(320 days)
The Shadowless Operation Light ZF 720 is intended to be used to provide visible illumination of the surgical area or the patient with high intensity and shadow free light during surgical procedures.
The Surgical Light ZF 720 is applicable for Open surgery, Endoscope surgery or other surgical procedures. With ceiling, wall and floor versions, the Surgical Light ZF 720 Systems are well-suited for various operating rooms. The device can be adjusted the color temperature, light intensity and light focus in accordance with the different visual habit by the users. And it is workable to connect to the monitor, video or other expansion devices with the requirements of the surgical environment. The Surgical Light ZF 720 consists of base assembly, pendent system and light head assembly integrated into one system. The Surgical Light ZF 720 provides optimum shadow resolution and ease of maneuverability. And the extension arm on the central block possesses the movement mechanism which enables the light heads swivel in all directions. With ceiling, wall and floor versions, the Surgical Light ZF 720 is well-suited for various operating rooms. It is also available in single, dual and triple configurations in compliance with users' requirements. The software is equipped in the device. Dispense with training before using the device.
The provided text describes a 510(k) premarket notification for a surgical light, the Umbel Corporation ZF 720. However, the details regarding clinical study design, specific acceptance criteria for performance metrics (e.g., lux levels, color temperature, shadow resolution), sample sizes for test and training sets, expert composition, adjudication methods, MRMC studies, or the method of ground truth establishment are not present in the provided document.
Instead, the performance data section states:
- "The Hazard Analysis of the device is in accordance with ISO 14971 Medical Application of Risk Management to Medical Devices."
- "The performance of product has been tested and verified by users."
- "Performance testing was conducted to verify the Surgical Light ZF 720 meets the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41."
This indicates that the device's performance was evaluated against engineering and safety standards (IEC 60601-1 and IEC 60601-2-41), and general user verification, rather than detailed clinical performance metrics derived from a study involving image analysis, AI assistance, or human reader performance. The device is a surgical lamp, not an AI/imaging diagnostic device, so the typical criteria associated with AI algorithms (e.g., sensitivity, specificity, AUC, human reader improvement with AI) are not applicable or expected for this type of submission.
Therefore, I will present what acceptance criteria and performance are stated or implied in the provided text, along with the limitations of the information for the questions asked.
Acceptance Criteria and Device Performance for Umbel Corporation ZF 720 Surgical Light
The provided documentation details the regulatory submission for a surgical light (ZF 720), which is a medical device for illumination during surgery. The performance evaluation for such a device typically focuses on meeting established electrical, safety, and functional standards, rather than diagnostic accuracy or human interpretation metrics common for AI-driven imaging devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied/stated) | Reported Device Performance/Verification Method |
|---|---|---|
| Risk Management | Compliance with medical device risk management standards | The device's Hazard Analysis is in accordance with ISO 14971 Medical Application of Risk Management to Medical Devices. |
| Electrical Safety & Performance | Compliance with general and specific medical electrical equipment standards | Performance testing was conducted to verify the Surgical Light ZF 720 meets the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41. |
| User Verification/Functionality | User satisfaction with performance (e.g., light intensity, shadow-free illumination, adjustability) | The performance of the product has been "tested and verified by users." |
| Substantial Equivalence | Demonstration of equivalence to predicate devices (Stryker Visum Surgical Lighting System K031068, MAQUET POWERLED Surgical Light System K070442) in intended use, technological characteristics, and performance. | Concluded to be "substantially equivalent to the predicate devices and effective when used as intended." (FDA conclusion) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Information Not Provided: The document does not specify test set sample sizes for any performance evaluations (e.g., number of units tested, number of users involved in verification).
- Data Provenance: Not explicitly stated, but the submission is from a US-based company (Umbel Corporation, Diamond Bar, CA), suggesting testing was likely conducted in a relevant controlled environment or lab setting conforming to international standards. The nature of the device (surgical lamp) means "retrospective or prospective" data is not applicable in the typical clinical study sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Information Not Provided: This question is more relevant to diagnostic devices where expert consensus forms ground truth. For a surgical light, "ground truth" is measured against engineering specifications (e.g., lux meters, colorimeters) and user feedback on functional aspects rather than "expert interpretation of images." The "users" who verified performance are not detailed in terms of number or specific qualifications.
4. Adjudication Method for the Test Set
- Information Not Provided/Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies with multiple readers interpreting data where discrepancies need resolution to establish ground truth. This concept does not apply to the performance testing of a surgical light against technical standards or general user verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, not applicable: An MRMC study is designed to assess the performance of diagnostic imaging (or AI-assisted diagnostic) systems by comparing the accuracy of multiple human readers across multiple cases, often with and without AI assistance. The ZF 720 is a surgical illumination device, not a diagnostic imaging or AI system. Therefore, an MRMC study was not conducted nor would it be relevant for its intended use and regulatory pathway. The concept of "human readers improving with AI vs. without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, not applicable: Similar to the MRMC study, this concept relates to the performance of artificial intelligence algorithms in a standalone diagnostic capacity. The ZF 720 is a physical surgical light, not an algorithm. Its performance is inherent to its physical design and measured through engineering standards and user feedback.
7. The Type of Ground Truth Used
- Engineering Standards and User Verification: The "ground truth" for the ZF 720's performance is established by:
- Compliance with IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- Compliance with IEC 60601-2-41 (Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis)
- User verification of functional aspects like "high intensity and shadow free light."
8. The Sample Size for the Training Set
- Not Applicable: "Training set" refers to data used to train machine learning models. As the ZF 720 is a physical device and not an AI algorithm, there is no "training set" in this context. The design and development process for a physical device involves engineering design, prototyping, and testing, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: Since there is no training set for this type of device, the concept of establishing ground truth for it does not apply.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.