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510(k) Data Aggregation
(132 days)
Hawkeye Control Unit with Eyas Endoscope
The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision.
The E Surgical Hawkeye Control Unit with Eyas Endoscope is an arthroscope system, consisting of the Hawkeye Control Unit (Medical Tablet plus Console Box), and the Eyas Endoscope. The Medical Tablet is a touch panel computer for the system function control, endoscope image displays and operation data storage. The Eyas Endoscope is a hand-held, single-use device for accessing the interior of a joint to capture the real-time image of the target site through a small incision. The Console Box is an interface between the Medical Tablet and Eyas Endoscope. There are 10 models of Eyas Endoscope in this system; including 2 different directions of view (0° and 30°) in combination with 5 different working lengths. All these models must be used in conjunction with Hawkeye Control Unit to perform as intended. The E Surgical Hawkeye Control Unit with Eyas Endoscope is also capable recording and storing the images in the system for later review.
This document is a 510(k) Premarket Notification from the FDA regarding the "Hawkeye Control Unit with Eyas Endoscope." It details the device, its intended use, a comparison to a predicate device, and summaries of bench testing and compliance with standards.
However, the provided text does not contain information about studies proving the device meets acceptance criteria related to a comparative effectiveness study involving AI or human readers, nor does it provide details about ground truth establishment with experts, adjudication methods, or standalone AI performance.
The document focuses on demonstrating substantial equivalence to a predicate device (Trice medical mi-eye2, mi-eye 2 monitor (K162475)) through comparison of features, operating principles, technology, and compliance with various recognized standards (electrical safety, biocompatibility, sterilization, software lifecycle, packaging).
The "Bench Testing Summary" section describes various tests performed on the device components (Console Box, Medical Tablet, Eyas Endoscope, and their packaging) to verify their functionality and performance against specifications. These are typical engineering and quality assurance tests, not clinical performance studies for diagnostic accuracy or comparative effectiveness with human readers, especially not for an AI component.
Given the provided text, it's not possible to fully answer the request as it pertains to AI model acceptance criteria and validation studies. The device as described is an arthroscope system for visualization and image capture, not an AI-powered diagnostic tool.
Therefore, for the specific questions asked that relate to AI model validation, the answer is: This document does not contain the requested information about AI model acceptance criteria or validation studies, as the device described is an arthroscope system, not an AI-powered diagnostic or assistive tool.
If we interpret "acceptance criteria" in the context of this document as the criteria for demonstrating substantial equivalence for an arthroscope system, then the "reported device performance" is its adherence to technical specifications and relevant safety/performance standards, as summarized in the bench testing.
Here's what can be extracted based on the provided text, focusing on the device's technical acceptance and testing, not AI:
Acceptance Criteria and Device Performance (Based on Technical Specifications and Bench Testing)
The document implicitly defines acceptance criteria through its comparison to a predicate device and its demonstrated compliance with international standards. The performance is reported as meeting these standards and having features functionally equivalent to the predicate.
