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The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the abutment must be maintained at 90° when in use.

This equipment measures the time between the healing abutment and the striking rod by mechanically striking the implanted abutment and quantifies the fluctuation between the implant abutment and the alveolar bone. It is a principle to measure the contact time according to the acceleration change at the moment of being hit by using the acceleration sensor mounted on the Attack Pole. The higher the number, the better the fixation between the implant fixture and the bone.

The provided text describes a 510(k) premarket notification for a medical device called "The Trust," which measures the stability of dental implants. To answer your request about acceptance criteria and the study proving the device meets them, I need to focus on the "Performance Data" section and the "Comparison Technological Characteristics with the Predicate Devices" table, as these are the most relevant parts.

Here's a breakdown based on the information provided and common expectations for such submissions:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table with specific pass/fail values. Instead, the document relies on demonstrating "similar performance" to a predicate device and meeting "established specifications." The key performance characteristic mentioned is the "Error of measurement value."

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

Based on the provided text, the study proving the device meets the acceptance criteria is primarily an equivalence test to the predicate device (AnyCheck IMT-100), rather than an independent clinical study with human subjects.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document does not explicitly state the sample size used for the performance comparison tests. It mentions "performance comparison tests with already licensed products" (refer to "002 Equivalence test to AnyCheck"). This often implies bench testing or testing on phantom models, rather than a large clinical test set with patient data.
   • Data Provenance: Not specified. Given it's a Korean manufacturer, it's likely the testing was conducted in South Korea. The type of study (retrospective or prospective) is not explicitly stated, but equivalence testing of this nature for dental handpieces typically involves prospective bench-top testing.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable/Not specified. For this type of device and performance testing, ground truth would likely be established by controlled experimental setups and direct measurement by engineers/technicians, rather than expert review of images or clinical outcomes.

3. Adjudication Method for the Test Set:

   • Not applicable/Not specified. As the "ground truth" is likely derived from calibrated measurements in a controlled environment, there wouldn't typically be a need for expert adjudication in the way it's used for AI diagnostic studies.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study is typically performed for AI-driven diagnostic devices where human readers interpret medical images. This device measures implant stability mechanically. There is no indication of such a study being conducted or required.
   • Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

5. Standalone (Algorithm Only) Performance:

   • Yes, implicitly. The "Performance Data" section refers to tests to ensure the device met "established specifications" and "consistent performance for the intended use." This strongly suggests bench testing or in vitro (non-human) testing of the device's measurement capabilities, which would be considered standalone performance. The "±3 ISV" error of measurement is a standalone performance metric.

6. Type of Ground Truth Used:

   • Likely bench-top measurements / calibrated experimental setup. The device measures a physical property (time between abutment and striking rod, quantified as ISV). The "ground truth" for evaluating its accuracy would come from highly controlled conditions where the "true" stability or a reference value is known (e.g., using standardized implant models with predefined stability levels or comparing to a gold standard measurement technique). It is not pathology, expert consensus, or outcomes data.

7. Sample Size for the Training Set:

   • Not applicable/Not specified. This device is described as a mechanical measurement device using an acceleration sensor, not an AI/machine learning device that requires a "training set" in the conventional sense. The "principle to measure the contact time according to the acceleration change... by using the acceleration sensor mounted on the Attack Pole" suggests a direct physical measurement.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there's no indication of a "training set" for an AI algorithm.

Summary of Device Performance Test and Conclusion:

The performance evaluation for "The Trust" appears to have focused on demonstrating its technical accuracy and equivalence to a legally marketed predicate device (AnyCheck IMT-100). The key performance metric highlighted is the "Error of measurement value" of ±3 ISV, which matches that of the predicate. The submission argues that similarities in operational principles and biological safety, despite minor design differences (e.g., how the calibrator is integrated, magnetic vs. screw connection for the attack pole), do not raise new questions of safety or effectiveness. Biocompatibility testing was also conducted according to ISO 10993 standards and found the materials to be non-toxic and non-sensitizing.

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The WATCHMAN TruSteer Access System is intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

The Boston Scientific WATCHMAN TruSteer™ Access System is composed of an Access Sheath and Dilator. The WATCHMAN TruSteer Access System is a steerable Access System intended to provide vascular and transseptal access specifically for the family of WATCHMAN™ FLX™ Left Atrial Appendage Closure Devices with Delivery Systems. The WATCHMAN TruSteer Access System will be used by interventional cardiologists and/or electrophysiologists who are trained in percutaneous and transseptal procedures.

