(35 days)
The Nurse's Assistant® 1.7 is intended to be used to route video from multiple sources to multiple destinations, to be used to turn on and off power to specific 110 volt receptacles within the OR, and to be used to adjust specific operating parameters of video displays, analog or digital recording, communication and playback equipment, endoscopic cameras, endoscopic light sources, surgical lamps, observation cameras, surgical cameras and operating room lights.
The Nurse's Assistant® 1.7 is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.
The Nurse's Assistant® 1.7 is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that provides operating room (OR) staff with a simple touch panel interface from which to activate, adjust and monitor certain settings of equipment located in the OR.
The provided text is a 510(k) premarket notification for the Nurse's Assistant® 1.7 O.R. Control System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove safety and effectiveness from scratch. Therefore, the information typically requested in your query (e.g., sample sizes, ground truth establishment, MRMC studies, specific acceptance criteria with performance metrics) is not present in this document, as it is not required for a 510(k) submission that demonstrates equivalence to existing predicate devices.
Instead, the document focuses on comparing the new device's intended use, indications for use, and technological characteristics to those of predicate devices. The "study" in this context is the comparison itself, which concludes that the Nurse's Assistant® 1.7 is substantially equivalent.
Here's an organized breakdown based on the available information, with explanations for what is not present:
Acceptance Criteria and Study for Nurse's Assistant® 1.7 O.R. Control System
Device: Nurse's Assistant® 1.7 O.R. Control System
Approach: This 510(k) submission leverages the concept of substantial equivalence to predicate devices rather than proving de novo safety and effectiveness through clinical trials with specific performance metrics. Therefore, the "acceptance criteria" and "study" are framed around demonstrating equivalence to already approved devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: The device must have an intended use substantially equivalent to the predicate devices. | "The Nurse's Assistant® 1.7 O.R. Control System has similar indications for use, intended use and technological characteristics as the predicate devices." |
| Indications for Use: The device must have indications for use substantially equivalent to the predicate devices. | "The Nurse's Assistant® 1.7 O.R. Control System has similar indications for use, intended use and technological characteristics as the predicate devices." |
| Technological Characteristics: The device must possess technological characteristics substantially equivalent to the predicate devices. | "The technological characteristics of the Nurse's Assistant® 1.7 are equivalent to the predicate devices listed above." |
| Safety and Effectiveness: The device must demonstrate substantial equivalence in terms of safety and effectiveness compared to predicate devices. | "The Nurse's Assistant® 1.7 is substantially equivalent to the predicate devices in terms of safety, effectiveness, and performance." |
| Performance: Test results for the new device must support substantial equivalence to predicate devices. | "Tests performed on the Nurse's Assistant® 1.7 demonstrate substantial equivalence to the predicate devices listed above." |
Explanation: For a 510(k) submission, the "acceptance criteria" are primarily established by the regulatory requirement to demonstrate substantial equivalence to legally marketed predicate devices. Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision figures) and numerical acceptance thresholds for these metrics are typically not provided in a 510(k) summary when equivalence is established through comparison of design and intended use, rather than de novo performance testing. The "reported performance" here refers to the conclusion of equivalence based on the comparison and any verification/validation testing performed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not mentioned. The document does not describe specific patient or image test sets in the typical sense of a clinical performance study. The "tests performed" refer to verification and validation activities to confirm the device operates as designed and is equivalent to predicates.
- Data Provenance: Not applicable/Not mentioned. The document does not refer to clinical data (e.g., from specific countries, retrospective/prospective studies) for performance evaluation.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable/Not mentioned. The determination of substantial equivalence does not involve establishing ground truth from experts for a diagnostic output.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. No clinical test set is described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe an MRMC study.
- Effect Size: Not applicable. An MRMC study was not conducted, so no effect size for human reader improvement with AI assistance is reported. This device is an OR control system, not a diagnostic AI tool.
6. Standalone Performance Study (Algorithm Only)
- Standalone Performance Study: No. This device is an O.R. Control System; it's an integrated hardware/software system to manage other medical equipment, not a standalone algorithm in the typical AI sense that would have an "algorithm only" performance study. The "tests performed" refer to engineering and functional verification to ensure the system operates correctly.
7. Type of Ground Truth Used
- Not applicable/Not mentioned. The concept of "ground truth" (e.g., pathology, outcomes data) is not relevant to this 510(k) submission, which focuses on functional equivalence of an OR control system, not diagnostic accuracy.
8. Sample Size for the Training Set
- Not applicable/Not mentioned. This device is a control system, not a machine learning model that would typically have a "training set" of data in the context of AI.
9. How Ground Truth for the Training Set Was Established
- Not applicable/Not mentioned. As there is no described training set, there is no ground truth establishment for it.
Conclusion from the Document:
The Nurse's Assistant® 1.7 O.R. Control System gained clearance based on demonstrating substantial equivalence to three predicate devices: Val Med Nurse's Assistant O.R. Control System (K010754), Olympus Integrated Endosurgery System EndoALPHA (K981993), and Karl Storz OR1 (KSEA SCB-ACC) (K023704). The "study" proving it meets "acceptance criteria" is the comprehensive comparison of its intended use, indications for use, and technological characteristics to these legally marketed devices, concluding that it is as safe and effective.
§ 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.