(63 days)
The GelPOINT Path is indicated for multiple instrument or camera access through the anus for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision, and fistula repair.
The GelPOINT Path is a sterile, single use, disposable surgical instrument designed to provide multiple instrument or camera access into the rectal cavity and lower sigmoid colon. The device is used in concert with standard laparoscopic instruments and is substantially equivalent to the predicate device in intended use, concept, function and performance.
The provided text describes a 510(k) submission for the GelPOINT Path Transanal Access Platform, a surgical device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance.
Therefore, many of the requested sections (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, specific ground truth methods) are not applicable as they relate to a different type of evaluation (e.g., AI/ML algorithm validation) than what is presented in this 510(k) summary for a surgical instrument.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the same way they would be for an AI/ML algorithm. Instead, the submission describes the overall goal of demonstrating "substantial equivalence" to the predicate device in specific performance aspects. The "acceptance criteria" are implied to be meeting or matching the performance of the predicate device (Covidien SILS Port) in these areas.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (GelPOINT Path) |
|---|---|---|
| Maximum insufflation flow rate capability | Performance comparable to predicate device | Substantially equivalent to predicate in "establishing rapid insufflation" |
| Sealing capability to allow and maintain insufflation | Performance comparable to predicate device | Substantially equivalent to predicate in "maintaining insufflation pressures as normal leakage occurs throughout the procedure" |
| Establishing retention in the rectum | Performance comparable to predicate device | Substantially equivalent to predicate in "Retention in the rectum" |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data or images. This 510(k) is for a physical surgical device, and testing would involve physical methods rather than data sets. The document mentions "dedicated test method" but does not provide details on sample sizes of devices tested or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context would likely refer to objective measurements of the device's physical performance, not subjective expert assessment of data.
4. Adjudication method for the test set
Not applicable. This concept is not relevant to the evaluation of this physical medical device.
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. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical access platform, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be established through objective engineering and performance testing. The "Conclusions Drawn From Testing" (rapid insufflation, maintaining insufflation pressures, retention) imply quantitative or qualitative measurements were taken to compare the GelPOINT Path against the Covidien SILS Port. The specific methodologies (e.g., pressure measurement, flow rate measurement, physical retention force testing) are not detailed but are standard for evaluating such devices.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not use a "training set."
Summary of Study:
The study conducted was a nonclinical performance comparison of the GelPOINT Path Transanal Access Platform against its predicate device, the Covidien SILS™ Port.
- Objective: To confirm substantial equivalence in performance characteristics related to insufflation and retention.
- Methodology: Applied Medical created a "dedicated test method" focusing on:
- Maximum insufflation flow rate capability
- Sealing capability to allow and maintain insufflation
- Establishing retention in the rectum
- While specific details of the test methods (e.g., number of devices tested, experimental setup, criteria for "rapid," "maintaining," and "retention") are not provided in this summary, the conclusion states that the GelPOINT Path was found to be "substantially equivalent" in these three areas.
- Conclusion: The tests supported the substantial equivalence argument for the GelPOINT Path by demonstrating comparable performance to the predicate device in the specified functional aspects.
§ 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.