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510(k) Data Aggregation
(61 days)
The eSPIN System is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).
The eSPIN System consists of access and positioning instruments to access the disc space and to position the hand-piece for discectomy, a handpiece, disposable cutting tips, a suction tube & alignments guide and electrical motor unit.
The provided text describes the 510(k) summary for NLT SPINE's eSPIN System, a device intended for cutting and grinding intervertebral disc material during discectomy.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (NLT SPINE eSPIN K120553, K130057; Medtronic Inc. Midas Rex K081475) | "Performance testing in bench (e.g. system mechanism durability & functionality) demonstrated that the eSPIN System is substantially equivalent to its predicate." |
| Safety and effectiveness | "The eSPIN System is as safe and effective as its predicate devices." |
| Same intended uses and similar indications, technological characteristics, and principles of operation as predicate devices | "The eSPIN System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device." |
| Minor technological differences with predicate devices raise no new issues of safety or effectiveness | "The minor technological differences between the eSPIN System and its predicate devices raise no new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
The document only states "Performance testing in bench (e.g. system mechanism durability & functionality)". There is no information provided about the specific sample size, country of origin, or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is "bench testing" focusing on mechanical performance rather than clinical data requiring expert review for ground truth.
4. Adjudication method for the test set
This information is not provided in the document. As the testing was bench-based, no human adjudication of diagnostic or clinical outcomes is mentioned.
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
There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. The device is a surgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the eSPIN System is a surgical instrument, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance data reported, the "ground truth" seems to be based on engineering benchmarks and predicate device performance standards as assessed through "bench testing" for "system mechanism durability & functionality." It's about how well the device mechanically performs its intended function, not a diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
This information is not provided. The device is a physical instrument, and while it might have undergone extensive internal development and testing (which could be considered analogous to a "training set" for an algorithm development, though not typically referred to as such for hardware), the document doesn't detail this.
9. How the ground truth for the training set was established
This information is not provided and is largely not applicable in the context of a physical surgical device's 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices through engineering and functional testing rather than algorithmic training against a defined ground truth.
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