(257 days)
DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
DAN Monopolar Lap Accessories consist of Standard insulated monopolar handles Insulated shafts Class I inserts (forceps, scissors, biopsy cups, needle holders) Electrodes The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
The provided text is a 510(k) summary for the DAN Monopolar Lap Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance studies with specific statistical acceptance criteria.
Therefore, the requested information regarding acceptance criteria and the detailed study proving the device meets those criteria is not present in this document.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document states:
"Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness."
This implies that the acceptance criterion for the submission was demonstrating substantial equivalence, and the reported performance is that the device is substantially equivalent based on design analysis and comparison. Specific metrics or numerical targets are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No formal test set data for performance evaluation is mentioned. The submission relies on design analysis and comparison to predicate devices, not a new performance study with a test set.
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. No test set requiring ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is mentioned.
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 (monopolar lap accessories) is a surgical instrument and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is irrelevant to this submission.
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. No formal ground truth was established for a performance study. The "ground truth" for this 510(k) would be the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. No machine learning or AI component, thus no training set.
9. How the ground truth for the training set was established
Not applicable. No machine learning or AI component, thus no training set or ground truth establishment for it.
In summary:
The 510(k) submission for DAN Monopolar Lap Accessories demonstrates substantial equivalence by comparing the design and basic functional characteristics of the new device to existing predicate devices. It does not present a new performance study with specific acceptance criteria, test sets, or ground truth as would be expected for a device relying on novel technology or diagnostic claims. The acceptance criterion for this submission was successful demonstration of substantial equivalence to already legally marketed devices.
§ 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.