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The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

The provided text describes the 510(k) premarket notification for the Mirage™ and X-pedion™ Hydrophilic Guidewires, asserting their substantial equivalence to a predicate device. The information primarily focuses on bench testing rather than AI/ML algorithm performance. Therefore, many of the requested details, such as those related to AI model training, expert ground truth, and human reader studies, are not applicable or cannot be extracted from this document.

Here's the relevant information based on the provided text:

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

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

The document does not specify the exact sample sizes (number of guidewires) used for each bench test. The data provenance is from non-clinical bench testing conducted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (the applicant).

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

Not applicable. This is a medical device clearance based on substantial equivalence demonstrated through non-clinical bench testing, not an AI/ML algorithm requiring expert-established ground truth. The "ground truth" for these tests would be the physical properties and performance measurements of the guidewires against engineering specifications.

4. Adjudication method for the test set

Not applicable, as this is bench testing of physical device properties, not a study involving human interpretation of data where adjudication would be necessary.

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 document is for a physical medical guidewire, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.

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

Not applicable. This is for a physical medical guidewire.

7. The type of ground truth used

The "ground truth" for the bench tests would be the physical and mechanical specifications for guidewires, as referenced by standards such as ISO 11070 and USP , as well as internal quality procedures (QP50324, TM0047). The tests evaluated observed performance against these predefined criteria.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device.

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

Not applicable. There is no training set for a physical medical device.

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The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.

The provided text describes the 510(k) premarket notification for the Mirage™ Hydrophilic Guidewire and X-pedion™ Hydrophilic Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, rather than a study on an AI/ML-based medical device.

Therefore, the information required to answer most of your questions about acceptance criteria for an AI/ML device, sample sizes for AI test sets, expert ground truthing, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not present in this document.

However, I can extract information related to the acceptance criteria and performance data for the physical medical device as described:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):

The document details numerous non-clinical bench tests performed to demonstrate the safety and performance of the guidewires. The results consistently state that "The Mirage™ and X-pedion™ Hydrophilic Guidewires met the acceptance criteria for [Test Name]."

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Since this is a 510(k) submission for a non-AI/ML medical device, the following information is not applicable or not provided in the document:

1. Sample sizes used for the test set and the data provenance: Not an AI device, so no "test set" in the AI sense. Bench tests follow specific standards, implying sample sizes per those standards, but not explicitly stated here.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth for a physical device is established via standardized physical and chemical tests, not expert human interpretation of data for AI.
3. Adjudication method for the test set: Not applicable for non-AI bench testing.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For a physical guidewire, "ground truth" is typically defined by adherence to engineering specifications, material properties, and performance under simulated clinical conditions, verified through empirical testing following established ISO and USP standards.
7. The sample size for the training set: Not applicable; this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable; this is not an AI/ML device.

In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not an AI/ML device requiring clinical validation for diagnostic or prognostic purposes.

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The SilverSpeed™, Mirage™, X-celerator™ Exchange , and X-pedion™ Hydrophilic Guidewires are indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.

The Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque, platinum distal coil. The guidewire is hydrophilically coated on the distal portion. For the Xcelerator ™ Hydrophilic Guidewire labeled as an "Exchange" quidewire, the proximal portion is coated with polytetrafluoroethylene (PTFE). The Exchange guidewire facilitates the exchange of one interventional device for another, while maintaining guidewire position in the anatomy.

The following modifications have been made to the device:

• Change in the degree of polymerization with the base coat . material.
• . Elimination of Brown Oxide pigment from base coat material.

The provided text describes a 510(k) premarket notification for a Hydrophilic Guidewire and its substantial equivalence determination. It does not include details of a clinical study or acceptance criteria with associated performance metrics for a device to meet specific performance targets. Instead, it focuses on non-clinical (bench and biocompatibility) testing to support changes to an existing device, and then a determination of substantial equivalence to predicate devices.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided.

However, I can extract the information related to the non-clinical performance and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission primarily relying on substantial equivalence and non-clinical testing for minor device modifications, the "acceptance criteria" are implied by successful completion of standard evaluations and demonstration of comparable performance to predicate devices. Specific quantitative targets for each test are not explicitly detailed in the provided text.

