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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.

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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The intended use of the Sechrist Model 3300E/ER Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure. 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 thirteen indications are: 1. 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. Intracranial Abscess 9. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia) 10. Osteomyelitis (Refractory) 11. Radiation Tissue Damage (Osteoradionecrosis) 12. Skin Grafts and Flaps (Compromised) 13. Thermal Burns

The Model 3300E/ER Hyperbaric Chamber is a monoplace (one patient) pressure chamber designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure. The Model 3300E/ER Hyperbaric Chamber is constructed with a horizontal seamless acrylic inner cylinder. One end is equipped with a hard anodized aluminum cover and the other with a hard anodized aluminum door assembly, with access ports available for patient support (such as patient monitoring and delivery of intravenous fluids). The control system is pneumatic/electronic containing the controls, indicators, chamber pressure display gauges, and intercom assembly.

The provided documents describe a 510(k) submission for the Sechrist Model 3300E/ER Hyperbaric Chamber. This documentation focuses on demonstrating substantial equivalence to a predicate device and adherence to industry standards, rather than presenting a study to prove acceptance criteria for device performance in terms of diagnostic accuracy or AI-assisted improvement.

Therefore, many of the requested elements regarding acceptance criteria for device performance studies (such as sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable to this type of regulatory submission for a hyperbaric chamber.

However, I can extract the information that is relevant to the device's "acceptance criteria" and the "study" that proves it meets those criteria, based on the provided text, which largely revolves around regulatory compliance and adherence to established standards.

Here's the information as it relates to the provided document:

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)

• Not Applicable. This submission is for a medical device (hyperbaric chamber), not a diagnostic or AI device that would typically involve a "test set" of patient data for performance evaluation in the context of diagnostic accuracy. The "testing" referred to is engineering and manufacturing compliance testing.

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 "test set" or diagnostic ground truth was established for this device in the provided document. The "ground truth" for the indications for use was established by a committee of experts (see point 7).

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

• Not Applicable. No "test set" or adjudication of diagnostic outcomes was performed or described.

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 not an AI-powered diagnostic device, and no MRMC study was conducted or described.

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

• Not Applicable. This is a medical device (hyperbaric chamber), not an algorithm or AI product.

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

• The "ground truth" for the indications for use is established by expert consensus from the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. This committee is comprised of practitioners and scientific investigators in various medical fields. Their recommendations for the thirteen specific indications are 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."

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device.

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

• Not Applicable. This is not a machine learning or AI device.

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The intended use of the Sechrist Model 3500CP-G Air/Oxygen Mixer is to enable qualified personnel to mix medical grade air and medical grade oxygen at operator selected ratios, for delivery to patients through various types of respiratory care and heart bypass oxygenation equipment.

The Sechrist Model Series 3500CP-G Air/Oxygen Mixer is a precision pressure regulation and proportioning device which is intended to mix medical grade air and medical grade oxygen. The mixer receives pressurized air and oxygen, at a nominal 50 psi, via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi, providing the pressures are within 20 psi of one another. Two outlets for the mixed gas are provided. The air/oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses.

The provided 510(k) summary for the Sechrist 3500CP-G Air/Oxygen Mixer does not contain information about a study conducted to prove the device meets specific acceptance criteria based on numerical performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through adherence to established quality system standards and verification of the device's intended function.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of submission.

Here's a breakdown of the available information and how it relates to your request:

Acceptance Criteria and Reported Device Performance

Study Information (Based on the provided text):

1. Sample size used for the test set and the data provenance:

   • Not applicable/Not provided. This 510(k) relies on demonstrating substantial equivalence to predicate devices and adherence to design/manufacturing standards, rather than a clinical performance study with a test set of data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided. No specific "test set" with "ground truth" derived from experts is mentioned for this type of submission.

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

   • Not applicable/Not provided.

4. 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 submission for a hardware device (gas mixer), not an AI/software device that would involve human readers or AI assistance.

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

   • Not applicable. This is a hardware device.

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

   • Not applicable/Not provided in the context of a performance study. The "ground truth" for this device's performance would be its ability to physically mix gases within specified tolerances, which would be verified through engineering testing and quality control during manufacturing, not typically a "ground truth" established by experts in a clinical study sense for a 510(k) submission like this.

7. The sample size for the training set:

   • Not applicable/Not provided. Training sets are relevant for machine learning algorithms, which is not the case here.

