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The ISOLA Spine 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOLA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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.

The ISOLA Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement.

The provided text is a 510(k) summary for the ISOLA Spine System and primarily focuses on its intended use, materials, and substantial equivalence to predicate devices. It states that "Performance data were submitted to characterize the CrossOver Cross Connector," which is part of the ISOLA Spine System. However, the document does not detail specific acceptance criteria or the study that proves the device meets those criteria, nor does it provide performance metrics.

Therefore, I cannot populate most of the requested tables and sections with the information available in the given text.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

The document broadly states: "Performance data were submitted to characterize the CrossOver Cross Connector." However, it does not provide details on what those performance data were, what the acceptance criteria for those data were, or the actual results.

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

Not specified in the document. The document mentions "Performance data were submitted," but gives no details about the sample size, type of study (e.g., in vitro, in vivo), or data provenance.

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/Not specified in the document. This type of information is usually relevant for studies involving subjective assessment (e.g., image interpretation for AI devices). For a spinal fixation system, performance data would likely involve mechanical testing, not expert assessment of ground truth.

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

Not applicable/Not specified in the document. As above, this is typically for studies involving subjective data interpretation, which is not described for this device.

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/Not specified in the document. This device is a physical spinal implant, not an AI or imaging device that would involve human readers or AI assistance.

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

Not applicable/Not specified in the document. This is a physical device, not an algorithm.

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

Not specified in the document. For a mechanical device, "ground truth" would likely be based on physical measurements of strength, fatigue, stability, etc., against predefined engineering standards. The document only mentions "Performance data were submitted to characterize the CrossOver Cross Connector" without elaborating on the type of data or how "truth" was established.

8. The sample size for the training set

Not applicable/Not specified in the document. This is a physical medical device. The concept of a "training set" typically applies to AI/machine learning models, which is not relevant here.

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

Not applicable/Not specified in the document. As above, this is not relevant for a physical medical device.

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The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The Posterior 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 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 fusion surgery.

The Anterior ISOLA system is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.

The Anterior ISOLA system is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:

1. Collapsing and unstable paralytic deformity.
2. Progressively increasing scoliosis.
3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
4. Inability to maintain sitting balance, necessitating the use of the hands.
5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
6. Spinal fractures (acute reduction or late deformity)
7. Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
8. Spinal tumor
9. Previous failed fusion surgery.

Spinal levels for Anterior ISOLA instrumentation are from T5-L4.

The primary purpose of this premarket notification is to add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the ISOLA Spine System. All implant components are manufactured of either ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy.

The provided documentation describes the ISOLA Spinal System, specifically focusing on the addition of indications for its pedicle screws. However, it does not contain information related to an AI/ML medical device, nor does it conduct a study with acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or reader improvement).

Therefore, I cannot provide the requested table and information about acceptance criteria or a study proving the device meets them, as the document details a traditional medical device (spinal system) and not an AI/ML-driven one. The performance data section only states: "Static and fatigue testing shows the constructs of the ISOLA Spinal System to perform consistently with previously cleared components." This indicates mechanical testing, not a clinical study to establish diagnostic or interpretive performance.

The document is a 510(k) summary for a spinal implant system seeking expanded indications for use. It primarily addresses substantial equivalence to existing predicate devices based on material, design, and indications, and mentions static and fatigue testing for mechanical performance, not AI/ML-related performance.

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