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The SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: Air or Gas Embolism; Carbon Monoxide / Smoke Inhalation; Compromised Skin Grafts and Flaps; Crush Injuries / Acute Traumatic Ischemia; Decompression Sickness; Enhanced Healing in Selected Problem Wounds; Exceptional Blood Loss (Anemia); Gas Gangrene (Clostridia Myonecrosis); Intracranial Abscess; Necrotizing Soft Tissue Infections; Radiation Tissue Damage (Osteoradionecrosis); Refractory Osteomyelitis; Thermal Burns.

The SIGMA Elite Series Hyperbaric Chambers and their predicate devices have the same intended use; as a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA. The SIGMA Elite Series Hyperbaric Chambers and their predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with pure oxygen, and the patient breathes the chamber atmosphere. Also, in each of the chambers, the pressure-time profile (i.e. the rate and direction of pressure change and the time held at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or an automatic electronic system. The purpose of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is safe and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance.

The provided text is for a 510(k) submission for a hyperbaric chamber, which is a medical device, and does not involve AI or algorithms that would have a "reported device performance" in the typical sense of diagnostic metrics like sensitivity or specificity.

Therefore, the specific information requested in the prompt, such as "reported device performance," "sample size," "ground truth," "MRMC study," and "training set," is not applicable to this type of device submission.

Instead, the acceptance criteria for this device are demonstrated by its compliance with recognized industry standards for design, manufacturing, and safety. The "study" that proves the device meets these criteria is a series of engineering and safety tests to ensure it adheres to these standards.

Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the difference in device type:

1. A table of acceptance criteria and the reported device performance

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

This information is not applicable and therefore not provided in the document. As a physical medical device (hyperbaric chamber), the "test set" would refer to the chambers themselves undergoing engineering and safety testing, not a dataset of patient information or images. The "provenance" would be the manufacturing location and standard compliance testing, not data collection.

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)

This is not applicable to the submission for a hyperbaric chamber. The "ground truth" for this device is compliance with engineering and safety standards, validated through testing by qualified engineers and technicians, not by medical experts interpreting results from the device.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review for diagnostic performance. For a hyperbaric chamber, it's about meeting quantifiable engineering and safety standards through documented testing, not subjective assessment.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This submission is for a physical medical device (hyperbaric chamber) and does not involve AI or human readers in the context of diagnostic interpretation.

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

This is not applicable. The device is a hyperbaric chamber, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness relies on adherence to established engineering, safety, and medical device standards (ASME, NFPA, CAN/CSA, EN standards). These standards themselves represent a form of "ground truth" in terms of what constitutes a safe and functional hyperbaric chamber, based on collective expert consensus in engineering and healthcare safety fields.

8. The sample size for the training set

This is not applicable. There is no "training set" for a hyperbaric chamber in the context of an algorithm or AI.

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

This is not applicable, as there is no "training set" for this type of device.

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The SIGMA 3400 Monoplace Hyperbaric Chamber is indicated for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows:

1. Air or Gas Embolism
2. Carbon Monoxide / Smoke Inhalation
3. Compromised Skin Grafts and Flaps
4. Crush Injuries / Acute Traumatic Ischemias
5. Decompression Sickness
6. Enhanced Healing in Selected Problem Wounds
7. Exceptional Blood Loss (Anemia)
8. Gas Gangrene (Clostridial Myonecrosis)
9. Intracranial Abscess
10. Necrotizing Soft Tissue Infections
11. Radiation Tissue Damage (Osteoradionecrosis)
12. Refractory Osteomyelitis
13. Thermal Burns

The Perry Baromedical Corporation SIGMA 3400 Monoplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA I Monoplace Hyperbaric Chamber, [510(k) K832127], and the Perry Baromedical Corporation SIGMA Plus Monoplace Hyperbaric Chamber, [510(k) 974863]. The SIGMA 3400 has the same intended use and the same technological characteristics as the SIGMA I and SIGMA Plus predicate devices. The scope and operation of the SIGMA 3400 is identical to that of the SIGMA I and SIGMA Plus in the following areas:

