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The 6500 Series V2masks are disposable, single-patient-use, adult oro-nasal masks intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to continuous ventilators which have adequate alarms and safety systems for ventilator failure. The masks are specifically indicated for use on adult patients (> 30 kilograms weight) to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. They are intended for use on patients who are appropriate candidates for noninvasive ventilation, in the home, hospital, or other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.

The 6600 Series V2masks are disposable, single-patient-use, adult oro-nasal CPAP/NIPPV masks which incorporate passive, continuous flow exhaust ports into the mask itself. They are intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that use this exhaust port configuration providing a minimum of 3 cm H20 pressure measured at the mask. The masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures >3.0 cm H20 at the mask) in homes, hospitals, or other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.

The 6700 Series V2masks are disposable, single-patient-use, adult oro-nasal CPAP/NIPPV masks without any passive, continuous flow exhaust port built into the mask. They are intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that incorporate the patient vent into the patient circuit instead of the mask. These masks provide a minimum of 3 cm H20 pressure measured at the mask. The masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures >3.0 cm H20 at the mask) in homes, hospitals, or other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.

The Disposable Single-Patient-Use Oro-Nasal V2mask™ devices consist of the following basic components: 1. Mounting Head Gear 2. Face Piece 3. Swivel Port Assembly. The Face Piece and the Swivel Port Assembly are cleanable and are disposable after 7 days of singlepatient treatment. However, they are not reusable after this time. The Mounting Head Gear is also cleanable and disposable after multiple uses. The Mounting Head Gear which comes in two sizes has straps which are adjustable in both length and tension. It holds the Face Piece against the patient's face to prevent any gas leakage. The Elbow of the Swivel Port Assembly for the 6600 Series V2masks™ incorporate a series of vent holes to provide a continuous air leak to flush out the dead space CO2 and prevent it from being rebreathed by the patient during CPAP or noninvasive positive pressure ventilation (NIPPV) therapy using the required single-limb patient circuit. The Face Piece for all sizes of the 6500 and 6700 Series V2masks™ are nonvented. They do not incorporate vent holes in the Elbow. However, the 6500 Series requires the incorporation of a an active exhalation valve into the expiratory limb of the patient circuit used with the continuous ventilation device providing the noninvasive ventilation. The 6700 requires the incorporation of an exhaust valve into the single-limb patient circuit of the CPAP or NIPPV device. This provides the required air flow to flush out the dead space CO2 and prevent it from being rebreathed. The Swivel Port Assembly for the 6600 Series and the 6700 Series V2masks™ consists of the following pieces: 1. Mask Adapter 2. Elbow with Ant--Asphyxia Valve (AAV) 3. 22 mm OD Swivel Port. The AAV functions as a safety mechanism which allows the patient to breathe fresh air if the NIPPV or CPAP output ceases. It allows a minimum IPAP, EPAP or CPAP pressure of 3 cm H20. The 6500 Series V2mask™ Swivel Port Assembly consists of the same pieces except the Elbow does not incorporate an AAV. The safety mechanism provided by an AAV is already provided by the continuous ventilator which would recognize an AAV in the mask as a patient circuit leak.

The provided text is a 510(k) summary for a medical device (V2masks™), which focuses on establishing substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the manner of an AI/algorithm-focused study. Therefore, most of the requested information regarding AI study design (sample sizes, expert consensus, MRMC, standalone algorithm performance, training set details) is not applicable or cannot be extracted from this document.

However, I can extract the general acceptance criteria inferred from the substantial equivalence claim and the reported device performance as described.

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

Acceptance Criteria and Device Performance

The document doesn't explicitly state numerical "acceptance criteria" for performance metrics in the typical sense of an AI study. Instead, it asserts substantial equivalence to predicate devices based on:

1. Intended Use, Indications for Use, and Intended Patient Population: The V2masks™ possess the same as predicate devices.
2. Safety and Effectiveness: No new questions regarding safety or effectiveness are raised compared to predicate devices.

