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Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient

This is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The FlowStar ® Analog Mixer device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device.

Two rotary knobs are used to select the desired total flow and N20/O2 gas mixture. The total flow can consist of between 0 (100% O₂) and 70 (30% O₂) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar® Analog Mixer device has an integrated O2 Flush knob which delivers at least over 40 l/min of pure oxygen if the user presses the knob to flush the N20 out of the patient circuit after the treatment or in the situation the patient is over sedated.

The FlowStar Analog Mixer device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level.

The FlowStar ® Analog Mixer has an integrated Bag T. The mixed gas to it. The Bag T is a device with one additional input and two outputs. The additional input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled by the mixing device when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the connected scavenger system and finally to the patient

The provided text is a 510(k) Premarket Notification for a medical device called "FlowStar Analog Mixer Flowmeter." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria for an AI/ML-based algorithm.

Therefore, the requested information regarding acceptance criteria, device performance from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from this document as it does not describe a clinical performance study of an AI/ML algorithm.

The document discusses:

• Device Description: A breathing gas mixer for administering Nitrous Oxide and Oxygen.
• Indications for Use: Administering an adjustable mixture of Nitrous Oxide and Oxygen to a conscious, spontaneously breathing patient.
• Safety Features: O2 fail-safe system, alarm for insufficient O2 supply, O2 flush knob, mechanical encodings to prevent gas mix-up.
• Non-Clinical Testing: Compliance with standards like ISO 18562 (biocompatibility), ISO 14971 (risk management), ISO 15223-1 (labeling symbols), CGA V-5 (connectors), ISO 11195 (gas mixers), and IEC 62366-1 (usability testing). This mainly involves bench testing to ensure the physical and functional aspects of the device meet safety and performance standards.
• Clinical Testing: The document explicitly states, "Clinical testing was not required to establish substantial equivalence."

In summary, this document is a regulatory submission for a physical medical device (a gas mixer), not a clinical performance study for an AI/ML algorithm. As such, the specific metrics and study design elements requested in your prompt (e.g., acceptance criteria for an AI model's accuracy, expert reads, ground truth for data sets) are not relevant to this type of device and its regulatory clearance process as described here.

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Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.

The device will be available in two models: (Details below) FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 50 %, and FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 70 %.

50% and 70% represent the maximum nitrous oxide concentration. The FlowStar Touch O2- N₂O Mixer for Analgesia is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a doctor or a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The Baldus® Touch O2- N2O Mixer for Analgesia device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device. An integrated Touch pad is used to select the desired N₂O /O2 gas mixture. The total flow can consist of between 0 (100% O2) and 70 (30% O2) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar TouchO2- N2O Mixer for Analgesia device has an integrated O2 Flush function which delivers at least 30 l/min of pure oxygen to flush the N20 out of the patient circuit after the treatment. The FlowStar TouchO2- N₂O Mixer for Analgesia device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level. The gas mixture output of the FlowStar TouchO2- N2O Mixer for Analgesia device is connected to the Bag T. The Bag T is a device with two inputs and two outputs. One input is the gas mixture from the mixing device. The other input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the scavenger system and finally to the patient. The main accessories for the proposed device are a Breathing Bag and a Double Mask Scavenger System.

The device includes a microprocessor-controlled valve system that precisely meters Oxygen and Nitrous Oxide gases for analgesic purposes. The inputs of the touchpad influence the gas flow inside of the device. The firmware is considered to be of a moderate level of concern.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the FlowStar Touch Digital Mixer Flowmeter:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Accutron Digital Ultra K052335) through comparisons of characteristics and compliance with recognized standards. The "performance" is implicitly demonstrated by meeting the standards and showing similar or improved characteristics compared to the predicate.

Below is a table summarizing the characteristics where performance could be inferred or compared:

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The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.

This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.

The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.

The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.

Here's an analysis of the acceptance criteria and study information for the MINISCAV™ device, based on the provided document:

The document describes a 510(k) premarket notification for the MINISCAV™ waste gas evacuation apparatus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical efficacy studies in the same way a PMA would. Therefore, the "study" mentioned here refers primarily to the non-clinical testing performed to show the device meets its performance specifications and is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format for each performance aspect. Instead, it describes various tests and what they demonstrated. I've extracted the implied criteria and the reported performance from the "Non-Clinical Testing Summary" and "Technology, Construction, Performance" sections.

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The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 moxa is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "PREMIO 10 moxa," which is an infrared lamp. This type of document typically confirms that a device has been cleared for market based on substantial equivalence to a predicate device, but it does not include detailed information about the acceptance criteria, study design, or performance metrics that would be found in a clinical study report or a detailed premarket submission.

Specifically, the document does not provide any information on:

1. Acceptance criteria or reported device performance
2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or type of ground truth used for a test set.
3. Sample size or ground truth establishment for a training set.

The letter focuses on regulatory compliance and substantial equivalence, not on the results of a performance study with detailed acceptance criteria and study methodologies.

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The Sedat Flamingo is indicated for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

The Sedat Flamingo inflation device is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the FLAMINGO is achieved by the manipulation of a grip handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the button locks located on device.

The provided text is a 510(k) summary for the Sedat Flamingo Angiographic injector/syringe. The document explicitly states: "H. Summary of Clinical Tests (Not Applicable)." and lists "G. Summary of Non-Clinical Tests Mechanical testing was presented."

