(726 days)
The following are approved indications:
- l: 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: Necrotizing soft tissue infections (Subcutaneous tissue, Muscle, Fascia).
- 9: Osteomyelitis (Refractory).
- 10: Radiation tissue damage (Osteoradionecrosis).
- ll. Skin grafts and flaps (Compromised).
-
- Thermal burns.
-
- Adjunctive hyperbaric oxygen in intracranial abscess.
The Wright 1000 Mono Hyperbaric Camber:
*Max operational pressure 30 PSIG.
*Constructed out of SA516-70N steel
*The 4 Large 14" Windows Constructed out of PVO Acrylic
*Hydrostatic tested at 45 PSIG.
*Welds are X-rayed
*Welds magna Flux tested after hydrostatic test.
*Manufactured by a ASME approved house and certified by ASME. Certification No. 28,352
*Manufactured under PVHO guidelines
*Manufactured under NFPA Guidelines
*Registered with National Board Of Pressure Vessel Inspectors.
*Wiring to National Electrical code.
*Electrical Testing: Electromagnetic and Safety testing Conducted.
*Spacious interior
*2 Way Communications
*Pressure and Oxygen monitoring With alarms.
*Programmable Treatment Pressure Alarms
*Variable ventilation
*Comfortable reclining chair
The provided text is a 510(k) summary for the Wright 1000 Mono Hyperbaric Chamber, a medical device. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about formal acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in the prompt regarding a clinical or performance study that proves the device meets acceptance criteria.
The 510(k) notification process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a new, dedicated study proving performance against defined acceptance criteria in the way a clinical trial or performance study would.
Therefore,Based on the provided text, I cannot describe the acceptance criteria or the study that proves the device meets them because this information is not present in the 510(k) summary. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a novel performance study against predefined acceptance criteria.
The document discusses:
- The device's physical specifications and manufacturing standards (e.g., max operational pressure, materials, testing conducted during manufacturing, certifications).
- Approved indications and contraindications for hyperbaric oxygen therapy.
- Comparison to a predicate device (HYOX System Limited 510(k) No. K874107).
The prompt asks for details that are typically found in a clinical trial report or a dedicated performance study, which are not part of this 510(k) summary document.
To directly answer your numbered points based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document lists manufacturing specifications and general indications for HBO therapy, but no specific performance acceptance criteria or outcome data from a study.
- Sample sized used for the test set and the data provenance: Not provided. No test set or study data is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No test set or ground truth establishment is referenced.
- Adjudication method for the test set: Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not provided.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This device is a physical hyperbaric chamber, so an "algorithm only" study is not applicable in this context.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
§ 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).