The "reported device performance" is demonstrated through the evidence presented to support this equivalency:

• Biocompatibility confirmation: All mask materials successfully underwent biocompatibility testing. The mask Face Piece (patient skin contact) is injection grade thermoplastic elastomer (TPE). The anti-asphyxia valve (breathed gases contact) is latex-free silicone rubber. Other Swivel Port Assembly components (breathed gases contact) are acrylic-based multipolymer. Head Gear materials are nylon, polyester straps, and polycarbonate clips.
• Verification and Validation Testing performed.
• Hazard Analyses performed. |
  | Effectiveness - No new questions of effectiveness raised | - Laboratory studies comparing the performance of the V2masks™ to the predicates.
• Laboratory performance verification and validation data.
• 6600 Series V2masks™ (Vented): Incorporate passive, continuous flow exhaust ports. The AAV allows a minimum IPAP, EPAP or CPAP pressure of 3 cm H2O. Vent holes provide continuous air leak to flush CO2 and prevent rebreathing.
• 6500 Series V2masks™ (Non-vented): Nonvented. Requires active exhalation valve in expiratory limb of patient circuit for continuous ventilation devices.
• 6700 Series V2masks™ (Non-vented): Nonvented. Requires exhaust valve into single-limb patient circuit of CPAP or NIPPV device. These masks provide a minimum of 3 cm H2O pressure measured at the mask.
• Swivel Port Assembly with Anti-Asphyxia Valve (AAV) for 6600 & 6700: AAV functions as a safety mechanism, allowing patient to breathe fresh air if NIPPV/CPAP output ceases. Enables minimum IPAP, EPAP, or CPAP pressure of 3 cm H2O. |

Regarding an AI/Algorithm Study:

As the provided document is a 510(k) summary for physical medical masks and not an AI/software as a medical device (SaMD), the following items are not applicable (N/A) or cannot be extracted:

2. Sample size used for the test set and the data provenance: N/A - Not an AI study using a test set in this context. The "test set" here refers to physical performance testing, not a dataset for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A - The ground truth for mask performance would be established through engineering and medical device standards, not expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A - Not an AI study relying on expert adjudication.
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: N/A - This is entirely irrelevant for a physical medical device like a mask.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A - This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical device, the "ground truth" would be established by objective measurements against engineering specifications, biocompatibility standards, and clinical performance parameters (e.g., pressure maintenance, CO2 clearance, seal integrity) demonstrated in laboratory settings.
8. The sample size for the training set: N/A - No AI training set.
9. How the ground truth for the training set was established: N/A - No AI training set.

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The Hans Rudolph 7600 Vmask series are reusable, multi-use, adult Oro-Nasal CPAP/NPV masks which incorporate a passive, continuous flow exhaust port at the patient connection. They are intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that use this exhaust port configuration providing a minimum of 3 cm H2O pressure measured at the mask.

The Masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures ≥ 3.0 cm H2O at the mask) in homes, hospitals, or other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.

7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV Masks consists of the following components:

1. Mounting Head Gear
2. Face Piece with Vent Holes
3. Swivel Port Assembly

The Face Piece and the Swivel Port Assembly are both sterilizable and reusable by multiple patients. The Mounting Head Gear is disposable after multiple uses by a single patient only.

The Mounting Head Gear is adjustable in both its size and tension and holds the Face Piece against the patient's face to prevent any gas leakage. The size range of adjustment have been determined by a Mask Human Factors Study. The Mounting Head Gear also holds both the Face Piece and the Swivel Port Assembly onto the patient's head and is capable of adjusting to varying head sizes as determined by the Mask Human Factors Study.

The physical properties and dimensional ranges of the Face Piece (Mask) sizes listed under section #3 above have been determined by a Mask Human Factors Study.

All Face Piece sizes incorporate a series of vent holes in the area of the nose to provide a continuous air leak to flush out the dead space CO2 and prevent it from being rebreathed by the patient. The incorporation of these holes do not interfere with the other performance requirements of the 7600 Series Mask. The vent holes also function to allow the patient to exhale normally.

