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The Scintillant Surgical Lights are intended to provide localized illumination of surgical sites.

The Scintillant Dual Tip Light is a sterile, single-use device designed to provide surgeons with localized brilliant white illumination of the surgical site. Utilizing an internal battery, the device is designed to stay operational for up to three hours of continuous use. Dual light tips in combination with flexible leads containing memory wire allows for the surgeon to direct light from multiple locations optimizing the illumination provided by the device and allowing for increased visibility within the surgical site.

The provided text describes a Special 510(k) submission for the Scintillant Dual Tip Surgical Light. This type of submission is for modifications to a manufacturer's own legally marketed device, where the modifications do not significantly alter the device's fundamental scientific technology, design, or indications for use.

Crucially, this submission does not involve an AI device. It's a traditional medical device (a surgical light) and the "study" referred to is non-clinical engineering rationale and confirmatory testing, not a clinical trial or performance study against acceptance criteria in the way one would for an AI/ML device. Therefore, many of the requested categories are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Acceptance: The proposed device ("Scintillant Dual Tip Surgical Light") was deemed substantially equivalent to the predicate device ("Scintillant Surgical Light K071180") because its fundamental scientific technology, design features, and indications for use are identical. The proposed device's lower operating temperature was seen as an improvement, not a new risk.

The following information is NOT APPLICABLE as the device is a surgical light, not an AI/ML device.

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

• N/A. This was a non-clinical submission for a physical device. Testing involved engineering rationales and confirmatory tests, not a "test set" in the context of AI/ML.

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)

• N/A. No expert ground truth was established for a "test set" as this is not an AI/ML device. Engineering rationales and confirmatory tests would have been performed by qualified engineers/technicians.

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

• N/A. No adjudication method for a "test set" was described for this device.

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

• N/A. This is not an AI device, so no MRMC study involving AI assistance would have been conducted or is relevant.

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

• N/A. This is not an AI algorithm.

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

• N/A. The "ground truth" for this device's performance was its ability to provide localized illumination, operate for a specified duration, and maintain safety, as demonstrated through engineering analysis and physical testing. This isn't a "ground truth" for a diagnostic or predictive algorithm.

8. The sample size for the training set

• N/A. This is not an AI/ML device that requires a training set.

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

• N/A. This is not an AI/ML device that requires a training set or associated ground truth.

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The Scintillant light is intended to provide localized illumination of surgical sites.
The Scintillant Surgical Light is intended to provide localized illumination of surgical sites.

The Scintillant Surgical Light is an untethered, self-contained medical lighting device that allows illumination inside the surgical field. The light can be hand-held and is provided with accessories which allow it to be attached to almost any surgical tool or instrument.
The light is provided sterile and is battery powered. The light consists of light-emitting diode (LED) mounted on the end of a flexible wand. A single button turns the light on and off. A battery and circuit board are contained in the device handle.

This is a 510(k) premarket notification for the Scintillant Surgical Light, a surgical lamp. The provided documents establish substantial equivalence to predicate devices, but do not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary (K071180) merely states that:

• The Scintillant Surgical Light is an untethered, self-contained medical lighting device for illumination inside the surgical field.
• It's hand-held, sterile, battery-powered, and uses an LED on a flexible wand.
• Its intended use is to provide localized illumination of surgical sites.
• It is technologically similar to predicate devices (AtriCure Dissector, Light Port Surgical Illuminator, VersaLight Multi-Function Surgical Illuminator, LightMat Surgical Illuminator), all being sterile, hand-held, battery-powered surgical field illuminating devices with the same overall intended use.
• The conclusion is that the device is as safe and effective as the predicate device and does not raise any new questions regarding safety and effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies with defined acceptance criteria and performance metrics for all new devices.

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