(327 days)
The L'DISQ® is indicated for coagulation and ablation of disc material to treat symptomatic patients with contained herniated discs.
The L'DISQ® is a plasma electrode which is 1.0 mm(PD01, PD02, PD03, PD04, PD05, PD07 and PC01) or 0.7 mm(PC02) thickness based on the high frequency electrosurgical system. L'DISQ® removes the disc lesions that are causing pain by a plasma based radiofrequency device. L'DISQ® is a single use device and there are 3-type of designs (L'DISQ, L'DISQ C, L'DISQ C.7) according to the level of spine treated.
The provided document describes the L’DISQ® electrosurgical device for treating herniated discs and its substantial equivalence to the predicate device, Perc™DC/DLR SpineWand™ (ArthroCare). The study focuses on performance testing to support this claim.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Removal Test for Nucleus Pulposus: Not explicitly stated, but implied to be effective in removing disc lesions. | The test result met all acceptance criteria. The L'DISQ® effectively removes the disc lesions that are causing pain by a plasma based radiofrequency device. |
| Durability Test for Electrode: Not explicitly stated, but implied to be durable enough for its intended single-use application. | The test result met all acceptance criteria. The device is a "single use device," suggesting it passed durability for its intended short-term application. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "we conducted following tests" without providing details on the number of samples or devices tested for either the removal or durability tests.
- Data Provenance: Not specified. The country of origin of the data (where the tests were conducted) is not mentioned, nor is whether the study was retrospective or prospective.
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)
- This information is not applicable as the studies described are performance tests (e.g., removal, durability) for an electrosurgical device, not diagnostic studies that require expert interpretation or ground truth establishment by medical professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable as the studies described are performance tests, not diagnostic studies requiring adjudication of expert opinions.
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
- This information is not applicable. The device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The L'DISQ® is a physical medical device, not a standalone algorithm. Its performance is inherent to its design and function, not an algorithm that can operate without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "Removal test for nucleus pulposus" and "Durability test for electrode," the ground truth would be based on objective physical measurements or predefined criteria for effective tissue removal and electrode integrity after use, respectively. The document does not specify the exact metrics or methods used to establish this "ground truth" (e.g., amount of tissue removed, structural integrity checks).
8. The sample size for the training set
- This information is not applicable. The L'DISQ® is a physical electrosurgical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- This information is not applicable as there is no training set for this type of device.
§ 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.