(191 days)
The Disc-FXTM System is intended for use in ablation and coagulation of intrervertebral disc material during discectomy procedures in the lumbar spine.
The Disc-FXTM System is a single-use disposable kit that contains the following disposable components:
- Trigger-Flex™ Dipolar System
- Trigger-Flex™ Depth Stop
- Guidewire
- Cannula, Straight
- Cannula, Beveled
- Cannula Depth Stop
- Tapered Dilator
- Trephine
The Ellman Disc-FX™ System, a device intended for ablation and coagulation of intervertebral disc material during discectomy procedures in the lumbar spine, demonstrated its performance through mechanical testing and a clinical experience summary.
Here's a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design Specifications | Met during mechanical performance tests. |
| Intended Performance Characteristics | Met during mechanical performance tests. |
| Safety and Effectiveness (compared to predicate devices) | Determined to be at least as safe and effective as predicate devices based on testing/clinical investigation results. |
| Sterilization Efficacy | A detailed Sterilization Protocol and Validation Summary were included for the Trigger-Flex™ device, with the data submitted for the entire system due to identical materials. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state a specific sample size for a test set in the conventional sense (e.g., number of patients or cases in a clinical trial).
Instead, it mentions:
- "Multiple discectomy procedures" for the clinical experience summary. The exact number of procedures or patients is not specified.
- Data Provenance: The nature of the clinical experience summary suggests it is retrospective or a limited prospective observational report of the device's use by a skilled physician. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying the clinical experience likely occurred in a region where such procedures are conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Only "a doctor skilled in percutaneous and endoscopic spine procedures" is mentioned as performing the discectomy procedures. This implies a single expert provided the clinical data.
Specific qualifications beyond "skilled" and the type of medical degree (e.g., orthopedic surgeon, neurosurgeon) or years of experience are not provided. The term "skilled" suggests proficiency in the relevant surgical techniques.
4. Adjudication Method for the Test Set
The document does not mention any formal adjudication method (e.g., 2+1, 3+1). The clinical experience appears to be based on the assessment and outcomes observed by the single "doctor skilled in percutaneous and endoscopic spine procedures." There is no indication of independent review or consensus building among multiple experts for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document only refers to mechanical performance tests and a clinical experience summary from a single practitioner. There is no mention of comparing human readers' performance with and without AI assistance, as AI is not a component of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Disc-FX™ System is an electrosurgical device and not an AI or algorithm-based product. Therefore, no standalone algorithm performance study was conducted.
7. The Type of Ground Truth Used
The ground truth for the clinical experience appears to be based on clinical observation and outcomes data as assessed by the "doctor skilled in percutaneous and endoscopic spine procedures" during the "multiple discectomy procedures." There is no mention of pathology, imaging, or other objective measures beyond the clinical assessment.
8. The Sample Size for the Training Set
This question is not applicable. The Disc-FX™ System is a medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.