(257 days)
The Innovia InnoPort™ Laparoscopic Access Device is a sterile, single use device intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.
The InnoPort Laparoscopic Access Port is a sterile, single use laparoscopic access device comprised of flexible polymer and a rigid plastic plate. The InnoPort forms a truncated cone approximately 5.0 centimeters long (not including instrument ports), with three individual laparoscopic instrument ports at the larger end. A fourth port connects to the infor system to provide intra-abdominal pneumoperitoneum, and a fifth port coulties of the insunprocedural smoke removal. The instrument ports are designed to accommodate 5 mm dinerer laparoscopic instruments while allowing full maneuverability without loss of neumperioneum. The complete device is designed to be inserted through a single incision into the abdominal cavity for the duration of surgery.
The prompt asks for acceptance criteria and study details related to a medical device's performance. However, the provided document is a 510(k) summary for the "InnoPort™ Laparoscopic Access Port," which is a physical medical device, not an AI or software-based device.
Therefore, many of the requested categories in the prompt, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set sample size," and "ground truth for training set," are not applicable to this type of medical device and its associated 510(k) submission.
The document focuses on demonstrating substantial equivalence to a predicate device through bench and in vivo tests, verifying its mechanical performance and safety, rather than evaluating an algorithm's diagnostic accuracy against a ground truth.
Here's an attempt to answer the applicable parts of the prompt based only on the provided text, while explicitly stating when information is not available or not applicable:
Acceptance Criteria and Device Performance Study Details for Innovia InnoPort™ Laparoscopic Access Port
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding performance metrics. Instead, it broadly states the device was tested to verify its ability to meet performance specifications related to the intended use.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Maintain Pneumoperitoneum | With minimal leakage |
| Instrument Introduction & Manipulation | Allows introduction and maneuverability of instruments |
| Overall Performance & Safety | Meets performance specifications; introduces no new safety or effectiveness issues when used as instructed |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided document. The document mentions "bench and in vivo tests" but does not quantify the number of tests, devices, or subjects used.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing included "bench and in vivo tests," which implies a combination of laboratory testing and potentially animal or human studies, but the specifics are not detailed. It is a prospective study in the sense that the testing was conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical laparoscopic access port, not an AI or diagnostic software. Ground truth in the context of expert consensus or diagnostic accuracy is not relevant for its performance evaluation in this 510(k) submission. The performance tests would likely involve engineers and possibly surgeons in simulated or live surgical settings, but not for "establishing ground truth" in a diagnostic sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As a physical device, adjudication methods for diagnostic output are not relevant. Performance was likely determined by direct observation, measurement, and functional assessment during bench and in vivo testing.
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. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a surgical instrument and does not involve "human readers" or AI assistance in the way an MRMC study evaluates.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This refers to the standalone performance of an algorithm. The InnoPort™ is a physical surgical device. Its "standalone performance" refers to its mechanical and functional integrity in isolation, which was assessed through bench testing and its in vivo behavior, but not as an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in these terms, but inferred: For a physical medical device like this, the "ground truth" for its performance would implicitly be defined by engineering specifications, material standards, biocompatibility requirements, recognized surgical practices, and the functional capabilities demonstrated by the predicate device. The in vivo tests would assess real-world functionality and safety. The performance is compared to the predicate device's established safety and effectiveness profile.
8. The sample size for the training set:
- Not Applicable. This concept applies to machine learning models. This device is a physical product, not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for this type of 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.