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The True Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a surgical fixation system, indicating that the device is substantially equivalent to a predicate device. It specifies the indications for use but does not delve into performance metrics or supporting studies.

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The True Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

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This is an FDA 510(k) clearance letter for a spinal fixation system, which is a physical medical device, not an AI/ML-driven software device. Therefore, the information requested about acceptance criteria, study details, ground truth, and human-in-the-loop performance is not applicable to this document. The letter simply states the device's substantial equivalence to a predicate device based on its indications for use.

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The True™ Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

The True™ Spinal Fixation System consists of pairs of longitudinal members (rods), anchors (polyaxial pedicle screws) and interconnections (rod-rod connectors). These are available in a variety of sizes to accommodate differing patient anatomy. Dual Rod use Only. The True™ Spinal Fixation System is intended to be used only as a dual rod system and must be used with two rods per connector in all cases. Do not use one rod per connector.

The provided text describes a 510(k) summary for the True™ Spinal Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data showing similar mechanical characteristics. It does not involve clinical studies with human participants that would typically assess diagnostic accuracy or the direct clinical impact of AI-assisted systems, which are the focus of most of the requested information.

Therefore, many of the requested categories are not applicable to the documentation provided.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

A mechanical testing study was performed.

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 (Test Set): Not specified in terms of number of constructs tested, but referred to as "the worst case True™ construct."
• Data Provenance: The device is manufactured by Innovative Surgical Designs, Inc. in Bloomington, Indiana, USA. The mechanical tests would have been performed in a laboratory setting, likely in the US, but specific details are not provided. The study is prospective in the sense that the tests were conducted specifically for this submission.

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

Not applicable. This device's ground truth for demonstrating substantial equivalence is based on established engineering standards (ASTM F1717 and ASTM 1798) and direct comparison to the mechanical performance of predicate devices, not expert human assessment or clinical ground truth.

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

Not applicable. This was a mechanical engineering study, not an imaging or clinical diagnostic study involving human interpretation.

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-assisted diagnostic device, nor does it involve human readers/interpreters in its primary function for which performance was assessed.

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

Not applicable. This is a physical medical implant device and not an algorithm or software. The "standalone" performance here refers to the mechanical integrity of the device itself.

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

The ground truth used for demonstrating substantial equivalence was the established mechanical performance of legally marketed predicate spinal fixation systems, as measured by standard ASTM material testing methods. This represents a comparative engineering "ground truth."

8. The sample size for the training set

Not applicable. This device did not involve any machine learning algorithms or a "training set."

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

Not applicable. There was no training set.

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