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 indications are:

Air or Gas Embolism
Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by Cyanide Poisoning
Clostridial Myonecrosis (Gas Gangrene)
Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
Decompression Sickness
Enhancement of Healing in Selected Problem Wounds
Exception Blood Loss (Anemia)
Intracranial Abscess
Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia)
Osteomyelitis (Refractory)
Radiation Tissue Damage (Osteoradionecrosis)
Skin Grafts and Flaps (Compromised)
Thermal Burns

Device Description

The model RST*200(™) hyperbaric chamber is a monoplace (one person) pressure chamber designed to be pressurized with air while is a monoplace (one person) presure chamber designed atmospheres absolute, ATA). atmospheres absolute, ATA).
The chamber comes with fixed tray system with comfortable custom mattress. The patient tray system is designed to accommodate a lying or sitting patient during a hyperbaric tray chamber is designed to accommodate a lying or sitting patient treatment. The chamber is designed to administer all of the standard treatment protocols for 3 ATA or less. The or less. The chamber includes the following sub systems:

Pressurization, Depressurization and Ventilation: This system includes pneumatically controlled valves and components. These valves and controls are used to control the pressurization rate and components. These valves and control and
Communications and Entertainment: The chamber is equipped with a system to facilitate clear and easy communication between the patient and changer operator. The communication system also permist the use of an auxiliary audion input for patient entertainment. Patient entertainment is anternational in input for patient entertainment Patient entertainment is automatically muted when withing audion the hand set from its cradle.
Windows: The chamber windows are positioned and sized to provide a feeling of comfort and spaciousness to
Oxygen Breathing System: The chamber is equipped with the necessary controls to administer oxygen to the patient whereby the patient wears a standard medical oxygen hood or mask.

AI/ML Overview

This document is a 510(k) premarket notification for the RSI 4200 (TM) MONOPLACE Hyperbaric Chamber. It describes the device, its indications for use, and a summary of substantial equivalence to predicate devices. However, this document does not contain any information about a study proving the device meets acceptance criteria in the way you've described for an AI/CAD diagnostic device.

Here's why and what information is missing:

This document describes a physical medical device (a hyperbaric chamber), not a diagnostic AI or software device. The concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as it applies to an AI/CAD system (e.g., performance metrics like sensitivity, specificity, F1-score, sample size of test sets, ground truth establishment by experts, MRMC studies) is not applicable to this type of submission.

Instead, for a physical device like a hyperbaric chamber, "acceptance criteria" are generally related to:

Compliance with recognized industry standards: As listed in the document (ASME Boiler and Pressure Vessel Code, ASME PVHO-1, NFPA 99).
Performance specifications: Such as maximum operating pressure, pressurization/depressurization rates, communication system functionality, oxygen delivery capability, safety features, and material integrity. These are typically verified through engineering tests, material certifications, and functional checks during manufacturing and quality control.
Substantial equivalence to predicate devices: The primary method for FDA clearance for Class II devices like this is demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to prove efficacy from scratch.

Therefore, many of the specific questions you've asked are not addressed (and wouldn't typically be expected to be addressed) in this type of 510(k) submission for a physical medical device.

However, I can extract the relevant information that is present, framed as closely as possible to your request, and explicitly state what is not available due to the nature of the device and document.

