(23 days)
The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
The ASC TriPort+ Laparoscopic Access Device is, like the parent TriPort and QuadPort devices cleared by the FDA under K101794, a laparoscopic multi-instrument port which performs 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 ASC TriPort+ Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort+ Laparoscopic Access Device performs the same function as the TriPort and QuadPort parent devices.
Like the parent ASC TriPort Laparoscopic Access Device, the proposed ASC TriPort+Laparoscopic Access Device is comprised of the following three components: - An introducer component, which delivers the Distal Ring of the ASC TriPort+ through a premade incision, into the abdominal cavity.
- A retractor 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 ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort+ Laparoscopic Access Device is identical in function to the ASC TriPort & QuadPort Laparoscopic Access Devices, which have been cleared for marketing under K101794.
The provided text describes a 510(k) submission for the ASC TriPort+ Laparoscopic Access Device. The submission focuses on demonstrating substantial equivalence to a predicate device (TriPort & QuadPort Laparoscopic Access Devices, K101794) rather than presenting a study to prove the device meets specific acceptance criteria in a quantitative sense as might be expected for an AI/CADe device.
Therefore, the information required for a detailed acceptance criteria table and a study analysis is largely not present in the provided document, as the submission emphasizes functional equivalence and design verification rather than performance metrics from a comparative clinical trial.
However, I can extract the relevant information where available and note where specific details are missing based on the prompt's requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Pneumoperitoneum Maintenance | Maintain pneumoperitoneum in the abdomen during surgical procedure. | Device functioned as intended in a porcine model; maintains pneumoperitoneum. |
| Instrument Passage | Allow multiple laparoscopic instruments to pass through to the abdomen at the same time. | Device functioned as intended in a porcine model; facilitates passage of laparoscopic instrumentation. |
| Incision Retraction | Retract a small abdominal incision (12-25mm). | Device retracts an abdominal incision (12-25mm). |
| Functionality | Perform same function as predicate devices (TriPort and QuadPort). | Device performs the same function as the parent TriPort and QuadPort devices; identical in function. |
| Safety | Modifications do not raise new issues of safety. | Validation testing in a porcine model demonstrated performance did not raise new issues of safety or effectiveness. |
| Effectiveness | Modifications do not raise new issues of effectiveness. | Validation testing in a porcine model demonstrated performance did not raise new issues of safety or effectiveness. |
| User Training | Formal user training not required. | Validation testing demonstrated formal user training was not required. |
| Sterility | Device is sterile. | Stated as "sterile". |
| Single-Use/Disposability | Device is disposable/single-use. | Stated as "sterile, single-use (disposable)". |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of cases or subjects in a traditional clinical study sense. The document refers to "Performance Testing" which included "Validation testing of the TriPort+ in a porcine model" and "on a simulator." The number of porcine models or simulation runs is not specified.
- Data Provenance: Porcine model (animal study) and simulator. The country of origin for this testing is not specified, but the submitter is based in Ireland. The testing is prospective in nature, as it was conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: "Clinicians with various levels of experience and expertise" were enrolled in the porcine model testing. The specific number is not provided.
- Qualifications of Experts: General description of "various levels of experience and expertise." No specific qualifications (e.g., "radiologist with 10 years of experience") are given. Their role appears to be operational and observational of the device's function rather than establishing ground truth in the sense of diagnostic interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not described. The testing involved direct observation of device function by clinicians. There's no mention of conflicting interpretations or a need for adjudication among multiple experts to establish a "ground truth" for diagnostic purposes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not performed as described in the document. This type of study is typical for assessing the impact of AI on human reader performance, which is not the focus of this device (a surgical access port).
- Effect Size: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The ASC TriPort+ is a physical medical device (laparoscopic access port), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the successful and safe operation of the physical device as assessed by observed performance and clinician feedback during the porcine model and simulator testing. This is analogous to "expert observation/assessment" of device functionality, rather than a diagnostic ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device design was iteratively improved, but these are design and engineering processes, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no training set. The "ground truth" for the device's design and modifications would be based on engineering principles, user feedback, predicate device performance, and internal design verification/validation testing.
§ 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.