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510(k) Data Aggregation
(200 days)
NUVASIVE LONG LATERAL SPINAL SYSTEM
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Long Lateral Spinal System is 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 spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.
The NuVasive Long Lateral System consists of a variety. of screws, rods, lock screws, and staples. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
The provided document is a 510(k) summary for the NuVasive® Long Lateral Spinal System, a medical device for spinal fixation. It details the device description, intended use, and substantial equivalence to predicate devices, but does not describe acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or AI/algorithm performance.
Instead, the performance data discussed relates to the mechanical and physical performance of the spinal implant device, demonstrating its structural integrity and comparability to existing devices.
Therefore, I cannot provide the requested information. The document does not contain:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI.
- Sample sizes for test sets or data provenance for AI/diagnostic studies.
- Number or qualifications of experts for ground truth establishment for AI/diagnostic studies.
- Adjudication method for AI/diagnostic studies.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study for AI.
- Information on standalone (algorithm only) performance.
- Type of ground truth used for AI/diagnostic studies.
- Sample size for a training set for AI.
- How ground truth for a training set for AI was established.
The "Performance Data" section (G) in the document refers to nonclinical testing, specifically:
- Static and dynamic compression testing per ASTM F1717
- Static torsion testing per ASTM F1717
- Implantation Cadaver Study
These tests are designed to demonstrate the structural and mechanical equivalence of the new spinal system to predicate devices, not its diagnostic or AI performance. The conclusion is that the device "meets or exceeds the performance of the predicate device" in these mechanical tests, thus establishing substantial equivalence for market clearance.
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(32 days)
NUVASIVE LONG LATERAL SPINAL SYSTEM
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Long Lateral Spinal System is 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 spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.
The NuVasive Long Lateral Spinal System consists of a variety of screws, rods, staples, and caps. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
The NuVasive Long Lateral Spinal System is a medical device designed for spinal stabilization. The provided documents focus on its substantial equivalence to predicate devices rather than independent performance metrics where "acceptance criteria" and "device performance" would typically refer to clinical accuracy or diagnostic efficacy.
Here's an interpretation of the request based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k)) | Reported Device Performance (from 510(k)) |
|---|---|
| Substantial equivalence to predicate devices (K091502, K011556, K965145, K993030) in areas including: design, intended use, material composition, function, and range of sizes. | The device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices. |
| Meet or exceed performance of predicate device for mechanical stability. | Results of static and dynamic compression testing (per ASTM F1717) and static torsion testing (per ASTM F1717) show that the subject Long Lateral Spinal System meets or exceeds the performance of the predicate device. |
| Safe and effective for intended use. | Based on performance testing and comparison to predicate devices, the device was found safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not applicable in this context. The "test set" here refers to the mechanical testing performed on the device components, not a clinical data set. The documents do not specify the number of units or replicates tested for the mechanical evaluations.
- Data provenance: The data comes from "nonclinical testing" performed by NuVasive, Inc. The exact location or origin of the materials tested is not specified (e.g., country of origin). The testing is inherently prospective for the purpose of demonstrating mechanical equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this 510(k) context refers to the established standards for mechanical performance (e.g., ASTM F1717) and the performance of the predicate devices. Expert consensus on clinical ground truth is not relevant for this type of submission. The evaluation was conducted by NuVasive's R&D and regulatory teams.
4. Adjudication method for the test set
Not applicable. This device utilizes non-clinical mechanical testing, not a clinical study requiring adjudication of expert interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a spinal implant system, not a diagnostic AI device. Therefore, MRMC studies or AI assistance for human readers are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is primarily based on:
- Benchmarking against predicate devices: The performance and characteristics of the legally marketed predicate devices (K091502, K011556, K965145, K993030) serve as the standard for substantial equivalence.
- Industry standards: Adherence to established ASTM International standards (ASTM F1717 for static and dynamic mechanical testing) dictates the methodology and acceptable parameters for evaluating device performance.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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