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

   • Not applicable/Not provided.

Summary of the 510(k) Approach:

The 510(k) for the Sechrist 3500CP-G Air/Oxygen Mixer demonstrates its acceptability through:

• Substantial Equivalence: Comparing the device's design, indications for use, and technological characteristics to legally marketed predicate devices (K802226, K992503, K841789, K863902, K901253). The key "study" here is the comparative analysis showing that the new device is functionally the same or very similar to existing cleared devices.
• Adherence to Standards: Compliance with established national and international quality management system standards (ISO 9001, ISO 13485, EN 46001, 21 CFR 820). This implies that the design, manufacturing, and performance verification processes are robust, reducing the need for a separate detailed clinical performance study in this context.
• Device Description: A detailed description of the device's function and operational parameters, which are presumed to be consistent with those of the predicate devices.

This type of submission typically relies on design verification and validation testing performed by the manufacturer, which demonstrates the device meets its own specifications, rather than a clinical study establishing performance against a "ground truth" in a patient population. These internal tests would verify parameters like pressure regulation accuracy, mixing ratio accuracy, and flow characteristics, but the 510(k) summary itself does not detail the results of these internal tests.

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The intended use of the device is to provide ventilation to neonatal, infant, and pediatric patients.

The Sechrist Millennium Infant Ventilator is an electro-pneumatic, continuous flow, time cycled, pressure limited infant ventilator. It is designed to ventilate neonatal to pediatric patients in Assist/Control, Synchronous Intermittent Mandatory Ventilation (SIMV), Continuous Positive Airway Pressure (CPAP), and Standby modes. In addition, pressure triggered ventilation and spontaneous breathing is also provided.

The ventilator has an electronically controlled pneumatic system. The pneumatic subsystem consist of an air/oxygen mixer, continuous flow control, pressure controls, and waveform control.

The electronically controlled subsystem uses the respiratory rate and inspiratory time control inputs to activate or deactivate the exhalation valve. The electronic subsystem also includes the pressure trigger sensing and manual breath functions.

Comprehensive alarm, display, and measurement subsystems are designed to provide patient safety and ease of user interface.

This 510(k) summary does not contain the detailed information necessary to fully answer the questions about acceptance criteria and a study proving the device meets those criteria. The provided document is a 510(k) summary for a medical device (ventilator), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Here's a breakdown of why the information is not present and what can be inferred:

• Acceptance Criteria and Reported Device Performance: This document states, "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for infant ventilators." This strongly indicates that there are no specific, quantitative acceptance criteria for this device that would be reported in a table. The primary method of demonstrating safety and effectiveness for a 510(k) submission, especially when no performance standards exist, is via substantial equivalence to a legally marketed predicate device.
• Study Details: Since the submission is based on substantial equivalence, a formal performance study proving the device meets specific acceptance criteria in the manner described by your questions (e.g., sample size, ground truth, expert consensus, MRMC studies) is typically not part of the 510(k) summary. Instead, the submission would rely on internal testing to ensure the device performs as intended and similarly to its predicate.

Based on the provided text, I can respond to your questions as follows:

1. A table of acceptance criteria and the reported device performance
   Not applicable. The document states, "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for infant ventilators." Therefore, specific, quantitative acceptance criteria for device performance are not provided. The submission relies on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable to theirs.

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 is a 510(k) summary demonstrating substantial equivalence. It does not describe a clinical or performance study with a test set, sample size, or data provenance in the context of proving specific acceptance criteria.

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 clinical or performance study involving expert-established ground truth for a test set is described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable. No clinical or performance study involving adjudication of a test set is described in this 510(k) summary.

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. MRMC studies, especially those involving AI assistance, are typically for diagnostic devices or those requiring human interpretation of output. This device is a ventilator, and the summary does not mention any AI components or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This device is an electro-pneumatic ventilator. The summary does not provide details of any standalone algorithm performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable. No ground truth is described as having been used for a performance study in this 510(k) summary.

8. The sample size for the training set
   Not applicable. No training set is mentioned as part of this 510(k) submission.

9. How the ground truth for the training set was established
   Not applicable. No training set or ground truth for a training set is mentioned in this 510(k) submission.

