(90 days)
The Ethicon Endo Surgery Sheath and Articulating External Accessory Channel accessory product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access.
The Ethicon Endo Surgery® Sheath and External Accessory Channel is a supplemental articulating accessory channel that attaches to an endoscope to enable improved access. The sterile, single-use, disposable device is available in two (2) basic configurations: a shorter gastroscope compatible system, and a longer colonoscope compatible system.
The flexible Sheath is installed over the insertion tube of the endoscope. The Sheath contains a track (C-Channel) along which the Articulating External Accessory Channel can be can be introduced and removed without removing and re-introducing the endoscope, allowing for multiple intubations and/or specimen retrieval independent of the endospor, The Articulating External Accessory Channel enables the use of two accessory devices simultaneously - one in the Articulating External Accessory Channel and the other in the endoscope working channel. The Articulating External Accessory Channel provides off axis articulation to off the shelf accessory devices, thereby allowing than user to more effectively direct devices to the targeted tissue.
The provided text is a 510(k) summary for the Ethicon Endo Surgery Sheath and Articulating External Accessory Channel. It describes the device, its intended use, and its similarities to and differences from predicate devices. It also mentions performance data, but it does not contain specific acceptance criteria or detailed study results needed to complete the requested table and answer many of the questions directly.
Based on the provided text, here's what can be extracted and what information is missing:
Missing Information: The document states "Bench testing was performed to demonstrate that the new device performs as intended" and "Animal testing was performed to evaluate the tissue effects associated with the new device relative to the predicate devices." However, it does not provide:
- Specific quantitative acceptance criteria (e.g., a certain force, a specific range of motion, a defined success rate).
- The actual results of these performance tests against specified criteria.
- The sample sizes for these tests.
- Details about the experts, ground truth, adjudication methods, or reader studies related to these tests.
Therefore, the table below will reflect the absence of this detailed information.
Acceptance Criteria and Device Performance Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in the provided document. The text broadly indicates "the new device performs as intended" and "evaluate the tissue effects associated with the new device relative to the predicate devices.") | Bench Testing: "Bench testing was performed to demonstrate that the new device performs as intended." (No specific quantitative performance metrics reported in this document.) |
| Animal Testing: "Animal testing was performed to evaluate the tissue effects associated with the new device relative to the predicate devices." (No specific quantitative tissue effect metrics or comparative results reported in this document beyond implying equivalence or safety.) | |
| Biocompatibility: "Device materials have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1." (Implicitly, the device passed ISO 10993-1 requirements, which would be the acceptance criterion.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Sample Size (Test Set): Not specified in the provided text for either bench or animal testing.
* Data Provenance: Not specified. The document is a US FDA 510(k) submission, so it's likely the studies were conducted to US standards or within the US, but this is not explicitly stated. The studies are described as performance data to support substantial equivalence, implying prospective testing for this submission.
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/Not specified. The performance data described ("Bench testing" and "Animal testing") do not inherently require human expert ground truth in the way medical image analysis or diagnostic studies would. Details on how "tissue effects" were evaluated in animal studies are not provided, so the role or qualifications of any experts involved in that assessment are unknown from this text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable/Not specified.
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
* No. This is a medical device (endoscopic accessory), not an AI diagnostic algorithm. An MRMC study or AI assistance is not relevant to the described performance testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* For Bench testing: Implied to be engineering specifications and design requirements (e.g., functional performance, mechanical properties).
* For Animal testing: Implied to be histological or clinical assessment of tissue effects. The text doesn't specify if this was pathology-confirmed.
* For Biocompatibility: Ground truth is adherence to ISO 10993-1 standards, which involves specific chemical, physical, and biological tests.
8. The sample size for the training set
* Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
* Not applicable.
§ 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.