The provided document is a 510(k) summary for the Boston Scientific WATCHMAN TruSteer Access System. It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device (WATCHMAN FXD Curve Access System, K212228).

However, this document does not contain information about a study proving that an AI-driven device meets acceptance criteria. It describes the verification testing for a physical medical device (an access system for cardiac procedures), not a software or AI-based device.

Therefore, I cannot provide the requested information, such as acceptance criteria for an AI device, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details, because this information is not present in the provided text.

The document explicitly states under "Clinical Testing": "Clinical evaluation was not required for this device." This confirms that no clinical study (which would typically involve test sets, human readers, and expert ground truth for AI performance evaluation) was conducted or reported for this submission.

The "Non-Clinical Performance Data" section lists various physical performance tests for the access system (e.g., Dimensional Characterization, Kink Resistance, Torque Transmission, Biocompatibility tests), which are typical for hardware medical devices, not AI software.

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TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxilla. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

TRUST is restricted to be used with 510(k) cleared abutment systems, and the design output from TRUST (the patient specific part of the abutment) must be manufactured according to the instruction of the selected Implant system.

TRUST includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, angulation, gingival marqin diameter, wall thickness). The design parameters, provided by abutment system manufacturers(Truabutment), for an abutment system are available via a Trust server when documentation of the 510(k) clearance of said implant system is confirmed by Rgorithm.

TRUST has no patient contact being a software only device. (stand-alone software)

The provided text describes a 510(k) premarket notification for a dental abutment design software called TRUST. However, it does not contain any information regarding acceptance criteria, reported device performance, or any study details like sample size, ground truth establishment, or expert qualifications.

The document primarily focuses on establishing substantial equivalence to a predicate device (Abutment Design, K200100) by comparing intended use, technological characteristics, and hardware/software requirements.

Here's a breakdown of what is and is not present in the provided text:

What is present:

• Device Name: TRUST
• Indication for Use: "TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device."
• Predicate Device: Abutment Design (K200100)
• Confirmation of Non-clinical Testing: "Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005. The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures."
• Cybersecurity Analysis: "The cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on October 02, 2014."
• Clinical Testing Statement: "Clinical testing is not a requirement and has not been performed."

What is explicitly missing or not described in the provided text, and therefore cannot be filled in based on this input:

• A table of acceptance criteria and the reported device performance. The document states that "All test results have been reviewed and approved, showing the TRUST to be substantially equivalent to the primary predicate device," but it does not provide the specific criteria or the performance metrics themselves.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (While it mentions "software only device," it doesn't quantify its standalone performance or discuss specific studies.)
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Conclusion:

The provided document describes a device (TRUST software) and its intended use, and states that non-clinical testing and cybersecurity analysis were performed to demonstrate substantial equivalence to a predicate device. However, it does not provide the specific details of acceptance criteria, device performance, or study methodology that would be required to complete the requested table and information points about test and training sets, ground truth, and expert evaluation.

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The V-TRUST TD-2202 portable ECG recorder is intended for recording and displaying ECG data of adult patients who are concerned about their heart rhythm. A patient can either equip a five lead-wires ECG cable to take a long term monitoring; or choose to use event reading option when feeling any heart condition occur. This recorder allows the patient to record their ECG data in SD memory card and playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia.

The V-TRUST TD-2202 portable ECG recorder can also wirelessly transmit recorded ECG to a Bluetooth-enabled computer.

The V-TRUST TD-2202 Portable ECG Recorder provides a long-period recording with multiple channels and transient recording with single channel for individual use. This portable electrocardiograph has a touch screen interface, TFT (Thin Film Transistor)-LCD waveform display, one SD (Secure Digital) memory card insertion port, data transmission via Bluetooth, and 24 hours of continuous recording (in non-compressed format).

The provided text describes a 510(k) summary for the V-TRUST TD-2202 Portable ECG Recorder, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and specific performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that "The bench tests were performed according to IEC 60601-1, IEC 60601-1-2 Medical and AAMI EC 38, and the results demonstrate that the V-TRUST TD-2202 Portable ECG Recorder conform to the standards and is safe and effective." This means the device met the requirements outlined in these consensus standards, which serve as the "acceptance criteria" for basic device performance, safety, and effectiveness. However, the exact numerical performance metrics against these standards are not provided in this summary.

