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510(k) Data Aggregation
(61 days)
CLAVEGUARD FREEDOM SURGICAL LIGHT
The Claveguard Freedom Surgical Light is designed to illuminate the surgical site in Operating theatres
The ClaveGuard Freedom surgical lights are suitable for all types of surgical procedures in operating rooms. The light is based on Light Emitting Diodes (LEDs) in combination with adaptive focus and shadow free illumination. It operates at a distance of 70-140cm from the surgical site. A light system may consist of 1 to 3 light heads supported by pivoting suspension system that is mounted to Healthcare facility's ceiling. The system may include optional monitor extension arms, monitor mounts, and in-light video camera.
This document describes the ClaveGuard Freedom Surgical Light, a surgical lamp designed to illuminate surgical sites. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study for establishing acceptance criteria for a new AI/ML device.
However, based on the provided text, we can infer the "acceptance criteria" relate to performance specifications defined by recognized international standards, and the "study" is the nonclinical testing conducted in accordance with those standards.
Here's an attempt to structure the information as requested, understanding that the context is a medical device for illumination, not an AI/ML diagnostic tool:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from IEC 60601-2-41:2001 & product design specifications) | Reported Device Performance |
|---|---|
| Conforms to IEC 60601-2-41:2001 specifications for performance of surgical lamps. | The ClaveGuard Freedom surgical light meets all requirements of the performance standard and achieved specified desired values per the product design specifications. |
| Basic safety and essential performance (per IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012) | Conforms to IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012. |
| Basic safety and essential performance of surgical luminaires for diagnosis (per IEC 60601-2-41:2009) | Conforms to IEC 60601-2-41:2009. |
| Electromagnetic compatibility (per IEC 60601-1-2:2007) | Conforms to IEC 60601-1-2:2007. |
| Programmable Electrical Medical System standards (per IEC 60601-1-4:2000) | Conforms to IEC 60601-1-4:2000. |
| Intended use: illuminate the surgical site in Operating theatres. | Designed to illuminate the surgical site in Operating theatres. |
| Operating distance | Operates at a distance of 70-140cm from the surgical site. |
| Technology basis | Based on Light Emitting Diodes (LEDs) in combination with adaptive focus and shadow free illumination. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices. The "test set" refers to the ClaveGuard Freedom Surgical Light device itself, which was subjected to a series of nonclinical tests to assess its compliance with international standards. It's implied that a representative sample of the device, or the device itself, underwent these tests.
- Data Provenance: The testing was conducted in accordance with international standards (IEC standards). The location of testing is not specified, but the manufacturer is ClaveGuard Pty Ltd, based in Australia. The document does not specify "retrospective or prospective" as this type of testing is typically prospective, involving specific performance measurements on the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the context of this document. The "ground truth" for a surgical light's performance is established by objective measurements against engineering and safety standards (e.g., light intensity, color rendering, shadow reduction, electrical safety, EMC). These are typically performed by accredited test laboratories and engineers, not by medical experts in the way ground truth is established for AI/ML diagnostic studies.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human reviewers (e.g., radiologists) in AI/ML performance studies. Here, compliance is determined by objective measurements against predefined standard requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The ClaveGuard Freedom Surgical Light is an illumination device, not a diagnostic tool requiring interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/ML algorithms. The ClaveGuard Freedom Surgical Light is a physical medical device, and its performance is evaluated through direct physical and electrical testing.
7. The Type of Ground Truth Used
The "ground truth" for the ClaveGuard Freedom Surgical Light's performance is based on objective measurements and validation against recognized international performance, safety, and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2, IEC 60601-1-4) and the product's own design specifications.
8. The Sample Size for the Training Set
This section is not applicable. The device is an electro-mechanical surgical light, not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
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