(147 days)
The Endomark™ Sterile India Ink is indicated for endoscopically marking lesions in the GI tract when the endoscopist anticipates the lesion will require surgical removal within thirty days.
The Endomark™ Sterile India Ink is a sterile, non-pyrogenic ink designed to be used as an endoscopic marker for marking polyps and lesions in the gastrointestinal tract. It is supplied in single-use 10 mL vials.
The provided text is a 510(k) summary for a medical device called Endomark™ Sterile India Ink. This is a premarket notification for a Class II medical device, and as such, it does not typically involve a detailed study with acceptance criteria and device performance as seen in clinical trials for new drug applications or more complex-device PMAs.
Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device, primarily through technological characteristics and, in this case, limited performance testing.
Therefore, many of the requested categories for a study proving acceptance criteria are not explicitly present in the provided document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative or qualitative table format that is then directly linked to reported device performance metrics in the way a clinical trial would. The "performance testing" mentioned is focused on demonstrating safety and equivalence.
The closest we can come to "acceptance criteria" and "reported device performance" from the text is:
| Acceptance Criteria (Implied) | Reported Device Performance and Evidence |
|---|---|
| Device is sterile. | Information submitted includes results of biocompatibility testing. |
| Device is non-pyrogenic. | Information submitted includes results of biocompatibility testing. |
| Ink components are safe and suitable for intended use. | Information submitted includes results of chemical analysis. |
| Device functions as an endoscopic marker. | Information submitted includes results of clinical experience. |
| Device is substantially equivalent to predicate device (Spot Endoscopic Marker). | The statement: "The Endomark™ Sterile India Ink is substantially equivalent to the predicate" and "The Endomark -sterile India Ink and the predicate device 1ave conomiance... endoscopically tattooing or marking the colon." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "clinical experience" as part of the performance testing but does not provide details on:
- Sample size used.
- Country of origin of the data.
- Whether the data was retrospective or prospective.
Given the context of a 510(k) for a relatively low-risk device, "clinical experience" might refer to data from investigator use, previous marketing of similar products, or limited observational studies, rather than a formal, large-scale clinical trial.
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 information is not provided in the document. The concept of "ground truth" established by experts in a structured test set is not detailed here, as the submission relies on demonstrating equivalence rather than proving novel clinical efficacy with a defined ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. An adjudication method is typically part of a formal clinical study design, which is not described here.
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, an MRMC comparative effectiveness study was not done. This device is an India ink marker for endoscopic use, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "type of ground truth used" in a formal sense for the "clinical experience." For a simple marker, the "ground truth" would likely be the visual confirmation by an endoscopist that the mark was successfully placed, visible, and persistent for the intended duration. However, the document does not detail how this "ground truth" was formally established or measured.
8. The sample size for the training set
This is not applicable as this device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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.