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

• Sample Size: Not specified. Bench testing typically involves testing multiple units of the device; no patient data is mentioned for performance evaluation beyond the device's ability to record.
• Data Provenance: Not applicable for the described bench tests. The tests are performed on the device itself, not on patient data.

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

• Not applicable. The "ground truth" for bench tests is defined by the technical specifications and requirements within the IEC and AAMI standards. No human experts are mentioned for establishing ground truth in this context.

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

• Not applicable. Bench tests don't typically involve adjudication in the way clinical studies do. Compliance with standards is usually a pass/fail outcome based on measurement against defined thresholds.

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:

• No. This device is a portable ECG recorder, not an AI-powered diagnostic tool. The document does not describe any MRMC study or AI assistance. Its purpose is to record and display ECG data for analysis by a physician, not to interpret it automatically.

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

• No. This device's primary function is data acquisition and display. There is no mention of an algorithm performing standalone interpretation.

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

• For the bench tests, the "ground truth" is adherence to the technical specifications and performance limits defined by the referenced international standards (IEC 60601-1, IEC 60601-1-2, and AAMI EC 38). These standards establish benchmarks for electrical safety, EMC, and fundamental ECG signal characteristics.

8. The sample size for the training set:

• Not applicable. This device does not appear to use machine learning or AI that would require a "training set."

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

• Not applicable, as there is no training set mentioned.

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The V-TRUST Handheld Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.

This device with reusable SpO2 sensor accessories is indicated for non-invasive spot checking or continuous monitoring.

The V-TRUST Handheld Pulse Oximeter is a light weight, portable and non-invasive pulse oximeter designed for use in measuring and displaying functional arterial oxygen saturation and pulse rate for adults during no motion based on the principle of spectrophotometry.

The V-TRUST Handheld Pulse Oximeter uses the same fundamental technology with the predicate device, 503 Pulse Oximeter. The SpO₂ and pulse rate software algorithms, interference-filtering software, and alarming system are identical to the software in the legally marketed predicate device cleared under K911124, with minor changes that do not raise new questions of safety or efficacy.

The V-TRUST Handheld Pulse Oximeter is allowed to link individual Solaris Compatible Reusable Adult SpO2 Finger Sensor (K061931) only. Solaris finger sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter device.

Here's a breakdown of the acceptance criteria and study information for the V-TRUST Handheld Pulse Oximeter:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 10 healthy subjects (5 males and 5 females).
• Data Provenance: Not explicitly stated (e.g., country of origin), but the study was a "hypoxia study" conducted in adherence to ISO 9919:2005, implying a controlled clinical environment. It is a prospective study because subjects were tested during no motion to determine accuracy against an ABG analyzer.

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

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. It mentions that the ground truth for SpO2 and heart rate was determined "against the artery blood gas (ABG) analyzer in hospital," implying a gold standard measurement rather than expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by an objective medical device (ABG analyzer) rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers. The study compared the device's performance against a gold standard and a predicate device.

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

Yes, a standalone performance study was done. The study evaluated the accuracy of the V-TRUST Handheld Pulse Oximeter's measurements (SpO2 and heart rate) directly against a clinical gold standard (ABG analyzer) and a predicate device, without involving human interpretation of the device's output.

7. The Type of Ground Truth Used

The ground truth used for SpO2 was established by an artery blood gas (ABG) analyzer in a hospital setting. For heart rate, the ground truth was also established through comparison against the ABG analyzer and the predicate device. This represents an objective, clinically accepted gold standard.

8. The Sample Size for the Training Set

The document does not provide information on a training set or its sample size. This is typical for a device like a pulse oximeter, where the fundamental technology (spectrophotometry) and algorithms are well-established and not based on a machine learning model that requires explicit "training data" in the same sense as an AI diagnostic tool. The software algorithms are stated to be "identical to the software in the legally marketed predicate device cleared under K911124."

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

Not applicable, as no specific training set for a machine learning model is mentioned or implied. The device's software algorithms are inherited from the predicate device.

