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The intended use of the Sechrist Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers are to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure.

Specific indication for 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 investigations in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic 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 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 third-party reimbursements and most insurance carriers have established reimbursement policy based on these recommendations.

The thirteen indications are:

• Air or Gas embolism 1.
• 2. Carbon Monoxide Poisoning

Carbon Monoxide Poisoning Complicated by Cyanide Poisoning

• 3. Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
• Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemia's 4.
• ನ. Decompression Sickness
• 6. Arterial Insufficiencies

Central Retinal Artery Occlusion

Enhancement of Healing In Selected Problem Wounds

• 7. Severe Anemia
• Intracranial Abscess 8.
• ರು Necrotizing Soft Tissue Infections
• 10. Osteomyelitis (Refractory)
• 11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
• 12. Comprised Grafts and Flaps
• 13. Thermal Burns

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). The typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute.

The Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers are monoplace pressure chambers designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psig) of pressure. These hyperbaric chambers consist of a mechanical and pneumatic system capable of controlling the operator defined pressurization profiles.

These Hyperbaric Chambers are constructed with a horizontal seamless acrylic viewport which varying internal diameter sizes.

Each model is equipped with a clear anodized aluminum cover on one end 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. Each Hyperbaric Chamber Model comes in two configurations designated with a suffix of "H" and "HR". The suffix "H" is the Standard configuration where the control panel is located on the left of the chamber when facing the door and the door opens from left to right. The suffix "HR" is the Reverse configuration where the control panel is located on the right side of the chamber and the door opens from right to left.

The functional performance system and the safety features incorporated in the Models 3300H/HR and 3600H/HR Hyperbaric Chambers are the same that have been incorporated into the design of the Model 4100H/HR predicate device.

A pressurization cycle counter is provided to maintain a record of the number of pressurization cycles the chamber experienced.

A two-way intercommunication system is used to maintain contact between patient and attendant.

The provided document is a 510(k) Summary for Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers. It focuses on demonstrating substantial equivalence to a predicate device (Sechrist Model 4100H/HR) rather than presenting a standalone study with acceptance criteria and device performance results in the format typically seen for novel medical devices or AI algorithms.

However, I can extract the relevant information regarding design changes, their requirements, and validation methods, which serve as the "acceptance criteria" and "study" in the context of demonstrating substantial equivalence for these modifications.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes modifications to existing hyperbaric chambers and compares them to a predicate device. The "acceptance criteria" in this context are the device specifications and regulatory standards the modified devices must meet, and "reported device performance" refers to the validation that these specifications are met, often demonstrating equivalence to the predicate.

2. ASME Boiler & Pressure Vessels Code Section VIII Division 1.
3. PVHO-1 Safety Standard for Pressure Vessels for Human Occupancy (Tested at 1.1 x MAWP). | 1. System Design Validation performed (Test Ref: 2009-0010).
4. ASME "U" Certificate of Authorization for ASME Boiler & Pressure Vessels Code Section VIII Division 1.
5. PVHO-1 testing (Appendix I, Enclosure 4) performed at 1.1 x MAWP.
   Outcome: "The data indicates the change does not affect the devices ability to perform to its product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device)." |
   | Over-Pressure Relief Valve Pressure Change (Model 3300H/HR: 35 psig; Model 3600H/HR: 36 psig) | 1. Device Specification (35 psig ± 2 psig for 3300H/HR; 36 psig ± 2 psig for 3600H/HR).
6. Final Test and Calibration Procedures (Document 150156). | 1. System Design Validation performed (Test Ref: 2009-0010).
7. Activation pressure of valves tested and verified (Document 150156, Section 5).
   Outcome: "The data indicates that the Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers activates the Relief Valves at the activation pressures as outlined in the product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device)." |
   | Gas Supply Flow Rate Change (Model 3300H/HR: 32 SCFM; Model 3600H/HR: 34 SCFM) | 1. Device Specification (32 SCFM for 3300H/HR; 34 SCFM for 3600H/HR).
8. Final Test and Calibration Procedures (Document 150156). | 1. System Design Validation performed (Test Ref: 2009-0010).
9. Device performs to specification after calibration (Document 150156). Each model is tested 100% using recommended supply pressure settings during manufacturing.
   Outcome: "The data indicates the change does not affect the devices ability to perform to its product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device)." |

Remaining Information (NotApplicable / Not Provided for this Device Type)

The provided document describes modifications to a hyperbaric chamber, which is a physical medical device. The questions related to sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness studies, standalone algorithm performance, ground truth type for test/training sets, and training set sample size are typically applicable to software as a medical device (SaMD) or AI/ML-based diagnostic/screening tools.

Since this submission is for a physical device (Hyperbaric Chamber) and demonstrates substantial equivalence based on engineering changes and performance specification verification, these specific metrics for data-driven algorithms are not applicable and therefore not provided in the document.

The "study" that proves the device meets the acceptance criteria consists of engineering validation and verification tests, compliance with specified industry standards (ASME, PVHO-1), and internal calibration procedures, all aimed at showing that the modified device performs to its specifications and equivalently to the predicate device in terms of safety and efficacy.

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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:

1. Air or Gas embolism
2. Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
3. Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
5. Decompression Sickness
6. Arterial Insufficiencies Central Retinal Artery Occlusion Enhancement of Healing In Selected Problem Wounds
7. Severe Anemia
8. Intracranial Abscess
9. Necrotizing Soft Tissue Infections
10. Osteomyelitis (Refractory)
11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
12. Compromise Grafts and Flaps
13. 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.

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.

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