(87 days)
The intended use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigators in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery, trauma surgery, thoracic surgery, otolaryngology, oral and maxillofacial surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted 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. These thirteen indications have been recommended for thirdparty reimbursement and most insurance carriers have established reimbursement policy based on the recommendations.
The thirteen indications are:
- Air or Gas embolism
- Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
- Decompression Sickness
- Arterial Insufficiencies Central Retinal Artery Occlusion Enhancement of Healing In Selected Problem Wounds
- Severe Anemia
- Intracranial Abscess
- Necrotizing Soft Tissue Infections
- Osteomyelitis (Refractory)
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
- Compromise Grafts and Flaps
- Thermal Burns
The Sechrist Model 4100H/HR Hyperbaric Chamber is a monoplace pressure chamber designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 ps) of pressure. The hyperbaric chamber is a mechanical and pneumatic system capable of controlling the operator defined pressurization profiles.
A hyperbaric oxygen chamber is a pressure vessel and control system that is designed to provide patient exposure to a very high oxygen concentration at higher than normal atmospheric pressure. Titration of the oxygen exposure is controlled by selecting the pressure achieved within the pressure vessel. Pressurization and de-pressurization rates are selected to minimize patient discomfort while increasing and decreasing the chamber pressure. Typical monoplace chambers are capable of pressurizing to 3 ATA (29.4 psig above atmospheric pressure). Typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute.
The Model 4100H/HR is constructed with a horizontal 41 inch internal diameter seamless acrylic cylinder. One end is equipped with a hard anodized aluminum cover and the other end with a hard anodized door assembly, with access ports available for patient interface (such as patient monitoring, delivery of intravenous fluids, etc.) locking mechanism and interlocking safety device. The cylinder, end cover and the door assembly are assembled together with stainless steel tie rods/nuts and hinge assembly. The Model 4100 comes in two configurations (4100H and 4100HR). In the Standard configuration-4100H-the control panel is located on the left of the chamber when facing the door. In the Reverse configuration-4100HR-the control panel is located on the right side of the chamber.
The Sechrist Model 4100H/HR Hyperbaric Chamber is a medical device. The provided text describes the device's technical specifications and how its performance was established, primarily through adherence to industry standards and a comparison to a predicate device for substantial equivalence.
Here's an analysis of the acceptance criteria and the study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
This device is not an AI/algorithm-based diagnostic or prognostic device that would typically have performance metrics like sensitivity, specificity, or AUC as primary acceptance criteria. Instead, its acceptance criteria are based on its ability to meet engineering specifications and comply with established industry safety and performance standards for hyperbaric chambers.
| Acceptance Criteria (based on industry standards and predicate device) | Reported Device Performance |
|---|---|
| Mechanical System Functionality: | Confirms device operates as designed. |
| - Administer 100% oxygen at pressures > ambient, up to 3 ATA (30 psig). | Capable of administering 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psig) of pressure. |
| - Control operator-defined pressurization profiles. | Mechanical and pneumatic system capable of controlling operator defined pressurization profiles. |
| - Typical pressurization/de-pressurization rates (0.4 to 5.0 psig/minute). | Typical monoplace chambers are capable of pressurizing to 3 ATA. Typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute. (Implies adherence to typical rates). |
| Construction and Design Compliance: | |
| - Horizontal 41-inch internal diameter seamless acrylic cylinder. | Constructed with a horizontal 41-inch internal diameter seamless acrylic cylinder. |
| - End cover and door assembly (hard anodized aluminum, access ports, locking mechanism, interlocking safety device). | One end equipped with a hard anodized aluminum cover and the other end with a hard anodized door assembly, with access ports, locking mechanism, and interlocking safety device. |
| - Assembly method (stainless steel tie rods/nuts and hinge assembly). | Cylinder, end cover and door assembly are assembled together with stainless steel tie rods/nuts and hinge assembly. |
| - Two configurations (4100H, 4100HR) for control panel location. | Comes in two configurations (4100H and 4100HR) for control panel location. |
| Safety and Quality Manufacturing Standards: | Device functioned as intended per approved specifications. |
| - Adherence to ASME Boiler and Pressure Vessel Code, Section VIII, Division 1. | Designed and manufactured in accordance with ASME Boiler and Pressure Vessel Code. |
| - Adherence to ASME PVHO-1 Pressure Vessels for Human Occupancy Standard. | Designed and manufactured in accordance with ASME PVHO-1 Standard. |
| - Adherence to NFPA 99 Safety Standard for Health Care Facilities, Chapter 20. | Designed and manufactured in accordance with NFPA 99. |
| Quality Assurance Measures Applied: | Requirements specifications reviews, performance testing and validation, environmental testing, electrical safety/EMC testing, manufacturing process control procedures, process validation, and design controls were applied. |
| Substantial Equivalence to Predicate Device (Sechrist Model 3200P/PR): | Model 4100H/HR is as safe and effective as the predicate. The Model 4100H/HR has the same intended uses, similar technological characteristics, and similar principles of operation. Minor technological differences raise no new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
This device is a hardware medical device, not a software algorithm that processes data. Therefore, the concept of a "test set" with data provenance (country of origin, retrospective/prospective) as seen in AI/diagnostic studies is not directly applicable.
The "testing" here refers to engineering and functional testing of the physical device and its control systems. The document states "Performance testing conducted confirms the device operates as designed." It also mentions "environmental testing, electrical safety/EMC testing." These tests would involve samples of the manufactured device itself, rather than a dataset of patient information. The number of devices tested is not specified, but typically this would involve a limited number of production or pre-production units to demonstrate compliance with specifications.
Data Provenance: Not applicable in the context of diagnostic data. The "data" here would be measurements from physical tests on the hyperbaric chamber.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a hardware device like a hyperbaric chamber, "ground truth" is established by engineering specifications, validated safety standards, and functional performance benchmarks (e.g., pressure achieved, oxygen concentration, integrity of seals). There isn't a "ground truth" established by human experts in the way that clinical images are adjudicated. The experts involved would be engineers, safety specialists, and regulatory affairs personnel who design, test, and approve the device against these objective criteria.
The "intended use" indications are established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. This committee is described as being comprised of practitioners and scientific investigators in various medical fields. While they define the clinical indications for which the device can be used, they do not establish "ground truth" for the device's technical performance.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among human readers establishing ground truth for diagnostic or prognostic studies. This device's performance is verified against objective physical and 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 a hyperbaric chamber, not an AI or diagnostic tool designed to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device, not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is its adherence to:
- Engineering Specifications: Designed parameters like internal diameter, pressure capabilities, material specifications.
- Industry Standards: Compliance with Section VIII, Division 1 of ASME Boiler and Pressure Vessel Code, ASME PVHO-1, and NFPA 99. These are highly detailed and rigorously defined safety and performance standards for pressure vessels and healthcare facilities.
- Predicate Device Equivalence: The performance of the new device is compared to a legally marketed predicate device (Sechrist Model 3200P/PR Hyperbaric Chamber) to demonstrate "substantial equivalence" in terms of safety and effectiveness.
The "ground truth" for the intended uses of hyperbaric chambers (the thirteen indications listed) is established by the clinical consensus and research findings accepted by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. This is based on:
- Sound physiologic rationale
- In vivo or in vitro studies
- Controlled animal studies
- Prospective controlled clinical studies
- Extensive clinical experience
8. The sample size for the training set
Not applicable. This is a hardware device, not an algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. No training set is used for this type of 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).