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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

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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An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

The BD Spinal needle consists of a non-lubricated stainless steel cannula attached to the needle hub using an insert molding process. When appropriate for the procedure, this needle includes a stylet. This stylet consists of nonlubricated stainless steel. The stainless steel stylet is attached to the stylet handle using an insert molding process. The needle assembly is protected with a polypropylene shield. The Spinal needle is packaged appropriately for either sterile or non-sterile, single use, purposes.

The provided document is a 510(k) summary for a medical device (BD Spinal Needle) seeking substantial equivalence to a predicate device. It is a regulatory submission, not a study report that details acceptance criteria and performance data for a new device's efficacy or safety. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in this document.

The document discusses the substantial equivalence of the BD Spinal Needle to existing predicate devices based on identical technological characteristics and intended use. This type of submission relies on the established safety and effectiveness of the predicate, rather than conducting new clinical performance studies for the new device itself.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable and not provided. This submission relies on demonstrating substantial equivalence to a predicate device, not on a new performance study with a test set of data.
• Data provenance: Not applicable. No new data from a test set is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable and not provided. No ground truth for a test set was established as part of this submission. The regulatory review process involves FDA experts evaluating the submission for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable and not provided. No test set requiring adjudication was used.

5. 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:

• No MRMC or AI-related study was done. This device is a physical medical instrument (spinal needle), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. The "ground truth" in this context refers to the established safety and effectiveness of the predicate device, which is assumed by the FDA for substantial equivalence evaluations. No new ground truth needed to be established for the submitted device's performance.

8. The sample size for the training set:

• Not applicable and not provided. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable and not provided. No training set was used.

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