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APPROVED USES AND THRESHOLD LEVELS FOR THE NUMBER OF HYPERBARIC TREATMENTS (As published by the Undersea and Hyperbaric Medical Society's (UHMS) Oxygen Committee 1995)

1. Air or Gas Embolism
2. Carbon Monoxide Poisoning and Smoke Inhalation
3. Clostridial Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
5. Decompression Sickness
6. Enhanced Healing in Selected Problem Wounds
7. Exceptional Blood Loss (anemia)
8. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia)
9. Osteomyelitis (refractory)
10. Radiation Tissue Damage (Osteoradionecrosis)
11. Skin Grafts and Flaps (compromised)
12. Thermal Burns

A hyperbaric oxygen treatment ("HBOT") chamber is a pressure vessel that is large enough to accommodate a person or persons. It is capable of being energized with a gas, either air, oxygen, or a mix of the two. Therapeutic pressures are rarely more than 100 PSIG.

The chamber itself can be fabricated from steel, acrylic or any substance designed to cope with the designed working pressure of the chamber.

A HBOT chamber normally has the following features *:

• at least one doorway large enough to permit entry and exit,
• a number of windows which permit observation of the occupants,
• a pressurization and depressurization system which also serves to ventilate the interior of the chamber,
• a way of providing 100% oxygen to the patient, either by way of breathing the compartment gas when the HBOT chamber is energized by oxygen or by a mask.

The provided document 'Sands Hyperbaric Systems 510(k) Summary' describes a hyperbaric oxygen chamber and its comparison to predicate devices, primarily for the purpose of receiving 510(k) clearance from the FDA. It does not contain a study proving the device meets specific acceptance criteria in the context of clinical or performance outcomes.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and intended use. The "acceptance criteria" discussed are mainly related to manufacturing standards, safety features, and functional specifications, rather than quantitative performance metrics for disease diagnosis or treatment efficacy studies.

Therefore, many of the requested sections (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of regulatory submission and are not present in the document.

Here's a breakdown of the information that is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical sense of a clinical study, but rather lists technical specifications and safety features against which the device is compared to predicate devices. The "reported device performance" refers to its adherence to these specifications and industry standards.

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

• Not Applicable. This document is a 510(k) summary for regulatory clearance based on substantial equivalence, not a clinical study. There is no "test set" of patients or data in this context. The testing mentioned (e.g., over-pressure valve tests, window hydrostatic tests) refers to device engineering and safety validation, not clinical efficacy.

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

• Not Applicable. No ground truth in a clinical sense was established for a test set. Engineering experts were involved in the design and testing processes (e.g., Mr. Vern Rez, Professional Engineer, for window manufacturing evaluation and audit; COMBRACO for relief valve certification).

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

• Not Applicable. No clinical test set or adjudication process as typically seen in clinical studies.

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 hyperbaric chamber, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

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

• Not Applicable. Not an AI algorithm.

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

• Not Applicable. For the device's technical specifications and safety features, the "ground truth" is adherence to established engineering codes, standards (ANSI/ASME-PVHO1, NFPA-99), and internal testing results. Clinical "ground truth" (e.g., pathology, outcomes) is not assessed for the device's performance in this document, as it focuses on the chamber's safety and functionality.

8. The sample size for the training set:

• Not Applicable. Not an AI algorithm.

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

• Not Applicable. Not an AI algorithm.

Summary of the Study (510(k) Submission):

The "study" presented here is a 510(k) premarket notification submitted to the FDA to demonstrate substantial equivalence of the Sands Series III Clinical Chamber to legally marketed predicate devices (Reneau Unit/PROTEUS CHAMBER K840841 and Sechrist Model 3200P/3200PR Hyperbaric Chamber K950386).

The approach taken is a technological characteristic comparison. The manufacturer argues that the Sands Series III is as safe and effective as the predicate devices, despite some differences in dimensions, weight, maximum operating pressure, and specific design choices (e.g., internal-swinging door, acoustic communication system instead of internal speakers, specific PVHO-1 addenda for windows). The key argument is that these differences either do not raise new questions of safety and effectiveness or are mitigated by adherence to recognized standards and validated engineering practices (e.g., ASME/PVHO-1 codes for pressure vessels and windows, use of certified relief valves, rigorous testing). The document explicitly states "Assessment of Non-Clinical Performance Data" and "Assessment of Clinical Performance Data" are "Not applicable to this summary" in the context of its 510(k) submission, indicating that new clinical studies were not performed or required for this type of clearance.

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