(248 days)
The EndoRotor® is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.
The EndoRotor®, with the design modifications and expanded indications for use described in the current 510(k) premarket notification, will continue to be marketed as the EndoRotor®. The new EndoRotor® will be referred to as the "modified EndoRotor" in this 510(k) Summary.
The overall device description remains unchanged since initial FDA clearance. Both the predicate and modified EndoRotor® are powered resection tools consisting of a power console, foot control, specimen trap with pre-loaded filter, and a single-use resection catheter that is inserted into the working channel of a compatible endoscope. The design modifications to the EndoRotor® described in the current 510(k) premarket notification include enhancements to improve the ease of use of the console and catheter components as well as provide flexibility to the gastroenterologist.
The provided text describes modifications to an existing device, the EndoRotor®, and does not present an AI/ML device or its associated performance studies. Therefore, I cannot extract information related to AI/ML specific acceptance criteria, and study details like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment.
Instead, the document details non-clinical and clinical performance testing conducted to support the substantial equivalence of the modified EndoRotor® to its predicate device (K170120) and to support expanded indications for use.
Here's the relevant information about the acceptance criteria and the studies that prove the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list acceptance criteria in a quantitative table format with corresponding numerical performance for the modified device in the same way an AI/ML device submission might. Instead, it states that:
| EndoRotor® Component | Testing Performed | Results |
|---|---|---|
| EndoRotor® Catheter | • Biocompatibility Testing | |
| • Functional Testing | • All components biocompatible | |
| • All acceptance criteria met | ||
| EndoRotor® Console | • Power-up and Set-up Testing | |
| • Functional Testing | • All acceptance criteria met |
2. Sample size used for the test set and the data provenance:
-
Non-clinical (Animal Testing for Predicate Device, applicable to modified):
- Sample Size: 6 porcine animals (4 recovery, 2 acute) for mucosal resections, totaling 124 mucosal resections. Additionally, 4 animals for design validation and usability assessment.
- Data Provenance: Porcine animal model.
-
Clinical (Investigator-led study in UK):
- Sample Size: 19 patients.
- Data Provenance: Retrospective, from Queens Alexandra Hospital in Portsmouth, United Kingdom.
-
Clinical (Commercial procedures in Western Europe):
- Sample Size: 78 patients.
- Data Provenance: Real-world commercial procedures in Western Europe (Austria, Germany, The Netherlands, Switzerland, and the United Kingdom). The document implies this data is also retrospective "compiled data provides real world clinical evidence".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical (Investigator-led study in UK):
- Number of Experts: Not explicitly stated, but the study was conducted by "Gastroenterologists" in Queens Alexandra Hospital.
- Qualifications: "trained gastroenterologist" as per the Indications for Use. The study authors are listed as Khandiah K, Subramanian S, Thayalasekaran S, Chedgy F, and Bhandari P, implying multiple gastroenterologists were involved.
- Clinical (Commercial procedures in Western Europe):
- Number of Experts: Not explicitly stated, but implies "Physicians" performing the procedures.
- Qualifications: "trained gastroenterologist" as per the Indications for Use.
4. Adjudication method for the test set:
Not explicitly mentioned for the clinical studies. Decisions appear to have been made by the treating gastroenterologists.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This is a medical device submission, not specifically an AI/ML device, and the studies performed focused on the safety and effectiveness of the device itself rather than human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a medical device (EndoRotor®), not an algorithm. The device is always under the control of a trained physician.
7. The type of ground truth used:
- Non-clinical (Animal Testing): Histopathological assessment of tissue response (favorable and clinically acceptable tissue response).
- Clinical (Investigator-led study in UK & Commercial procedures): Physician assessment of lesion presence/scarring and procedure outcomes (disease eradication, luminal preservation, avoidance of surgery, no incidences of perforation or delayed bleeding). This can be considered expert consensus/clinical outcomes data.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; therefore, there isn't a "training set" in that context. The device's design improvements were based on feedback and engineering enhancements.
9. How the ground truth for the training set was established:
Not applicable for the same reason as above.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.