• The critical component of both systems consists of an ASME pressure vessel that is designed, fabricated, and tested in accordance with the requirements of the ASME Boiler and Pressure Vessel Code, Section VIII, Division 1; and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy.
• The pressure vessel consists of certified metal components constructed of materials in conformance with the ASME Boiler and Pressure Vessel Code, Section II - Materials. In addition to the metal parts, the pressure retaining boundary consists of an acrylic plastic cylinder, designed and constructed to the requirements of ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy.
• The pressure vessel is protected from accidental over pressurization by an ASME "UV" stamped pressure relief valve.
• The medium used for pressurization of the chamber is medical grade oxygen.
• Treatment capacity of the chamber is one patient.
• Communication between the patient / attendants is through an intrinsically safe communications system.
• The SIGMA I, SIGMA Plus and SIGMA 3400 chambers are used to provide Hyperbaric Oxygen Therapy, prescribed by a licensed physician, where medical grade oxygen is administered to patients while under pressure, by the patient breathing oxygen from the chamber atmosphere that is pressurized with pure oxygen. The breathing of oxygen at elevated pressure promotes the movement of oxygen into the patient's tissues.
• The chamber pressurization and depressurization control system is completely pneumatic, with no electrical or electronic components.
• Chambers are Class "B" monoplace hyperbaric systems.

Differences do exist between the SIGMA 3400, the SIGMA Plus and the SIGMA I chambers; they include:

• The PVHO-1 acrylic cylinder in the SIGMA 3400 chamber is 33.3" inside diameter and 90" long; the PVHO-1 acrylic cylinder in the SIGMA Plus chamber is 40" inside diameter by 65" long, and the PVHO-1 acrylic cylinder in the SIGMA I chamber is 25.25" inside diameter by 80" long.
• The acrylic cylinder of the SIGMA 3400 has been designed for a operational temperature range of 32 degrees F to 100 degrees F. The SIGMA I and SIGMA Plus cylinders were designed for a 32 degree F to 125 degree F operating range. Based on the actual operating environment of a hospital, the higher 125 degree temperature limit would never be reached in normal operation, as the chamber rooms are required to be maintained at temperatures less than 75 degrees F for patient comfort.
• The pneumatic controls for the SIGMA 3400 chamber and the SIGMA I chamber are mounted in a panel mounted on one side of the chamber. The pneumatic controls for the SIGMA Plus chamber are mounted in a control box that is suspended from a moveable arm.
• The SIGMA 3400 monoplace chamber has an aluminum chassis with integral side covers; the SIGMA Plus Chamber has gelcoated fiberglass cosmetic covers on the sides and ends of the chamber; and the SIGMA I Hyperbaric Chamber has aluminum side cosmetic covers as part of the chassis.
• The SIGMA 3400 monoplace chamber has provision for changing from oxygen to air pressurization during treatment, which allows the operator more control of the environment inside the chamber. The SIGMA Plus and SIGMA I chambers are oxygen only pressurization.

The provided text is a 510(k) summary for the PERRY BAROMEDICAL SIGMA 3400 Monoplace Hyperbaric Chamber. It aims to establish substantial equivalence to existing predicate devices (SIGMA I and SIGMA Plus Monoplace Hyperbaric Chambers) rather than proving the device meets specific performance acceptance criteria through a study.

Therefore, the document does not contain information on:

1. A table of acceptance criteria and reported device performance: The document focuses on demonstrating substantial equivalence in design, intended use, and technological characteristics, not on presenting specific performance metrics that would be compared against acceptance criteria.
2. Sample size used for the test set and data provenance: No testing or study data on the device's performance is provided.
3. Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment is mentioned as no performance studies are detailed.
4. Adjudication method for the test set: Not applicable as no test set performance is discussed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance: This device is a hyperbaric chamber, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a hyperbaric chamber.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance studies are detailed.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/machine learning device.

The document primarily focuses on demonstrating substantial equivalence by stating that the SIGMA 3400 has the same intended use and technological characteristics as its predicate devices, with minor differences in dimensions, operating temperature range, control panel mounting, chassis, and the addition of an oxygen to air pressurization change function. The claim is that these changes "enhance its ease of operation, and do not adversely effect the safety and effectiveness of the device."

The "Indications for Use" section lists the clinical medical conditions for which the SIGMA 3400 Monoplace Hyperbaric Chamber is indicated, in accordance with guidelines established by the Undersea and Hyperbaric Medical Society. This section serves as a statement of clinical utility rather than a report of performance against acceptance criteria.