1. Table of acceptance criteria and the reported device performance (Interpreted as technical and functional equivalence):
| Acceptance Criterion (Implicit from comparison/standards) | Reported Device Performance (from document) |
|---|---|
| Indications for Use: Provide visualization and image capture of interior body cavity through surgical incision. | Identical to predicate. "The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision." |
| Product Code: HRX (Arthroscope) | HRX (Identical) |
| Operating Principle: Transmission of light to illuminate and image arthroscopic joint, relaying image for processing and display. | Identical to predicate. |
| Input Power: 100-240 V | 100-240 V (Identical) |
| Light Source: LED (SMD Type) | LED (SMD Type) (Identical) |
| Image File Format: PNG | PNG (Identical) |
| Video File Format: Standard video format | MPG (Functionally identical to predicate's AVI/MP4; applied for different media players, no safety/effectiveness concerns raised). |
| Output Port: Data/Image/Audio output | USB, HDMI, Audio jack (Functionally identical to predicate's USB; HDMI/Audio jack outputs do not raise safety/effectiveness concerns per cybersecurity report). |
| Component Design: System components | Tablet, Console Box, Endoscope (Similar to predicate's Tablet, Endoscope. Console box provides power/stand, no safety/performance impact). |
| Physical Dimensions/Weight: Reasonable for use | Tablet: 28 x 18 x 1.83 cm (vs. 33.5 x 21.6 x 3.8 cm for predicate) Console Box: 16.9 x 19.6 x 12.2 cm. Weight: 2.2lb (tablet and console each). (Similar; differences in design mechanisms do not raise safety/effectiveness concerns). |
| Display: Integrated viewing screen | 10.1" LCD (vs. 12.3" LCD for predicate). |
| Working Conditions: Temperature, Humidity, Pressure | Temp: 10-30°C, RH: 30-75%, Pressure: 700-1013 hPa (Minor differences but similar to predicate; typical working conditions; considered substantially equivalent). |
| Transport/Storage Conditions: Temperature, Humidity, Pressure | Temp: -20-60°C, RH: 25-85%, Pressure: 500-1013 hPa (Minor differences but similar to predicate; considered substantially equivalent). |
| Patient Contact Materials: Biocompatible | SUS 304, ABS, PC, Copper Clad Laminate, Polyimide, CaZrO3, Expoy Resin, Acrylate Urethane, Silicone (Biologically identical to predicate's SUS 304). |
| Audio Indicator: Operation/Warning Tones | Yes (vs. No for predicate, which has visual signal only. This is an additional feature, not a deficiency). |
| Flushing Feature: Present and functional | Yes, requires cannula (Functionally identical to predicate). |
| Endoscope Sterilization Method: EO | Ethylene Oxide (Identical) |
| Operation Environment: Clinical settings | Operating rooms, treatment rooms, and clinics (Identical). |
| Standard Compliance: Electrical safety, biocompatibility, software, sterilization, packaging. | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, ISO 10993-1, ISO 11135, ISO 11607-1, ISO 11607-2. (Almost identical to predicate; application device conforms to latest versions). |
| Console Box Bench Testing: | Visual Inspection, Power Supply, Plug Insertion & Extraction Force (Passed). |
| Medical Tablet Bench Testing: | Visual Inspection, Luminance Adjustment, Capturing and Recording, Battery Capacity Check, Tablet Charging, Software/Firmware Version, HDMI Signal Output, Image Function, USB Storage, Tone (button/warning) (Passed). |
| Package Bench Testing: (Control Unit) | Package and Device Integrity, Label Visibility (Passed). |
| Eyas Endoscope Electrical Testing: | EEPROM Function, Continuity Resistance (Passed). |
| Eyas Endoscope Optical Testing: | Luminance Intensity, Sensitivity, White Balance, SFR, Uniformity, Color Response, Dust Spot, Dark, Noise, Stray Light, Color Performance, Direction of View, Field of View (Passed). |
| Eyas Endoscope Mechanical Testing: | Activation Force, Plug Insertion & Extraction Force, Dynamic Strain Relief, Static Strain Relief, Weld Integrity, Camera Tube Wobble, Activation Over Time, Leakage, Fluid Ingress Test (Passed). |
| Package Bench Testing: (Eyas Endoscope) | Visual Inspection, Peel Open, Seal Width, Seal Strength, Dye Leak (Passed). |
Since the device is not an AI-powered diagnostic system, the following questions cannot be answered from the provided document:
- Sample size used for the test set and the data provenance: Not applicable for an AI test set. The document describes bench testing on the device itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not established here.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance is its adherence to engineering specifications and international standards, demonstrated by bench testing.
- The sample size for the training set: Not applicable, as this is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary, this FDA 510(k) document indicates substantial equivalence for an arthroscope system based on standard engineering and performance tests, not on AI model validation.
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