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

• Sample Size (Test Set): Not specified for any of the non-clinical tests. The text indicates "no clinical or animal testing was performed" beyond the specified biocompatibility and bench tests. The dog study (thromboresistance) is an animal study, but its sample size is not mentioned.
• Data Provenance: The tests are standard laboratory/bench tests and an animal study. No human clinical data from any country is presented. The testing would have been conducted by the manufacturer or contracted labs.

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

• Not applicable. The "ground truth" here is determined by objective physical and chemical testing standards and biological responses in laboratory settings, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

• Not applicable. As above, this pertains to clinical data interpretation, not objective non-clinical testing.

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

• No, a MRMC comparative effectiveness study was not done. The submission explicitly states "no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device," except for the listed biocompatibility and bench tests.

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

• Not applicable. This device is a physical medical device (guidewire), not a software algorithm.

7. The Type of Ground Truth Used

• For biocompatibility: Established ISO and ASTM standards, and direct biological responses (e.g., cytotoxicity, sensitization, hemolysis, pyrogenicity, in-vivo thromboresistance in dogs).
• For bench testing: Engineering specifications, performance characteristics comparable to predicate devices, and internal quality control standards.
• For shelf-life: Stability and performance measurements over time, extrapolated from accelerated aging data.

8. The Sample Size for the Training Set

• Not applicable. This is for a physical device, not an AI/ML model that requires a training set. The "training" for this device's development would be engineering design, material science, and manufacturing process development.

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

• Not applicable. See point 8.

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The Mirage Quattro channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Mirage Quattro is to be used by adult patients (>66lb />30kg) for whom positive airway pressure has been prescribed.

The Mirage Quattro is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/institutional environment.

The Mirage Quattro provides an interface such that airflow from a positive pressure source is directed to the patient's nose and mouth. The mask is held in place with adjustable headgear that straps the mask to the face.

The Mirage Quattro is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

The Mirage Quattro is a prescription device supplied non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ResMed Mirage Quattro device:

ResMed Mirage Quattro - Acceptance Criteria and Study Analysis

This 510(k) summary focuses on a "Special 510(k): Device Modification" for the ResMed Mirage Quattro, comparing it to a previously cleared version (K063122). The primary modification appears to be an extended therapy pressure range.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for parameters like CO2 performance or pressure-flow characteristics. Instead, it relies on substantiating equivalence to the predicate device.

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

The document states that "Bench testing is sufficient to demonstrate safety and efficacy of the modified Mirage Quattro." This indicates that no clinical "test set" with human subjects was used for this modification. The testing was entirely bench-based, meaning it likely involved laboratory equipment and simulations rather than patient data.

• Sample Size for Test Set: Not applicable, as testing was bench-based.
• Data Provenance: Not applicable, as no human data was collected.

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

Not applicable, as no clinical test set requiring expert ground truth establishment was conducted. The assessment was based on engineering and performance specifications, likely evaluated by internal ResMed engineers and regulatory affairs personnel.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was conducted.

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

No. The document explicitly states, "Bench testing is sufficient to demonstrate safety and efficacy of the modified Mirage Quattro." This rules out any clinical studies, including MRMC studies, for this particular modification.

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

This question is not directly applicable in the context of a medical device like a mask, which is a physical interface and not an algorithm or AI. The testing performed would be considered "standalone" in the sense that it was bench testing of the device itself, without human interaction.

7. The Type of Ground Truth Used

The "ground truth" for this modification was primarily:

• The performance specifications and characteristics of the predicate device (Mirage Quattro K063122), which had previously demonstrated safety and efficacy.
• Engineering and performance test results (e.g., pressure-flow, CO2 flush, material safety) showing that the modified device met these specifications and performed equivalently or acceptably within the extended pressure range.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm or AI model was involved in this device modification.

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

Not applicable, as no machine learning algorithm or AI model was involved.

