(128 days)
The QuadPort+ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
The ASC QuadPort+ Laparoscopic Access Devices are, like the parent TriPort+ device cleared by the FDA under K110004, laparoscopic multi-instrument ports which perform the following two functions.
- Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery.
- Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the device.
The QuadPort+ laparoscopic multi-instrument port is sterile and disposable. The QuadPort+ laparoscopic multi-instrument ports perform the same function as the TriPort+ parent device.
Like the parent ASC TriPort+ Laparoscopic Access Device, the QuadPort+ laparoscopic multiinstrument port is comprised of the following three components: - An introducer component, which delivers the Distal Ring of the device through a pre-made . incision, into the abdominal cavity.
- A retroctor component, which retracts an abdominal incision to allow the passage of ● laparoscopic instruments.
- A valve component which maintains the pneumoperitoneum established for the surgical ● procedure.
The QuadPort+ laparoscopic multi-instrument port is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The QuadPort+ laparoscopic multi-instrument port functions in the same way as the ASC parent TriPort+ device cleared by the FDA under K110004.
The provided document describes the acceptance criteria and study for the ASC QuadPort+ Laparoscopic Access Device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined Design & Performance Requirements) | Reported Device Performance |
|---|---|
| Device is easy to insert. | The device was easy to insert. |
| Instruments are easy to insert and withdraw. | Instruments are easy to insert and withdraw. |
| Device maintained pneumoperitoneum. | Device maintained pneumoperitoneum. |
| Surgeons are able to manipulate instruments for a laparoscopic procedure. | Surgeons were able to manipulate instruments for a laparoscopic procedure. |
| Surgeons are able to conduct a typical laparoscopic procedure. | Surgeons were able to conduct a typical laparoscopic procedure. |
| The device stayed in position during surgery. | The device stayed in position during surgery. |
| Does not raise new issues of safety or effectiveness. | Validation testing in a porcine model demonstrated that the performance did not raise any new issues of safety and effectiveness. |
| IFU adequately allows for device use without further training. | Validation testing in a porcine model demonstrated that the IFU adequately allowed for the use of the device without any further training. |
| Meets defined design and performance requirements. | Following Design Verification testing of the QuadPort+ along with Design Validation testing in a porcine model and on a simulator, the device has met the defined design and performance requirements outlined in the Design Inputs. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of subjects. The study involved a "porcine model," implying animal subjects.
- Data Provenance: The study was conducted on a "porcine model," which suggests an experimental, prospective study in a controlled animal setting. The country of origin is not specified but is likely the location of Advanced Surgical Concepts (Ireland) or a contracted research facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated as a specific number. The document mentions "clinicians who were experienced with single port devices."
- Qualifications of Experts: They were "experienced with single port devices." Specific qualifications like "radiologist with 10 years of experience" are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The criteria are reported as direct observations (e.g., "The device was easy to insert"), implying a consensus or direct observation by the participating clinicians rather than a secondary adjudication process.
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, an MRMC comparative effectiveness study was not done. This device is a laparoscopic access device, not an AI-powered diagnostic tool. The performance study evaluated its functional aspects in a surgical setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This device is a physical surgical instrument, not an algorithm. The performance was evaluated with clinicians using the device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Type of Ground Truth: The ground truth was established through expert observation and assessment during a simulated surgical procedure in a porcine model. The clinicians directly observed and evaluated the device's functional performance against predefined criteria.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not provided. This device is a physical medical instrument, not a machine learning algorithm that requires a training set. The "design inputs" and "design verification testing" serve a similar purpose to initial development and validation, but not in the context of a "training set" for AI.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable/not provided for the reasons stated above. The "ground truth" for the device's design and manufacturing (analogous to training for an algorithm) would be established through engineering specifications, material testing, and internal design verification processes against known quality and safety standards, but not in the sense of labeled data for AI.
§ 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.