(83 days)
The Xenoscope™ is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.
The Xenoscope™ System contains two separate functioning components. First, the Xenoscope™ Laparoscope Device is a 0°, 30 Fr (10mm), 10 - 36 cm long, single-use, high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. Second, the Xenoscope™ Dongle, which converts the camera image onto the video display screen for the surgeon to use, is provided with the Xenoscope™. Together, the Xenoscope™ and the Xenoscope™ Dongle comprise the Xenoscope™ Laparoscopic System and work synergistically together.
The Xenocor® Xenoscope™ Laparoscopic System is a medical device intended for diagnostic and therapeutic procedures within the thoracic and peritoneal cavities, including female reproductive organs. The provided text outlines the acceptance criteria and supporting studies for its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 for External communicating device, direct tissue contact, duration ≤ 24 hours. | All data met pre-determined acceptance criteria. (Implied compliance with ISO 10993-1) |
| Electrical Safety and Essential Performance | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, EN 60601-1:2006 / A1:2013 / A11:2011 / A12:2014, CAN/CSA-C22.2 No. 60601-1:14, AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-2-18:2009. | All data met pre-determined acceptance criteria. (Implied compliance with listed standards) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 Medical Device (2007), IEC 61000-4-2 (2008), IEC 61000-4-3 (2006), A1(2007), A2(2010), IEC 61000-4-4 (2012), IEC 61000-4-5 (2005), IEC 61000-4-6 (2008), IEC 61000-4-8 (2009), IEC 61000-4-11 (2004), CISPR 11 Emissions Class A (2009), A1(2010), IEC 61000-3-2 AC Current Harmonic Emissions (2006), A1(2009), A2(2009), IEC 61000-3-3 Voltage Fluctuations Emissions (2008). | All data met pre-determined acceptance criteria. (Implied compliance with listed standards) |
| Software Testing | Assessment of "moderate" level of concern for firmware in the dongle, ensuring no harm or misdiagnosis when used by a trained surgeon. | The software level of concern has been determined to be moderate, and is deemed to not result in harm to the patient or misdiagnosis of the patient condition when the device is used by a trained surgeon. (Implied that the software meets safety and performance expectations) |
| Design Validation | Evaluation of the Xenoscope™ System by trained surgeons in a simulated clinical setting. | Evaluated by three (3) trained surgeons (intended users) using a simulated use model in an environment that simulated the intended clinical settings. The system met all acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Design Validation (Usability/Performance Test Set): 3 trained surgeons.
- Data Provenance: Not explicitly stated, but the "simulated use model in an environment that simulated the intended clinical settings" suggests a prospective, controlled study specifically for device validation. The "country of origin of the data" is not mentioned. For the other tests (Biocompatibility, Electrical Safety, EMC, Software), the data provenance is from laboratory testing adhering to international standards, not derived from clinical data sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: 3.
- Qualifications of Experts: Described as "trained surgeons (intended users)". Specific experience levels (e.g., "10 years of experience") are not provided, but being "trained surgeons" implies relevant clinical expertise for evaluating a laparoscopic system.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the design validation study (e.g., 2+1, 3+1). It states that the "three (3) trained surgeons" performed the evaluation and the system "met all acceptance criteria." This implies a consensus or individual satisfaction with performance, but the process for resolving any potential disagreements among the three is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The documentation focuses on demonstrating substantial equivalence primarily through technical specifications and functional/safety testing against standards, along with a design validation study. There is no mention of comparing human reader performance with or without AI assistance. The device itself is an endoscope system, not an AI diagnostic tool that assists human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable in the context of this device. The Xenocor Xenoscope is a laparoscopic system that is inherently designed for human-in-the-loop operation by a surgeon, not a standalone AI algorithm. The only "software" mentioned is firmware that converts a digital video signal for display, which does not operate as a standalone diagnostic algorithm.
7. Type of Ground Truth Used
The ground truth for the design validation study was based on the expert evaluation and feedback of the three trained surgeons using the device in a simulated clinical setting. For the other tests (Biocompatibility, Electrical Safety, EMC, Software), the ground truth was adherence to established international and national performance and safety standards.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an AI algorithm or model development. The Xenoscope is a hardware device with supporting firmware, not a machine learning system that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the information provided in the document.
§ 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.