Search Results

The Headlight is indicated for use in transmitting illumination to a body cavity or surgical procedure.

Not Found

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for the IsoLED AC-Powered LED Headlight System, indicating that the device has been found substantially equivalent to a predicate device.

It includes:

• Device name: IsoLED AC-Powered LED Headlight System
• Regulation Number and Name: 21 CFR 878.4580, Surgical lamp
• Regulatory Class: Class II
• Product Code: FST
• Indications for Use: "The Headlight is indicated for use in light transmitting illumination and body cavity illumination procedures."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone performance.
• Training set details.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device

The Solid State Procedure Headlight is indicated for providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.

This product features an articulated projector that is mounted to a comfortable adjustable headband. The range of adjustability accommodates the majority of users. The actual source for the illumination is a high intensity white LED.

This submission describes a medical device, the "Solid State Procedure Headlight," and its comparison to a predicate device. However, it does not contain a study that presents specific acceptance criteria and detailed device performance data in a way that would allow for a complete answer to all parts of your request.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for performance specifications (e.g., light intensity, beam uniformity, color temperature, etc.) nor does it report specific device performance data against such criteria. Instead, it refers to general safety standards and an overall statement of effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission mentions "design reviews and testing" but does not detail the nature of these tests, the number of units tested, or the type of data collected.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The device is an illumination tool, not an imaging or diagnostic AI device that would typically rely on expert-established ground truth for its performance evaluation in this context. The evaluation described here focuses on safety standards and functional comparisons to a predicate device.

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

This information is not provided and is not applicable given the type of device and the evaluation described.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not relevant for this device. This is a spotlight/headlamp, not an AI-powered diagnostic tool. There is no AI component or "human readers" in the context of interpretation of images or data.

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

A standalone performance study in the context of an algorithm is not applicable as this device is an illumination tool and does not contain an algorithm.

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

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. The assessment of this device is based on its ability to provide illumination and meet safety standards, as well as being substantially equivalent to a predicate device. "Effectiveness" is determined by its ability to fulfill its intended purpose (providing illumination) rather than making a diagnostic determination that requires a ground truth standard.

8. The sample size for the training set

This information is not provided and is not applicable for this type of device. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not provided and is not applicable for this type of device.

Ask a specific question about this device

The Solid State Portable Headlight is indicated for providing a portable, battery powered illumination for performing general exams, foreign body removal, and minor suturing.

This product consists of a light source that is held in place by a comfortable, adjustable and consumable Terrycloth headband with Velcro adjustments. The range of adjustability accommodates the majority of users. The portable Headlight is small, light weight and adjustable in both pointing direction and illuminated spot size.

The provided text is a 510(k) summary for the "Solid State Lamp (LED) Headlight" and primarily focuses on regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria in the context of clinical or diagnostic accuracy.

Therefore, many of the requested sections about acceptance criteria and study details (like sample size for test sets, expert ground truth, MRMC studies, standalone performance) cannot be filled from the provided document. The document describes conformity to general safety standards and states that design reviews and testing ensure the device performs within its environment.

Here's an attempt to extract the available information based on your request:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text refers generally to "testing" and "design reviews" but does not detail the specific test sets, their sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The nature of this device (a headlight) suggests that "ground truth" in the diagnostic sense is not applicable. The evaluations would likely focus on engineering performance, safety, and functional effectiveness.

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

This information is not provided in the document.

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

This information is not applicable / not provided. This device is a headlight, not an AI-powered diagnostic tool. Therefore, MRMC studies with human readers and AI assistance are not relevant.

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

This information is not applicable / not provided. This device does not involve an algorithm.

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

This information is not provided in the document. For a medical device like a headlight, "ground truth" would likely relate to objective measurements of light output, battery life, durability, and ergonomic performance, evaluated against engineering specifications and relevant safety standards, rather than diagnostic outcomes.

8. The sample size for the training set

This information is not applicable / not provided. This device is not an AI/ML model that requires a "training set."

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

This information is not applicable / not provided. This device is not an AI/ML model.

Ask a specific question about this device