Search Results

Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.

Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from of skin abrasions, lacerations, minor irritations, cuts and intact skin.

Spectricept Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze).

Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the bottle in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.

Spectricept Skin and Wound Cleanser is a non-sterile aqueous solution in a 8oz PET bottle.

This document is a 510(k) clearance letter for a medical device called "Spectricept Skin and Wound Cleanser." It states that the device is substantially equivalent to a previously cleared predicate device (K213514). It is a chemical product, not an AI/ML powered device, so many of the requested categories related to AI performance are not applicable.

Here's the summary of the information provided for the Spectricept Skin and Wound Cleanser:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a chemical product clearance, the "acceptance criteria" are related to safety and performance through non-clinical testing, rather than performance metrics like sensitivity, specificity, or AUC as would be seen for an AI/ML device. The "reported device performance" indicates that the device met these criteria.

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

This is not applicable as the device is a chemical cleanser and the evaluation is based on non-clinical laboratory testing, not a dataset of patient cases. The testing involves standardized laboratory procedures and materials.

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

This is not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert labels on medical images) is not relevant here. The "ground truth" for the non-clinical tests is adherence to established international standards and laboratory protocols performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts in AI/ML performance studies. Here, the "truth" is determined by the outcome of a standardized laboratory test against a defined pass/fail criterion.

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

This is not applicable. The device is a wound cleanser, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This is not applicable. The device is a liquid chemical cleanser, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's clearance is based on:

• Established International Standards: Such as ISO 10993 series and ASTM F756 for biocompatibility.
• Pharmacopoeial Standards: Such as USP and USP for microbiological evaluation.
• Chemical Composition Analysis: Assuring the formulation is as specified.
• The comparison to the predicate device (K213514) relies on the fact that the two devices are identical in formulation, mechanism of action, and intended use, and the additional biocompatibility testing supported an extended contact time.

8. The Sample Size for the Training Set

This is not applicable. There is no concept of a "training set" for this type of device clearance. The device is a chemical product, not an AI/ML model trained on data.

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

This is not applicable as there is no training set for this device.

Ask a specific question about this device

Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.

Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, moistening, debridement and removal of foreign material including debris from of skin abrasions, minor irritations, cuts and intact skin.

Spectricent Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze).

Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.

This document is a 510(k) premarket notification for a medical device called "Spectricept Skin and Wound Cleanser." It seeks to demonstrate substantial equivalence to a legally marketed predicate device (Microcyn Plus Wound Care Solution). The information provided focuses on non-clinical testing and comparison to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria in a human population.

Therefore, many of the requested elements regarding clinical studies, human readers, and ground truth establishment in a clinical context are not applicable or extractable from this document.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in a quantitative, human performance sense, as it's primarily a non-clinical submission for substantial equivalence. Instead, it details various bench tests and biocompatibility evaluations that the device passed to demonstrate safety and effectiveness, and to show similarity to the predicate device.

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

This document describes non-clinical laboratory testing, not a clinical study involving human patient data. Therefore, the concept of a "test set" in the context of patient data, data provenance, or retrospective/prospective study design does not apply. The "samples" would refer to manufacturing lots or batches of the device product used for the various bench and biocompatibility tests. The document does not specify the number of samples used for each non-clinical test.

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)

This is not applicable as there was no clinical test set requiring expert ground truth establishment. The evaluations were based on standardized laboratory tests and their established evaluation criteria.

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

Not applicable, as there was no clinical test set for human review or adjudication.

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 submission for a wound cleanser and does not involve AI or human reader studies.

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

Not applicable. This device is a wound cleanser, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the established scientific protocols, standards (e.g., ISO, ASTM, USP), and specifications for each test. For example:

• Biocompatibility: Standards like ISO 10993 define acceptable biological responses.
• Bench Testing: Specifications for pH range, FAC levels, fill volume, and performance criteria for preservative effectiveness or time to kill.

8. The sample size for the training set

Not applicable. This is not a machine learning model, so there is no training set.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device