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510(k) Data Aggregation
(203 days)
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
The ENDOEYE HD II - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy and endoscopic surgery within the abdominal cavities, which is basically identical to the predicate devices for the same application areas.
Here's a breakdown of the acceptance criteria and study information for the Olympus EndoEYE HD II, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not present a formal table of acceptance criteria with corresponding performance metrics for the Olympus EndoEYE HD II as one might expect from a detailed clinical or performance study report. Instead, it describes various non-clinical tests and validations performed to demonstrate substantial equivalence to predicate devices.
However, based on the information provided, we can infer the types of acceptance criteria and the confirmation that the device met these criteria through testing.
| Acceptance Criterion (Inferred from Non-Clinical Testing) | Reported Device Performance / Confirmation |
|---|---|
| Safety: | |
| Risk analysis in accordance with ISO 14971:2007 | Risk analysis was carried out, and design verification tests were identified and performed as a result of this assessment. |
| Compliance with IEC 60601-1 (General medical electrical equipment safety) | Applied |
| Compliance with IEC 60601-1-1 (Safety requirements for medical electrical systems) | Applied |
| Compliance with IEC 60601-2-18 (Safety for endoscopic equipment) | Applied |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Applied |
| Material safety (identical to predicate device) | "The subject device has identical materials as the predicate device." |
| Performance: | |
| Image Resolution | Verification testing for resolution was conducted. |
| Color Correctness | Verification testing for color correctness was conducted. |
| Spectrum Analysis | Spectrum analysis was conducted. |
| Fog Free Functionality | Validation of the Fog Free function was conducted. |
| Durability after multiple sterilization cycles | Testing to confirm the durability of the device after multiple sterilization cycles was conducted. |
| Reprocessing: | |
| Reprocessing validation in accordance with FDA guidance | "Reprocessing validation was carried out in accordance with 'Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996.'" |
| Compliance with DIN EN ISO 17664 (Processing of medical devices) | Applied |
| Compliance with DIN EN ISO 17665-1 (Sterilization of health care products - Moist heat) | Applied |
| Compliance with DIN EN ISO 14161 (Sterilization of health care products - Biological indicators) | Applied |
| Compliance with ISO 11138, part 3 (Sterilization of health care products - Biological indicators - Moist heat) | Applied |
| Compliance with DIN EN 556-1, Part 1 (Sterilization of medical devices - Requirements for medical devices to be designated "STERILE") | Applied |
| Compliance with DIN EN 285 (Sterilization - Steam sterilizers - Large sterilizers) | Applied |
| Software Validation: | |
| Compliance with FDA Guidance for software in medical devices | "The software validation activities were performed in accordance with the FDA Guidance, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" |
| Software Level of Concern | "The device software is considered a 'Minor Level of Concern.'" |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing for performance, safety, and reprocessing. It does not mention a "test set" in the context of clinical data or human evaluation (e.g., patient images). Therefore:
- Sample Size for Test Set: Not applicable as no clinical test set/data is described. The testing involved physical devices and their components.
- Data Provenance: Not applicable as no clinical data is described. The tests were likely conducted internally by the manufacturer (Olympus Winter & Ibe GmbH) in Germany.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Since the testing described is non-clinical/technical (e.g., resolution, sterilization, durability), the "ground truth" would be established by engineering and quality assurance standards and measurements, not by medical experts interpreting data like radiologists.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable given the non-clinical nature of the described testing. Adjudication methods are typically used in studies involving human interpretation of data where consensus among experts is required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical performance, not through a comparative clinical study with human readers assessing diagnostic performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone algorithm study is not mentioned. The device is a video laparoscope, a physical instrument for visualization during surgery, not an AI algorithm.
7. Type of Ground Truth Used
The ground truth used for the described non-clinical testing would be based on objective technical specifications, engineering standards, and validated measurement techniques. For example:
- Resolution: Measured against established optical resolution charts/targets.
- Color Correctness: Measured against color calibration standards.
- Sterilization Effectiveness: Demonstrated through biological indicator kill rates and physical/chemical indicators conforming to sterilization standards (e.g., DIN EN ISO 17665-1).
- Durability: Assessed by subjecting devices to a specified number of sterilization cycles and then re-evaluating performance against initial specifications.
- Software Functionality: Verified against software requirements specifications.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical instrument, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI/machine learning algorithm described.
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