(37 days)
Aslan Modular Instruments are intended to be used by a qualified surgeon for grasping, manipulating, cutting and/or coagulating tissue in endoscopic (videoscopic) procedures.
Aslan Modular Instruments comprise a modular line of re-usable instruments consisting of various size shafts, handles of various configurations, and a number of interchangeable tips which can be used in laparoscopic surgery for grasping, cutting, and cauterizing delicate tissues using monopolar electrocautery. The tips and shafts, sized to fit through 5mm, 10mm or 12mm cannulae, range in length from 12cm to 45cm. For ease of cleaning, the tip, together with its actuating rod, can be completely removed from the shaft, and the tip-and-shaft assembly may be completely removed from the handle.
The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the ASLAN LAPAROSCOPIC SET (also referred to as Aslan Modular Instruments or Aslan Sensor™ Modular Instrument).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Aspect Tested) | Reported Device Performance |
|---|---|
| Strength of Materials | Met or exceeded requirements for intended use. |
| Electrical Conductivity | Met or exceeded requirements for intended use. |
| Ease of Cleaning | Met or exceeded requirements for intended use. |
| Ease of Use | Met or exceeded requirements for intended use. |
| Resistance to High Voltage (for electrocautery use) | Passed tests without a single failure, in compliance with ANSI/AAMI HF18-1993. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the "benchtop evaluations." It states "each of the instruments in the laparoscopic set" was tested, implying all instrument types/configurations were covered, but not how many units of each were tested.
- Data Provenance: The study was conducted as "benchtop evaluations." The country of origin of the data is not explicitly stated, but the manufacturer, Aslan Medical Technologies, Ltd., is based in Kalamazoo, Michigan, USA. The study type is prospective, as it involves testing the new device to demonstrate its performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the study involved benchtop evaluations of physical properties and electrical safety in a controlled environment, not clinical data requiring expert review for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as the study involved objective physical and electrical tests, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No.
- Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as this is a medical device (surgical tools) and not an AI-assisted diagnostic or imaging system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Yes, in a way. The "benchtop evaluations" represent a standalone performance assessment of the instrument's physical and electrical characteristics without direct human interaction (beyond operating the test equipment). However, it's not an "algorithm" in the conventional AI sense.
7. Type of Ground Truth Used
The ground truth was based on pre-defined engineering specifications and established industry standards (e.g., strength requirements, electrical conductivity benchmarks, cleaning protocols, and specifically, ANSI/AAMI HF18-1993 for high voltage resistance).
8. Sample Size for the Training Set
This information is not applicable. The device is a set of physical surgical instruments, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above (not an AI/ML model).
§ 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.