(74 days)
The 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 Acutherm Decompression Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.
The proposed Intradiscal Catheter System, consisting of the Spinecath Intradiscal Catheter and the Acutherm Decompression Catheter, is used as part of the Intradiscal Electrothermal Therapy (IDET) and Targeted Disc Decompression (TDD) procedures. The procedures require the use of an introducer needle and the ORA-50S Electrothermal Spine System Generator or the Smith & Nephew Electrothermal 20S Spine Generator. The introducer needle transects the disc annulus and assists the surgeon in the placement of the catheters in the intradiscal space. The ORA-50S Electrothermal Spine System Generator or the Smith & Nephew Electrothermal 20S Spine System delivers radiofrequency energy to the catheters where the energy is converted to thermal energy.
The provided text describes the Smith & Nephew Intradiscal Catheter System (K073466). However, it does not contain details about specific acceptance criteria or an analytical study with performance metrics, sample sizes, ground truth establishment, or expert qualifications in the way typically expected for a detailed AI/ML device submission.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through performance and biocompatibility testing, implying that if it performs comparably, it meets the inherent "acceptance criteria" of the predicate.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document. The submission focuses on demonstrating identical performance to predicate devices (K013622 and K993967) rather than providing specific quantitative acceptance criteria for parameters like accuracy, sensitivity, specificity, or precision, which are common for AI/ML devices.
The document states: "Performance testing of the proposed Intradiscal Catheter System demonstrates that it performs identically to the predicate Nucleotomy Catheter (K013622) and Spinecath Intradiscal Catheter (K993967)." This implies that the 'acceptance criteria' are met by showing functional equivalence to the established predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The type of testing mentioned is "performance testing" and "biocompatibility testing," which are typically laboratory or bench tests, not clinical studies with patient data in the context of AI/ML evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. The document describes a medical device, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this type of device would relate to its physical and functional performance (e.g., coagulation capabilities, decompression effectiveness, material properties), which are evaluated through engineering and biological tests, not expert consensus on data interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods are typically used in clinical studies involving human interpretation or uncertain diagnoses, which is not the type of study described here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable/provided. MRMC studies are used to evaluate the impact of a device (often AI/ML) on human readers' performance, typically in diagnostic tasks. This submission is for a surgical catheter system, not a diagnostic imaging device with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a surgical tool used by a human, not an algorithm operating independently.
7. The Type of Ground Truth Used
The ground truth used for performance validation would likely be based on engineering specifications and pre-defined functional outcomes for the catheters (e.g., precise temperature delivery, effective tissue coagulation, successful decompression in a controlled environment). For biocompatibility, the ground truth is established by validated toxicology and material science standards. No pathology or outcomes data are mentioned in this summary in the context of device performance testing.
8. The Sample Size for the Training Set
This information is not applicable/provided. This is a hardware medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reason as point 8.
Summary of what the document does state about the study:
The study described is focused on demonstrating substantial equivalence to previously cleared predicate devices (Nucleotomy Catheter K013622 and Spinecath Intradiscal Catheter K993967).
- Study Type: Performance testing (implied bench testing or in-vitro studies) and biocompatibility testing.
- Purpose: To show that the "proposed Intradiscal Catheter System performs identically" to the predicate devices and that it "does not pose a substantial biocompatibility risk."
- Results: The results of "all performance and biocompatibility testing are enclosed" (referring to the full 510(k) submission, not this summary document). The summary states these tests demonstrate identical performance and no substantial biocompatibility risk.
§ 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.