Search Results

When labeled for pedicle screw fixation, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft and intended to be removed after solid fusion is attained.
The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondvlolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformittes (scoliosis, lordosis and kyphosis), turnor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for TI-sacral fixation. Screw fixation is from L3-S1.

The Pediatric ISOLA Components consist of side-tightening hooks with downsized dimensions to accommodate the anatomic limitations found where internal fixation is performed on pediatric or small stature individuals. The hooks are used with components already available in the ISOLA Spine System including 3/16 inch diameter rods, transverse connectors, sublaminar wires and cables, dual and tandem connectors, slotted connectors, sacral and iliac screws.

This document is a 510(k) summary for the ISOLA Pediatric Components, which are part of the ISOLA System for spinal fixation. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way a medical device utilizing AI/ML would.

The document focuses on:

• Description and materials of the pediatric components (side-tightening hooks with downsized dimensions, made of ASTM F-138 stainless steel).
• Indications for use, specifically for grade 3 or 4 spondylolisthesis at L5-S1 when labeled for pedicle screw fixation, and for a broader range of conditions (deformities, tumor, fracture, failed surgery, degenerative disc disease, spondylolisthesis) for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum.
• Contraindications (active infection, severe osteoporosis, conditions precluding fusion, obesity, degenerative diseases, foreign body sensitivity).
• PERFORMANCE DATA: "Static and fatigue testing show the constructs of the ISOLA Pediatric Components to perform consistently with previously cleared components."
• SUBSTANTIAL EQUIVALENCE: "The ISOLA Pediatric components are equivalent to other ISOLA Components in intended use and attachment."

Based on the provided text, here's an analysis against your requested information categories:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Static Testing	Performed consistently with previously cleared components
   Fatigue Testing	Performed consistently with previously cleared components

2. Sample size used for the test set and the data provenance: Not specified. This typically refers to mechanical testing, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/ML is not relevant for this type of mechanical device testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a clinical study requiring 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: Not applicable. This device is a mechanical implant, not an AI/ML-driven diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for mechanical testing would be established engineering standards and specifications.

8. The sample size for the training set: Not applicable. This is not a machine learning device.

9. How the ground truth for the training set was established: Not applicable.

In summary:

This document describes a traditional medical device (spinal fixation components). The "performance data" refers to mechanical testing (static and fatigue) to ensure the new pediatric components perform similarly to existing, cleared components, thereby establishing substantial equivalence. It is not an AI/ML device, and therefore, most of the requested information regarding AI/ML study design and ground truth establishment is not applicable.

Ask a specific question about this device