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Giltech Plus Hydrogel Wound Dressing is intended to be used in the management of.

1. Minor burns
2. Decubitus ulcers
3. Superficial lacerations, cuts and abrasions
4. Postoperative incisions
5. Sunburn

This hydrogel retains cold temperature. Its' high specific heat, due to high water content, allows it to have a cooling effect.

This document is a 510(k) clearance letter from the FDA for a medical device called "Hydrogel Wound Dressing". This type of document does not contain the detailed study information requested in the prompt.

Here's why and what information can be extracted:

• 510(k) Clearance: This is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically require extensive clinical trials with detailed acceptance criteria and performance data like a PMA (Premarket Approval) submission would.
• "Substantially Equivalent": The core of a 510(k) is to show substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness. The studies conducted are often limited and comparative, not necessarily focused on meeting specific quantitative performance metrics against a hard acceptance criterion in the way an AI algorithm study would.

Therefore, most of the requested information cannot be found in this document:

1. Table of acceptance criteria and reported device performance: Not present. This document only states that the device is "substantially equivalent" to predicate devices.
2. Sample size, data provenance: Not mentioned.
3. Number of experts and qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: Not applicable or mentioned. This is a physical wound dressing, not an AI algorithm.
6. Standalone performance: Not applicable or mentioned for an AI device. The document is about a hydrogel dressing.
7. Type of ground truth: Not applicable or mentioned.
8. Sample size for training set: Not applicable or mentioned.
9. Ground truth for training set: Not applicable or mentioned.

Information that can be extracted:

• Device Name: Hydrogel Wound Dressing (Trade Name: Giltech Plus Hydrogel Wound Dressing)
• Indications for Use:
  1. Minor burns
  2. Decubitus ulcers
  3. Superficial lacerations, cuts and abrasions
  4. Postoperative incisions
  5. Sunburn
• Regulatory Class: Unclassified
• Product Code: MGQ
• Applicant: Giltech Plus, Inc.

To get the type of detailed study information requested, you would typically need to consult a Premarket Approval (PMA) document, a clinical study report linked to an IDE (Investigational Device Exemption), or a scientific publication detailing the device's development and testing, rather than a 510(k) clearance letter.

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The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as:

(a) Stage I and II pressure sores (decubitus ulcers)

(b) Skin tears or lacerations

(c) Superficial burns and abrasions

(d) Surgical wounds

Transparent Dressing

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Giltech Plus Transparent Dressing." This document addresses the substantial equivalence of the device and its indications for use, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the input text. The document is strictly a regulatory clearance and does not delve into the technical details of device validation.

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The Giltech Plus Connecting Tube Sets will consist of: (a) Insufflation Tubing Sets (b) Suction / Irrigation Sets (c) Urinary Extension Tubing (d) Tubing Sets necessary to connect two devices, however never to be used to transmit a gas or a liquid for intravenous or intramuscular transmission.

Not Found

I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, or a study conducted to prove the device meets any criteria.

The document is an FDA 510(k) clearance letter for the "Giltech Plus Connecting Tube Set." This letter primarily:

• Confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976.
• Outlines general regulatory obligations for the manufacturer.
• Lists the "Indications For Use" for the device, which describes its intended functions and types of tubing sets included.

The document does not contain details about:

1. Acceptance criteria or reported device performance.
2. Sample size or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size or ground truth establishment for a training set.

Ask a specific question about this device