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The DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles are electrosurgical electrodes which are intended for use as accessories to electrosurgical devices to cut tissue (dissection) and control bleeding for general, plastic, and reconstructive surgery.

The DSP Worldwide Suowden-Pencer Micro Diamond-Point™ Dissection Needles are inserted into the electrosurgical handpiece. As with all other electrosurgical electrodes, energy is applied to the tissuc with the highest concentration at the tip of the electrode. The Micro Diamond-Pointer Dissection Needles are provided in a variety of lengths and contigurations The electricie of a tungeten needlo rip inserted into a stainless steel sleeve. This needle assembly is then covered with two layers of heat shrink tubing for insulation. Micro Diamond-Point™ Dissection Needless are provided nonsterile, for single use only. Devices are provided three per package and require sterilization prior to use. Sterilization instructions are provided in device labeling.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is a 510(k) summary for a medical device (electrosurgical dissection needles) and primarily focuses on:

• Device identification and contact information.
• Device description and intended use.
• Comparison to a predicate device to claim equivalence.

It does not include the kind of detailed study results or performance metrics you are asking for.

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The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes.

The DSP Worldwide Snowden-Pencer Dermatome Blade is secured to the Padgett Dermatome head using the securing nut. The blade oscillates on the horizontal plane to harvest a split thickness of skin from a donor site for grafting. It is provided in one size only and consists of the stainless steel used for many surgical applications. Blades are provided sterile, single use, and disposable in individual Tyvek and polypropylene pouches. Devices are sterilized using gamma sterilization.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies. The document only describes a dermatome blade, its intended use, and claims equivalence to a predicate device.

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The DSP Worldwide Snowden-Pencer Xenon Lightsource is intended for use as an accessory to fiberoptic endoscopes to provide illumination during endoscopic procedures.

The DSP Worldwide Snowden-Pencer Xenon Lightsource is a fiberoptic illuminator for use in endoscopic surgical procedures. The device includes a Power Switch/Circuit Breaker, Light Guide receptacle which accepts the fiber optic cables (designed to accept ACMI cables with Storz, Olympus, and Wolf adapters also available), Lamp Usage Clock which indicates elapsed bulb usage (in hours), Light Intensity Control which allows illumination to be adjusted (clockwise to increase intensity and counterclockwise to decrease intensity), Light Intensity Indicator which provides a graphic representation of the level of light intensity, a Lamp Door on the side of the unit to provide access for replacement of the lamp module, a Cooling Fan to cool the Xenon bulb and the power supply of the unit. Detailed specifications for the Lightsource were provided.

This 510(k) premarket notification for the DSP Worldwide Snowden-Pencer Xenon Lightsource does not contain information about acceptance criteria or a study proving the device meets specific performance acceptance criteria in the way this request is typically understood for AI/ML or diagnostic devices.

The document focuses on demonstrating substantial equivalence to a predicate device (Karl Storz Xenon Light Source) based on design, operational principles, and technological characteristics, rather than reporting on a clinical or performance study with quantified acceptance criteria and device performance results.

Therefore, many of the requested fields cannot be filled. I will explain why for each point.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" for performance evaluation in the context of diagnostic accuracy or AI/ML. The assessment is based on a comparison of technical specifications and intended use against a predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There's no performance evaluation involving expert ground truth in this submission.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This document describes a medical device (a light source for endoscopy), not an AI/ML or diagnostic imaging device that would typically undergo such a study.

6. If a Standalone Performance Study was done

A standalone performance study in the context of diagnostic algorithms or AI performance was not conducted or reported. The 510(k) summary focuses on demonstrating equivalence through design and specifications.

7. The Type of Ground Truth Used

Not applicable. There is no ground truth concept as typically applied to AI/ML or diagnostic studies in this submission.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable.

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