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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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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.

Ask a specific question about this device

The ISSYS LP Spinal Fixation System is intended to help provide immobilization of 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.

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

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).
• o Spondylolisthesis
• Fracture o
• Spinal deformities such as scoliosis, kyphosis, lordosis o
• o Tumor
• Revision of failed fusion attempts o
• o Pseudarthrosis
• Spinal stenosis o

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

The ISSYS LP Spinal Fixation System is comprised of a variety of pedicle screws, rods, cross connectors and staples sizes that may uniquely fitted for each individual case. All implants are manufactured from medical grade titanium alloy (Ti6A14V-ELI).

The provided 510(k) summary for the ISSYS LP Spinal Fixation System does not contain information about specific acceptance criteria or a detailed clinical study demonstrating device performance against such criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that instead of proving the device meets specific performance metrics through a new study, the manufacturer asserts that the new device is as safe and effective as existing, legally marketed devices.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's a breakdown of what can be inferred and what is missing:

Acceptance Criteria and Device Performance Study for ISSYS LP Spinal Fixation System

Given the nature of a 510(k) submission, particularly for a device like a spinal fixation system, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to a predicate device. This often involves mechanical testing and assessment of material properties rather than clinical performance metrics in the same way an AI diagnostic device might have.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only mentions "pre-clinical testing" and "substantial equivalence." It does not list specific numerical acceptance criteria or performance metrics in a table.

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set from the provided document. The "tests" were pre-clinical (likely mechanical and material characterization). The sample size for these pre-clinical tests (e.g., number of screws tested for fatigue) is not mentioned.
• Data Provenance: Not applicable for clinical data. For pre-clinical data, it would typically be internal laboratory testing or testing by a contract research organization. No specific origin is mentioned.

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

• Not applicable. This device is a surgical implant, and the assessment is based on physical and mechanical properties, not expert interpretation of diagnostic images or clinical assessments for "ground truth."

4. Adjudication method for the test set

• Not applicable. As described in 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

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

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

• Not applicable. This is not an algorithm or diagnostic device.

7. The type of ground truth used

• For a device like this, "ground truth" relates to validated engineering specifications, material standards (e.g., ASTM F136 for Ti6Al4V-ELI, ISO 10993 for biocompatibility), and performance benchmarks established by predicate devices. No external "ground truth" (like pathology or outcomes data) for clinical performance is mentioned as part of this 510(k) submission's evidence for substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not a machine learning device, so there is no "training set."

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

• Not applicable. As described in point 8.

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