(186 days)
The Stryker RF Intradiscal Adapter is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Adapter will be used with the previously cleared Stryker Intradiscal RF Generator and catheters such as Smith & Nephew SPINECATH™ & Acutherm™ catheters.
The Stryker RF Intradiscal Adaptor when used with the separately cleared Stryker RF Generator and the separately cleared Smith & Nephew SPINECATHTM Intradiscal Catheter(K993967) and ACUTHERM TM Decompression Catheter or equivalent. The Stryker RF Intradiscal Adaptor is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
The provided text is a 510(k) summary for the Stryker RF Intradiscal Adapter. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, this document does not contain information about clinical studies with acceptance criteria, reported device performance, or details about test datasets, expert involvement, or adjudication methods for AI performance.
Instead, the submission for this device relies on the concept of substantial equivalence to already legally marketed devices. This means that Stryker is asserting that their device is as safe and effective as a previously cleared device, based on similarities in intended use, technological characteristics, and principles of operation, rather than on new clinical performance data from a standalone study.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the provided document does not include such a study.
Here's a breakdown of why the requested information cannot be extracted from this document, specifically addressing each point you asked for:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to predicate devices based on design and intended use, not on quantifiable performance metrics from a dedicated study.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is mentioned, as no new clinical performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring ground truth establishment is detailed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 an adapter for electro-surgical equipment, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is hardware, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
The "Safety and Effectiveness" section explicitly states: "Based upon the comparison to the predicate devices, the Stryker RF Intradiscal Adapter is substantially equivalent to a legally marketed device." This confirms that the approval pathway relies on equivalence, not on new performance data demonstrating the device meets a predefined set of acceptance criteria.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.