Therefore, a study demonstrating the device meets acceptance criteria via clinical tests, multi-reader multi-case studies, independent standalone algorithm performance, or using experts to establish ground truth is not applicable based on this document. The device's substantial equivalence was established through non-clinical mechanical testing and comparison to a predicate device.

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

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

The document does not specify quantified acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it relies on substantial equivalence to a predicate device and mechanical testing.

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. No clinical test set or data provenance from clinical data is mentioned for this 510(k) submission.

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

Not applicable. No clinical ground truth or experts were used for this 510(k) submission.

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

Not applicable. No clinical test set or adjudication method is mentioned for this 510(k) submission.

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 mechanical inflation device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a mechanical inflation device, not an algorithm.

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

Not applicable in a clinical sense. The "ground truth" for this device's performance was established through mechanical testing and comparison to a predicate device's design, materials, and function.

8. The sample size for the training set

Not applicable. No training set is mentioned for this 510(k) submission.

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

Not applicable. No training set is mentioned for this 510(k) submission.

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The SEDAT MYSHELL LITE is indicated for assisting, manipulating, and maintaining a seal around diagnostic/interventional devices with an outside diameter

The Sedat Myshell Lite consists of a variety of Y-connectors with a double silicone haemostatic valve within a reduce volume, well fitted for handling interventional procedures. The valve opening/closure mechanism could be activated by the thumb like a control button transforming the resilient valve in a variable geometry permitting to enlarge the valve opening of the silicone membrane. The interventionists make better adjustments for the seal introduction point and the size of the vascular instruments able to be introduced or removed to suit the individual pathology and anatomical conditions of the patient.

Here's an analysis of the provided text regarding the Sedat Myshell Lite device's acceptance criteria and the study used to demonstrate it:

Disclaimer: This device is a medical device (Y-connector with a double silicone haemostatic valve) and NOT an AI/algorithm-powered device. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and training sets are not applicable or cannot be extracted from the provided 510(k) summary. I will highlight what information is present and what is missing based on the nature of this particular device approval.

Acceptance Criteria and Device Performance

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Nautiflux is recommended for use in angiographic and coronarographic procedures to inject contrast media and to allow the physician to monitor the blood pressure.

Nautiflux is a universal and compact automatic set consisting of an injection handle and a fluid delivery system for use in angiographic and coronarographic procedures.

The provided text describes the 510(k) summary for the Nautiflux device. However, it explicitly states "Summary of Clinical Tests (Not Applicable)" and does not include any information about detailed performance testing with acceptance criteria, sample sizes, or specific performance metrics.

Therefore, I cannot provide the requested information from the given text. The document indicates that the device's substantial equivalence was based on non-clinical performance testing and equivalence in indications for use, design, material, and function to previously cleared devices, rather than a clinical study with detailed acceptance criteria and reported performance.

Based on the provided text, the answer is that the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets them.

The sections that would typically contain this information (like performance data, clinical trial results, or detailed non-clinical testing outcomes with pass/fail criteria) are either explicitly stated as "Not Applicable" for clinical tests or are summarized with a general statement that "Performance testing was presented" without specifying the criteria or results.

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The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states. The device consists of a solid, titanium needle.

The device consists of a solid, titanium needle.

This document is an FDA 510(k) clearance letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the given input. The categories in your request are relevant to the evaluation of AI/ML-driven medical devices, which this document is not about.

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DOLPHIN Inflation Device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

DOLPHIN is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc).

The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device.

Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device.

All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.

The provided document is a 510(k) summary for the "DOLPHIN Inflation Device". It is a premarket notification for a medical device and describes its indications for use, technological characteristics, and how its substantial equivalence to predicate devices was demonstrated. However, this document does not contain acceptance criteria or detailed study data to prove device performance against such criteria in the way typically expected for an AI/ML device or a device requiring specific performance metrics like sensitivity/specificity for a diagnostic tool.

Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device (Indeflator 20/30) based on intended use, conditions of use, design, materials, packaging, sterilization, and location. The "Performance Data" section briefly states that "The safety and efficacy of DOLPHIN has been demonstrated through a variety of preclinical tests and analyses, as well as non-clinical comparisons to the Indeflator 20/30." It does not provide specific numerical acceptance criteria or detailed results of these tests.

Therefore, I cannot populate the requested table and answer the study-specific questions as the detailed information on acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/ML device are not present in this 510(k) summary.

The questions you've asked are typical for the evaluation of AI/ML-based diagnostic or prognostic devices, which often require extensive clinical performance studies with specific statistical endpoints. The "DOLPHIN Inflation Device" is a manual, mechanical device (an angiographic injector and syringe) used to inflate and deflate balloon catheters during cardiovascular procedures. Its evaluation for 510(k) clearance primarily focuses on demonstrating its functional equivalence and safety compared to existing devices, rather than establishing diagnostic accuracy metrics.

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MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter

MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (

The provided text states that "The safety and efficacy of MYSHELL and its accessories... have been demonstrated," but it does not provide any specific acceptance criteria or details of a study verifying those criteria.

Therefore, I cannot populate the table or answer the specific questions about the study from the provided document. The submission is a 510(k) summary for a medical device (Y-Connector/Hemostatic Valve), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results with acceptance criteria.

Information not found in the provided document:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance for the test set.
• Number of experts used to establish ground truth for the test set.
• Qualifications of experts.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Effect size (if MRMC was done).
• Whether a standalone performance study was done.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

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