The Swivel Port Assembly consists of the following pieces:

1. Mask Adapter
2. Elbow with Anti-Asphyxia Valve
3. 22 mm Swivel Port

The 22 mm Swivel Port is sized to connect to all standard CPAP or ventilation device tubing types. The Elbow provides 360° of swivel rotation both at the Mask Adapter and at the 22 mm Swivel Port. The Anti-Asphyxia Valve is detachable from the Elbow for cleaning, sterilization and replacement.

The Anti-Asphyxia Valve functions as a safety mechanism which allows the patient to breathe fresh air if the CPAP or ventilation device output ceases.

The provided text describes a 510(k) premarket notification for the Hans Rudolph 7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV Masks. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (Hans Rudolph 7600 Series Reusable (Single-Patient Multi-Use) Oro-Nasal CPAP/NPPV Masks, K020759).

The key difference for the new device is that its labeling has been modified to include use on multiple patients after proper cleaning and sterilization/disinfection. Therefore, the "study" proving the device meets acceptance criteria primarily revolves around verification data for the recommended sterilization and disinfection processes.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for the "test set" in terms of clinical performance or a specific number of masks tested for sterilization/disinfection. It refers generally to "verification data" for these processes.

• Sterilization/Disinfection Verification Data: This would typically involve laboratory testing of multiple units of the device subjected to the proposed cleaning, disinfection, and sterilization cycles. The number of cycles and devices tested would be determined by relevant standards (e.g., ISO, AAMI). The document doesn't specify the exact number of samples.
• Biocompatibility Testing: Conducted at a "nationally recognized biological testing laboratory." The sample size for such testing is usually dictated by the specific biocompatibility tests performed (e.g., cytotoxicity, irritation, sensitization).
• Human Factors Study: This would involve human subjects, but the number is not specified.
• Data Provenance: The studies mentioned ("Biocompatibility Testing," "Mask Human Factors Study," "Verification and Validation Testing," "Risk Assessment Analysis," and "Comparative Testing") are internal to the manufacturer (Hans Rudolph, Inc.) or conducted by contract labs on their behalf. The data is likely prospective for the specific tests mentioned, as they are newly performed to support the 510(k) for the multi-patient use claim.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for testing.

• For biocompatibility testing, the "nationally recognized biological testing laboratory" would have its own qualified scientists and technicians.
• For sterilization/disinfection verification, experts in microbiology and sterilization validation would be involved, likely employed by the testing lab or as consultants.
• For the Mask Human Factors Study, human factors specialists would design and conduct the study, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., for subjective assessments) as it focuses on objective performance criteria (sterilization effectiveness, material properties, fit).

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

There is no MRMC comparative effectiveness study mentioned. This filing is for a medical device (CPAP/NPPV masks), not an AI-powered diagnostic or assistive tool. Therefore, the concept of AI assistance and human reader improvement is not applicable here.

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

There is no standalone algorithm performance study mentioned. This device is a physical medical accessory, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Objective Performance Metrics: For sterilization/disinfection, this would be quantitative measures of microbial reduction or inactivation, likely against recognized standards.
• Material Science Standards: For biocompatibility, adherence to ISO standards (e.g., ISO 10993 series) and specific test results (e.g., cytotoxicity, irritation scores).
• Dimensional Measurements and Fit: For the human factors study, this would involve anthropometric data and user feedback on fit and comfort, likely measured against pre-defined ranges or standards.
• Engineering Validation: For the vent hole performance and anti-asphyxia valve function, this would be based on fluid dynamics, pressure measurements, and functional testing.

8. The Sample Size for the Training Set

There is no "training set" as this is not a machine learning or AI device. The concept of training data is not applicable.

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

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

Ask a specific question about this device

The Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The mask is multi-patient reusable. It is intended for use on adult patients above 30 kilograms weight, who are appropriate candidates for noninvasive ventilation, in the home, hospital, or other clinical setting.

