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These devices, both sterile and non sterile, are indicated for external use only and are intended to be used to clean wounds, to scrub or prepare incision sites, to absorb fluids, and dress wounds.

Furlong Industries' Non-X-Ray Detectable Gauze Sponges/Bandages, both sterile and non sterile, consist of cotton, rayon or rayon/polyester formed material and/or cellulose. This device is for externation of conly for cleaning wounds, scrubbing, dressing and fluid absorption.

The provided text does not contain information on acceptance criteria or a study proving device performance. The document is a 510(k) submission for a medical device (non-absorbable gauze for external use) and primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, the "Clinical Tests" section on page 1 of the "SUMMARY OF SAFETY AND EFFECTIVENESS" states:

"5. CLINICAL TESTS: There are no clinical studies that have been performed on these devices, both for the predicate and the new devices."

This explicitly indicates that no clinical studies were performed to evaluate the performance of this device against acceptance criteria. Therefore, no information on sample sizes, ground truth, expert involvement, or any type of performance study (standalone or MRMC) is available in the provided text.

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THIS PRODUCT IS INTENDED TO BE USED BY:

• SURGEONS
  • NURSES
  • LAB TECHNICIANS
  • I. V. TEAM
  FOR THE FOLLOWING PROCEDURES:
  • WOUND DRESSING
  • DEBRIDEMENT
  • CLEANING
  • PREPPING AND SCRUBBING

Not Found

This document is a 510(k) premarket notification acceptance letter for a medical device called "Symtex Gauze Pads and Symtex Gauze Sponges." It states that the FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.

Based on the provided text, there is no information available regarding acceptance criteria or the study that proves the device meets those criteria. This document is solely an FDA clearance letter, not a study report or a detailed device submission.

Here's why the requested information cannot be extracted:

• Type of Device: The device is "Gauze Pads and Gauze Sponges." These are typically low-risk, well-established medical devices (Class I or II, often exempt from extensive clinical trials). The FDA's substantial equivalence determination for such devices often relies on comparison to existing, legally marketed predicate devices, rather than new performance studies with specific acceptance criteria.
• Nature of Document: This is a regulatory clearance letter, which confirms the device's clearance for marketing. It summarizes the FDA's decision but does not include the detailed technical or clinical data that would have been part of the 510(k) submission itself.
• Lack of Performance Data: The letter simply states "The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration." It does not mention any specific performance metrics, clinical outcomes, or study results.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone studies, or ground truth establishment, as this information is not present in the provided document.

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Management of venous cuts, for example, cuts resulting from any shape objects and abrasions, other superficial injuries, superficial wounds, burns (1st and 2nd degree) donor sites, post operative wound.

vitop® Dressing

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Vitop® Dressing," indicating that the device is substantially equivalent to legally marketed predicate devices.

The letter does not contain details about specific acceptance criteria testing, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. It focuses solely on the regulatory approval.

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The intended uses of gauze sponges are absorption of blood and body fluids, wound dressing, prepping and scrubbing, and debridement. This product is patient contacting material.

GAUZE SPONGES

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding Broadline Gauze Sponges. This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document is a regulatory approval notice, not a scientific study report.

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Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.

The Crosstex Non-Woven Sponges consist of non-woven materials quarter folded into:

• 2 X 2" (light) 4-Ply
• 2 X 2" (light)
• 3 X 3" (Premium) 4-Ply
• 4 X 4" (Premium) 4-Ply
  sponges used for the absorption of liquids from the patient's skin.

The provided document describes a 510(k) submission for "Crosstex Non-Woven Sponges," which are medical sponges used for absorbing fluids. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing novel performance criteria through a study with specific acceptance criteria as would be typical for a device with a more complex functional output (e.g., an AI-powered diagnostic tool).

Therefore, many of the requested categories in your prompt are not applicable to this type of device and submission. This is a basic medical device (a sponge) where "performance" is primarily assessed through physical and biocompatibility testing against established standards and comparison to similar predicate devices.

Here's an analysis based on the provided text, indicating where information is not applicable (N/A) for this specific submission:

1. A 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)

• Test Set Sample Size: Not explicitly stated. The document refers to "testing" performed for biocompatibility and physical properties, but does not provide details on the number of sponges tested.
• Data Provenance: Not specified. Testing would typically be conducted in a laboratory setting. No country of origin for "data" is relevant in the context of a physical product's performance testing.
• Retrospective or Prospective: N/A. This is for product testing, not a clinical study on patient data.

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. This device does not involve subjective interpretation or ground truth establishment by medical experts in the way a diagnostic device would. Performance is measured objectively through standardized tests.

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

• N/A. Adjudication methods are relevant for subjective assessments (e.g., expert reads) which are not part of this device's performance evaluation.

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 a non-AI, non-diagnostic physical product. MRMC studies are not applicable.

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

• N/A. This is a non-AI physical product.

