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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

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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The eSPIN 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 or retrolisthesis 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 powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and direct connection to a motor via motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator unit for discectomy. The eSPIN needs to be connected to an electrical motor or drill. The required motor/drill specifications are provided in the eSPIN User Manual. The primary changes from the cleared eSPIN are: Addition of Suction tube and irrigation system. Minor modifications to the device design.

Here's a breakdown of the acceptance criteria and study information for the NLT SPINE's eSPIN device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state a numerical sample size for the test set of the specific performance tests (e.g., how many manipulator units were tested, how many tips were tested, how many cadavers were used).

• Test Set Description: The "Performance Data" section lists several types of tests:
  • Bending mechanism durability of manipulator unit
  • Verification of tip bending angle
  • Verification of discectomy cleaning work limits
  • Verification of motor parameters
  • Tip attachment strength under tensile force
  • Durability of tip bristle and tip under rotational and tensile loading
  • Biocompatibility evaluation
  • Cadaver studies
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) for a medical device modification, these would typically be internal, prospective verification and validation tests conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

There is no mention of experts being used to establish "ground truth" in the traditional sense for these performance tests. The tests described are engineering and biocompatibility evaluations, as well as cadaver studies, which rely on established measurement techniques, protocols, and scientific standards.

• Regarding the cadaver studies: While general medical expertise would be involved, the document does not specify the number or qualifications of experts for judging annulus breach or radiopacity. These are objective observations.

4. Adjudication Method for the Test Set

Not applicable. The described tests are primarily objective performance verification and validation tests, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices and involves human readers interpreting cases with and without AI assistance to measure reader improvement. The eSPIN is a surgical instrument.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance tests described are essentially "standalone" in that they evaluate the device's physical and mechanical capabilities independently. The device itself (the eSPIN) is the "algorithm" in this context, and its performance characteristics were assessed. There is no AI algorithm being evaluated in this submission.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests is based on:

• Engineering specifications and standards: For mechanical durability, bending angles, work limits, motor parameters, strength, and durability.
• International standards (ISO 10993): For biocompatibility.
• Direct observation and measurement: For annulus breach (in cadaver studies) and radiopacity (in cadaver studies).
• Predicate device's established performance: The overall goal of the submission is to demonstrate substantial equivalence to the predicate, implying that the predicate's performance serves as the benchmark or "truth" for safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical surgical instrument, not an AI/machine learning algorithm requiring a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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The eSpin 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 or retrolisthesis 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 powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and a motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator for discectomy. The eSpin needs to be connected to an Electrical Motor. The required motor specifications are provided in the eSpin User Manual.

The NLT SPINE eSpin device is a medical device intended for discectomy procedures. The provided text, K120553, is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing novel acceptance criteria and proving performance against them through a detailed study like one would for a new technology or higher-risk device.

Therefore, the supplied text does not contain specific acceptance criteria, detailed performance metrics (like sensitivity, specificity, accuracy), or a study design for proving these metrics. It describes the device, its intended use, and states that performance testing in bench and cadaver models demonstrated substantial equivalence to the predicate device.

However, based on the information provided, here's an attempt to structure an answer, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence, explicit "acceptance criteria" and quantitative performance metrics (e.g., sensitivity, specificity, or specific success rates) are not provided in the document for the eSpin device itself. The primary acceptance criterion for a 510(k) is demonstrating that the new device is "as safe and effective" and "substantially equivalent" to a predicate device.

2. Sample size used for the test set and the data provenance

The document states "Performance testing in bench and cadaver models".

• Sample Size: Not specified. The number of bench tests or cadaver models used is not reported.
• Data Provenance: The location of the testing (e.g., country of origin) is not specified. It is likely conducted by the manufacturer, NLT SPINE Ltd. in Kfar-Saba, Israel, or a contract lab. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The performance testing described (bench and cadaver models) would not typically involve expert radiologists or similar for "ground truth" establishment in the context of diagnostic or interpretive accuracy. Instead, it would involve direct measurement of physical properties, material analysis, mechanical testing, and functional assessment.

4. Adjudication method for the test set

Not applicable. The type of performance testing (bench and cadaver models) does not involve adjudication methods like 2+1 or 3+1, which are typically used for assessing agreement among human reviewers in diagnostic studies.

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. The eSpin device is a surgical instrument (arthroscope and accessories for discectomy), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

Not applicable. The eSpin is a physical surgical device, not a standalone algorithm.

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

For "bench and cadaver models," the ground truth would be based on:

• Bench Testing: Engineering specifications, material properties, mechanical test standards, and direct measurements of cutting/grinding efficacy and safety parameters (e.g., material removal rate, damage to surrounding tissue, tip integrity).
• Cadaver Models: Direct observation and assessment of the device's ability to cut and grind intervertebral disc material as intended, without damaging adjacent structures, and evaluating its handling characteristics in a simulated surgical environment. This is typically assessed by surgeons or technical experts.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models.

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

Not applicable, as there is no training set for this type of device.

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