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The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment in a hot water bath at 160° - 170° F for 30 minutes.

The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are used for the cleaning and high-level disinfection of reusable and disposable breathing circuit parts used in Respiratory Therapy and Anesthesia. Pasteurization kills pathogenic vegetative bacteria and viruses by immersion in water at 160° - 170° F for 30 minutes. Full immersion pasteurization has been identified by the Centers for Disease Control as suitable for high-level disinfection of all parts not used subcutaneously.

The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are identical systems with the exception of the heater capacity. The Pasteurmatic 3000 has three 3,000 watt heaters for a system capacity of 9,000 watts. The Pasteurmatic 3500 has three 5,000 watt heaters for a system capacity of 15,000 watts to allow more rapid heating of the water during the pasteurization cycle when used as a combined washerpasteurizer.

Both systems rotate stainless steel baskets of tubes and parts vertically in a stainless steel tank during both washing and pasteurizing. This forces water through the full length of the tubes and drives out all the air bubbles.

The provided text describes the Olympic Pasteurmatic 3000 and 3500, medical washer-disinfectors, and their substantial equivalence to a predicate device. However, it does not contain a detailed study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot provide the requested information in the specified format from the provided text. The document states: "Tests were performed to demonstrate that the performance of the Pasteurmatic 3000 and Pasteurmatic 3500 meet or exceed that of the predicate device," but it does not elaborate on what those tests were, what the acceptance criteria for those tests were, or what the reported performance was.

Missing Information:

• Detailed Acceptance Criteria and Performance Table: The document does not specify quantitative acceptance criteria for cleaning or high-level disinfection effectiveness (e.g., specific log reduction of microorganisms, cleanliness metrics). It only states the intended use involves "killing vegetative bacteria and viruses in a hot water bath at 160°-170°F for 30 minutes."
• Sample Size and Data Provenance: No information on sample sizes for test sets or data provenance (country, retrospective/prospective).
• Ground Truth Establishment (Experts, Adjudication, Qualifications): No mention of experts, ground truth establishment methods, or adjudication. This kind of information is typically relevant for interpretative devices (e.g., AI in radiology), not for a physical disinfection device.
• MRMC Comparative Effectiveness Study: No such study is mentioned as the device is a physical disinfector, not an AI-assisted diagnostic tool.
• Standalone Performance Study: No detailed standalone performance study is explicitly described with results. The statement "Tests were performed to demonstrate that the performance... meet or exceed that of the predicate device" implies such tests were done, but the details are absent.
• Type of Ground Truth: Not applicable in the context of the provided information about this device.
• Training Set Information: Not applicable as this is a physical device, not an AI/machine learning model.

Given the nature of the device (medical washer-disinfector) and the content of the 510(k) summary, the standard format for reporting AI/diagnostic device studies does not directly apply here. The 510(k) pathway primarily relies on demonstrating substantial equivalence to an already legally marketed device (the predicate device) through functional and performance comparisons, rather than extensive de novo clinical trials with specific statistical endpoints often seen for novel diagnostic or AI devices.

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The Olympic CFM 6000 is intended to be used by a variety of clinicians to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab:

• to monitor the state of the brain -
• for determination of, and long-term monitoring of, the neurological status of a patients that may have suffered an hypoxic-ischemic event.
• for monitoring of neurological status to assist in the clinical management and treatment of the patient by observing how the treatment affects the neurological status as shown by the CFM.
• to assist in the prediction of neurological outcome -
• to monitor and record frequency and intensity of seizures to assist in management of anti-convulsive therapy.
• to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy ー and long-term outcome in infants who have suffered an hypoxic-ischemic event.

The Olympic CFM 6000 consists of two main components: A Data Acquisition Module and a Main System module. The Data Acquisition Module is used to connect the patient electrode leads, amplify the signal, and perform the analog-to-digital conversion. The Main system accepts data from the amplifier. processes and stores the signal. and displays the CFM, impedance, and EEG traces and provides the user interface for control of the device.

The Olympic CFM 6000 aims to demonstrate clinical equivalence to its predicate device, the Olympic Medical Lectromed Cerebral Function Monitor (K020335), by reproducing the analog signal processing and display digitally.

1. Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the device's performance. However, the overarching acceptance criterion is that the output of the CFM 6000 is "clinically identical" to that of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "clinical input data" but does not specify the sample size or the provenance of this data (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts and Their Qualifications for Ground Truth Establishment

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No information is provided about a multi-reader, multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. This device is an EEG monitor, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

The study described is focused on the comparison of the Olympic CFM 6000 against its predicate device to demonstrate clinical identity, implying it is assessing the standalone performance of the new device relative to a known standard. However, the term "standalone (i.e. algorithm only without human-in-the loop performance)" as it relates to AI is not applicable here, as this is a medical device, not an AI algorithm in the contemporary sense. The device is designed to acquire and process EEG signals for clinicians to interpret.

7. Type of Ground Truth Used

The ground truth for the comparison tests was the output of the predicate device, the Olympic Medical Lectromed Cerebral Function Monitor. The study aimed to show that the new device's output was "clinically identical" to this established predicate.