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

• The "ground truth" for this device's performance is objective measurement against established physical and chemical standards and comparison to a legally marketed predicate device's characteristics. No clinical outcomes data or expert consensus on features is mentioned or needed for this type of device.

8. The sample size for the training set

• N/A. There is no "training set" as this is not an AI/machine learning device.

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

• N/A. Not an AI/machine learning device.

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Wound cover for patient care.

Gauze, Sponges Various Sizes, Non-Sterile and Sterile

The provided text is a 510(k) premarket notification letter from the FDA regarding "Gauze Sponges." This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies typically associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request for the specific information regarding a study, as this information is not present in the provided text. The document is simply an FDA clearance for a medical device (gauze sponges) that was deemed substantially equivalent to existing devices, without the need for the types of performance studies you are asking about for AI/ML products.

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A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids.

Tracheostomy Sponge

The provided document is a 510(k) clearance letter from the FDA for a device called "Dynarex Tracheostomy Sponge." This type of document does not typically contain the detailed information necessary to answer your questions about acceptance criteria and a study proving a device meets those criteria.

510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on new clinical performance data in the way a PMA (Premarket Approval) would require.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria for the tracheostomy sponge, nor does it provide a table of reported performance. Its purpose is to state that the device is substantially equivalent to existing ones.
2. Sample size used for the test set and the data provenance: Not applicable, as a clinical study with a test set is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a physical medical dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document only states the device's Indications for Use: "A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids." The FDA's determination is based on the device being "substantially equivalent" to predicate devices already on the market, implying that it performs similarly for these stated indications.

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STARRYSHINE Gauze Sponges are intended for use to control bleeding, absorb body fluid, and protect wounds from contamination

STARRYSHINE GAUZE SPONGE Are composed of USP type VII gauze, available in the thickness of 8 ply (2" x 2") 4 ply (2" x 2"), it's non-sterile and made with 100% cotton.use in control bleeding, absorb body fluids and protect wounds from contamination.

The provided text is a 510(k) summary for a medical device (STARRYSHINE Gauze Sponges). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about a study proving the device meets specific acceptance criteria using performance data.

This type of submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study with performance metrics. For devices like gauze sponges, substantial equivalence is typically demonstrated by showing similar or identical composition, function, and intended use as an existing device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not available in the provided document.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not available. The document does not specify quantitative acceptance criteria or provide performance data.

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

• Not applicable/Not available. No test set or associated data provenance is mentioned as part of a performance study.

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

• Not applicable/Not available. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set

• Not applicable/Not available. No adjudication method is mentioned.

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

• Not applicable. This device is a gauze sponge, not an AI-powered diagnostic tool, so an MRMC study with AI assistance is irrelevant.

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

• Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

• Not applicable/Not available. No ground truth is mentioned. The equivalence is based on the characteristics of the device itself and comparison to a predicate.

8. The sample size for the training set

• Not applicable/Not available. No training set is mentioned.

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

• Not applicable/Not available. No ground truth for a training set is mentioned.

Summary of what the document implies about "meeting acceptance criteria":

The "acceptance criteria" here are implicitly centered around demonstrating substantial equivalence to an existing, legally marketed predicate device. The study that "proves" the device meets these criteria is the submission of information detailing the device's characteristics and directly comparing them to the predicate.

• Acceptance Criteria (Implicit for Substantial Equivalence):

  • Similar or identical composition (USP type VII gauze, 100% cotton).
  • Similar or identical function (control bleeding, absorb body fluids, protect wounds from contamination).
  • Similar or identical intended use (dental office or hospital setting).
  • Similar or identical physical characteristics (e.g., thickness: 8 ply, 4 ply; size: 2" x 2").
  • Safety and effectiveness comparable to the predicate device.

• Reported Device Performance (as presented for substantial equivalence):

  • The device is composed of USP type VII gauze, 100% cotton.
  • Available in 8 ply (2" x 2") and 4 ply (2" x 2").
  • Intended for use in controlling bleeding, absorbing body fluids, and protecting wounds from contamination.
  • The manufacturer states: "TC DENTAL PRODUCTS INC. has concluded that the STARRYSHINE Gauze sponges are effective and safe for their intended use and perform as well as legally marketed predicate device, Such as Surgicade Non-sterile gauze sponges."

In essence, the "study" described is the comparison to the predicate device, Surgicade TM Non-Sterile Gauze Sponges, which serves as the benchmark for establishing safety and effectiveness. No specific quantitative performance data of STARRYSHINE Gauze Sponges itself is provided beyond its descriptive attributes and intended use.

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JoAn II ™ is designed for external application for use in absorbing fluids.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device named "JoAn II™," which is described as being "designed for external application for use in absorbing fluids." This document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment, expert qualifications, or sample sizes for training or testing.

Therefore, I cannot provide the requested information. The letter only confirms that the device has been found substantially equivalent to a pre-amendment device and can be legally marketed.

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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.

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