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The monoplace hyperbaric chamber is indicated for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows:

1. Air or Gas Embolism
2. Carbon Monoxide / Smoke Inhalation
3. Compromised Skin Grafts and Flaps
4. Crush Injuries / Acute Traumatic Ischemias
5. Decompression Sickness
6. Enhanced Healing in Selected Problem Wounds
7. Exceptional Blood Loss (Anemia)
8. Gas Gangrene (Clostridial Myonecrosis)
9. Intracranial Abscess
10. Necrotizing Soft Tissue Infections
11. Radiation Tissue Damage (Osteoradionecrosis)
12. Refractory Osteomyelitis
13. Thermal Burns

The Perry Baromedical Corporation SIGMA Plus Monoplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA I Monoplace Hyperbaric Chamber, [510(k) K832127]. The SIGMA Plus has the same intended use and the same technological characteristics as the SIGMA I predicate device. The scope and operation of the SIGMA Plus is identical to that of the SIGMA I in the following areas:

• The critical component of both systems consists of an ASME pressure vessel that is designed, fabricated, and tested in accordance with the requirements of the ASME Boiler and Pressure Vessel Code, Section VIII, Division I; and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy.
• The pressure vessel consists of certified metal components constructed of materials in conformance with the ASME Boiler and Pressure Vessel Code, Section II - Materials. In addition to the metal parts, the pressure retaining boundary consists of an acrylic plastic cylinder, designed and constructed to the requirements of ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy.
• The pressure vessel is protected from accidental over pressurization by an ASME "UV" stamped pressure relief valve.
• The medium used for pressurization of the chamber is either compressed pure oxygen or compressed breathing air.
• Treatment capacity of the chamber is one (1) patient.
• Communication between the patients / attendants is through an intrinsically safe communications system.
• The SIGMA I and SIGMA Plus chambers are used to provide Hyperbaric Oxygen Therapy, prescribed by a licensed physician, where medical grade oxygen is administered to patients while under pressure; either by the patient breathing the chamber atmosphere, (when pressurized with oxygen), or by the patient breathing oxygen from a breathing hood or breathing mask, (when pressurized with breathing air); The breathing of oxygen at elevated pressure promotes the movement of oxygen into the patient's tissues.
• The chamber pressurization and depressurization control system is completely pneumatic, with no electrical or electronic components.

Differences do exist between the SIGMA Plus and the SIGMA I Monoplace chamber; they include:

• The PVHO-1 acrylic cylinder in the SIGMA Plus chamber is 40" inside diameter, and the PVHO-1 acrylic cylinder in the SIGMA I chamber is 25.25" inside diameter. Both acrylic cylinders are designed with a 20 to 1 safety factor.
• The pneumatic controls for the SIGMA Plus chamber are mounted in a control box that is suspended from a moveable arm, allowing use from either side of the chamber; while the pneumatic controls for the SIGMA I chamber are mounted in a panel on one side of the chamber.
• The SIGMA Plus Monoplace Hyperbaric Chamber has painted fiberglass cosmetic covers on the sides and ends of the chamber; the SIGMA I Monoplace Hyperbaric Chamber has a wheeled aluminum support chassis.

Here's an analysis of the provided text to extract the requested information. Please note that this document is a 510(k) summary for a hyperbaric chamber, which describes substantial equivalence to a predicate device, rather than a clinical study establishing performance against a new set of acceptance criteria for a novel device. Therefore, many of the requested categories (like sample size, ground truth, expert qualifications, MRMC studies) are not applicable or cannot be found in this type of submission.

Analysis of the Provided Text (K974868 - SIGMA Plus Monoplace Hyperbaric Chamber 510(k) Summary)

This document is a 510(k) Summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. It focuses on demonstrating "substantial equivalence," not on new performance acceptance criteria or a dedicated study proving device performance against such new criteria.

Therefore, many of the questions asked are not directly addressed in this type of regulatory document. I will fill in what can be inferred or directly stated, and note when information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of a 510(k) submission focused on substantial equivalence. The "acceptance criteria" here would be the FDA's regulatory criteria for determining substantial equivalence to a predicate device, which are inherent in the 510(k) process itself rather than defined performance metrics for a novel device. The "reported device performance" is implicitly that it performs equivalently to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a regulatory submission for substantial equivalence based on design and technical characteristics comparison, not a clinical trial or performance study involving a "test set" of patients or data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission does not involve "ground truth" derived from expert review of data/cases. It relies on established engineering and safety standards (ASME, PVHO-1) and the comparison to an already cleared predicate device.

4. Adjudication Method for the Test Set

Not applicable. No "test set" or adjudication process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a monoplace hyperbaric chamber, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (hyperbaric chamber), not an algorithm or software.

7. The Type of Ground Truth Used

Not applicable in the sense of expert consensus, pathology, or outcomes data for a performance study. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (SIGMA I) and compliance with relevant engineering and safety standards (ASME codes, PVHO-1).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

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