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The Flexi-Lite Hyperbaric chamber is a hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician. Caution: Federal law restricts this device to sale by or on the order of a physician.

The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 4 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523/1023 "oil-less, breathable air compressor" to pressurize the chamber and provide a suitable environment for the occupant. The Flexi-Lite construction utilizes a dual bag design with the inner the ooonpining the pressure and an exterior bag to provide structural support. All components are attached to the inner bag utilizing bulkhead connections. It is outfitted with two externally mounted metal relief valves (set at 4 psi), two metal Air addition valves (one external & one internal), two metal depressurization valves (one external & one internal), two pressure gauges (one external & one internal), and one metal Air sampling port. In total it weighs 39 lbs (compressor adds another 54 lbs).

Here's an analysis of the provided text regarding the Flexi-Lite Hyperbaric Chamber (K101262), focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the device is a hyperbaric chamber, not an AI/ML-driven device, diagnostic algorithm, or medical imaging analysis tool. Therefore, many of the requested categories related to algorithm performance, expert review, and ground truth for AI studies are not applicable to this submission.

The document describes a traditional medical device submission for substantial equivalence to a predicate device. The "acceptance criteria" discussed are primarily related to the device's functional and safety characteristics compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: "SE" indicates Substantially Equivalent to the predicate device, K051759.

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

The document explicitly states: "Bench testing was performed as determined by the hazard analysis." This indicates physical testing on the device itself.

• Sample Size for Test Set: Not explicitly stated for each test, but it would typically involve one or more physical units of the Flexi-Lite hyperbaric chamber. The nature of bench testing implies testing of representative product units rather than a "data set" in the context of an algorithm.
• Data Provenance: The testing was non-clinical, meaning it focused on engineering performance and safety. It doesn't involve patient data, country of origin of data, or retrospective/prospective studies in the sense of clinical trials. The data would originate from the manufacturer's internal testing facilities or an accredited testing lab.

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

Not applicable. The "ground truth" for this type of device (a physical hyperbaric chamber) is its functional performance, safety features (e.g., relief valve settings), and material specifications, as validated by engineering tests against predetermined criteria or predicate device specifications. This doesn't involve "experts" establishing ground truth in the way a diagnostic algorithm requires clinical expert consensus.

4. Adjudication method for the test set

Not applicable. This is not a comparative clinical study requiring adjudication of interpretations. Bench testing results are typically objective measurements or pass/fail determinations based on engineering standards.

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 not an AI-assisted diagnostic tool. No MRMC study was performed as it is not relevant to a hyperbaric chamber.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's substantial equivalence determination relies on:

• Engineering Specifications: Adherence to defined physical dimensions, material properties, pressure ranges, and component functionality (e.g., relief valve settings).
• Safety Standards: Compliance with recognized safety standards relevant to medical devices and pressure vessels.
• Predicate Device Equivalence: Direct comparison of features and performance parameters to a legally marketed predicate device (Flexi-Lite Hyperbaric Chamber K051759). The predicate device itself serves as the benchmark for acceptable performance and safety.
• Hazard Analysis: Identification and mitigation of potential hazards, with "bench testing" verifying that these mitigations are effective.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this device.

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To provide mild hyperbaria for the treatment of Acute Mountain Sickness (AMS) and its associated mild symptoms. The Flexi-Lite Hyperbaric chamber is a rugged & portable hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician.

The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 5 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523 "oiless, breathable air compressor" to pressurize the chapplice und provide a suitable environment for the occupant. The Flexi-Lite construction utilizes and bag design with the inner bag containing the pressure and an exterior hag to provide structural support. All components are attached to the inner bag utilizing oulkhead connections. It is outfitted with two externally mounted metal relief valves (set out nedit two metal Air addition valves (one external & one internal), two metal depressurization valves (one external & one internal), two pressure gauges (one external & one internal, and one metal Air sampling port. In total it weighs 39 lbs (compressor adds another 54 lbs).

This document is a 510(k) premarket notification for the Flexi-Lite Hyperbaric Chamber, seeking to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria for a study demonstrating device performance, nor does it present results from such a study.

Instead, the submission focuses on comparing the new device's attributes, intended use, and specifications to existing, predicate hyperbaric chambers to argue for substantial equivalence. The FDA letter confirms the determination of substantial equivalence based on the provided information, allowing the device to be marketed.

Therefore, I cannot provide the requested information about acceptance criteria and study results because this type of information is not present in the provided text. The document is a regulatory submission for market clearance, not a clinical or performance study report.

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