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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 ORATEC SpineCATH Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.

The devices described in this 510(k) are sterile, disposable devices intended for use with the ORATEC ElectroThermal Spine System Generator.

This 510(k) summary provides limited information regarding the specific studies performed. Here's what can be extracted and reported, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum temperature reached) or the detailed quantitative results of the "performance testing (validation testing)."

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

This information is not provided in the document. The summary only mentions "results of validation testing (performance testing)" without detailing the test set size, type of data (e.g., in-vitro, ex-vivo, animal, human), or its provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. This type of device (intradiscal catheter) does not typically involve image interpretation, so "ground truth" as it relates to expert review of images is not applicable here. The "ground truth" for this device would relate to engineering specifications and biological outcomes, which would be established through technical standards and clinical studies, respectively.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of medical device testing (e.g., mechanical, electrical, biocompatibility), adjudication is typically not performed in the same way as in diagnostic AI studies. Test results are usually compared against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided. The ORATEC SpineCATH™ Intradiscal Catheter is a medical device (catheter) used in a physical intervention, not an AI diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

This information is not applicable and not provided. This device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device would be established through a combination of:

• Engineering Specifications: For mechanical properties, electrical safety, material compatibility, and function.
• Biocompatibility Testing: To ensure the materials are safe for use in the human body.
• Performance Data: Demonstrating the ability of the catheter to achieve its intended function (e.g., coagulation and decompression) in relevant models (e.g., ex-vivo tissue, animal models, and ultimately, human clinical data from the predicate device and potentially limited clinical data for the modified device if applicable, though not detailed here).
• Clinical Outcomes Data: For the predicate device, showing its effectiveness in treating symptomatic patients. For the modified device, the "ground truth" for substantial equivalence relies on demonstrating that the modifications do not negatively impact the clinical outcomes or safety established for the predicate.

The document states that "performance testing (validation testing)" was done, implying that the device was tested against these types of established standards and expected performance characteristics.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is not an AI algorithm that requires a training set. The "training" for a physical device is its design and manufacturing process, validated through testing.

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

This information is not applicable and not provided. As explained above, this device is not an AI algorithm.

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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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