(104 days)
The UniARM is for use in holding medical devices such as endoscopes and retractors in surgery.
the Mitaka UniARM-device is for use in holding medical devices in surgery such as neuro endoscopes, general endoscopes, and hand held instruments. It is a balanced device using pneumatic brakes that can be released from a single switch near the endoscope or hand held instrument. Often referred to as a third arm it provides a stable platform to hold an endoscope or hand held instrument allowing the surgeon the use of his two arms. The system can be released by the push of one button and fixes with the release of that button. A second button is depressed by the palm as a safety device.
The provided document describes the Mitaka UniARM, an endoscope holder. The study details are limited to a performance comparison with predicate devices and a non-clinical test of brake holding power. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific numerical thresholds for performance. Instead, it compares the UniARM's functionalities to predicate devices and describes a non-clinical test.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Balance | Effectively balances both endoscope and holding arm | "Arm balances both endoscope and holding arm perfectly" (compared to "Adjustable Spring" for Kroner and "Arm is balanced but surgeon holds weight of endoscope system" for Mitaka Point Setter) |
| Power Source | Uses a power source suitable for its function | "All Pneumatic" (same as Mitaka Point Setter; Kroner is "Electric & Pneumatic") |
| Attachment Method | Securely positions the device within the OR | "Sits on rollable Base" (compared to "OR table rail" for both Kroner and Mitaka Point Setter) |
| Holds | Capable of holding endoscopes and hand instruments | "Endoscopes and hand instruments" (same as both predicate devices) |
| Brake Holding Power (Non-clinical) | Brake holding power is sufficient and comparable to predicate | Tested using a force gauge; "The same force measurement system is used on the Point Setter." (Implies comparable or superior performance, though no specific values are given.) |
| Clinical Performance (In-patient use) | Safe and effective in actual surgical settings | "The system has been tested in operating rooms with patients for over one year in Japan where it is manufactured." (No specific metrics provided beyond this statement.) |
| Overall Equivalence | Substantially equivalent to predicate devices with improvements | "Clinical, performance, and non-clinical validation compared to Kroner-Wingman and Mitaka Point Setter show that the devices are substantially equivalent to the UniARM. The UniARM merely offers improvements in reach, holding power, and convenience." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for either the non-clinical or clinical tests.
- Data Provenance:
- Non-clinical: Performed by Mitaka Kohki Co., Ltd. (manufacturer) – implied to be in Japan.
- Clinical: Japan, retrospective (implied, as it states "has been tested for over one year").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The clinical testing mentioned ("tested in operating rooms with patients") suggests evaluation by surgeons, but their number and specific qualifications are not detailed.
4. Adjudication Method 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
No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The evaluation focuses on the device's functional equivalence and improvements over predicate devices, not on the improvement of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This relates to AI/software performance. The Mitaka UniARM is a mechanical device, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.
7. The Type of Ground Truth Used
- For the non-clinical brake holding power test: The "ground truth" was established by force gauge measurements against the device's own internal design specifications and comparison to the predicate device's measured performance.
- For clinical performance: The "ground truth" was implicitly based on surgeon experience and patient outcomes during the one year of use in Japan, though no specific metrics or 'truth' establishment method is detailed beyond general positive clinical use.
8. The Sample Size for the Training Set
This information is not applicable. The UniARM is a mechanical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (mechanical device, no training set).
§ 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.