(269 days)
Cutting and coagulation of skin.
The iSurg(MC6B) is an isolated output monopolar electrosurgical generator configured as a table top standalone device, Height 3.5in (89mm), Width 10.5in (267mm), Depth 6.5in (165mm), Weight 6lb (2,73kg) It produces 50 watts into 500 ohms at 3.0 MHz.
The iSurg(MC6B) generates RF current via an AM modulated power oscillator comprised of a class C beam power vacuum tube Hartley oscillator. The power oscillator runs at full power when actuated. Power control is by means of an attenuator in the form of variable air capacitor.
MOPP (Means of Patient Protection) is in the form of magnetic coupling to an isolated winding on a separate core in the RF coil providing type BF floating patient applied parts in accordance with IEC 60601-2-2. The RF coil primary serves as an intermediate stage with PE connection. MOOP is provided by the low voltage control board (61.010) which galvanically isolates the foot pedal from mains and earth and couples to the oscillator through opto-coupler and relay. SELV common on this board floats. The 81.001A Switch Board uses high isolation relays powered by the low voltage board to isolate the relay coils from the oscillator board. Oscillator actuation is by means of earthing the cathode of the beam power tube via a relay; oscillator OFF state is when the cathode of the beam power tube floats. Tube bias is by means of grid leak via the 10K grid load. The 10K grid load resistor is wire wound type with significant inductance: the current to ground through it is close to DC accordingly. It is current through this resistor that is sensed for the RF ON indicator and active tone (a function of the low voltage control board). The low voltage board also includes a warm up delay to prevent cathode stripping of the vacuum tube.
The provided text does not describe acceptance criteria for a device, nor a study proving the device meets said criteria.
Instead, the document is an FDA 510(k) Premarket Notification for an electrosurgical cutting and coagulation device called iSurg (MC6B). The purpose of this notification is to demonstrate "substantial equivalence" to a predicate device already on the market, not to prove the device meets specific performance acceptance criteria through clinical or standalone studies as requested in the prompt.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Acceptance Criteria & Reported Performance: The document does not specify quantitative performance acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or report such performance against established criteria. It focuses on comparing the technological characteristics of the iSurg (MC6B) to predicate devices.
- Study That Proves the Device Meets Acceptance Criteria: No such study is described. The document explicitly states: "No clinical testing was performed in association with this submission." It also dedicates a section to "Non-Clinical Testing" which details a "Histology Study," but this appears to be for characterization of the device's effects rather than proving it meets specific performance acceptance criteria for regulatory approval.
However, I can provide information based on the Histology Study presented, although it does not align with the definition of a study proving devices meet acceptance criteria:
1. A table of acceptance criteria and the reported device performance
As stated above, no specific acceptance criteria for performance metrics (like diagnostic accuracy, sensitivity, or specificity) are defined or reported against. The "Histology Study" describes observations of the device's effect on tissue.
Observations from Histology Study (Not Acceptance Criteria):
| Feature/Condition | Reported Observation (Worst-Case) |
|---|---|
| Incision Electrode - Cut Mode (Group 1) | |
| Maximal Power | 0.421 mm (width), 0.125 mm (depth) of cautery effect |
| Nominal Power | 0.210 mm (depth) of cautery effect (slightly greater than maximal power depth) |
| Minimal Power | No cautery effect appreciable |
| Incision Electrode - Blend Mode (Group 2) | |
| Nominal Power | 0.473 mm (width), 0.190 mm (depth) of cautery effect |
| Maximal Power | 0.369 mm (depth), 0.148 mm (width) of cautery effect |
| Minimal Power | No cautery effect appreciable |
| Excision Electrode - Cut Mode (Group 3) | |
| Maximal Power | 6.239 mm (width), 1.612 mm (depth) of cautery effect |
| Minimal Power | No cautery effect appreciable |
| Excision Electrode - Cut Mode (Group 4) | |
| Maximal Power | 6.039 mm (width), 0.917 mm (depth) of cautery effect |
| Minimal Power | No cautery effect appreciable |
| Ball Electrode - Hard Coagulation Mode (Group 5) | |
| Nominal Power | 2.256 mm (width), 1.209 mm (depth) of cautery effect |
| Minimal Power | No cautery effect appreciable |
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 (Histology Study): Not explicitly stated as a total number of samples. It mentions "Three different electrodes were used," and "Five different electrocautery test article effects... were each evaluated at minimal, nominal, and maximal power in triplicate." This implies $3 \text{ electrodes} \times 5 \text{ combinations} \times 3 \text{ power levels (min, nom, max)} \times 3 \text{ triplicates} = N$ samples if each combination was tested with each electrode, or more likely $5 \text{ test effects} \times 3 \text{ power levels} \times 3 \text{ triplicates} = 45$ distinct evaluations (some test effects might combine electrode and waveform). The description is somewhat ambiguous regarding the exact number of tissue samples.
- Data Provenance: "ex-vivo pig skin." The country of origin is not specified.
- Retrospective or Prospective: Prospective (experimental setup).
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. This was a histological evaluation of tissue effect, not a diagnostic study with "ground truth" derived from expert consensus. The "ground truth" here is the physical tissue effect observed via histology. The evaluation would typically be performed by a pathologist or histologist, but their number and qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was an experimental study on tissue, not a diagnostic study requiring adjudication of expert readings.
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 MRMC comparative effectiveness study was done. The device is an electrosurgical generator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an electrosurgical device, not a diagnostic algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's performance is its physical effect on tissue.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the histology study was the observed pathological/histological effect on the ex-vivo porcine skin samples. This involved assessing the "length and depth of electrocautery effect."
8. The sample size for the training set
Not applicable. This document describes a new medical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.
§ 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.