(121 days)
The Disc-FX System is intended for use in ablation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine.
The Disc-FX® System is a single-use, disposable kit which is intended for use in ablation and coagulation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine. This device originally received requlatory clearance under 510(k) number K052241 with indications for use limited to the lumbar spine. The design of the Disc-FX® System remains unchanged; the purpose of this 510(k) submission is solely to expand the existing indications of use to include both cervical and thoracic applications.
The Disc-FX® System consists of the following components:
- Trigger Flex® Bipolar System
- Triager Flex® Depth Stop
- Surgical guidewires
- Straight cannula
- Beveled cannula
- Tapered dilator
- Trephine
This document is a 510(k) premarket notification for the Disc-FX System, seeking to expand its indications for use from only the lumbar spine to include cervical and thoracic applications. The submission primarily relies on demonstrating substantial equivalence to a previously cleared version of the Disc-FX System (K052241) and the Arthrocare Coblator IQ™ Perc-D® Spinewand® (K100353).
The document does not contain acceptance criteria or detailed results of a study proving the device meets specific acceptance criteria in the typical format of a clinical performance study with sensitivity, specificity, or similar metrics. The information provided focuses on non-clinical testing to support substantial equivalence for the expanded indications.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/device performance study. The non-clinical testing sections broadly mention "various performance tests including mechanical testing and simulated use tests" and "Comparison of the thermal effect of the subject device on intervertebral tissue as compared to predicate." However, specific numerical acceptance criteria and reported numerical results against those criteria are not provided for these tests in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This submission does not describe a clinical performance study with a test set of patient data to evaluate algorithmic performance. The submission uses non-clinical testing (mechanical, simulated use, thermal effect, electrical safety, biocompatibility).
- Data Provenance: Not applicable.
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. As no clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 such study is mentioned or described in this document. The submission explicitly states: "Clinical testing was not included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is an electrosurgical system, not an AI algorithm. Its performance is evaluated through non-clinical functional tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, "ground truth" would relate to engineering specifications, material properties, safety standards, and physiological responses in simulated environments, rather than clinical ground truth diagnoses.
8. The sample size for the training set
Not applicable. The device is a medical instrument (electrosurgical system), not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.