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For Over-the-Counter Use: SilverSeal Hydrogel Wound Dressing made with X-Static is indicated for the topical management of minor superficial wounds, minor lacerations, minor abrasions and minor first degree burns.

Hydrogel Wound Dressings with X-Static are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. Hydrogel Wound Dressings with X-Static are made of flexible sterile nonadherent hydrogel consisting of water and polymer with nylon fibers coated with metallic silver suspended in the hydrogel.

The provided document is a 510(k) summary for the SilverSeal® Hydrogel Wound Dressing, a medical device. It does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.

The document states:
"Hydrogel Wound Dressing with X-Static is the same product that was cleared in K040019 as the X-Static SilverSeal Hydrogel Wound Dressing. Therefore, the performance data provided in K040019 (section 6.2 pages 12-13 of K040019) is applicable to the 510(k) and no new performance data is provided."

This means that the current submission (K171041) relies on the performance data of a previously cleared device (K040019) and does not include any new studies or performance data. Furthermore, the device is a wound dressing, not an AI or algorithm-based device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as these concepts are not applicable to the type of device and submission described in the provided text.

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MIST Systems produce a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates, and bacteria.

MIST Systems (e.g., UltraMIST System) are low frequency ultrasound devices, which utilize a fluid (e.g., saline) mist to deliver the ultrasound to the treatment site. The atomized fluid allows the treatment to be performed without direct contact to the patient. MIST Systems are made up of a main generator component, treatment wand, and disposable applicator.

MIST Systems deliver low-frequency ultrasound to the treatment site using an atomized fluid mist. The mist is generated from a small, portable system consisting of a generator, a treatment wand (encasing an ultrasound transducer), and a disposable applicator that has been designed to connect to a user-provided fluid source (e.g., IV saline bag). The system provides a flow of fluid (irrigant) to the tissue surface by the use of low frequency, low intensity ultrasound. Only the mist touches the tissue, not the ultrasound radiation surface (horn tip), thus the term "non-contact" ultrasound. The flow of fluid as an irrigant is controlled by a peristaltic pump on the generator unit. The fluid is dispensed onto the ultrasound radiation surface where the mist is generated. The mist is projected by fundamental atomization or nebulization and acoustic streaming or acoustic radiation force respectively.

The acceptance criteria and device performance evaluation details for the Alliqua Biomedical, Inc. Stimucel System (K162721) are summarized below, based on the provided 510(k) summary.

It's important to note that this submission is a 510(k) for a device with minor modifications (enclosure material change) to an already cleared predicate device (K140782, UltraMIST® System). Therefore, the study presented focuses on demonstrating that these specific modifications do not adversely affect the safety and performance, rather than establishing original effectiveness for the first time. The information provided aligns with a non-clinical testing approach to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The submission does not detail a "test set" in the traditional sense of patient data. Instead, the testing described is related to the physical and electrical performance of the device components and biocompatibility of materials.

• General Safety Testing (IEC 60601-1 3rd Ed.): Performed on the subject device to verify changes in enclosure material. This would involve specific units of the manufactured device. The exact number of units tested is not specified in the summary but is typically dictated by testing standards.
• Biocompatibility Testing (Cytotoxicity): Performed on the new enclosure materials. This involves samples of the material itself. The exact number of samples is not specified.

Data Provenance: The non-clinical testing was performed by Intertek (for general safety) and WuXi AppTec (for biocompatibility), which are accredited testing laboratories. The data is thus derived from laboratory testing of the device and its materials. This is a form of prospective testing for the specific modifications. Country of origin of the data is not explicitly stated but generally follows the location of these testing facilities.

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

This type of information is not applicable for the non-clinical testing performed for this 510(k) submission. The "ground truth" for these tests are objective measurements against established engineering and safety standards (e.g., IEC 60601-1, ISO biocompatibility standards). The results are interpreted by qualified engineers and scientific personnel at the testing laboratories (Intertek, WuXi AppTec) who specialize in these types of evaluations.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements against defined technical and safety specifications, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence for minor material changes to an existing device through non-clinical performance and safety testing. MRMC studies are typically used to evaluate the diagnostic performance of imaging devices where human interpretation is involved.

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

Not applicable. The device, UltraMIST, is a physical medical device (low energy ultrasound wound cleaner) and not a software algorithm evaluating data independently.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is based on:

• Established international standard performance requirements (e.g., IEC 60601-1 for electrical safety and performance).
• Biocompatibility standards for medical device materials (e.g., ISO standards for cytotoxicity).
• Comparison to the performance of the legally marketed predicate device (K140782), specifically demonstrating that the modified device's performance is equivalent.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for machine learning models, which is not what this device is.

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

Not applicable, as no training set was used.

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