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The Mirage Micro channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Mirage Micro is:

• to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed.
• intended for single patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

The headgear colour of the modified device has changed. The color of the outer layer of the fabric is being changed from dark blue to tan. All other aspects of the device remain unchanged.

The modified Mirage Micro is safe when used under the conditions and purposes intended as indicated in the labelling provided with the product.

The modified Mirage Micro is a prescription device supplied nonsterile.

Both the masks incorporate vent holes to provide continuous air leak to flush out the dead space within the mask and minimize the amount of CO2 rebreathed by the patient. The design of the mask components is such that the incorporation of these vent-holes does not interfere with the intended performance of the masks. Both masks connect to a conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1:2004)

Both masks have provisions for connecting oxygen and pressure sensing tubing via luer ports.

Both masks are constructed using molded plastic components and fabric headgear. All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1).

Both the modified device and the previously cleared device can be reused in the hospital / institution environment.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable. This document is for a Special 510(k) for a minor device modification (headgear color change). No new clinical or performance test data was generated with a specific test set. The submission relies on a comparison to the predicate device and the assertion that the change is cosmetic and does not impact performance.
• Data Provenance: Not applicable for a new test set. The basis for substantial equivalence is the prior clearance of the predicate device (Mirage Micro Mask K072940) and the established safety and effectiveness of vented nasal masks with CPAP/Bilevel therapy.

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

• Not applicable. No new ground truth was established for a test set as part of this Special 510(k) submission.

4. Adjudication method for the test set:

• Not applicable. No test set requiring adjudication was used.

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 passive medical device (a mask); it does not involve AI or human readers for interpretation. Therefore, an MRMC study is not relevant.

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

• No. This device is a passive medical device and does not involve any algorithms or software-driven performance that would require standalone testing.

7. The type of ground truth used:

• The ground truth for the safety and effectiveness of the device is based on the prior clearance and established performance of the predicate device (Mirage Micro Mask K072940). The current submission argues that the modified device is substantially equivalent because the change is purely cosmetic (headgear color) and does not alter the fundamental design, materials, or intended use that were proven safe and effective by the predicate.

8. The sample size for the training set:

• Not applicable. This device is a passive medical device, and this submission is for a minor modification. It does not involve machine learning or AI, and therefore no training set.

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

• Not applicable. As there is no training set involved, no ground truth needed to be established for it.

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The Mirage FX channels airlow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Mirage FX is:

• to be used by patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed .
• intended for single-patient re-use in the home environment and multipatient re-use in the ● hospital/institutional environment.

The Mirage FX provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Mirage FX is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage FX is a prescription device supplied non-sterile.

Here's an analysis of the acceptance criteria and study information for the RESMED Mirage FX Traditional 510k submission, based on the provided text:

Acceptance Criteria and Device Performance

The submission describes the Mirage FX device as "substantially equivalent" to predicate devices, meaning it meets the same safety and effectiveness standards. The specific criteria are based on the technological characteristics and performance of the predicate devices.

Study Information

Based on the provided text, the submission primarily relies on bench testing and comparison to predicate devices to demonstrate substantial equivalence. No clinical studies (on human subjects) are described in detail.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data. The evaluation primarily involved bench testing of the device itself and comparison to physical characteristics of predicate devices.
   • Data Provenance: Not applicable in the context of a clinical test set. The bench testing would have been conducted by ResMed.

2. 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. Ground truth for a clinical test set (e.g., disease presence) was not established through expert review for this submission. The "ground truth" for the device's performance was established through engineering specifications and comparison to the performance of medically accepted predicate devices via bench testing.

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

   • Not applicable. There was no clinical test set requiring expert adjudication.

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 MRMC study was mentioned. This device is a medical mask for positive airway pressure therapy, not an AI-assisted diagnostic or treatment device.

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

   • Not applicable. This is not an algorithmic device. The "standalone" performance refers to the bench testing of the device's physical functions (e.g., pressure-flow characteristics, CO2 clearance) without a human user.

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

   • The "ground truth" for this substantial equivalence claim is effectively the established safety and effectiveness of the predicate devices and the physical/engineering standards (e.g., ISO standards, pressure-flow characteristics) achieved through bench testing. For CO2 performance, it was deemed "substantially equivalent" to the Ultra Mirage II.

