(87 days)
The "Re-New Forceps" Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
The "Re-New Forceps" Laparoscopic Surgical Tips are an extension of the "Re-New" Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures.
The "Re-New Forceps" Laparoscopic Surgical Tips consist of a series reusable tip configurations. The tip assembly, designed with a double thread, permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include:
- · Grasper,
- · Fenestreded Forceps.
- · "Dolphin Nose" Dissector,
- · "Babcock", and
- · "Maryland" Dissector
The provided text describes a 510(k) premarket notification for "Re-New Forceps" Laparoscopic Surgical Tips and focuses on demonstrating substantial equivalence to a predicate device ("Re-New" K962119). It does not contain information about acceptance criteria, device performance metrics, or study designs (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) typically associated with direct studies proving a device meets specific performance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets those criteria, as this information is absent from the provided document.
The document is a 510(k) summary, which is primarily concerned with establishing substantial equivalence to a legally marketed predicate device, rather than detailed performance study results against specific acceptance criteria.
Here's what can be inferred or stated based on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
- Information Not Available: The document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics (e.g., force measurements, dissection efficiency, tissue damage scores) against such criteria. The basis for clearance is "substantial equivalence" to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Available: No information regarding sample sizes for a test set, data provenance, or whether any studies were retrospective or prospective is provided. The submission focuses on device description and comparison to a predicate.
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)
- Information Not Available: There is no mention of experts, ground truth establishment for a test set, or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Available: No information regarding adjudication methods is provided.
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
- Information Not Available: This device is a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human "readers" and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Information Not Available / Not Applicable: This is a manual surgical instrument, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Information Not Available: No ground truth data or its source is mentioned in relation to performance evaluation. Substantial equivalence relies on comparing the new device's technical characteristics and intended use to those of the predicate device.
8. The sample size for the training set
- Information Not Available: No training set or associated sample size is mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Information Not Available / Not Applicable: No training set or ground truth for such a set is relevant or discussed 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.