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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:

1. Trigger Flex® Bipolar System
2. Triager Flex® Depth Stop
3. Surgical guidewires
4. Straight cannula
5. Beveled cannula
6. Tapered dilator
7. 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.

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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:

1. Trigger-Flex™ Dipolar System
2. Trigger-Flex™ Depth Stop
3. Guidewire
4. Cannula, Straight
5. Cannula, Beveled
6. Cannula Depth Stop
7. Tapered Dilator
8. 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

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.

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