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SPYROFLEX Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Abrasions Blisters Burns (sun burns, carpet burns, friction burns, minor chemical and heat burns) Cuts Lacerations Poison Ivy Rash Scrapes

SPYROFLEX® is a sterile, conformable, absorptive dressing. SPYROFLEX dressings consists of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while maintaining a protective moist healing environment. The wound contact surface of SPYROFLEX is a porous, non-toxic adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane acts as a reservoir for wound exudate. The outer layer performs as a barrier to bacteria, dirt, and liquids.

This document is a 510(k) summary for a wound dressing, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with acceptance criteria, expert adjudication, or MRMC studies.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable or cannot be extracted from the provided text.

Here is an attempt to address the requested information based only on the provided text, indicating where information is not present:

Acceptance Criteria and Device Performance Study for SPYROFLEX® Pigmented Wound Dressing

As this is a 510(k) submission, the primary "acceptance criterion" for market clearance is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented are primarily laboratory tests to support safety and basic functionality.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The term "laboratory tests" is used generally.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests are described as "laboratory tests."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable. The provided document does not describe studies involving human readers or expert-established ground truth for performance. The "ground truth" for the safety endpoints (non-toxic, non-irritating, non-sensitizing) would be derived directly from the results of the laboratory tests themselves rather than expert consensus on diagnostic images or similar.

4. Adjudication Method for the Test Set

• Not applicable. No human adjudication process is described for the laboratory tests mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically relevant for diagnostic imaging AI devices, not wound dressings.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a physical wound dressing, not an algorithm. Therefore, a standalone (algorithm only) performance study is not relevant or applicable. The "performance" described relates to its physical and biological properties.

7. Type of Ground Truth Used

• The "ground truth" for the safety claims (non-toxic, non-irritating, non-sensitizing) was established through laboratory test results. For example, irritation would be assessed via standard dermatological patch tests, and toxicity via cytotoxicity assays or similar.
• The "ground truth" for functional claims (absorptive, breathable, barrier properties) would also be established through physical and material science laboratory testing methodologies.

8. Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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SPYROFLEX Pigmented Wound Dressings are intended for use in the management of.
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Blisters
Incisions
Severe sunburn
Poison Ivy
Dermabrasions and other dermatologic procedures
Facelifts and other plastic surgery procedures (e.g. laser resurfacing)
Partial-thickness wounds
Superficial burns
Abrasions and lacerations
Full-thickness wounds
Skin tears
Dermal lesions
Minor chemical burns
Thermal burns

SPYROFLEX Pigmented 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.
SPYROFLEX dressings are constructed of two layers, each specifically engineered to give SPYROFLEX its unique blend of "ease of use" features while providing a microenvironment conducive to moist wound healing.
The wound contact surface of SPYROFLEX is a porous adhesive which facilitates ease of application to the wound site. A second layer consisting of a microporous polyurethane membrane absorbs and acts as a reservoir for wound exudate. This layer is also moisture vapor permeable which facilitates the reduction of exudate while maintaining a moist environment to promote optimal wound repair. SPYROFLEX is impermeable to microorganisms and liquids.

The provided text describes a medical device, SPYROFLEX® Pigmented Wound Dressing, and its intended use. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.

The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment as this information is not present in the provided document.

To summarize the parts that cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not provided.
6. If a standalone performance (algorithm only) was done: Not applicable, as this is a physical wound dressing, not an algorithm.
7. The type of ground truth used: Not applicable, as this is a physical wound dressing.
8. The sample size for the training set: Not applicable, as this is a physical wound dressing, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

The document states that "SPYROFLEX Pigmented Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing." However, no details on these "laboratory tests" (e.g., methodology, sample sizes, specific criteria, results) are provided to form acceptance criteria or their fulfillment.

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