Search Results

The ISOBAR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.

Here's an analysis of the provided text regarding the ISOBAR Spinal System, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary for a medical device submitted to the FDA in 2001. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical efficacy studies as would be required for a Class III device or for certain novel technologies today. Therefore, many of the typical elements you'd find in a modern AI/software as a medical device (SaMD) study are not present in this document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not discuss a "test set" in the context of performance data from patient outcomes or clinical trials. The "test set" mentioned in the modern context of AI/SaMD studies (i.e., a dataset used to evaluate an algorithm's performance) is not applicable here.

The performance data mentioned relates to mechanical testing (fatigue tensile testing) of the device components. The sample size for this mechanical testing is not specified in the summary. Data provenance is also not applicable as it's a lab-based mechanical test, not clinical data.

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

This information is not applicable to the provided document. The device is a physical implant, not a diagnostic algorithm that requires expert-established ground truth from clinical images or data.

4. Adjudication Method for the Test Set

This information is not applicable to the provided document, for the same reasons as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. The ISOBAR Spinal System is a surgical implant, not a diagnostic tool, and the submission predates widespread AI in medical devices requiring such studies.

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 concept is completely irrelevant to a physical spinal implant device.

7. The Type of Ground Truth Used

For the mechanical performance data (fatigue tensile testing), the "ground truth" is defined by the acceptance criteria established by the ASTM F1717-96 standard. This standard specifies how the test should be conducted and what constitutes a passing performance. It's an engineering ground truth, not a clinical one.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an algorithm that undergoes "training" on a dataset. The design and manufacturing processes are informed by engineering principles and existing medical knowledge, not a training set in the AI sense.

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

This information is not applicable, for the same reasons as point 8.

Summary of Key Findings from the 510(k) for K013440:

• Device Type: Physical spinal implant system (pedicle screws, rods, nuts, crosslink members, hooks).
• Approval Basis: Substantial Equivalence to predicate devices (TSRH™ Spinal Implant System and ISOLA® Spinal System).
• Performance Data: Primarily focused on mechanical testing (fatigue tensile testing according to ASTM F1717-96) and demonstrated material conformity (Ti-6AI-4V to ASTM F136).
• Clinical Studies: No clinical studies with human subjects are described in this 510(k) summary. The FDA's review for substantial equivalence at the time did not require such studies for this type of device if mechanical performance and material equivalence were demonstrated to predicate devices.
• Absence of AI/SaMD Concepts: The concepts of "test set," "training set," "expert ground truth," "adjudication," and "MRMC studies" are entirely out of scope for this 2001 510(k) submission for a physical implant.

Ask a specific question about this device