Search Results

The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at the fifth humbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft, having the device fixed or attached to the lumbar and sacral spine and intended to be removed after solid firsion is attained.

Benefit of spinal fusions utilizing any pedicle screw fixation has not been adequately established in patients with stable spines.

Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visoeral injury.

The ISOLA Soinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to The non-pedicle screw indications are ilium/sacrum. the spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.

As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.

The two piece Twister connector design utilizes the attributes of the one piece slotted connectors. It consists of a slotted transverse member with splines which mate with the splines of the V Groove body. Together these two pieces create the slotted connector assembly. The spline connection or joint is the medium by which the screw/connector interface can be manipulated and secured. This two piece design allows for intraoperative sagittal alignment in 7° increments. The slotted portion of each design provides further surgical latitude for placement of the screw. The machine threaded portion of the screw is locked to the connector with a nut.

This document describes a 510(k) summary for the ISOLA System ISOLA Twister Connector (Titanium) and does not contain information about acceptance criteria or a study proving that a device meets such criteria. Specifically, it is lacking all the requested information for the acceptance criteria and performance study.

The document focuses on the description, material, indications, and substantial equivalence of the device. It includes a brief statement under "PERFORMANCE DATA" that "Static and fatigue testing shows the constructs of the ISOLA Twister Connector to perform consistently with previously cleared components." However, this is a general statement and does not provide acceptance criteria or the detailed study requested in the prompt.

Therefore, I cannot populate the table or provide any of the other requested details based on the provided text.

Ask a specific question about this device

The ISOLA Spinal System, when used with pedicle screws, is 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 illium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.

As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.

The two piece Twister connector design utilizes the attributes of the one piece slotted connectors. It consists of a slotted transverse member with splines which mate with the splines of the V Groove body. Together these two pieces create the slotted connector assembly. The spline connection or joint is the medium by which the screw/connector interface can be manipulated and secured. This two piece design allows for intraoperative sagittal alignment in 7° increments.

The slotted portion of each design provides further surgical latitude for placement of the screw. The machine threaded portion of the screw is locked to the connector with a nut.

All implant components are manufactured of ASTM F-138 stainless steel.

This document describes a 510(k) summary for the AcroMed ISOLA Twister Connector, a component of the ISOLA System, which is a spinal fixation device. The summary focuses on comparing the Twister Connector to previously cleared AcroMed Slotted Connectors and does not contain detailed acceptance criteria or a specific study proving the device meets particular numerical performance targets.

Here's an analysis based on the provided text:

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

The document does not provide specific numerical acceptance criteria or detailed performance metrics. It makes a general statement about consistency with previously cleared components.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the static and fatigue testing. It also does not provide information on the data provenance (country of origin, retrospective/prospective).

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)

This is a medical device for spinal fixation, not a diagnostic or AI-based device requiring expert ground truth for interpretation. Therefore, this information is not applicable and not present in the document.

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

Not applicable, as this is a mechanical device performance test, not a diagnostic or interpretive study requiring expert 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 is not an AI-assisted diagnostic or interpretive device.

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

Not applicable. This is a mechanical device.

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

For mechanical devices like this, the "ground truth" would be established by engineering standards and validated testing protocols that simulate anatomical loads and conditions. The document refers to "Static and fatigue testing," implying these engineering tests were used. The "ground truth" here is the physical performance under specified conditions, measured against established benchmarks (previously cleared components).

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI or machine learning system that requires a "training set."

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

Not applicable.

Summary of Device Performance Study:

The provided text states: "Static and fatigue testing shows the constructs of the ISOLA Twister Connector to perform consistently with previously cleared components."

This indicates that the study performed involved physical mechanical testing (static and fatigue) of the device. The acceptance criteria appear to be based on demonstrating "consistency" in performance with already cleared components from the same manufacturer (AcroMed Slotted Connectors). This "consistency" likely refers to meeting or exceeding the established performance benchmarks that allowed the previous devices to be cleared for market.

The document does not provide specific numerical details about:

• The loads applied during static testing.
• The number of cycles or load levels during fatigue testing.
• The specific failure points or deformation limits observed.
• The exact performance metrics of the previously cleared components that served as the benchmark.

In the context of 510(k) submissions, demonstrating substantial equivalence often relies on comparing performance to a predicate device. This statement suggests that the ISOLA Twister Connector's mechanical properties were evaluated against those of similar devices already on the market and found to be comparable, thereby supporting its safety and effectiveness for its intended use.

Ask a specific question about this device