(104 days)
The AnchorPort® SIL Kit has applications in abdominal minimally invasive surgical procedures to include single skin incision applications and specifically where the surgeon anticipates using at least three 5mm cannula ports to establish a path of entry for operating endoscopic instruments.
The subject is a surgical trocar and cannula kit is composed of biosafe materials. The device incorporates an expandable elastomer sheath, which serves to hold the cannula vertically in place during endoscopic surgery. The device is used to create and maintain a port of entry during endoscopic surgery. It is fully disposable and is intended for single use only.
The information provided does not contain traditional "acceptance criteria" and "reported device performance" in the context of AI/ML device studies (e.g., sensitivity, specificity, AUC, F1-score). This document is a 510(k) summary for a medical device that is a surgical trocar and cannula kit, not an AI/ML diagnostic or predictive device. Therefore, the questions related to AI/ML specific aspects like sample size for test sets, data provenance, ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through nonclinical (bench top) and in vivo animal studies. The acceptance criteria here are implicitly met by demonstrating that the device performs "at least as safely and effectively as the predicate(s)" across various performance attributes.
Here's a breakdown based on the provided text, adapted to the context of a non-AI/ML device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric / Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Bench Data (In Vitro): | |
| Leak rate (without trocars, after multiple trocars, after vigorous manipulation) | Confirmed that the device is "substantially equivalent in all manner of operation to the predicate devices" and "at least as safe and effective as the predicate" in maintaining pneumoperitoneum during ordinary use and severe manipulation. |
| Device insertion and removal evaluation | Confirmed that the device is "substantially equivalent" and "at least as safe and effective as the predicate" regarding insertion and removal forces. |
| Minimum size of skin incision | Confirmed that the device is "substantially equivalent". |
| Device fixation | Confirmed that the device is "substantially equivalent" and "at least as safe and effective as the predicate" regarding fixation. |
| Rigidity / Flexibility | Confirmed that the device is "substantially equivalent". |
| Size / Dimension | Confirmed that the device is "substantially equivalent". |
| Sealing Instrument for maintaining insufflation | Confirmed that the device is "substantially equivalent" and "at least as safe and effective as the predicate" in maintaining pneumoperitoneum. |
| Deployment method | Confirmed that the device is "substantially equivalent" regarding the method of deployment. |
| Animal Data (In Vivo - Porcine Cholecystectomy): | |
| Ease of port insertion, suturing, and time to insert | "AnchorPort® performed as well as or better than the predicate(s)" in aspects of insertion. "The clinical outcome... was a success with no adverse effects or complications." |
| Ease of insertion and withdrawal | "AnchorPort® performed as well as or better than the predicate(s)" in aspects of insertion and removal forces. |
| Ability to maintain pneumoperitoneum | "AnchorPort® performed as well as or better than the predicate(s)" in aspects of maintenance of pneumoperitoneum. |
| Ability to manipulate instruments for laparoscopic surgery | Demonstrated "conclusively that the device is substantially equivalent." "Performed at least as safely and effectively as the legally marketed devices." |
| Ability to conduct a typical laparoscopic procedure: cholecystectomy | "The clinical outcome of the porcine cholecysectomy was a success with no adverse effects or complications." Demonstrated "conclusively that the device is substantially equivalent." "Performed at least as safely and effectively as the legally marketed devices." |
| Ability of anchoring plate to hold the ports in position | "AnchorPort® performed as well as or better than the predicate(s)" in aspects of anchoring and fixation. Demonstrated "conclusively that the device is substantially equivalent." "Performed at least as safely and effectively as the legally marketed devices." |
2. Sample size used for the test set and the data provenance
- Test Set (Bench Data): Not explicitly stated how many devices were tested for each bench test, but it is implied that a sufficient number was used to confirm substantial equivalence. No country of origin is mentioned for the bench data itself, but the submission is from SurgiQuest, Inc. in Orange, CT (USA). This is retrospective for the submission, as the tests were performed to support the 510(k).
- Test Set (Animal Data): The document mentions "in vivo animal studies were performed, including a porcine cholecysectomy." The exact number of animals or procedures is not specified, but it refers to "studies" (plural). No country of origin for the animals is specified, but the submission is from a US company. This is retrospective for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the in vivo animal studies, it states: "by surgeons familiar with the predicate device(s)." The exact number and specific qualifications (e.g., years of experience) are not provided. For bench testing, "robust engineering test methods" were used, implying engineers or technical experts established the ground truth (e.g., measurements, performance against specifications), but details are absent.
4. Adjudication method for the test set
- Not applicable/Not specified in the provided text. The evaluation appears to be direct performance assessment (bench tests) and expert observation/assessment (animal studies), rather than an adjudicated review for ground truth establishment.
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 is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- Bench Data: Objective measurements against engineering specifications and comparison to predicate device performance.
- Animal Data: Direct observation and assessment of device performance by "surgeons familiar with the predicate device(s)" during a surgical procedure (porcine cholecystectomy), with the "clinical outcome" being a success. This can be considered expert observation/assessment and outcome data (no adverse effects).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.