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The following indications for use are for Over The Counter Use: Superficial Abrasions, Scrapes, Cuts, and Lacerations Minor Burns and scalds

Spyrogel Hydrogel Wound and Burn Dressings are sterile individually packaged hydrogel dressings.

The provided 510(k) summary for the Spyrogel® Hydrogel Wound and Burn Dressing does not contain information on acceptance criteria or a study proving that the device meets such criteria. This document is a premarket notification for a Class I device seeking substantial equivalence to existing products, rather than demonstrating performance against specific metrics through clinical trials.

The summary primarily focuses on:

• Description of the Device: Spyrogel® Hydrogel Wound and Burn Dressings are sterile, individually packaged hydrogel dressings.
• Intended Use: Over-the-counter use for superficial abrasions, scrapes, cuts, lacerations, minor burns, and scalds.
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to Spenco's 2nd Skin Moist Burn Pads and Johnson and Johnson's Nu-Gel, which are self-adhesive wound dressings for a wide variety of wounds.
• Safety Tests: Laboratory tests showed the device to be nontoxic, nonirritating, and nonsensitizing.
• FDA Response: The FDA letter confirms the substantial equivalence and outlines labeling limitations (e.g., not for third-degree burns, not to claim accelerated healing, not as a long-term dressing or artificial skin, not a treatment/cure).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as these details are not present in the provided text. The document indicates a regulatory pathway based on substantial equivalence, which often relies on demonstrating similarity to a predicate device rather than presenting detailed performance metrics from new clinical studies against predefined acceptance criteria.

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Spyrosorb Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of partial and full thickness wounds.

The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers
Diabctic ulcers
Pressure sores
Donor sites
Burus, Minor and Chemical
Abrasions and laccrations
Incisions

The following indications for use are for Over The Counter Use:
Superficial Abrasions, Scrapes, Cuts, and Laccrations
Minor Burns

Spyrosorb Foam Island Wound Dressings are sterile, absorplive dressings.

Spyrosorb combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable.

The wound contact surface of Spyrosorb is an absorptive foam island dressing. A second layer consisting of a microporous polyurethane self adhesive membrane facilitates the case of application to the wound site. The outcrmost layer acts as a barner to exogenous moisture and bacteria while allowing permeability to moisture vapor and oxygen.

This document is a 510(k) summary for the Spyrosorb® Foam Island Wound Dressing, an unclassified medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment typically found in comprehensive pre-market approval studies for novel devices or software.

Therefore, much of the requested information regarding acceptance criteria and study details cannot be extracted from the provided text. The submission primarily emphasizes the device's characteristics and intended use, comparing them to already marketed dressings.

Here's a breakdown of what can and cannot be answered based on the input:

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

The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, or accuracy that would require such a table. It states:

• "Spyrosorb Foam Island Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing."

This is a general statement about safety testing, not performance against specific clinical or technical acceptance criteria for wound healing efficacy or absorption rates, for example.

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

The document does not detail any specific clinical test sets, sample sizes, or data provenance for performance evaluation. The "laboratory tests" mentioned are general safety tests.

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)

Not applicable. The submission does not describe a study involving expert-established ground truth for device performance.

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

Not applicable. No such clinical test set is described.

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 is a medical dressing, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a medical dressing, not an algorithm.

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

Not applicable. The document refers to "laboratory tests" for safety (nontoxicity, nonirritation, nonsensitization), not performance requiring clinical ground truth.

8. The sample size for the training set

Not applicable. This is a medical dressing, not a device requiring a training set in the context of machine learning.

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

Not applicable. See point 8.

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Prescription Use: SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Venous stasis ulcers, Diabetic ulcers, Pressure sores, Donor sites, Blisters, Incisions, Severe sunburn, Poison Ivy, Partial-thickness wounds, Superficial burns, Abrasions and lacerations, Full-thickness wounds, Skin tears, Dermal lesions, Minor chemical burns, Thermal burns.

Over-The-Counter Use: SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Abrasions, Superficial Blisters, Minor Burns, Superficial Cuts, Superficial Lacerations, Superficial Scrapes, Minor Rash.

SPYROFLEX Foam Island Wound Dressings are sterile, absorptive dressings. SPYROFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. The wound contact surface of SPYROFLEX is an absorptive foam island dressing. A second layer consisting of a microporous polyurethane self adhesive membrane facilitates the ease of application to the wound site. This layer is moisture vapor permeable and impermeable to microorganisms and liquids.

The provided text is a 510(k) summary for the SPYROFLEX® Foam Island Wound Dressing, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria, performance metrics, or ground truth establishment typically associated with AI/software devices.

Therefore, the requested information (points 1-9) about acceptance criteria, study findings, sample sizes, expert qualifications, and ground truth establishment is not available in the provided document.

The document does state:

• Device Performance: "SPYROFLEX Foam Island Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing." However, no specific acceptance criteria or detailed results of these laboratory tests are provided.
• Substantial Equivalence: The primary "study" is the demonstration of substantial equivalence to SPYROFLEX Pigmented Wound Dressings and Tielle Hydropolymer Dressings. This is based on similar indications for use, material properties (absorptive foam, microporous polyurethane self-adhesive membrane), and functional characteristics (provide absorption and breathability, conformable, sterile).

Without clear acceptance criteria or a detailed study report, it's impossible to fill out the table or answer the specific questions posed.

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