(156 days)
The SIC 8000 is indicated 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 other suitable endoscopic device.
SIC 8000 is an injectable liquid composition in the form of an oil-in-water (o/w) emulsion for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, such as the esophagus, the small intestine, the colon, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy. SIC 8000 is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The emulsion, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).
The provided document is a 510(k) summary for the SIC 8000 device, which is an injectable liquid composition for submucosal lift during gastrointestinal endoscopic procedures. While it states that "A series of performance tests and animal studies were conducted which demonstrated the quantitative mechanical performance, tolerance and usability of SIC 8000 in endoscopic procedures," the document does not provide specific details on the acceptance criteria, the study design, sample sizes, expert qualifications, adjudication methods, or whether MRMC or standalone studies were performed.
Therefore, I cannot fully answer your request based solely on the provided text. The requested information regarding acceptance criteria and the study that proves the device meets them, along with specific details about the study design, is not present in this 510(k) summary.
Based on the available information, here's what can be deduced, with significant gaps:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not detailed in the document. The summary only generally states that "A series of performance tests and animal studies were conducted which demonstrated the quantitative mechanical performance, tolerance and usability of SIC 8000 in endoscopic procedures."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: The document mentions "animal studies," implying the data originated from animal models, but it does not specify the country of origin or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- 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:
- This device is described as an "injectable liquid composition" for submucosal lift, not an AI software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device. The document does not mention any AI components.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Again, as this is an injectable substance and not an AI algorithm, the concept of a standalone algorithm performance study is not applicable. The document does not mention an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Given it's an injectable composition for medical procedures, the ground truth would likely involve direct observation during endoscopic procedures, histological analysis (pathology) of resected tissues, and potentially short-term outcomes data to assess the efficacy of the lift and success of the resection. However, the document does not explicitly state how ground truth was established for the "performance tests and animal studies."
8. The sample size for the training set:
- Not applicable as this is not an AI device that typically relies on a training set in the conventional sense for machine learning. The term "training set" is usually associated with AI/ML model development.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as point 8.
In summary:
The provided 510(k) summary is a high-level overview intended to demonstrate substantial equivalence to a predicate device. It does not contain the detailed study protocols, results, acceptance criteria, or statistical analysis that would be present in a comprehensive clinical or performance study report. To obtain the requested information, one would typically need access to the full 510(k) submission, which includes the detailed performance data.
§ 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.