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The AOTI Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of open acute or chronic wounds, such as;

• skin ulcerations due to diabetes, venous stasis, post surgical infections o and gangrenous lesions
• decubitus ulcers O
• amputations/infected stumps 0
• skin grafts O
• burns O
• frostbite o

The Hyper-Box Topical Wound Oxygen System is a non-invasive device intended to allow the application of topical oxygen at slightly above atmospheric (hyperbaric) pressure to wounds and ulcers of the extremities.

The provided text is a 510(k) summary for the Hyper-Box Topical Wound Oxygen System, which is a medical device. This type of submission focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, rather than presenting a clinical study to prove effectiveness based on specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

Instead, the document focuses on regulatory compliance and comparison to predicate devices.

Here's the relevant information that can be extracted from the provided text:

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

• Not Applicable. The document does not describe specific performance acceptance criteria for clinical effectiveness or report device performance against such criteria. The "combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use" refers to general regulatory compliance and engineering specifications, not clinical performance metrics.

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

• Not Applicable. No clinical test set or data provenance is mentioned in the document.

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)

• Not Applicable. No ground truth establishment by experts is described as there is no clinical test set.

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

• Not Applicable. No adjudication method is described as there is no clinical test set.

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 not an AI-assisted device, and no MRMC study is mentioned.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No clinical ground truth is described in the context of device performance evaluation.

8. The sample size for the training set

• Not Applicable. This is not an algorithm, so there is no training set.

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

• Not Applicable. This is not an algorithm, so there is no training set or ground truth for one.

Summary of what is known from the document:

• Device Name: Hyper-Box Topical Wound Oxygen System
• Intended Use: Treatment of open acute or chronic wounds, such as skin ulcerations due to diabetes, venous stasis, post surgical infections, gangrenous lesions, decubitus ulcers, amputations/infected stumps, skin grafts, burns, and frostbite.
• Classification: Class III per 21 CFR 878.5650 (Topical oxygen chamber for extremities)
• Predicate Devices (used for demonstrating substantial equivalence, not for performance comparison in a clinical study context):
  • Advanced Hyperbaric Technologies Inc. Topical Hyperbaric Oxygen Extremity Chamber (Pre-Amendment)
  • Vascular One, Inc VX-400 Topical Hyperbaric Oxygen Chamber (K022028)
  • GWR Medical O2 Boot device (K971507)
  • Metro Medical Manufacturing HEC 1000 Topical Oxygen Chamber for Extremities (K020466)
• Regulatory Basis for Clearance: Substantial equivalence to predicate devices, based on similar intended use and similar technological features, materials, and design, and compliance with various voluntary, international standards (EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994 and 93/42/EEC Medical Device Directive). Software design and development followed FDA's "Guidance for the Content of Premarket Submissions for Software contained in medical devices."

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