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The Dekompressor™ Percutaneous Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.

The Dekompressor™ is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus.

The provided text is a 510(k) summary for the Stryker Dekompressor™ Percutaneous Discectomy Probe, and as such, it does not contain a detailed study report with acceptance criteria and device performance results. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data with specific performance metrics against acceptance criteria.

Therefore, most of the requested information cannot be extracted directly from this document. The document focuses on:

• Device Description and Intended Use: The Dekompressor™ is a single-use disposable probe for aspirating disc material in percutaneous discectomies of the lumbar, thoracic, and cervical spine.
• Technological Comparison: The device is stated to have the same technology as the Stryker Dekompressor™ Lumbar Discectomy Probe (K013513) and is equivalent to several other predicate devices. This implies that its safety and effectiveness are established through comparison to devices already on the market, rather than through independent studies with new acceptance criteria.
• Regulatory Classification: Classified as an Arthroscope and accessories (21 CFR 888.1100, Class II).
• FDA Clearance: The letter confirms FDA's determination of substantial equivalence (K032473) to legally marketed predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is absent:

Stryker Dekompressor™ Percutaneous Discectomy Probe (K032473)

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or quantitative device performance metrics (e.g., success rates, aspiration volume, tissue removal efficiency) against such criteria are provided in this 510(k) summary. The submission relies on establishing substantial equivalence to predicate devices, implying that the performance is considered acceptable if it is comparable to that of the already cleared predicate devices.

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

• Sample Size: Not specified. Substantial equivalence claims often rely on bench testing, design comparisons, and sometimes non-clinical data rather than large-scale human clinical trials with defined test sets in the context of performance metrics.
• Data Provenance: Not specified. Given the nature of a 510(k) for substantial equivalence, the "data" would primarily be engineering specifications, material properties, and comparison to predicate devices, rather than data from a clinical "test set" in the traditional sense for evaluating new performance against set criteria.

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

Not applicable or not specified. "Ground truth" in the context of performance criteria for diagnostic accuracy or treatment efficacy is not presented here. The evaluation is based on technical and functional equivalence to predicate devices.

4. Adjudication method for the test set:

Not applicable or not specified for performance against acceptance criteria.

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 device is a surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.

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

Not applicable. This is a medical device (surgical probe), not an algorithm or AI system.

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

Not applicable in the context of performance against acceptance criteria for a new device study. The "ground truth" for a 510(k) like this centres on proving that the new device is as safe and effective as a legally marketed predicate device, often through engineering and functional comparisons.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device.

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