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The Oratec SpineCATH Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

The SpineCATH Intradiscal Catheter is a single use electrothermal device utilizing a flexible shaft design and thermally activated tip. The entire length of the shaft is fully insulated and when activated, only the tip delivers thermal energy. In addition, a thermocouple is located at the tip of the catheter to monitor temperature. The SpineCATH Intradiscal Catheter is for use only with the Oratec generator.

The provided text is a 510(k) summary for the SpineCATH Intradiscal Catheter. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and detailed performance metrics in the way modern AI/ML device submissions do.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not available in the provided document. The document describes a traditional medical device submission where equivalence is demonstrated through design, materials, and intended use, rather than through a performance study against predefined metrics.

Here's a breakdown of what is available based on the request:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting specific quantitative performance acceptance criteria in the way a diagnostic or AI/ML device would.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. There is no mention of a "test set" in the context of device performance evaluation in this document. The submission relies on demonstrating substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth establishment is not relevant for this type of submission, which focuses on device design and intended use equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided.

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

• No. This is not an AI/ML device, and no MRMC study is mentioned.

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

• Not applicable. This is not an algorithm-only device.

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

• Not applicable / Not provided. No ground truth in the context of performance metrics is established or used.

8. The sample size for the training set

• Not applicable / Not provided. No training set is mentioned as this is not an AI/ML device.

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

• Not applicable / Not provided.

Summary of Device and Substantial Equivalence:

• Device Name: SpineCATH Intradiscal Catheter
• Intended Use: For the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
• Product Description: Single-use electrothermal device with a flexible shaft, thermally activated tip, fully insulated shaft, and a thermocouple at the tip for temperature monitoring. It is for use only with the Oratec generator.
• Basis for Substantial Equivalence: The SpineCATH Intradiscal Catheter is claimed to be substantially equivalent in design to the Oratec EndoTAC Monopolar Cautery Probe (K972358). Its intended use (decompression of intervertebral discs) is considered substantially equivalent to currently available mechanical and laser devices, specifically mentioning Surgical Dynamics' Nucleotomes (K931109, K942987) and Laserscope's KTP/532 and KTP/Y AG Laser Systems (K896183, K913758).
• Biocompatibility: Meets the requirements of ISO 10993 for External Communicating Devices, Tissue/Bone/Dentin Limited Contact, Communicating.

The FDA's letter concurs with the finding of substantial equivalence, allowing the device to be marketed.

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