(50 days)
The LiVac Retractor is designed as an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue to provide improved access and visualisation of surgical sites.
The LiVac Retractor System is a soft silicone ring connected to suction tubing and is designed to maintain apposition between two substantially planar, conformable, solid organ surfaces, most typically the diaphragm and either lobe of liver, or spleen, thereby exposing the organs beneath. The system is comprised of three components: 1.) LiVac Retractor, 2.) LiVac Bevel, and 3.) LiVac Connector. The suction tubing is connected to a sterile suction hose via the connector, which is positioned partially within the abdominal wall. The LiVac Connector can lie alongside a 12-15mm port within the secondary channel of the LiVac Bevel as per Hasson technique, or within a single incision laparoscopic port device.
This document describes results from a 510(k) premarket notification for the LiVac Retractor System. It includes information on performance data, but it does not contain specific acceptance criteria, reported device performance metrics in a table format, nor details about sample sizes, data provenance, ground truth establishment, or expert involvement for a study proving device meets acceptance criteria.
The document states: "LiVac completed a number of tests on their device to demonstrate that it meets all design requirements for performance characteristics, biocompatibility, sterilization, shelf-life and risk. The LiVac Retractor System passed all testing in accordance with internal LiVac performance testing, as well as those international standards shown below to support substantial equivalence of the subject device."
However, the specific "design requirements for performance characteristics" that would serve as acceptance criteria are not explicitly detailed with quantitative targets. Instead, a series of "Pass" results are listed for functional performance, biocompatibility, sterilization, packaging/shelf-life, and risk analysis.
Here's an attempt to answer the questions based on the provided text, acknowledging the significant gaps in information for many points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Functional performance (device retraction times) | Pass |
| Biocompatibility (per ISO 10993) | Pass |
| Sterilization validation (per ISO 11137-1/-2/-3 and ISO 11737-1/-2) | Pass |
| Packaging and Shelf-Life (per ISO 11607-1/-2) | Pass |
| Risk analysis (per ISO 14971) | Completed with all risk mitigated to as low as possible |
| Performance and safety in laparoscopic surgery | Both primary and secondary performance objectives were achieved. Both primary and secondary safety objectives were achieved. No new risks were identified. |
Note: The document only states "Pass" or "objectives were achieved" without providing the specific quantitative criteria that define a "Pass" or what those objectives numerically were.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Performance Data (Test Set): No specific sample sizes for bench tests are provided.
- Animal Studies (Test Set): "three non-clinical studies on pigs" and "A fourth study was conducted by an independent surgeon in Italy." Data provenance: University of Melbourne (Australia), School of Veterinary Science - Animal laboratory, and Italy. These were prospective studies.
- Clinical Study (Test Set): "an open label study of the performance and safety of the LiVac Retractor in laparoscopic surgery at two hospitals in Victoria, Australia." This was a prospective study. No specific number of patients (sample size) is provided for the clinical study.
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)
- Bench/Animal Studies: Not applicable in the context of expert ground truth. Performance was evaluated through direct observation and measurement in these studies.
- Clinical Study: The study was open label, and both performance and safety objectives were evaluated. While presumably surgeons were involved in assessing performance and safety, the document does not specify the number or qualifications of experts used to establish any formal "ground truth" or expert consensus in the typical sense for a diagnostic device. The outcomes were likely observed and recorded by the surgical team and researchers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Bench/Animal Studies: Not applicable.
- Clinical Study: The document does not provide any information regarding an adjudication method.
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
This document describes a medical device (a retractor) and its performance, not an AI or diagnostic imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers improving with AI assistance is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is for a medical device (retractor), not an algorithm or AI. Therefore, a standalone algorithm-only performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Performance: Direct measurement and observation of device function.
- Animal Studies: Direct observation of device use during surgical procedures in animals, and evaluation of surgical outcomes.
- Clinical Study: "Performance and safety of the LiVac Retractor in patients undergoing upper abdominal single or multi-port laparoscopic surgery." The ground truth here would be the observed events and outcomes during surgery, as monitored by the surgical team, and potentially patient follow-up data. This is akin to outcomes data or direct observation of device performance and patient safety.
8. The sample size for the training set
This document does not describe any training set. The studies mentioned are focused on demonstrating the performance and safety of a physical medical device (retractor) through testing, not on training a model.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.