(29 days)
The intended use of the Sechrist Model 3300E/ER Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure. Specific indications for use of hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. The current specific thirteen indications are: 1. Air or Gas Embolism 2. Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by Cyanide Poisoning 3. Clostridial Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias 5. Decompression Sickness 6. Enhancement of Healing in Selected Problem Wounds 7. Exceptional Blood Loss (Anemia) 8. Intracranial Abscess 9. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia) 10. Osteomyelitis (Refractory) 11. Radiation Tissue Damage (Osteoradionecrosis) 12. Skin Grafts and Flaps (Compromised) 13. Thermal Burns
The Model 3300E/ER Hyperbaric Chamber is a monoplace (one patient) pressure chamber designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure. The Model 3300E/ER Hyperbaric Chamber is constructed with a horizontal seamless acrylic inner cylinder. One end is equipped with a hard anodized aluminum cover and the other with a hard anodized aluminum door assembly, with access ports available for patient support (such as patient monitoring and delivery of intravenous fluids). The control system is pneumatic/electronic containing the controls, indicators, chamber pressure display gauges, and intercom assembly.
The provided documents describe a 510(k) submission for the Sechrist Model 3300E/ER Hyperbaric Chamber. This documentation focuses on demonstrating substantial equivalence to a predicate device and adherence to industry standards, rather than presenting a study to prove acceptance criteria for device performance in terms of diagnostic accuracy or AI-assisted improvement.
Therefore, many of the requested elements regarding acceptance criteria for device performance studies (such as sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable to this type of regulatory submission for a hyperbaric chamber.
However, I can extract the information that is relevant to the device's "acceptance criteria" and the "study" that proves it meets those criteria, based on the provided text, which largely revolves around regulatory compliance and adherence to established standards.
Here's the information as it relates to the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Compliance with Standards/Characteristics) | Reported Device Performance (Demonstrated Compliance/Characteristics) |
|---|---|
| Intended Use: Administer 100% oxygen at pressure > ambient, up to 3 atmospheres absolute (30 psi). | The device is designed to administer 100% oxygen at pressure > ambient, up to 3 atmospheres absolute (30 psi). |
| Safety and Manufacturing Standards: | The device is designed and manufactured in accordance with: |
| - ASME Boiler and Pressure Vessel Code, Section VIII, Division 1 | - Explicitly stated as compliant. |
| - ASME PVHO-1 Pressure Vessels for Human Occupancy Standard | - Explicitly stated as compliant. |
| - NFPA 99 Safety Standard for Health Care Facilities, Chapter 20 | - Explicitly stated as compliant. |
| Quality Assurance Measures: | Applied during development: |
| - Requirements specification reviews | - Applied. |
| - Performance testing and validation | - Applied. |
| - Environmental testing | - Applied. |
| - Electrical safety/EMC testing | - Applied. |
| - Manufacturing process control procedures | - Applied. |
| - Process validation | - Applied. |
| - Design change controls | - Applied. |
| Substantial Equivalence: | Demonstrated substantial equivalence to: |
| - Sechrist Industries, Inc. Model 3200P/PR (K950386) | - Stated as substantially equivalent. |
| - Several pre-amendment products | - Stated as substantially equivalent. |
| Design Features & Materials: Similar to predicate. | Stated as having similar design features and materials to predicate and pre-amendment devices. |
| Functionality: Similar to predicate. | Stated as having similar functionality to predicate device. |
| Indications for Use: Supported by Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. | The device is intended for the thirteen specific indications established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a medical device (hyperbaric chamber), not a diagnostic or AI device that would typically involve a "test set" of patient data for performance evaluation in the context of diagnostic accuracy. The "testing" referred to is engineering and manufacturing compliance testing.
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 "test set" or diagnostic ground truth was established for this device in the provided document. The "ground truth" for the indications for use was established by a committee of experts (see point 7).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No "test set" or adjudication of diagnostic outcomes was performed or described.
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-powered diagnostic device, and no MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device (hyperbaric chamber), not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the indications for use is established by expert consensus from the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. This committee is comprised of practitioners and scientific investigators in various medical fields. Their recommendations for the thirteen specific indications are based on "sound physiologic rationale, in vivo or in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers."
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable. This is not a machine learning or AI device.
§ 868.5470 Hyperbaric chamber.
(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).