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Compliance with Standards/Requirements)	Reported Device Performance/Compliance
Industry Standards:
1. ASME Boiler and Pressure Vessel Code, Section VIII, Division 1	Designed and manufactured in accordance with this standard. Vessel construction is similar to predicate devices (Millennium series) and is in accordance with this code.
2. ASME PVHO-1 Pressure Vessels for Human Occupancy Standard	Designed and manufactured in accordance with this standard. Windows are designed to meet the applicable sections of PVHO.
3. NFPA 99 Safety Standard for Health Care Facilities, Chapter 20	Designed and manufactured in accordance with this standard. Communication system designed to meet requirements of NFPA 99 Chapter 20 for hyperbaric facilities.
Functional/Design Requirements (Implicit in Substantial Equivalence):
1. Ability to be pressurized with air to 3 ATA or less	Device description states it is designed to be pressurized to atmospheres absolute (ATA) and administer standard treatment protocols for 3 ATA or less.
2. Accommodate a lying or sitting patient	Patient tray system designed for this purpose.
3. Control pressurization, depressurization, and ventilation rates	System includes pneumatically controlled valves and components for this purpose.
4. Facilitate clear patient-operator communication	Equipped with a communication system for this purpose; operation similar to Sechrist 2500B predicate device. Automatically mutes entertainment when handset taken off-cradle.
5. Provide patient comfort and spaciousness (windows)	Windows positioned and sized to achieve this.
6. Administer oxygen to the patient (via hood/mask)	Equipped with necessary controls for this.
7. Substantial equivalence to predicate device pressure controls, communication system, and vessel construction	Pressure controls are "very similar" to predicate devices (Sechrist 2500B, Millennium series). Communication system "similar" to Sechrist 2500B. Vessel construction "similar" to Millennium series predicate devices and in accordance with ASME code. RSI accepts it is substantially equivalent to predicate devices and safe and effective.

For the following points, the information is not applicable or not present in the provided document, as it pertains to AI/CAD diagnostic studies, not physical medical devices cleared via substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. This document describes a physical hyperbaric chamber, not a diagnostic algorithm. There is no "test set" of data in the context of an AI/CAD study. Performance is demonstrated through compliance with engineering standards and comparison to predicate devices.

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 ground truth establishment for a diagnostic test set is mentioned or required for this type of device. The "ground truth" for a hyperbaric chamber's safety and effectiveness is its adherence to recognized engineering and safety standards, and its proven performance in predicate devices.

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

Not Applicable. No diagnostic test set or adjudication process is mentioned.

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 a physical medical device. MRMC studies are for evaluating the impact of AI on human reader performance in diagnostic tasks.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

Not Applicable (in the context of AI/CAD). For this device, "ground truth" for safety and performance relies on engineering principles, compliance with established industry standards (ASME, NFPA, PVHO), and successful track records of predicate devices.

8. The sample size for the training set:

Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning.

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

Not Applicable. See point 8.

Summary

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RSI 4200 (TM) MONOPLACE Hyperbaric Chamber: 510(K) Submittal Section: Summary

510(k) Summary

as required by 807.92(c) Date: 12/30/2010

Product: Monoplace Hyperbaric Chamber RS14200 (m) Model: 510K Number: K102831

General Information:

Classification: Class II, CBF AN (73), Anesthesiology Panel (Title 21, CFR 868.5470)

Trade Name: Chamber, Hyperbaric
Owner: Reimers Systems Inc. 8210-D Cinder Bed Rd. Lorton VA 22079 703-952-0240
Nayil Alam Contact: Electrical Engineer 703-952-0240 nayil@reimerssystems.com

Performance Standards:

A performance standard under Section 514 has not been promulgated for this device type. However, the device is designed and manufactured in accordance with the following industry standards:

ASME Boiler and Pressure Vessel Code, Section VIII, Division 1 .
ASME PVHO-1 Pressure Vessels for Human Occupancy Standard . Regulation Number: 868.5470
NFPA 99 Safety Standard for Health Care Facilities, Chapter 20 . Regulation Number: 868.5470

Predicate Devices: 807.92(a)(3)

i. Sechrist Industries Model 2500B (K934164)
ii. Millennium 2000, 2001, 2002, 2003, 2004, 2005 (K041007)

1.4

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Device Description: 807.92(a)(4)

The chamber comes with fixed tray system with comfortable custom mattress. The patient tray system is designed to accommodate a lying or sitting patient during a hyperbaric tray
chamber is designed to accommodate a lying or sitting patient treatment. The chamber is designed to administer all of the standard treatment protocols for 3 ATA or less. The or less. The chamber includes the following sub systems:

Pressurization, Depressurization and Ventilation: 1 .

