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The Advanced Medical Monopolar Scissors, Maryland Dissecting Forceps, Lap Clinch, Rat Tooth LapClinch, Babcock, Straight Grasping Forceps with Ratchet are indicated for use in gynecological and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators.

The Advanced Medical Reducer has application in gynecologic laparoscopy and other abdominal procedures and is designed to be used with the Advanced Medical Disposable Surgical Trocar to allow the surgeon to insert undersized instruments through the Trocar without losing insufflation.

The Advanced Medical Laparoscopic Smoke Filter is intended for the filtration of contaminants from smoke, generated during laparoscopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria and viruses).

The Advanced Medical Hasson Trocar and Dilating Tip Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.

The Advanced Medical Shielded Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.

The Advanced Medical Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down (lap approach).

The Secondary Trocar is used in endoscopic surgery (abdominal and thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laparoscopes and probes. There is a seal on the cap which closes the port of entry.

The Advanced Medical Stainless Steel Veress Needle is for the initial induction of pneumoperitoneum.

The Advanced Medical Suction/Irrigation Set is intended for use in endoscopic procedures such as laparoscopy, pelviscopy, and thorascopy, for suctioning of large clots, retrieving spilled stones, high flow irrigation and hydro-dissection.

The Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and surgical procedures) to cut, dissect, manipulate and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories.

The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated gamma procedure per AAMI/ISO International standard 11137 (EN 552) to a SAL of 10-6.

This submission describes the "Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories". Based on the provided text, the device is considered substantially equivalent to predicate devices, and no clinical trials were conducted to establish new acceptance criteria or performance metrics distinct from the predicates.

Here's a breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Test Set Sample Size: Not applicable. The document explicitly states "Clinical testing was not conducted." The non-clinical testing for electrical, safety, and EMC would have used a sample size determined by the specific testing protocols for those standards, but this information is not provided in a way that relates to an "AI test set" or patient data.
   • Data Provenance: Not applicable, as no clinical data was used for a test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable, as no clinical testing or "test set" requiring expert ground truth was conducted for this 510(k) submission.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable, as no clinical testing or "test set" requiring adjudication was conducted.

4. 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 or comparative effectiveness study was done. This is not an AI device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as this is a medical device (surgical instruments), not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical tests (electrical, safety, EMC), the "ground truth" was compliance with established international standards (IEC 60601-2-2) and sterile processing standards (AAMI/ISO 11137). For the substantial equivalence argument, the ground truth was the performance and characteristics of the legally marketed predicate devices.

7. The sample size for the training set:

   • Not applicable, as this is a medical device, not an AI model requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as this is a medical device, not an AI model requiring a training set.

In summary: The submission for the "Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories" relies on demonstrating substantial equivalence to already cleared predicate devices and compliance with relevant non-clinical performance standards (electrical safety, EMC, sterilization). No clinical studies or AI-related evaluations (training sets, test sets, expert ground truth, MRMC studies) were conducted or reported for this submission.

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