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Radio BioAquaCare™ is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.

Under the direction of a health care professional, Radio BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, radiation dermatitis, and (2) 2nd degree burns and donor sites.

Radio BioAquaCare™ is intended for single use only. Radio BioAquaCare™ is not intended for treatment of third degree burns.

Radio BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG.Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in Radio BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. Radio BioAquaCare™ contains up to 85% water which enables the dressing to provide a moist environment even if the wound bed is dry. Radio BioAquaCare™ will not breakdown during use, so all of the Radio BioAquaCare™ components are removed from the wound when the dressings are removed. Radio BioAquaCare™ does not include any medicinal substance, animal/human tissue, or biologics. Radio BioAquaCare™ is supplied with gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.

Radio BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. Radio BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 8 cm x 10 cm, 8 cm x 20 cm, 8 cm x 27 cm, 8 cm x 30 cm, 8 cm x 40 cm, 8 cm x 50 cm, 10 cm x 10 cm, 10 cm x 20 cm, 10 cm x 27 cm, 10 cm x 30 cm, 10 cm x 40 cm, 10 cm x 50 cm, 15 cm x 10 cm, 15 cm x 20 cm, 15 cm x 30 cm, 15 cm x 40 cm, or 15 cm x 50 cm). Radio BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 lean room environment.

Here is the breakdown of the acceptance criteria and study information for BAGTech's Radio BioAquaCare™, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria for the Radio BioAquaCare™ device. Instead, it relies on demonstrating technological identity and substantial equivalence to previously cleared predicate devices. The performance is described in qualitative terms, asserting that the device "functioned as intended and the performance observed was as expected" based on the validation of prior studies.

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

The document does not specify a distinct "test set" with a defined sample size for Radio BioAquaCare™. The performance data presented for Radio BioAquaCare™ is based on extrapolation from studies conducted on its predecessor, BioAquaCare™. The nature of these studies (in vitro and animal studies) is mentioned, but no sample sizes or data provenance (country of origin, retrospective/prospective) are provided for these underlying studies.

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

Not applicable. The filing does not describe a test set or the involvement of experts for ground truth establishment. The device's performance is asserted based on existing studies of a prior, technologically identical device.

4. Adjudication method for the test set

Not applicable. There is no described test set or adjudication process.

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 hydrogel wound dressing, not an AI-assisted diagnostic or imaging device, so MRMC studies are not relevant.

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

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

7. The type of ground truth used

For Radio BioAquaCare™ itself, the "ground truth" is established through technological identity to the predicate device, BioAquaCare™. The assumption is that because Radio BioAquaCare™ is "technologically identical" to BioAquaCare™, the performance observed in BioAquaCare™'s in vitro and animal studies (which would have used various experimental endpoints as their "ground truth") is directly applicable. The document does not detail the specific ground truths of those underlying studies (e.g., pathology, measured outcomes).

8. The sample size for the training set

Not applicable. This is a medical device (wound dressing), not an AI/ML model, so there is no concept of a "training set" in this context.

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

Not applicable. As above, there is no "training set" for this device.

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BioAquaCare™ is an hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.

Under the direction of a health care professional, BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and diabetic ulcers; and (2) 2nd degree burns and donor sites.

BioAquaCare™ is intended for single use only.

BioAquaCare™ is not intended for treatment of third degree burns.

BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG-Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. BioAquaCare™ contains up to 95% water which enables the dressing to provide a moist environment even if the wound bed is dry. BioAquaCare™ will not breakdown during use, so all the BioAquaCare™ components are removed from the wound when the dressings are lifted away. BioAquaCare™ does not include any medicinal substance, animal/human tissue or biologics. BioAquaCare™ is supplied either with or without medical grade gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.

BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 10 cm x 10 cm, 8 cm x 20 cm, 10 cm x 20 cm, or 10 cm x 27 cm). BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 clean room environment.

The medical device described in the provided text is BioAquaCare™, a hydrogel wound dressing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the BioAquaCare™ device. Instead, it describes general performance observations from "various in vitro and animal studies." The primary claim is substantial equivalence to predicate devices, implying that its performance is at least comparable.

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

The document states "Various in vitro and animal studies were conducted." However, it does not provide specific sample sizes for these studies. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

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

The document does not mention using experts to establish ground truth for a test set. This type of device (hydrogel wound dressing) would typically involve laboratory testing and animal models, rather than clinical studies requiring expert adjudication of images or patient data to establish ground truth.

4. Adjudication Method for the Test Set

Since there is no mention of expert involvement in establishing ground truth for a test set, there is no adjudication method described.

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

An MRMC comparative effectiveness study was not mentioned or indicated to have been performed. This type of study is more common for diagnostic imaging devices where human readers interpret results.

6. Standalone Performance Study

The document describes "various in vitro and animal studies" to characterize the device's performance, implying a standalone algorithm/device performance evaluation rather than a human-in-the-loop study. The phrase "BioAquaCare™ functioned as intended and the performance observed was as expected" refers to the device's intrinsic characteristics.

7. Type of Ground Truth Used

The ground truth for the performance studies was likely established through laboratory measurements and direct observation of biological responses in animal models. For example, biocompatibility would be assessed using established assays, and wound healing effectiveness would be measured by physiological parameters and visual assessment in animal subjects. The document does not explicitly state "expert consensus," "pathology," or "outcomes data" in the context of ground truth for these studies, but rather focuses on characterizing the device's function.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device is not an AI/ML algorithm that requires training data. It is a physical medical device (a wound dressing).

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

As the device is not an AI/ML algorithm, there is no training set and therefore no ground truth established for a training set.

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