(42 days)
The ADAPt™ Universal Laparoscopic Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
The ADAPt™ Universal Laparoscopic Port consists of an obturator and cannula set which will accommodate instruments in the 5-10mm range with a cannula length of 100mm and the 5-10-12mm range with cannula lengths of 100mm and 125mm. The device utilizes a set of three seals. The first seal is the Floating Top Seal which accommodates instruments ranging from 10mm to 12mm. The second seal is the Floating Caged Seal which accommodates instruments in the 5mm range. The third seal is the Duck Bill Seal used to maintain insufflation, if no instruments are placed in the port during surgery.
The ADAPt™ Universal Laparoscopic Port is considered substantially equivalent to its predicate device (The ADAPT™ Laparoscopic Port and Accessory, K010007). The evaluation of this device is based on determining its substantial equivalence to the predicate device rather than fulfilling specific, independent acceptance criteria.
Here's a breakdown of the information based on your request, understanding that the context is substantial equivalence for a medical device rather than a diagnostic AI system:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence determination for a medical device (a surgical trocar), the "acceptance criteria" are not reported as quantitative performance metrics in the same way they would be for an AI diagnostic algorithm. Instead, the acceptance is based on demonstrating that the device performs as intended and is equivalent to a predicate device, thereby not raising new questions of safety or effectiveness.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Basic Design and Function | Identical to the predicate device (K010007). |
| Material Compatibility (Patient Contact) | All materials (except for Valox core overmolded with CLS 8110 Silicone Parylene N Cating 1.0-1.8 uM thick) were cleared in the predicate device. New material was tested in accordance with ISO 10993-1. |
| Performance Characteristics | Equivalent to marketed predicate devices. |
| Safety and Effectiveness | Changes do not introduce any new issues of safety and effectiveness. |
| Intended Use | Aligns with the predicate device for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices. |
2. Sample size used for the test set and the data provenance
The document states that "bench testing has been performed." However, it does not specify the sample size for this bench testing or the provenance of any data used (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The study relies on bench testing comparisons to a predicate device, not on expert-adjudicated ground truth as would be typical for a diagnostic AI.
4. Adjudication method for the test set
This information is not applicable and not provided. The evaluation is based on bench testing of the device's physical and functional characteristics.
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
No such study was done. This is a medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No such study was done. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is the performance and safety established for the predicate device (K010007) and the bench testing results demonstrating that the modified ADAPt™ Universal Laparoscopic Port performs equivalently and safely. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for an AI diagnostic.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
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.