7. The sample size for the training set

   • Not applicable. This device does not involve machine learning algorithms that require a "training set."

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

   • Not applicable. This device does not involve machine learning algorithms.

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The Mirage Micro channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Micro is: - to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed. - to be used for single-patient re-use in the home environment and multi-patient reuse in the hospital/institutional environment.

Not Found

This appears to be a 510(k) clearance letter from the FDA for a medical device (Mirage Micro™). It does not contain the information required to answer your prompt.

The document is a regulatory approval, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance, labeling, and reporting requirements.

Specifically, the document does NOT include any of the following:

• A table of acceptance criteria or reported device performance.
• Information on sample sizes for test sets, data provenance, or training sets.
• Details about expert involvement, ground truth establishment, or adjudication methods.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the provided text.

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The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Echo is: to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

The Mirage Echo provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Mirage Echo is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage Echo is a prescription device supplied non-sterile.

Here's an analysis of the Mirage Echo Traditional 510k, based on the provided text, focusing on acceptance criteria and supporting studies.

Based on the provided information, the 510(k) submission for the Mirage™ Echo nasal mask describes a comparative study against predicate devices (Mirage Micro and Ultra Mirage II Mask) to demonstrate substantial equivalence, rather than a study with explicit, quantitative acceptance criteria for device performance as one might see for an AI algorithm.

The core of the "study" is a set of comparisons and assertions of substantial equivalence, relying on bench testing and the existing clinical acceptance of similar technology.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional 510(k) for a medical device (nasal mask), the "acceptance criteria" are primarily established implicitly by demonstrating substantial equivalence to predicate devices, focusing on safety, performance characteristics, and intended use. The performance is reported as "substantially equivalent" to the predicates.

2. Sample Size for the Test Set and Data Provenance

The provided text does not mention a "test set" in the context of clinical data or patient-specific evaluation. The performance data refers to bench testing. Therefore, information regarding:

• Sample size for the test set
• Data provenance (e.g., country of origin, retrospective/prospective)
  is not applicable as no clinical test set data is described. The submission relies on "bench testing" and comparison of technical specifications.

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

This information is not applicable. Since no clinical test set data is described, there's no mention of experts establishing a ground truth for such a set. The "ground truth" for this type of submission is typically derived from established engineering principles, international standards (e.g., ISO), and the performance of legally marketed predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable. No clinical test set data is described that would require an adjudication method.

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

A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, potentially with AI assistance. The Mirage Echo is a medical device (nasal mask) for therapy delivery, not a diagnostic tool requiring interpretation.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done, nor would it be relevant for this type of device. The Mirage Echo is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is established through bench testing results, adherence to international standards (e.g., ISO 10993-1 for biocompatibility, ISO 5356-1:2004 for connectors), engineering specifications, and the established performance and safety profile of legally marketed predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as it focuses on demonstrating substantial equivalence in physical and functional characteristics.

8. Sample Size for the Training Set

This information is not applicable. The Mirage Echo is a physical medical device, not an AI algorithm that undergoes a "training set" process.

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

This information is not applicable. As it's not an AI algorithm, there is no "training set" or ground truth for such a set.

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The Mirage Micro channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Mirage Micro is:

• to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed.
• intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.

The Mirage Micro provides seal such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.

Mirage Micro is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

Mirage Micro is a prescription device supplied nonsterile.

The provided text is a 510(k) summary for the ResMed Mirage Micro, a vented nasal mask. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with acceptance criteria and a comprehensive study report. Therefore, much of the requested information regarding specific acceptance criteria, test sets, experts, and detailed study methodologies is not present in the provided text.

Here is the information that can be extracted or reasonably inferred from the document:

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

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

The document explicitly states: "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Micro, as was the case with the predicate devices."