This system includes pneumatically controlled valves and components. These valves and controls are used to control the pressurization rate and components. These valves and control and

2. Communications and Entertainment:

The chamber is equipped with a system to facilitate clear and easy communication between the patient and changer operator. The communication system also permist the use of an auxiliary audion
input for patient entertainment. Patient entertainment is anternational in input for patient entertainment Patient entertainment is automatically muted when withing audion
the hand set from its cradle. the hand set from its cradle.

3. Windows:

The chamber windows are positioned and sized to provide a feeling of comfort and spaciousness to

4. Oxygen Breathing System:

The chamber is equipped with the necessary controls to administer oxygen to the patient whereby the patient wears a standard medical oxygen hood or mask.

{2}------------------------------------------------

Indications For Use:

1. Air or Gas Embolism
Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by 2. Cyanide Poisoning
Clostridial Myonecrosis (Gas Gangrene) 3.
Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias 4.
Decompression Sickness 5.
Enhancement of Healing in Selected Problem Wounds 6.
Exception Blood Loss (Anemia) 7.
1. Intracranial Abscess
1. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia)
1. Osteomyelitis (Refractory)
1. Radiation Tissue Damage (Osteoradionecrosis)
1. Skin Grafts and Flaps (Compromised)
1. Thermal Burns

{3}------------------------------------------------

Summary of Substantial Equivalence:

RSI considers the following design characteristics to be substantially equivalent to previously listed devices. While this device is not entirely like any of the predicate devices, it is a compilation of the sub-systems from the predicate devices. Each of the major sub-systems used on the model RS14000"" has been shown to be safe and effective on predicate devices. These sub-systems are described below:

1. Vessel Construction: The construction of the model RS1°20(7) hyperbaric chamber is similar to the Millenium 2000, 2001, 2002, 2003, 2004, 2005 (K041007) in that it is a welded metal pressure vessel with commonly used shapes and windows. The design and construction of the pressure shell is in accordance with the very commonly used and accepted ASME Boiler and Pressure vessel code, section VIII, division 1. Windows are designed to meet the applicable sections of PVHO (pressure vessel for human occupancy) standard.
1. Pressure Controls: The pressure controls are very similar to the pneumatic pressure controls of the Sechrist 2500B (K934164) and the Millenium 2000, 2001, 2002, 2003, 2004, 2005 (K041007) . However, RS1200 (") chamber controls are simpler and easy to use.
1. Communications System: The communication system is designed to meet the requirements of NFPA 99 Chapter 20 for hyperbaric facilities. The chamber interior microphone and speaker arrangement and operation is similar to that of Sechrist 2500B (K934164) chamber.

Oxygen Breathing System: The chamber is equipped with the necessary controls to administer oxygen to the patient whereby the patient wears a standard medical oxygen hood or mask
General: The RS1400(m) has been designed, built and tested in compliance with all of the applicable requirements of the performance standards listed herein. Each predicate device with a similar function must also meet these requirements.

RSI accepts that the model RST220 ("" is substantially equivalent to the predicate devices and is safe and effective.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Navil Alam Electrical Engineer Reimers System, Incorporated 8210 - D Cinder Bed Road Lorton, Virginia 22079

AUG 1 9 2011

Re: K102831

Trade/Device Name: RSI 4200 Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: August 8, 2011 Received: August 18, 2011

Dear Mr. Alam:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Alam

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDR1's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D. nene

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K102831

Device Name: RSI 4200

Indications For Use:

1. Air or Gas Embolism
Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by ri Cyanide Poisoning
1. Clostridial Myonecrosis (Gas Gangrene)
1. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
1. Decompression Sickness
1. Enhancement of Healing in Selected Problem Wounds
1. Exception Blood Loss (Anemia)
1. Intracranial Abscess
1. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia)
1. Osteomyelitis (Refractory)
1. Radiation Tissue Damage (Osteoradionecrosis)
1. Skin Grafts and Flaps (Compromised)
1. Thermal Burns

Prescription Use- - - X_______________________________________________________________________________________________________________________________________________________________________	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

oncurrence of CDRH, Office of Device Evaluation (ODE)

L. Shuttles

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K/0283/

Page 1 of 1

RSI 510(K) Submittal

Regulation Number and Section

§ 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).