In summary: The provided text is a 510(k) summary for a ventilator that primarily focuses on demonstrating substantial equivalence to existing predicate devices. It explicitly states that no performance standards have been established for infant ventilators. Therefore, the document does not include information about specific acceptance criteria, detailed performance studies, sample sizes, ground truth establishment, or expert involvement as would be found for a device requiring such studies to prove performance against specified criteria.

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The intended use of the device is to enable qualified personnel to mix medical grade air and medical grade oxygen, at operator selected ratios, for delivery to patients through various types of respiratory care equipment.

The Sechrist Series 3500HL Air-Oxygen Mixer is a precision pressure regulation and proportioning device which is designed to mix medical air with medical oxygen, for delivery to patients through a variety of respiratory care equipment.

The mixer receives air and oxygen at a nominal 50 psi via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi providing the pressures are within 20 psi of one another.

Two outlets for the mixed gas are provided. One is located on the side of the unit for the convenient connection of a flowmeter. The second outlet may be used to power other respiratory or cardiopulmonary care equipment requiring a controlled FI02.

The air-oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses. Flowmeters may also be purchased separately.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) summary for the Sechrist Air-Oxygen Mixer does not describe traditional acceptance criteria in terms of quantitative performance metrics or a detailed study designed to prove the device meets those criteria.

Instead, the submission focuses on substantial equivalence to a previously cleared device (Sechrist Air-Oxygen Mixer K802226). The "performance standards" listed are quality assurance and regulatory compliance standards, not in-depth performance specifications of the device itself.

Therefore, many of the requested sections below will indicate "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission, which relies on a comparison to a predicate device rather than a de novo performance study.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) relies on substantial equivalence to a predicate, specific quantitative acceptance criteria for this new device are not explicitly stated in the document as performance targets for a study. The document focuses on showing that the changes made do not affect the intended use or fundamental scientific technology, implying the performance remains equivalent to the predicate.

For the purpose of illustrating what would be considered "acceptance criteria" based on the device description, I've inferred potential operating parameters as "acceptance criteria" and noted how the device description states it meets them. However, these are descriptive operational characteristics, not formal performance study acceptance criteria.

Study Information

Since this is a substantial equivalence submission for minor modifications, a formal performance study as typically understood for a new device (especially one proving performance against specific acceptance criteria) was not conducted or detailed in this summary. The core "study" here is an analysis of the modifications to demonstrate they do not alter the fundamental safety and effectiveness or intended use compared to the predicate device.

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

• Not Applicable / Not Provided. No dedicated "test set" of patient data or device performance data for a new study is mentioned, as the submission focuses on changes to an already cleared device.

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

• Not Applicable / Not Provided. No new "ground truth" establishment was required for this substantial equivalence submission concerning modifications. The device's safety and effectiveness were established by the predicate device's clearance.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided. No formal "test set" or adjudication process described as part of this submission.

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 breathing gas mixer, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This is a hardware device; the concept of a standalone algorithm performance does not apply.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Not Applicable / Not Provided explicitly. For a substantial equivalence claim, the "ground truth" effectively rests on the prior clearance of the predicate device (K802226), which implicitly established the safety and effectiveness of the device type. The current submission argues that the modifications do not negatively impact this established "truth."

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. No "training set" in the context of machine learning or complex algorithm development is relevant or mentioned for this device.

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

• Not Applicable / Not Provided. As noted above, no training set or ground truth establishment for such a set is relevant to this device's submission.

Summary of the "Study" Proving Acceptance:

The "study" in this context is the analysis and comparison of the modified device against the predicate device (Sechrist Air-Oxygen Mixer K802226). The acceptance criteria for this type of submission are that the modifications:

1. Do not affect the intended use.
2. Do not alter the fundamental scientific technology of the device.
3. Do not raise new questions of safety or effectiveness.

The conclusion stated in the 510(k) summary (Section 1) serves as the "proof":

"Modifications made to the cleared device include flowmeter options and corresponding labeling changes made to the User's Manual that were not contained in the original 510(k). These changes do not affect the intended use or alter the fundamental scientific technology of the device. Therefore, the modified device is substantially equivalent to the cleared device."

This statement confirms that the device meets the implicit "acceptance criteria" for a special 510(k) submission, meaning it maintains substantial equivalence to its predicate. The detailed technical documentation submitted to the FDA (which is not fully available in this summary) would have provided the evidence for this claim (e.g., engineering analysis, risk assessment, potentially limited verification testing of the new flowmeter components, though not detailed here).

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