(218 days)
The ASC R-Port Laparoscopic Access Device is intended for use as an endoscopic instrument or camera port during minimally invasive abdominal laparoscopic surgery.
The ASC R-Port Laparoscopic Access Device (ASC R-Port) is a laparoscopic instrument access port that is used to perform the same function as a standard trocar. The ASC R-Port is offered with four different Introducer components which can be used to deploy the ASC R-Port. The surgeon will select the appropriate Introducer based on whether the first ASC R-Port, second or subsequent ASC R-Port is being introduced and the size of the instruments to be passed through the ASC R-Port.
The ASC R-Port is a sterile, latex-free, disposable laparoscopic instrument port which performs two functions as follows:
- It retracts a small abdominal incision to allow laparoscopic instruments pass through to the abdomen
- It ensures that pneumoperitoneum is maintained in the abdomen during the surgical procedure whether or not a laparoscopic instrument is passing through the port.
The ASC R-Port is comprised of the following:
- a retracting portion which retracts an abdominal incision to allow the passage of laparoscopic instruments
- a valve portion which maintains the pneumoperitoneum established for the surgical procedure.
Deployment of the first ASC R-Port is accomplished using a Hasson cut-down incision. This is also common practice for the deployment of a first trocar. Deployment of the second and subsequent ASC R-Ports is very similar to the deployment of standard trocars in that the incision is created by a bladeless dissecting-tipped introducer which is removed following creation of the abdominal incision.
The provided 510(k) summary for the Advanced Surgical Concepts R-Port Laparoscopic Access Device does not contain detailed information about specific acceptance criteria, performance metrics, or the study design that typically proves a device meets such criteria.
Instead, this document is a regulatory submission focused on demonstrating substantial equivalence to existing predicate devices. It describes the device's function and intended use, and briefly mentions that "Biocompatibility and verification testing have been performed which demonstrated that the ASC R-Port functions as intended and is safe and effective for its intended use." However, it does not provide the specifics of these tests.
Therefore, I cannot populate most of the requested fields based on the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Biocompatibility and verification testing have been performed," but does not list any specific acceptance criteria (e.g., minimum seal integrity, maximum insertion force, leakage rates) or their corresponding results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention sample sizes for any testing, nor the provenance of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable for this type of device. This question is typically relevant for AI/imaging devices where expert interpretation establishes a "ground truth" for diagnostic or classification tasks. The R-Port is a surgical access device, and its performance is evaluated through engineering and biocompatibility testing, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device. Similar to point 3, adjudication methods are used to resolve disagreements among human experts in diagnostic or classification tasks, which is not relevant to the R-Port.
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 for this type of device. MRMC studies are specific to AI-assisted diagnostic or imaging devices. The R-Port does not involve human "readers" or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable for this type of device. This question is for AI/algorithm performance. The R-Port is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated, but implicitly related to engineering specifications and biocompatibility standards. For a device like the R-Port, "ground truth" for performance would be compliance with validated engineering specifications (e.g., ability to maintain pneumoperitoneum, material strength, sealing properties) and established biocompatibility standards. The document only generically mentions "Biocompatibility and verification testing."
8. The sample size for the training set
- Not applicable. This question pertains to AI/machine learning models which require training sets. The R-Port is a physical medical device.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, the provided 510(k) document is a high-level regulatory summary for a physical surgical device and does not delve into the detailed performance study specifics that your questions are designed to uncover for AI/diagnostic devices.
§ 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.