(53 days)
Avitar Hydrasorb Sterile Dressings are external wound dressings designed to provide a moiest healing environment, manage exudate, and protect the wound from contamination. Hydrasorb Sterile Dressings are indicated as external wound dressings for use in the local management of external wounds such as post surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, superficial burns, other external wounds inflicted by trauma, and as a secondary dressing or cover dressing for packed wounds. Hydrasorb Sterile Dressing -Fenestrated also absorbs fluid quickly and efficiently and maintains a moist wound healing environment. is an ideal dressing in the local management of exudate that may occur at surgically induced body drainage sites such as a tracheostomy, G-tube, J-tube, Penrose drain, chest tube, nephrotomy tube, or sump In generallit can be used anywhere there is a need to manage drain. the surrounding skin due to potential skin irritation or maceration.
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The provided document is a 510(k) premarket notification decision letter from the FDA regarding the Avitar Technologies, Inc. Hydrasorb™ Sterile Dressings. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, much of the requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not typically part of a 510(k) submission and is not present in the provided text.
The document states that the Avitar Hydrasorb™ Sterile Dressings are "comparable in their effectiveness" to several predicate devices. This statement of comparability constitutes the "acceptance criteria" in the context of a 510(k) – that the new device performs as well as, or no worse than, an existing device.
Here's a breakdown of what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance |
|---|---|
| Comparable in effectiveness to legally marketed predicate devices. | Avitar Technologies, Inc. Hydrasorb™ Sterile Dressings are comparable in their effectiveness to: Lyofoam Sterile Dressings (Acme United Corporation)Epi-Lock Wound Dressings (Calgon Vestal Laboratories)Allevyn Hydrophilic Polyurethane Foam (Smith & Nephew, Inc.) The product is also stated to be "the same product as Hydrasorb Sterile Dressings distributed by Calgon Vestal." |
| Provide a moist healing environment. | The device is designed to provide a moist healing environment. |
| Manage exudate. | The device is designed to manage exudate. Hydrasorb Sterile Dressing - Fenestrated also absorbs fluid quickly and efficiently and maintains a moist wound healing environment, making it ideal for managing exudate at surgically induced body drainage sites. |
| Protect the wound from contamination. | The device is designed to protect the wound from contamination. |
| Indicated for various external wounds. | Indicated as external wound dressings for use in the local management of external wounds such as post surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, superficial burns, other external wounds inflicted by trauma, and as a secondary dressing or cover dressing for packed wounds. For the fenestrated version: indicated for use anywhere there is a need to manage exudate around surgically induced body drainage sites (e.g., tracheostomy, G-tube, J-tube, Penrose drain, chest tube, nephrotomy tube, or sump drain) to reduce potential skin irritation or maceration. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. A 510(k) submission primarily relies on non-clinical data and comparison to predicate devices, and often does not include detailed clinical study data with specific test set sample sizes.
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 information is not provided in the document. The concept of "ground truth" established by experts for a test set is typically associated with clinical studies, especially those involving diagnostic devices or AI, which are not the focus of this 510(k) for a wound dressing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are relevant to clinical studies involving human interpretation or assessment, which is not described here.
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
An MRMC study is not mentioned and is not applicable to this type of device (wound dressing) or regulatory submission (510(k)). This type of study is usually for AI-powered diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" algorithm performance is not applicable to this device. This term refers to the performance of artificial intelligence algorithms, which are not involved in this wound dressing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily relies on the physical and functional characteristics of the device and comparison to predicate devices. There is no explicit mention of a "ground truth" in the context of expert consensus, pathology, or outcomes data for a specific test set within this 510(k) summary. The "ground truth" for "effectiveness" is implicitly defined by the established performance of the predicate devices.
8. The sample size for the training set
This information is not provided and is not applicable. The concept of a "training set" (in the context of machine learning or AI) is not relevant to this traditional medical device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the same reasons as point 8.
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