(88 days)
Rocket Electrode is to be used as a gynecologic electrocautery device for tissue excision. It is designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. This is to excise cervical lesions, perform biopsies, or treat chronic cervititis under direct visual observation
This group of electrodes consists basically of a metal shaft partly insulated with two extensions connected by means of a metal wire (square and loop types). Or in case of the other types, it may be connected by blade, ball or needle. All the electrodes are supplied with different sizes
The provided 510(k) submission for the "Rocket Electrode" does not contain a study that proves the device meets specific acceptance criteria related to its performance on diagnostic tasks.
Instead, this submission is for a medical device (electrocautery electrodes) that establishes substantial equivalence to existing predicate devices. The safety and effectiveness are determined by comparing its technological characteristics to those of already approved devices, rather than through a standalone performance study with predefined acceptance criteria.
Here's why the requested information cannot be fully provided based on the input:
- Type of Device: The "Rocket Electrode" is a gynecologic electrocautery device for tissue excision. It's a surgical instrument, not a diagnostic imaging or AI-powered device that performs a diagnostic task. Therefore, metrics like sensitivity, specificity, or AUC, which are common for AI/diagnostic devices, are not applicable here.
- Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not require extensive clinical trials or performance studies against specific acceptance criteria in the same way a device seeking PMA approval or a novel diagnostic AI algorithm might.
However, I can extract information related to the comparison with predicate devices and the intent of the submission:
1. Table of acceptance criteria and the reported device performance
- No specific acceptance criteria (e.g., sensitivity, specificity, AUC) are listed because this is not a diagnostic device and the submission method is 510(k) substantial equivalence.
- Instead of "performance," the submission focuses on technological characteristics comparison to demonstrate comparable safety and effectiveness.
- The reported "performance" is that the device's technological characteristics are "Equivalent" or "Similar" to the predicate device.
| Feature / Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence) | Rocket Electrode Performance (Relative to Predicate K942986 from Aaron Medical Industries) |
|---|---|---|
| Indications for use | Similar/Equivalent to predicate | Equivalent (m) |
| Target population | Similar/Equivalent to predicate | Equivalent (m) |
| Design | Similar/Equivalent to predicate | Equivalent (m) |
| Materials | Similar/Equivalent to predicate | Equivalent (m) |
| Performance (general) | Similar/Equivalent to predicate | Equivalent (m) |
| Sterility | Similar/Equivalent to predicate | Equivalent (m) |
| Biocompatibility | Similar/Equivalent to predicate | Equivalent (m) |
| Mechanical Safety | Similar/Equivalent to predicate | Equivalent (m) |
| Chemical Safety | N/A (Not Applicable for predicate, thus implicitly for new device in this context) | N/A (as per predicate) |
| Anatomical sites | Similar/Equivalent to predicate | Equivalent (m) |
| Human Factors | Similar/Equivalent to predicate | Equivalent (m) |
| Energy used and/or delivered | Similar/Equivalent to predicate | Equivalent (m) |
| Compatibility w/ environment & other devices | Similar/Equivalent to predicate | Equivalent (m) |
| Where used | Similar/Equivalent to predicate | Equivalent (m) |
| Standards met | Similar/Equivalent to predicate | Equivalent (m) |
| Electrical Safety | Similar/Equivalent to predicate | Equivalent (m) |
| Thermal Safety | Similar/Equivalent to predicate | Equivalent (m) |
| Radiation Safety | N/A (Not Applicable for predicate, thus implicitly for new device in this context) | N/A (as per predicate) |
Abbreviations: m = Equivalent, N/A = Not Applicable
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. There is no "test set" in the context of a diagnostic performance study, as this is a device for surgical intervention, not diagnostic analysis. The submission is a comparison of product specifications.
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. There is no "ground truth" establishment by experts in a diagnostic context for this type of device submission. The substantial equivalence determination is based on a regulatory review of engineering and design specifications compared to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication related to diagnostic outcomes is mentioned or required for this type of device.
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
- Not applicable. This device is an electrocautery electrode used by a surgeon, not an AI diagnostic tool. Therefore, an MRMC study or AI-assistance evaluation is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The concept of "ground truth" in a diagnostic sense does not apply to this device. The "truth" in this submission relates to whether the device's physical and functional characteristics are substantially equivalent to marketed devices for its intended use.
8. The sample size for the training set
- Not applicable. This device is a physical instrument, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth in the AI/diagnostic sense is involved.
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).