8. Sample Size for the Training Set

The document does not mention the use of a "training set" in the context of machine learning or AI. The development process described involves reproducing analog signal processing digitally, implying engineering and validation against the known behavior of the predicate device rather than training an algorithm on a distinct dataset.

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

As no training set (in the AI context) is mentioned, there is no information on how its ground truth would have been established. The development likely involved direct engineering to mimic the existing analog CFM technology.

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The Olympic Medical Lectromed Cerebral Function Monitor System is intended to be used by a variety of clinicians to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab:

• to monitor the state of the brain .
• for determination of, and long-term monitoring of, the neurological status of patients that may have suffered an hypoxic-ischemic event.
• for monitoring of neurological status to assist in the clinical management and treatment of the patient by observing how the treatment affects the neurological status as shown by the CFM.
• to assist in the prediction of neurological outcome -
• to monitor and record frequency and intensity of seizures to assist in management of anti-convulsive therapy.
• to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy and long-term outcome in infants who have suffered an hypoxic-ischemic event.

The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module that produces three outputs that may be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the Olympic Medical Lectromed Cerebral Function Monitor System, focusing on:

• Device classification and name
• Company information
• Intended use
• Predicate devices
• Device description
• Safety and Standards (mentioning BS EN 60601-1-1 and BS EN 60601-1-2: 1993)
• FDA's substantial equivalence letter
• Indications for Use statement

There is no section detailing specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or technical benchmarks) or any study results demonstrating that the device meets such criteria. The document asserts compliance with general safety standards and substantial equivalence to predicate devices, but lacks the detailed performance study information you requested.

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The Olympic Medical Lectromed Cerebral Function Monitor System is intended to monitor the state of the brain by acquisition of EEG signals in the intensive care unit, operating room, and for clinical research.

The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module which produces three outputs which mav be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.

The provided text is a 510(k) summary and an FDA clearance letter for the Olympic Medical Lectromed Cerebral Function Monitor System. It does not contain details about specific acceptance criteria or dedicated studies proving the device meets them, in the sense of a performance study with metrics like sensitivity or specificity.

Instead, the documentation focuses on:

• Classification and Intended Use: Defining what the device is and what it's for.
• Predicate Device Comparison: Establishing substantial equivalence to previously cleared devices (Aspect Medical Systems A-2000 EEG Monitor with BIS and SpaceLabs 90482 EEG BIS Module). The implication is that if the predicate devices meet safety and effectiveness, then a substantially equivalent new device also meets them.
• Device Description: What the device consists of.
• Safety and Standards: Listing general electrical safety and EMC standards (BS EN 60601-1-1 and BS EN 60601-1-2: 1993) that the device meets. These are general product safety standards, not performance criteria specific to EEG monitoring accuracy.

To answer your request, I will extract the information that is present and note when specific details (like clinical study results, expert qualifications, or sample sizes for performance evaluations) are not found in this document.

Acceptance Criteria and Device Performance Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide quantitative performance metrics such as sensitivity, specificity, accuracy, or any other objective measure against a clinical ground truth for the device's ability to 'monitor the state of the brain'. The "performance" is primarily established through its substantial equivalence to predicate devices and adherence to general safety standards.

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

The provided documentation does not describe a specific "test set" or a clinical study with a defined sample size for evaluating the device's performance against clinical outcomes or a ground truth.

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

Not applicable. The document does not mention a test set with expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. The document does not mention a test set or an adjudication process.

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. The device is an EEG monitor, not an AI-assisted diagnostic tool for human readers. This document focuses on the device's ability to acquire EEG signals, not to interpret them with AI assistance.

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

Not applicable in the context of an algorithm's diagnostic performance. The device is a monitor that acquires and outputs EEG signals, not an algorithm that interprets them in a standalone capacity for diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

No specific clinical ground truth (e.g., pathology, outcomes data, or expert consensus on EEG interpretation) is mentioned as being used to assess the performance of the Olympic Medical Lectromed Cerebral Function Monitor System within this document. The assessment relies on substantial equivalence to existing devices and compliance with safety standards.

8. The Sample Size for the Training Set

Not applicable. The document does not describe a training set for a machine learning model.

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

Not applicable. The document does not describe a training set or its ground truth establishment.

Summary of what the document implies about "proving" the device meets acceptance criteria:

The primary method of demonstrating that the Olympic Medical Lectromed Cerebral Function Monitor System meets its purpose and is safe is through its substantial equivalence to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as the predicate devices, which would have undergone their own review processes (though not detailed in this specific document). Compliance with general electrical safety and EMC standards (BS EN 60601-1-1 and BS EN 60601-1-2) is also cited as proof of basic safety. No specific clinical performance studies with quantitative metrics, ground truth, or expert review are described within this 510(k) summary.

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For the treatment of Neonatal Hyperbilirubinemia.

The Olympic Bili-Bassinet has three phototherapy fixtures built into a bassinet.

The two identical overhead fixtures swing and lock in their up position. They are mounted on counter-balanced arms. Thier storage position is recessed into the sides of the bassinet.

