(7 days)
The Modified Endo Stitch™ 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues
The Modified Endo Stitch™ is an endoscopic suturing device that contains two jaws at its distal end, with opposing handles and a toggle lever at its proximal end.
The provided text describes a 510(k) premarket notification for a medical device called the "Modified Endo Stitch™ Endoscopic Suturing Device." However, the document does NOT contain explicit acceptance criteria, detailed study designs, or specific performance metrics that would typically be found in a clinical study report.
The information primarily focuses on the device description, intended use, materials, and a general statement about performance data.
Therefore, many of the requested details cannot be extracted from the provided text. Below is an attempt to answer the questions based on the available information and to indicate where the information is not present.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific acceptance criteria and detailed quantitative performance metrics are not explicitly stated. The document only broadly mentions:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated) | In-vitro and in-vivo testing has been performed in support of the intended use of this device. (Page 21, {1}) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "In-vitro and in-vivo testing has been performed" but does not specify sample sizes, origin of data, or study design (retrospective/prospective).
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. Such details would typically be part of a detailed study report, which is not present here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 an endoscopic surgical suturing device, not an AI-powered diagnostic or imaging interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance is not relevant to this type of device and is not described in the provided text.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a manual surgical tool and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document only states that "In-vitro and in-vivo testing has been performed in support of the intended use of this device." (Page 21, {1}). It does not specify the type of ground truth used for these tests. In the context of a surgical device, "ground truth" would likely relate to the successful and safe performance of the suturing function, potentially evaluated through physical-mechanical testing (in-vitro) and animal or human studies (in-vivo) assessing factors like suture strength, tissue closure, and absence of complications, but these specifics are not elaborated.
8. The sample size for the training set
This information is not provided in the document. The concept of a "training set" is usually associated with machine learning or AI models, which is not the nature of this device.
9. How the ground truth for the training set was established
This question is not applicable as the device is a manual surgical tool and not an AI-powered system that requires a "training set" with established ground truth in the typical sense.
§ 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.