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The TD-8002 Multi-Parameter Spot-Check Monitor measures systolic and diastolic pressure, pulse rate, ear temperature, blood glucose and oxygen saturation of arterial hemoglobin (SpO2).
The device is intended to be used by clinicians and medically qualified personnel.
For glucose measurements, it quantitatively determines glucose levels using capillary and venous whole blood.
For blood pressure measurements, it is intended to be used to measure noninvasively the systolic and diastolic blood pressure and pulse rate of adults.
For pulse oximeter measurements, is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2 ) and pulse rate for adults.
For ear thermometer, it is intended for the intermittent measurement and monitoring human body temperature.

The V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor, Model TD-8002 (TD-8002) is a patient monitor that measures and displays real time physiological data of the patient, including blood glucose measurement. The TD-8002 can be used to monitor one or more of the following parameters: Noninvasive blood pressure (NIBP), blood oxygen saturation (SpO2), pulse rate, body temperature, and blood glucose. For all these vital parameters, the TD-8002 will be capable of limit alarms for SpO2, and storing monitoring data for retrospective review.
The TD-8002 has two monitoring devices built in the main unit: oximeter and NIBP monitor. The other two monitoring devices, infra-red ear thermometer and blood glucose meter are connected to the main unit via USB cable. All of the devices for monitoring vital signs are cleared by the FDA.
The oximeter sensor connected to the main unit of TD-8002 is the same as the Solaris Compatible Reusable Adult SpO2 Finger Sensor (Model S100A-090103 or Model S100A-300103) cleared under K061931.

The provided text is a 510(k) summary for the V-TRUST TD-8002 Multi-Parameter Spot Check Monitor. It does not contain specific acceptance criteria, detailed study designs, or performance metrics beyond a general statement that the device "meets its intended use and is equivalent to the predicate devices." The document primarily focuses on establishing substantial equivalence to previously cleared devices.

Therefore, many of the requested details about acceptance criteria, study specifics, and performance data cannot be extracted from this summary.

Here's a breakdown of what can be inferred or directly stated, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Blood Pressure Accuracy
• Pulse Rate Accuracy
• Ear Temperature Accuracy
• Blood Glucose Accuracy
• SpO2 Accuracy
• Pulse Rate (from SpO2) Accuracy | "The laboratory and clinical studies for the performance of V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor demonstrate that the performance of this system meets its intended use and is equivalent to the predicate devices."
  (No specific performance metrics like mean absolute difference (MAD), bias, or limits of agreement are reported in this summary.) |

Explanation of Inferred Criteria: The 510(k) process relies on demonstrating substantial equivalence to predicate devices. This implicitly means that the new device must perform at least as well as, or within acceptable tolerances compared to, the predicates for each parameter it measures. However, the exact quantitative acceptance criteria (e.g., specific AAMI standards for NIBP, ISO standards for glucose, or specific SpO2 accuracy limits) are not detailed in this summary.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified, beyond general "laboratory and clinical studies." It does not mention country of origin or whether studies were retrospective or prospective.

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

• This information is not provided in the 510(k) summary. Given the nature of the device (physiological measurements), ground truth would likely be established using highly accurate reference methods (e.g., arterial line for NIBP, CO-oximeter for SpO2, laboratory analyzer for glucose). The expertise of individuals involved in operating these reference methods would be relevant, but "experts to establish ground truth" in the AI/image analysis sense is not applicable here.

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

• Not applicable/not specified. This type of adjudication is typically relevant for subjective assessments, particularly in imaging studies involving AI. For objective physiological measurements, the ground truth is established by a reference device, not by expert consensus.

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

• No, an MRMC comparative effectiveness study was not done. This device is a multi-parameter spot-check monitor, not an AI-assisted diagnostic tool for human readers. Its function is to directly measure physiological parameters.

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

• Yes, the performance referenced ("laboratory and clinical studies for the performance of V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor") would inherently be a standalone performance assessment of the device's accuracy in measuring each parameter. The device itself is designed to provide direct measurements, not to assist a human in interpreting something.

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

• While not explicitly stated, for each parameter, the ground truth would be established by a highly accurate reference method or device. For example:
  • Blood Pressure: Likely invasive arterial line measurements or a highly calibrated reference NIBP device.
  • Pulse Rate: Could be derived from ECG or a highly accurate reference pulse oximeter/NIBP device.
  • Ear Temperature: A highly accurate reference thermometer (e.g., rectal probe, calibrated oral thermometer).
  • Blood Glucose: A laboratory-grade glucose analyzer using plasma or serum separated from the same blood sample.
  • SpO2: A CO-oximeter measurement from arterial blood gas.

