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The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.

The Integra™ LED Surgical Headlight System is a self-contained headlight system that can be operated using either battery or direct power supply. Using a battery pack gives the surgeon complete portability allowing unrestricted movement in and around the operating suite. The direct power supply option can be used as a primary power source for unlimited operating time, or as a back-up to the battery system.

The Integra™ LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air at a very low flow rate through ports on the side and back of the headlight module, quietly cooling the LED. The air is drawn through a system of ducts and is gently exhausted behind the surgeon.

The provided text describes the Integra™ LED Headlight System, a surgical headlight. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Instead, the document focuses on:

• 510(k) Summary details: Contact information, device trade name, common name, classification, product code, and predicate device.
• Device Description: Discusses the power options (battery/direct), LED light source, and active cooling system.
• Indications For Use: States that the device provides illumination for visualization during minor surgical, diagnostic, or therapeutic procedures.
• Performance Standards: Lists various international electrical and medical safety standards (CAN/CSA, EN, IEC, UL) that the device conforms to, but these are general safety standards, not specific performance acceptance criteria for its intended function (illumination quality, brightness, etc.).
• Technological Characteristics: Compares features of the Integra LED Surgical Headlight with its predicate device (Welch Allyn Solid State Headlight), highlighting improvements in user control of attenuated light level, fan monitoring/control, and over-temperature monitoring/control.
• Substantial Equivalence: Concludes that the Integra LED Surgical Headlight is substantially equivalent to the predicate device based on performance testing (though the specific performance testing data and acceptance criteria are not detailed in this summary).
• FDA Communication: A letter from the FDA confirming the 510(k) clearance based on substantial equivalence to the predicate device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets them, because this information is not present in the provided text.

The document states: "The Integra™ LED Surgical Headlight is substantially equivalent to the legally marketed predicate device based on performance testing. The Integra™ LED Surgical Headlight System has the same intended use, technological characteristics, and general operation as the predicate device identified. Minor differences between these devices simply improve performance and operating characteristics of the device and do not raise any new questions in regards to the system's safety or effectiveness." This implies that performance testing was conducted, but the specifics of what was tested, what the acceptance criteria were, and what the reported performance was are not provided.

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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.

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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.

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The Headlamp HL2000 has indicated use in the following situations:

There is a requirement for illuminating a surgical field. .

· There is a requirement for munimaling on and The doctor wears this device on hishler end to the headlamp. The headlamp contains a
end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.

The doctor wears this device on hishler end to the headlamp. The headlamp contains a end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.

The provided text is a 510(k) clearance letter from the FDA for a device named "HeadLamp, HL2000". This document focuses on the regulatory clearance process and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input. The document explicitly states:

• It is a review of the 510(k) notification and a determination of substantial equivalence.
• It refers to "indications for use" as stated in an enclosure (which is not provided in the text).
• It confirms the device can be marketed subject to general controls.

The text does not detail any performance study or the results of such a study.

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