(228 days)
The Prosurg's Neoscope 3D™ -3D Digital Video Endoscopic System ( Rigid & Flexible) is intended to provide "Real -Time" 3D images and video to surgeons for endoscopic examination, diagnosis and treatment for Minimally Invasive surgical Procedures within Abdominal and Female Reproductive organs, using surgical devices and accessories.
The Neoscope 3D™ -3D Digital Video Endoscope design consists of two CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end, connecting wires along the length of the hollow tubular structure and a USB / HD Connector at the proximal end. The distal end of the 3D Endoscope containing two CMOS sensors and LEDs / Fiber optic is protected by sealed, clear window to prevent any fluid passageway within 3D Endoscope. The NeoScope flex 3D ™ - Flexible Video Endoscopic device is designed with Articulating / Deflecting Distal tip controlled by lever mechanism in the handle.
The Single Use. NeoScope 3D™ - Rigid and Flexible models are provided sterile for use by physician. The Rigid Neoscope 3D is designed to provide zero (0) degree, thirty (30) degree and forty five (45) degree field of view. The Neoscope flex 3D™ Flexible endoscope is designed to provide minimum 90 degree tip deflection & field of view.
The NeoScope 3D ™- 3D Digital Video Endoscopic System (Rigid / Flexible) consists of four main components:
(a) Digital Video Endoscope with two CMOS Sensor & Built-in LEDs / Fiber optic in Stainless steel Tube. Or Single Use, NeoScope flex 3D- Flexible Endoscope with Articulating / Deflecting Distal Tip. (Patient Contact Item)
(b) Video Processing Module with USB 2.0 / 3.0 / HD / DVI connecting ports. (Commercially Available, Non -Patient contact item)
(c) 3D Laptop /Tablet computer with windows Operating System, 3D Monitor / 3D TV, USB 2.0 /3.0 / HD / S-Video Connecting Cables. (Commercially Available, Non- patient contact item)
The Single Use Neoscope 3D Video Endoscope consists of CMOS (2) imaging sensors & LED mounted at the distal tip. The 3D Laptop / Tablet computers is designed to power Imaging Sensors and LED. The Neoscope 3D is provided Sterile, for Single use only.
The provided document is a 510(k) summary for the NeoScope 3D™ - 3D Digital Video Endoscopic System. It outlines the device description, indications for use, technological characteristics, and a summary of performance testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not explicitly define acceptance criteria as a quantitative threshold or present a detailed study with specific performance metrics against those criteria in the way one might expect for an AI algorithm performance study.
Instead, the performance testing section lists types of tests conducted to ensure safety, effectiveness, and substantial equivalence, rather than a statistical evaluation of diagnostic accuracy. The FDA's review concludes that the device is "substantially equivalent" based on these tests.
Since the document does not relate to an AI/ML algorithm or a diagnostic device where acceptance criteria typically refer to metrics like sensitivity, specificity, or AUC, many of the requested points are not applicable or cannot be extracted from the provided text.
Here is an attempt to address your points based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with explicit acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that are typically reported for AI/ML diagnostic devices. Instead, it lists various performance tests conducted to demonstrate the device's safety, effectiveness, and substantial equivalence to legally marketed predicate devices. The "reported device performance" is implicitly that the device passed these tests and was found substantially equivalent.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Dimensional Measurements (Outer Diameter, Working Length) | Conformity to specified dimensions. | Passed |
| Field of View (in air) | Conformity to specified field of view. | Passed |
| Image Resolution (Number of Pixels) | Conformity to specified resolution. | Passed |
| Direction of View | Conformity to specified direction of view. | Passed |
| LED Brightness, Voltage & Current measurement | Conformity to specified electrical parameters. | Passed |
| Tip Deflection Control Mechanism (flex) & Angle of Tip deflection | Conformity to specified deflection range/control. | Passed |
| USB / HD Connection compatibility | Compatibility with 3D Laptop / Tablet / Monitor. | Passed |
| Electrical Safety Test (IEC 601-1) | Conformity to IEC 601-1 standard. | Passed |
| Electromagnetic Compatibility (IEC 601-1-2) | Conformity to IEC 601-1-2 standard. | Passed |
| Thermal (Heat) Temperature at the Distal Tip (LED) | Conformity to safety limits for temperature. | Passed |
| Product Labeling & IFU Requirements & Accuracy | Compliance with labeling regulations and accuracy of instructions for use. | Passed |
| Packaging Integrity & Sterility Assurance Test | Maintenance of sterile barrier and sterility. | Passed |
| Accelerated Aging Test (one Year) | Device functionality and integrity maintained after accelerated aging. | Passed |
| Sterilization Assurance Level (ISO 11135-1:2007) | Achievement of required sterility assurance level. | Passed |
| ETO Residual Levels (ISO 10993-7:2008) | Ethylene oxide residual levels within acceptable limits. | Passed |
| Biocompatibility (ISO 10993-1:2009) | Device materials are biocompatible. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The performance testing appears to be bench testing on the device itself (e.g., measuring dimensions, resolution, electrical properties) rather than testing on a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is not applicable to the type of performance testing described (bench testing of an endoscopic system).
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to the type of performance testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done and is not applicable, as this device is an endoscopic system providing 3D images, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm was not done and is not applicable. The device itself is an imaging system designed for human-in-the-loop use by surgeons.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" (in the context of diagnostic accuracy) is not applicable here. The "truth" for the performance tests listed would be the established engineering specifications, safety standards, and compliance with regulatory requirements. For example, the ground truth for "Dimensional Measurements" would be the engineering drawing specifications.
8. The sample size for the training set
This information is not provided and is not applicable, as this is hardware device clearance, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as this is hardware device clearance, not an AI/ML algorithm requiring a training set with established ground truth.
Summary Explanation:
The provided document is a 510(k) premarket notification for a medical device (NeoScope 3D™ - 3D Digital Video Endoscopic System) that allows surgeons to visualize endoscopic procedures in 3D. The "acceptance criteria" and "performance study" described are focused on demonstrating that the physical device meets its specifications, safety standards (e.g., electrical safety, biocompatibility), and regulatory requirements, and that it is "substantially equivalent" to previously cleared predicate devices.
This is fundamentally different from a study proving the diagnostic performance of an AI/ML algorithm, which would involve evaluating its accuracy (e.g., sensitivity, specificity) against a clinical ground truth on a test set of patient data. Therefore, many of the questions asked, which are highly relevant for AI/ML device evaluations, do not apply to the traditional hardware device clearance described in this FDA 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.