8. The sample size for the training set

• This information is not applicable and not provided. The V-TRUST TD-8002 is a device that uses established measurement principles (e.g., oscillometric for NIBP, spectrophotometry for SpO2, enzymatic for glucose). It does not employ machine learning algorithms in the sense that would require a "training set" for an AI model.

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

• This information is not applicable and not provided, as there is no "training set" in the context of this device's technology.

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The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.

This oral dam is made of natural rubber latex, which completely covers a person's pubic areas during oral genital stimulation. This dam has a smooth surface (both sides), nominal lay flat width 154 mm, nominal length 250 mm, and nominal thickness 0.07mm. It is non- lubricated, and food grade cornstarch is used as a dressing material.

The condoms from which the oral dams are made conform to current established national and international voluntary standards which include ASTM D3492:2008; and have been previously cleared by the USFDA (ref: K070830).

The condoms will be offered in the following Colors and Flavors:

1. Yellow Banana
2. Red Strawberry
3. Green Mint

The provided document is a 510(k) Pre-Market Notification for a male latex condom (Trust Dams). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with detailed acceptance criteria and expert-read studies.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria for an AI/algorithm-based device and the study proving it meets those criteria. Specifically:

• No acceptance criteria table or reported device performance is present because this is a physical medical device (condom), not an AI algorithm. The performance is assessed against established standards for latex condoms.
• No sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details are provided, as these are concepts relevant to AI/algorithm validation, not to the pre-market notification for a physical medical device like a condom.
• No training set details are relevant here.

The document indicates that the device (Trust Dams) is made from natural rubber latex condoms that conform to established national and international voluntary standards, specifically ASTM D3492:2008 Male Latex Condom Standard. The predicate device is "Sheer Glyde Dams (K990067)", and the condoms from which the oral dams are made were previously cleared by the USFDA (K070830).

The "technological characteristics" section states: "This oral dam has the same technological characteristics as the listed predicate device identified above. The latex condoms (sheaths) from which the dams are made conform with the ASTM D3492:2008 Male Latex Condom Standard." This conformity to an established industry standard is the primary basis for demonstrating substantial equivalence for this type of device.

In summary, the provided text does not contain information about an AI or algorithmic device study. It details the 510(k) submission for a physical medical device (latex dam) and bases its substantial equivalence on adherence to existing condom standards.

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1 - Intended Use: The DHD TRUST is intended for use as a nebulizer.

• 2 Indications:
• The DHD TRUST provides additional hydration to help loosen secretions for patients whom extended therapy is required.
• The DHD TRUST delivers aerosolized medications and diagnostic formulations.
• 3 Target Patient Population
  Patients with asthma, pneumonia, COPD, or any other condition in which appropriate medications would be nebulized.

The DHD TRUST is indicated for use as a single patient use nebulizer. TRUST is a small plastic device that threads onto a regulated flow meter supplying air or oxygen. A reservoir bottle threads to the bottom of TRUST to hold water and/or medication. Trust has a secondary port on the side of the device to allow for supplemental air, oxygen, or heliox.

The provided text describes a 510(k) premarket notification for the DHD Healthcare Corporation's "TRUST" nebulizer. It details the device's intended use, technological characteristics, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or software. The study mentioned relates to particle size delivery for a physical medical device (nebulizer) and aims to show equivalence to a predicate device, not performance benchmarks for an AI system.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance for an AI/ML device, nor can I discuss sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided document.

The "Summary of Studies" section only states:
"Testing of particle size delivery was performed in accordance with the guidance document "REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS". The results of this testing shows particle size delivery to be equivalent between TRUST and the predicate."

This describes a physical performance test for a nebulizer, not an AI/ML model.

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This Device is A latex Condom: designed to Prevent PREGNANCY & help reduce the Risk. OF TRANSMISSION TO sexually transmitted diseases.

latex Condom

This document is a 510(k) clearance letter from the FDA for two brands of condoms: Trustex® and Impulse® Mint Flavored Condoms in Green Color. As such, it does not contain the information requested about acceptance criteria and a study proving a device meets them.

The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices and therefore can be marketed. It discusses regulatory compliance, labeling requirements (including expiration dating), and general responsibilities under the Federal Food, Drug, and Cosmetic Act.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any study.
• Information on expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information from this document.

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