• Sample Size for Test Set: Not specified. Since it refers to "bench testing," it would involve testing physical prototypes or samples rather than human subjects. The number of masks tested is not provided.
• Data Provenance: Bench testing results. Country of origin is not specified, but the applicant (ResMed) is a global company. Based on the submission being to the FDA, it's likely the testing was conducted in a manner consistent with US regulatory requirements, potentially in the US or by a facility accredited for such testing. The testing is prospective in the sense that it was performed to support this specific submission.

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

Not applicable. This was a bench testing study comparing the modified device to a predicate device based on physical characteristics and performance measurements (CO2, pressure-flow). There was no "ground truth" derived from expert interpretation of images or clinical outcomes in the traditional sense that would require a panel of experts.

4. Adjudication method for the test set

Not applicable, as no expert review or adjudication of clinical data was performed. The evaluation relied on objective measurements from bench testing.

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 medical mask for respiratory support, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the performance data (CO2, pressure-flow, flow impedance), the "ground truth" would be established by the objective measurements obtained from the bench testing against predefined engineering specifications and comparison to the predicate device's performance. For biocompatibility, the ground truth refers to compliance with ISO 10993-1 standards using validated material testing methods.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no training set.

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

Not applicable, as there is no training set for this device.

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The Mirage Micro channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Mirage Micro is:

• to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed.
• intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.

The Mirage Micro provides seal such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.

Mirage Micro is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

Mirage Micro is a prescription device supplied nonsterile.

The provided document is a 510(k) summary for the ResMed Mirage Micro Traditional, a vented nasal mask, seeking substantial equivalence to predicate devices. It is not a study that proves the device meets acceptance criteria in the way typically seen for AI/ML-based medical devices or diagnostics. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics and performance data via bench testing.

Therefore, many of the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" with numerical thresholds in the sense of a diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparative performance and technological characteristics. The "reported device performance" is essentially a statement of equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for the test set: Not applicable. The submission refers to "bench testing" and "comparison with predicate" rather than a clinical trial or a test set of data points in the context of an AI/ML device.
• Data provenance: Not applicable. Bench testing is typically performed in a laboratory setting. No country of origin for clinical data is mentioned as none was used.

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

• Number of experts: Not applicable. Ground truth establishment by experts is not described as part of this bench testing for a mechanical device.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. This concept is relevant for expert disagreement resolution in diagnostic studies, not for mechanical device bench testing.

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

• MRMC study: No. This is a medical device, not an AI/ML diagnostic.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This is a medical device, not an AI/ML diagnostic.

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

• Type of ground truth: Not explicitly stated as "ground truth" in the AI/ML sense. The performance of the new device was compared against the performance of the predicate devices (Mirage Micro K071808 and Mirage Quattro K063122) through bench testing parameters like CO2 performance, pressure-flow characteristics, and flow impedance. The "truth" is based on the established safety and efficacy of the predicate devices.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is a medical device, not an AI/ML system.

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

• Ground truth for training set establishment: Not applicable. This is a medical device, not an AI/ML system.

Summary of the Study (as described in the 510(k) Summary):

The submission for the Mirage Micro Traditional nasal mask relies on a bench testing study to demonstrate substantial equivalence to its predicate devices (Mirage Micro Mask K071808 and Mirage Quattro Mask K063122).

The core of the "study" involved:

• Comparison of Technological Characteristics: Detail how the new device's design, materials, and features are similar to the predicates. This includes aspects like the dual-wall silicone interface, vent hole design, standard connectors, luer ports, and biocompatible materials.
• Performance Data Comparison (Bench Testing): Direct comparison of the new device's performance against the predicate Mirage Micro regarding:
  • CO2 performance: Stated as "substantially equivalent."
  • Pressure-flow characteristics: Stated as "substantially equivalent."
  • Flow impedance: Stated as "substantially equivalent."
  • Operation on standard flow generator settings: Stated as designed to operate on the same settings.

The conclusion drawn from this comparison and bench testing is that the new Mirage Micro is substantially equivalent because it shares the same intended use, similar technological characteristics, does not raise new questions of safety and effectiveness, and is at least as safe and effective as the predicate devices. Clinical data was deemed unnecessary as "Use of vented nasal masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy..."

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