The phototherapy pad is a pad/mattress, which is transparent to light. Unlike a fiberoptic pad, which used plastic optical fibers within the pad to transmit the light from the remote light box, the Bili-Bassinet light box is below the pad/mattress and shines through the pad.

All fixtures use conventional blue (type "B") fluorescent phototherapy lamps. "Daylight" and high-intensity (type BB) fluorescent lights are available for use in the overhead fixtures.

The provided document describes the Olympic Bili-Bassinet, a device intended for the treatment of Neonatal Hyperbilirubinemia using phototherapy. The submission aims to establish substantial equivalence to predicate devices rather than proving novel effectiveness. Therefore, the "acceptance criteria" discussed here relate to safety and performance specifications relative to established standards and the predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

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Machine for pasteurizing (high-level disinfection) respiratory therapy and anesthesia parts, in a health care setting by health care workers.

The Olympic Mini-Pasteurmatic is a small, compact machine. which makes use of pasteurization to achieve high-level disinfection of respiratory therapy and anesthesia breathing circuit parts. After hand washing, the parts are placed in the drum shaped "basket." The basket is submerged in hot water and rotated vertically. This vertical rotation flushes water through tubes and other hollow parts, allowing air to escape and improving water contact with all surfaces of the parts. The Mini-Pasteurmatic is filled with water, which is heated to pasteurizing temperature by internal heaters.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and studies:

Acceptance Criteria and Device Performance for Olympic Mini-Pasteurmatic

Study Information:

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

   • Sample Size: Not specified in the provided document.
   • Data Provenance: Not specified. The document only mentions "Tests were performed to verify the following," without detailing the source or nature of the data.

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

   • Not applicable/Not specified. This device cleans and disinfects, so "ground truth" would likely be based on physical measurements and microbiological testing rather than expert-derived interpretations.

3. Adjudication method for the test set:

   • Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation), which is not relevant for this device's testing.

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:

   • No. This is a medical device for pasteurization (disinfection), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

   • Yes, in essence. The "tests performed" (water temperature, thermostat, cold water start time) evaluate the device's inherent functional performance independently, without human interaction influencing the core disinfection process. This is a standalone performance assessment of the hardware.

6. The type of ground truth used:

   • Engineering/Performance Specifications and Physical Measurements: The ground truth for the tests (water temperature, thermostat performance, cold water start time) would be based on the device's design specifications and measurable physical properties. For "high-level disinfection," the ultimate ground truth would be the microbial reduction achieved, though the document only lists engineering verification.

7. The sample size for the training set:

   • Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • Not applicable. There is no training set mentioned or implied.

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For WAZMING BLANKETS/LINEN o R or Solutions SOLUTIONS MUST 136 . 197 EXTERNAL ાર્ટ હ ONLy ,

All Olympic Warmettes are essentially double walled, insulated cabinets with transparent doors. The Warmettes normally remain on continuously. The temperature is user selectable. The Model 10 uses a resistance element heater encapsuled in a high temperature r lie Model 10 uses a roclocanos element of the interior. Due to the small size, forced air circulation is not needed. The Models 30, 31 and 40 make use of a fan to force recirculating air past The Models 50, of and 10 make see above the main chamber) and then into the resistence heating bientified (roothe heaters via an air duct built into the left wall. The Models 31 and 40 differ from the Model 30 in two respects: · The selectable maximum temperature is higher. - · The delivery duct/plenum inside the right wall is more efficient, allowing the Models 31 and 40 to operate at the higher temperatures.

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device called "Warmette" by Olympic Medical. It is a Class I device, a powered heating unit intended for warming blankets/linen or external solutions.

Based on the provided text, the device Warmette (Models 30, 31, and 40) meets acceptance criteria primarily through nonclinical testing, demonstrating substantial equivalence to a predicate device (Olympic Warmette Model 10). There is no mention of a study involving human readers or clinical trials for performance evaluation in the context of typical AI/diagnostic device acceptance criteria. The device is a heating cabinet, not an AI or diagnostic tool.

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

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

The document doesn't explicitly state "acceptance criteria" in a formal table with pass/fail thresholds for specific performance metrics in the way one would see for a diagnostic device. Instead, it demonstrates performance by comparing its specifications to a predicate device and verifying certain safety functions. The key performance parameter is temperature range and accuracy.

¹ Preliminary specifications, will not exceed the range of the predicate device (75° - 150°F)

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 as the device is a heating unit, not a diagnostic or AI-driven device with a "test set" in the context of patient data. The "tests" refer to engineering and safety verification.

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 information is not applicable. The "ground truth" for a heating unit involves physical measurements and engineering standards, not expert medical interpretation of data.

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

This information is not applicable. Adjudication methods are relevant for ambiguous diagnostic findings, which is not relevant to this device.

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

This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic tools. This device is a powered heating unit, not an AI or diagnostic device.

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

This information is not applicable. This device does not involve an algorithm or AI.

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

The "ground truth" in this context is based on engineering specifications, physical measurements, and compliance with recognized safety standards. For example, a thermometer would be used to verify the actual temperature of the unit and its contents, and electrical testing equipment would verify electrical safety parameters.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning model, so there is no "training set."

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

This information is not applicable. There is no training set for this device.

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