(347 days)
The SPINUAT-P is indicated for ablation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
The SPINAUT-P is a minimally invasive RF electrode device offered in 496mm length for percutaneous disc decompression surgery using radiofrequency energy and designed for use with radiofrequency generators in RF procedure. SPINAUT-P is intended to be placed into the epidural space or posterolateral / posterocentral area in the disc to remove, ablate or coagulate disc material in the area. The electrode consists of two stainless steel shafts with straight electrode configuration design. The shaft is housed in a coating composed of Polyamide. The device is single-use gamma radiation sterilized and is compatible with most standard electrosurgical generators that provide a cable with two pin outlet (2-pin, 22mm) with 1kVp maximum electrical capacity.
The provided text is a 510(k) summary for the SPINAUT-P device, an electrosurgical device for disc decompression. It details the device's technical specifications and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. However, it does not contain any information about a clinical study involving human patients or the performance of a device against specific acceptance criteria in a clinical setting.
The document focuses on non-clinical (bench and lab) testing to support a premarket notification for a medical device. Therefore, I cannot provide details on acceptance criteria and a study that proves the device meets those criteria in a clinical context, or information related to human reader studies.
Here's a breakdown of what can be extracted from the document regarding non-clinical performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document primarily focuses on demonstrating that the SPINAUT-P device meets electrical safety, biocompatibility, sterilization, and some performance characteristics comparable to predicate devices. It lists test descriptions and referenced standards, implying that the acceptance criteria are met by adhering to these standards and the established "pre-set criteria" mentioned.
| Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|
| Electrical Safety | ||
| RF leakage current ≤ 7.2dfL mA (as per predicate) | ≤ 7.2dfL mA | Explicitly stated as met, comparable to predicates. |
| Electrical conductivity | Electrode is able to pass electricity. | Met. |
| Cable Dielectric Strength | Complies with IEC 60601-2-2 Edition 5.0 2009-02, Clause 201.8.8.3.104 and 201.8.8.3.103. | Met. |
| High Frequency Leakage | Complies with ANSI/AAMI HF 18:2001 Electrosurgical Devices Clause 4.2.5.2. | Met. |
| Material & Physical Properties | ||
| Tensile Strength of Electrode Cord | Complies with ANSI/AAMI HF18:2001 Clause 4.2.5.5. | Met. |
| Appearance (Visual Inspection) | "Visual Inspection" conducted. | Implied satisfactory. |
| Size Measurement | "Measure the size of the test article by vernier calipers." | Implied satisfactory and consistent with specifications. |
| Sterilization | ||
| Sterility | Complies with ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3 and Korean Pharmacopeia (10th Edition). | Met pre-set criteria. |
| Shelf Life | ||
| Shelf Life Validation | 3-year shelf life validated using ASTM F1980-07 (accelerated aging). | Met pre-set criteria. |
| Packaging integrity | ||
| Package Tensile Test | Complies with ASTM D882-12. | Met. |
| Package Peeling Test | Complies with ASTM F88/F88M-09. | Met. |
| Package Dye Penetration Test | Complies with ASTM F1929-12. | Met. |
| Biocompatibility | ||
| Cytotoxicity | Complies with ISO 10993-5:2009/(R) 2014. | Supported as biocompatible. |
| Skin Sensitization | Complies with ISO 10993-10 Third Edition 2010-08-01. | Supported as biocompatible. |
| Intracutaneous reactivity | Complies with ISO 10993-10 Third Edition 2010-08-01. | Supported as biocompatible. |
| Acute Systemic Toxicity | Complies with ISO 10993-11 Second edition 2006-08-15. | Supported as biocompatible. |
| Pyrogen | Complies with USP 37-NF32:2014, . | Supported as biocompatible. |
| Haemolysis | Complies with ISO 10993-4:2002. | Supported as biocompatible. |
| Performance Comparison (Porcine Spines) | ||
| Tissue Removal Performance | Demonstrated comparable performance to predicate device (L'disQ). | The test demonstrated the device being as safe and as effective as the predicate. |
| Durability of Electrode | Demonstrated comparable performance to predicate device (L'disQ). | The test demonstrated the device being as safe and as effective as the predicate. |
| Ability to be introduced, directed to and extracted from the surgical site (target area) | Demonstrated comparable performance to predicate device (L'disQ). | The test demonstrated the device being as safe and as effective as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions tests on "porcine spines" for performance comparison, but does not specify the number of porcine spines or individual tests conducted. For other tests (sterilization, shelf life, biocompatibility, electrical safety), it refers to established standards (e.g., ISO, ASTM, ANSI/AAMI, USP) which dictate sample sizes, but these specific numbers are not presented in the summary.
- Data Provenance: The data is from non-clinical (bench and lab) testing, not human studies. The tests were performed by or for IMEDICOM Co., Ltd. (Republic of Korea). The specific location of testing labs is not detailed beyond the company's origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to the non-clinical testing described. Ground truth or expert consensus is typically associated with clinical studies involving human data, where human experts (e.g., radiologists, pathologists) provide annotations or diagnoses.
4. Adjudication Method for the Test Set
- This information is not applicable as the document describes non-clinical laboratory testing, not a clinical study where adjudication of human expert opinions would be necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not conducted. The document focuses on demonstrating substantial equivalence through non-clinical testing, not a clinical trial comparing human readers with and without AI assistance. The device itself is an electrosurgical tool, not an AI diagnostic or assistance system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone algorithm performance study was not conducted. This device is an electrosurgical accessory, not an AI algorithm.
7. Type of Ground Truth Used
- For the non-clinical performance comparison using porcine spines, the "ground truth" would be the objective measurements and observations of tissue removal, durability, and navigability, compared against the predicate device under controlled experimental conditions.
- For other tests (electrical, sterility, biocompatibility), the "ground truth" is adherence to the published specifications and pass/fail criteria defined by the referenced international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP).
8. Sample Size for the Training Set
- This information is not applicable. The device is an electrosurgical tool, 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 for the same reason as point 8.
§ 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.