(163 days)
REVEEL is designed as an organ and tissue retractor for the use in endoscopic surgical procedures to elevate organs and tissue to provide better access as well as visualization of surgical sites.
REVEEL is a single use device intended for mobilizing and maneuvering organs and tissue during endoscopic surgical procedures. It is comprised of a proximal handle, a rigid shaft, and a distal retraction surface.
The "REVEEL ENDOSCOPIC RETRACTOR" is a medical device and therefore does not involve AI or algorithms in its operation. The provided documents focus on its substantial equivalence to predicate devices based on design, materials, and non-clinical testing.
Therefore, many of the questions related to acceptance criteria for an AI/algorithm-based device and its study are not applicable (N/A) to this product.
Here's a breakdown of the requested information based on the provided text, indicating where the information is not relevant for this type of device:
Description of the Acceptance Criteria and Study for the REVEEL ENDOSCOPIC RETRACTOR
The REVEEL ENDOSCOPIC RETRACTOR is a single-use manual device intended for mobilizing and maneuvering organs and tissue during endoscopic surgical procedures. Its acceptance criteria and supporting studies are based on demonstrating substantial equivalence to legally marketed predicate devices, focusing on design, functional performance through bench and pre-clinical testing, and safety aspects like biocompatibility and sterilization.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Summary) |
|---|---|---|
| Substantial Equivalence to Predicates | Demonstrate substantial equivalence to PRETZELFLEX (K123110), AUTO SUTURE ENDO RETRACT II (K914190), and NATHANSON (K942002) in terms of: |
- Sterilization method
- Packaging
- Product architecture
- Retraction surface
- Patient contact materials
- Mechanism of operation
- Method of insertion
- Incision site and size | The REVEEL ENDOSCOPIC RETRACTOR is stated to be substantially equivalent to the identified predicate devices across all these characteristics. |
| Bench Testing | - Ensure device performs as intended - Evaluate mechanical integrity and functionality | Bench testing was performed to ensure the device performs as intended. Specific performance metrics are not detailed but imply successful completion of these tests. |
| Simulated Transportation & Shelf Life | - Validate packaging integrity post-transport - Confirm device integrity over shelf life | Simulated transportation and shelf life testing were conducted, implying successful validation. Specific results are not detailed. |
| Sterilization Validation | - Ensure device sterility | Sterilization validation was performed, implying successful validation. Specific methods or results are not detailed. |
| Biocompatibility Testing | - Confirm patient contact materials are safe - Comply with ISO 10993 standards | Biocompatibility testing was performed, indicating compliance with safety standards for patient contact. Specific results are not detailed. |
| Pre-Clinical Testing (Functional Performance) | - Demonstrate functionality in real-life simulation (insertion, actuation, device mobilization and retraction, visualization of gastroesophageal junction, de-actuation and removal) | Use of porcine and cadaveric models demonstrated that the device is capable of functioning as intended for all listed aspects. This confirms the device's ability to perform its intended use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Specific sample sizes for bench tests, simulated transportation, shelf life, sterilization, and biocompatibility are not provided in the summary. For pre-clinical testing, "porcine and cadaveric models" were used, but the exact number of models is not specified.
- Data Provenance: The studies were conducted by RETRACTION LIMITED, located in Hong Kong. The data provenance (country, retrospective/prospective) related to the specific test execution is not explicitly detailed beyond the company's location. The studies are by nature prospective as they are part of a premarket notification for a new device.
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)
This question is Not Applicable (N/A). The device is a manual surgical retractor, not an AI/diagnostic device that requires expert-established ground truth for performance evaluation in the context of image interpretation or similar tasks. The "ground truth" for this device's performance is its physical functionality and safety as demonstrated through engineering tests and pre-clinical simulations. The "experts" involved would be engineering and medical professionals conducting the tests, but their specific roles and qualifications are not detailed as they would be for ground-truthing diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are typically used in studies where a panel of experts review and reach consensus on diagnostic outcomes (e.g., in medical imaging). This is not relevant for the physical and functional testing of a surgical retractor.
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
This question is Not Applicable (N/A). MRMC studies are used for evaluating the performance of diagnostic imaging systems, often involving human readers and AI. The REVEEL ENDOSCOPIC RETRACTOR is a manual surgical tool and does not involve AI, human readers, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is Not Applicable (N/A). The device is a manual tool and does not employ any algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device primarily relies on:
- Engineering specifications and standards: For bench testing, mechanical properties, and material safety.
- Performance as "intended": In pre-clinical models (porcine and cadaveric), the "ground truth" for functionality is the observable success of the device in performing retraction, mobilization, and providing visualization, as determined by the surgical operators/evaluators participating in the simulation. This is essentially functional verification against its stated intended use.
- Regulatory compliance: For sterilization and biocompatibility.
8. The sample size for the training set
This question is Not Applicable (N/A). The REVEEL ENDOSCOPIC RETRACTOR is a physical medical device, not an AI algorithm, and therefore does not have a "training set."
9. How the ground truth for the training set was established
This question is Not Applicable (N/A). As there is no training set for an AI algorithm, no ground truth needed to be established for it.
§ 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.