Search Results

• For Irrigation of Medical Device Only .
• Not for Injection or Flushing of Skin Tissues .

Not Found

The provided text is a 510(k) summary from the FDA for a medical device (Sterile Water & Sterile 0.9% Sodium Chloride) and does not describe a study or specific acceptance criteria and performance related to an AI/ML powered device. The document is a clearance letter indicating the device is substantially equivalent to previously marketed devices.

Therefore, I cannot provide the requested information. The document does not contain details about:

1. Acceptance criteria or device performance data.
2. Sample sizes for test or training sets.
3. Data provenance.
4. Expert qualifications or the number of experts.
5. Adjudication methods.
6. MRMC comparative effectiveness studies.
7. Standalone performance.
8. Type of ground truth.
9. How ground truth was established for training data.

Ask a specific question about this device

Hydrogel sterile dressing is for the wound management of partial and full thickness pressure ulcer, stasis ulcers, first & second degree burns, cuts, abrasions, irritations of the skin and skin condition associated with periostomal care.

Sterile Hydrogel

I am sorry, but based on the provided text, there is no information about the acceptance criteria for a device, a study that proves a device meets acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set details.

The text is a fragment of a 510(k) clearance letter from the FDA to Dumex Medical Surgical Products LTD regarding their "Sterile Hydrogel" device. It indicates that the FDA has found the device to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

It primarily discusses:

• The FDA's review and determination of substantial equivalence.
• Regulatory classifications and controls applicable to the device.
• Contact information for further regulatory inquiries.
• The intended use of the "Sterile Hydrogel" device.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

Ask a specific question about this device

FOR GENERAL USE - DN AS DRADABADA No 2 WOND AACK WOUND MANAGEMENT CONDUIT IN

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance for any medical device. The documents are FDA 510(k) clearance letters and related forms for a "Dumex Iodoform Packing Strip." These documents confirm that the device is substantially equivalent to legally marketed predicate devices and allow it to be marketed, but they do not detail performance studies or acceptance criteria.

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device

The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications: minor cuts, minor burns and minor lacerations. Under the guidance of a health care professional, the Thalafix Natural Sea-Salt Dressing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.

The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt.

This document is an FDA 510(k) clearance letter for a medical device called "Thalafix Natural Sea Salt Dressing." It does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to a predicate device and outlines specific labeling limitations.

Ask a specific question about this device

The Hydrogel dressing is intended for use to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment around the wound. The dressing is appropriate applied to the following indications: minor cuts, minor lacerations. Under the guidance of a health professional the hydrogel dressing is also indicated for surgical incisions and excisions, venous stasis ulcers and decubitus ulcers.

Dumex Pak-its Cotton Gauze Packing Impregnated with Hydrogel

This document is a 510(k) clearance letter from the FDA for the "Dumex Pak-its Cotton Gauze Packing Impregnated with Hydrogel". It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance as requested.

The letter approves the marketing of the device based on its substantial equivalence to a predicate device, and it outlines limitations on labeling and claims. It does not provide details of clinical trials, performance studies, or the specific criteria used to evaluate the device's efficacy or safety.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details based on the provided text.

Ask a specific question about this device

Non-Woven dressing impregnated with Sodium Chloride is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to the wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications:minor cuts, minor burns and minor lacerations. Under the guidance of a heatth care professional, "AbsorbaSalt" Cotton Gauze Packing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.

Dumex Pak-its Non-Woven Dressing Impregnated with Sodium Chloride

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Dumex Pak-its Non-Woven Dressing:

Based on the provided document, which is a 510(k) premarket notification letter from the FDA, the information requested about acceptance criteria and a study proving device performance is not explicitly available in this format.

The document primarily focuses on:

• Confirming "substantial equivalence" of the device to existing predicate devices. This means the FDA has determined the new device is as safe and effective as a legally marketed device that was on the market before May 28, 1976, or has been reclassified.
• Stating specific limitations on labeling claims for the device (e.g., no claims of accelerating wound healing, no claims for third-degree burns).
• Outlining general regulatory requirements for the device.
• Listing the "Indications for Use."

A 510(k) submission typically includes data to support substantial equivalence, which might involve performance data. However, the FDA letter itself is a summary of the regulatory decision, not the full performance study report. Therefore, I cannot extract the detailed study information you requested directly from these pages.

However, I can infer some aspects and highlight what information is missing based on your request categories:

Here's an attempt to fill out the table, acknowledging that most of the requested detail is not present in the provided FDA letter:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified. It's likely from a combination of bench testing, possibly some preclinical data, and comparison to existing predicate devices. Whether it's retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For substantial equivalence, the "experts" are often the manufacturers providing data, and FDA reviewers.

4. Adjudication method for the test set

• Not specified.

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

• MRMC Study: Unlikely to be applicable. This device is a wound dressing, not an imaging AI diagnostic tool. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant in this context.

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

• Not applicable as this is a physical medical device (wound dressing), not an algorithm or AI system.

7. The type of ground truth used

• For a physical device like a wound dressing, "ground truth" would typically refer to objective measures of performance (e.g., absorbency tests, biocompatibility tests, clinical outcomes in trials if clinical data was part of the submission), and comparison to the performance of predicate devices. The letter indicates that the device's performance is assumed to be equivalent to the predicate.

8. The sample size for the training set

• Not applicable to this type of device and submission (no "training set" in the AI/ML sense).

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

• Not applicable to this type of device and submission.

Summary of missing information:

The provided document is an FDA clearance letter for a 510(k) submission. It confirms regulatory clearance based on "substantial equivalence" to a predicate device and outlines labeling restrictions. It does not contain the detailed study design, specific performance metrics, sample sizes, or expert review processes that would be submitted by the manufacturer to the FDA as part of the 510(k) application itself. To get that level of detail, one would need access to the full 510(k) submission report, which is usually hundreds or thousands of pages long.

Ask a specific question about this device

The "AbsorbaSalt" Cotton Gauze Packing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will Sur that is mondou for act on moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the dressing is appropriate would offications will our cuts, minor burns and minor lacerations. Under the guidance for the following multions: himor outs, rather attern Gauze Packing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.

The "AbsorbaSalt" Cotton Gauze Packing is a dry dressing impregnated with crystalline seawater salt.

This document is a 510(k) clearance letter from the FDA for a medical device called "Dumex Pak-its 'AbsorbaSalt' Cotton Gauze Packing." It states that the device is substantially equivalent to legally marketed predicate devices. However, the letter does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document primarily focuses on regulatory clearance and limitations on labeling claims rather than detailed performance study results.

Ask a specific question about this device

The Dumex Pak-its-Woven Ribbon Packing is intended to absorb exudate from discharging wounds into a secondary dressing. The packing is indicated for the following exudating wounds: minor cuts, abrasions and incisions. The packing may also be used on infected wounds under the care of a health care professional.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Dumex Pak-its Woven Ribbon Packing" device, outlining its substantial equivalence to a predicate device and its intended use and limitations.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the given input.

Ask a specific question about this device

Ask a specific question about this device