(57 days)
Embrella™ Endoscopic Distal Attachment is intended to the distal end of the endoscope to facilitate endoscopic therapy and maintain an appropriate endoscopic field of view.
The proposed device Embrella™ Endoscopic Distal Attachment is an additional device, made of medical grade silicone rubber designed to attach to the distal end of the endoscope. Its shape is umbrella shaped, with six flexible wings that easily to fold backwards and forwards. It can be used to facilitate endoscopic therapy and maintain an appropriate endoscopic field of view.
Embrella™ Endoscopic Distal Attachment has two models, one is EM-S-01, which is compatible with endoscopy distal diameter 12.8-14.5mm; the other is EM-S-02, which is compatible with endoscopy distal diameter 11.5-13.0mm.
The provided text is a 510(k) Summary for the Embrella™ Endoscopic Distal Attachment. It states that the device is substantially equivalent to a predicate device (EndoRing™ K133359) and lists various tests performed. However, it does not contain specific acceptance criteria or detailed results of a study that proves the device meets specific performance metric acceptance criteria in the way one would expect for a detailed AI/ML device performance study.
Instead, the document focuses on demonstrating substantial equivalence through:
- Comparison of technological characteristics (materials, design, configuration, indications for use, sterilization, etc.).
- Performance Bench Testing: "Dimension; Operating Performance; Matching Performance; Tension Performance;"
- Animal Testing: "Endoscopy View Testing."
The document explicitly states: "No clinical study is included in this submission." This means there is no multi-reader multi-case (MRMC) study, standalone algorithm performance study, or human-in-the-loop study with detailed metrics like sensitivity, specificity, or AUC, as might be expected for an AI/ML diagnostic device.
Therefore, many of the requested points cannot be directly answered from the provided text. I will address the points based on the information available and note where information is not present.
Summary of Acceptance Criteria and Study Performance for Embrella™ Endoscopic Distal Attachment
Based on the provided 510(k) summary, the acceptance criteria and study proving device performance are primarily centered around demonstrating substantial equivalence to a predicate device (EndoRing™ K133359) through bench testing and animal testing, rather than a clinical trial with statistical metrics, given that this is a mechanical accessory device, not an AI/ML diagnostic.
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that bench tests and animal tests were performed to demonstrate equivalence to the predicate device. Specific quantitative acceptance criteria (e.g., "Tension performance must be > X Newtons") and exact numerical results are not provided in this summary. The acceptance criterion implied is "equivalent to the predicate device."
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Dimension Performance | Dimensions meet specified requirements and are equivalent to predicate. | "The testing performed demonstrated that the proposed device and predicate device are equivalent." |
| Operating Performance | Device operates as intended and equivalent to predicate. | "The testing performed demonstrated that the proposed device and predicate device are equivalent." |
| Matching Performance | Device properly matches with endoscope and is equivalent to predicate. | "The testing performed demonstrated that the proposed device and predicate device are equivalent." |
| Tension Performance | Device withstands specified tension and is equivalent to predicate. | "The testing performed demonstrated that the proposed device and predicate device are equivalent." |
| Endoscopy View Testing | Maintains appropriate endoscopic field of view, equivalent to predicate. | "The testing performed demonstrated that the proposed device and predicate device are equivalent." (Performed on animals.) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact sample sizes for the bench tests or the "Endoscopy View Testing" on animals. Details like the number of devices tested or the number of animals used are not provided.
- Data Provenance: Not explicitly stated, but the submission is from a Chinese company (Micro-Tech (Nanjing) Co., Ltd.) to the FDA. The tests would presumably have been conducted in a controlled environment to support regulatory submission. The document implies these were retrospective tests conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information is provided regarding the number or qualifications of experts involved in establishing "ground truth" for the performance tests. Given these are bench and animal tests for a mechanical device, formal expert adjudication in the sense of image interpretation (like for AI/ML) is not mentioned.
4. Adjudication method for the test set:
- Not applicable/Not described. The tests appear to be physical/mechanical performance validations rather than subjective interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- No MRMC study was done. The document explicitly states: "No clinical study is included in this submission." Therefore, there is no information on human reader improvement with AI assistance (as this is not an AI device).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical endoscope accessory, not an algorithm or AI system.
7. The type of ground truth used:
- For the bench tests (Dimension, Operating, Matching, Tension), the "ground truth" would be engineering specifications and measurements.
- For the "Endoscopy View Testing" (animal testing), the "ground truth" would be direct observation and assessment of the endoscopic field of view during the procedure. The "truth" is established by the observed physical performance of the device itself.
8. The sample size for the training set:
- Not applicable. This device is a mechanical accessory, not an AI/ML system that requires training data.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML model.
§ 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.