(265 days)
EndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
EndoClot® Submucosal Injection Agent is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a plastic bottle and a spiral plunger syringe. AMP® particles are dissolved with sterile 0.9% saline to make the agent prior to use. The syringe has a Luer lock fitting to ensure a secure connection to a standard, commercially available endoscopic injection needle. The agent can be injected by rotating the plunger.
This document does not contain the information required to fully answer the request. The document describes a medical device, the EndoClot Submucosal Injection Agent, and its substantial equivalence to predicate devices, but it does not provide detailed acceptance criteria and the results of a specific study proving the device meets these criteria in the format requested.
However, I can extract what is available regarding performance and testing:
Key Takeaways (Missing Data for Comprehensive Answer):
- No explicit "acceptance criteria" table with corresponding "reported device performance" values are provided. The document states that performance tests were conducted and that the device meets design specifications, but it doesn't quantify those specifications or the results in a comparative table.
- The document describes device verification rather than a clinical study for demonstrating "AI vs. human" comparative effectiveness. The device is a physical submucosal injection agent, not an AI or imaging diagnostic tool that would typically involve such a study.
- No information is provided about training sets, expert qualifications, adjudication methods, or specific sample sizes for establishing ground truth, as these are typically relevant for AI/diagnostic device studies.
Extracted Information Regarding Device Performance and Testing:
Here's an attempt to structure the available information, noting where requested details are absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments/Details from Document |
|---|---|---|
| Material Properties | N/A (Not explicitly stated) | The document states "the properties (pH, density, viscosity and osmolality) of the agent are close to the predicate device". Specific values or acceptance ranges are not provided. |
| Cushion-forming Duration | "better" | The EndoClot® Submucosal Injection Agent "has better cushion-forming duration" compared to the predicate device. Specific duration values or metrics are not provided. |
| Biocompatibility | "biocompatible and safe" | Met standards: ISO10993-5:2009, ISO10993-6:2016, ISO10993-10:2010, ISO 10993-11:2006, OECD 471:1997, OECD 473:2014, OECD 474:2014, ASTM F756-13, USP40 NF35. |
| Sterility | "safe" | Met standard: ISO 11737-2: 2009/(R)2014. |
| Efficacy (Animal Study) | "safe and effective" | Animal studies demonstrated the device is "safe and effective" for submucosal lift during EMR/ESD procedures. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (for Animal Study): Not specified. The document states "Animal studies have also been conducted," but does not give the number of animals.
- Data Provenance: "porcine model" (animal study).
- Retrospective/Prospective: Not specified, but animal studies are typically prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This information is typically relevant for diagnostic devices that require expert review (e.g., radiologists interpreting images). The EndoClot device is a physical injection agent, and its performance (e.g., lift, duration, safety) is assessed directly through physical and biological tests, not by expert interpretation of data.
4. Adjudication Method for the Test Set
- Not Applicable. As above, adjudication methods are usually for resolving discrepancies in expert interpretations, which is not relevant for this type of device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant for this device. This type of study would compare human readers' performance with and without an AI diagnostic aid. The EndoClot device is a physical medical device (submucosal injection agent), not an AI diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This question is also focused on AI/algorithmic performance, which does not apply to a physical medical device like the EndoClot Submucosal Injection Agent.
7. The Type of Ground Truth Used
- For Biocompatibility and Sterility: Established by adherence to recognized international standards and guidance documents (e.g., ISO, OECD, ASTM, USP).
- For Material Properties (pH, density, viscosity, osmolality): Likely established through laboratory measurements and comparison to predicate device specifications.
- For "Cushion-forming duration": Likely established through laboratory or in-vivo testing to measure duration of submucosal lift.
- For Efficacy/Safety: Established through observed outcomes in the porcine model following EMR/ESD procedures, likely including visual assessment of lift and histological examination for safety.
8. The Sample Size for the Training Set
- Not Applicable. This question relates to machine learning models. The EndoClot device is a physical product and does not involve a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, this relates to machine learning.
§ 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.