clarifies, "An engineering analysis and testing demonstrate meentined properies, and 'Guidance for Spinal Systems 510(k)' Dated May 3, 2004 was completed for the ISSYS LP Spinal Fixation System, including the subject components."

Without the actual ASTM F1717 and F1798 reports, a specific table of acceptance criteria and reported device performance cannot be generated. However, the general acceptance criterion is that the device components meet the mechanical performance requirements specified in these ASTM standards and the FDA guidance document. The reported device performance is that it does meet these requirements, as indicated by the FDA's 510(k) clearance.

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: Not specified in terms of clinical patients or data points for an AI model. The "sample size" would refer to the number of physical components tested per ASTM F1717 and F1798. This information is typically detailed in the full test reports, which are not included here.
• Data Provenance: Not applicable in the AI/ML sense. The "data" here refers to mechanical test results. The device firm, Custom Spine, Inc., is based in Parsippany, NJ, USA. The testing likely occurred in a U.S.-based lab or a lab certified to perform these ASTM standards. The tests are prospective in nature regarding the device's design, meaning they are performed on newly manufactured components to ensure they meet specifications.

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 for a non-AI/ML mechanical device. Ground truth, in this context, would be defined by the physical measurement results compared against the ASTM standard specifications, not by expert consensus on clinical data.

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

Not applicable for a non-AI/ML mechanical device. Mechanical test results are objective measurements that either meet or do not meet a predefined numerical and procedural standard.

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 device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for this device's performance is adherence to established engineering and material science standards, specifically ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) and ASTM F1798 (Standard Guide for Evaluation of Spinal Implants in an Anatomical Model). These standards define the mechanical properties and performance requirements for spinal fixation systems. The device's components must demonstrate mechanical properties (e.g., strength, fatigue life, stiffness) that meet or exceed the performance of the predicate devices and the requirements of these standards.

8. The sample size for the training set:

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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