Not Found

The provided FDA 510(k) clearance letter for the Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria.

This document is a clearance letter, which means the FDA has determined that the device is "substantially equivalent" to a legally marketed predicate device. This determination is based on a review of the company's 510(k) submission, which would have included information comparing the new device to the predicate device. However, the clearance letter itself only states the outcome of that review and the indications for use.

Therefore, I cannot provide the specific details you've requested. Here's why and what's typically missing:

1. Acceptance Criteria and Reported Device Performance: This letter summarizes the regulatory decision, not the performance data itself.
2. Sample Size and Data Provenance: This information would be in the detailed submission, not the clearance letter.
3. Number of Experts and Qualifications: This applies to studies, which are not detailed here.
4. Adjudication Method: Again, this is study-specific information.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is a type of study often done for AI/CAD devices, but not relevant for a physical medical device like a mask, and certainly not detailed in this clearance letter.
6. Standalone Performance: This device is a physical mask for ventilation, not an algorithm.
7. Type of Ground Truth: This refers to the reference standard in a diagnostic study, which is not applicable here.
8. Sample Size for Training Set: Not applicable for this type of device or documentation.
9. Ground Truth for Training Set: Not applicable for this type of device or documentation.

To obtain the kind of detailed information you're asking for, you would typically need to review the full 510(k) submission, which is significantly more extensive than the clearance letter. These submissions often include detailed test reports, performance data, and comparisons to predicate devices.

Ask a specific question about this device

The Hans Rudolph 7600 Vmask series is a reusable, single patient multi-use, adult Full-Face CPAP/NIPPV mask which incorporates a passive, continuous flow exhaust port at the patient connection. It is intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that use this exhaust port configuration providing a minimum of 3 cmH20 pressure measured at the mask.

The Masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures ≥ 3.0 cm H2O at the mask) in homes, hospitals, and other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.

The 7600 Series Reusable Full-Face CPAP/NIPPV Masks consists of the following components:

1. Mounting Head Gear
2. Face Piece with Vent Holes
3. Swivel Port Assembly

The Face Piece and the Swivel Port Assembly are both sterilizable and reusable. The Mounting Head Gear is disposable after multiple uses.

The Mounting Head Gear is adjustable in both its size and tension and holds the Face Piece against the patient's face to prevent any gas leakage. The size range of adjustment have been determined by a Mask Human Factors Study. The Mounting Head Gear also holds both the Face Piece and the Swivel Port Assembly onto the patient's head and is capable of adjusting to varying head sizes as determined by the Mask Human Factors Study.

The physical properties and dimensional ranges of the Face Piece (Mask) sizes listed under section #3 above have been determined by a Mask Human Factors Study.

All Face Piece sizes incorporate a series of vent holes in the area of the nose to provide a continuous air leak to flush out the dead space CO2 and prevent it from being rebreathed by the patient. The incorporation of these holes do not interfere with the other performance requirements of the 7600 Series Mask. The vent holes also function to allow the patient to exhale normally regardless as to whether he or she is connected to single or dual level CPAP system or an MNT. MNS or CBK ventilator and regardless of the make or model of the CPAP or MNT. MNS or CBK ventilator blower device being used.

The Swivel Port Assembly consists of the following pieces:

1. Mask Adapter
2. Elbow with Anti-Asphyxia Valve
3. 22 mm Swivel Port

The 22 mm Swivel Port is sized to connect to all standard CPAP or MNT, MNS or CBK ventilator blower tubing types. The Elbow provides 360° of swivel rotation both at the Mask Adapter and at the 22 mm Swivel Port. The Anti-Asphxyia Valve is detachable from the Elbow for cleaning, sterilization and replacement.

The Anti-Asphxyia Valve functions as a safety mechanism which allows the patient to breathe fresh air if the CPAP or MNT, MNS, or CBK ventilator blower output ceases.

The provided text describes a 510(k) premarket notification for a medical device, the Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks. This type of submission is a claim of substantial equivalence to a legally marketed predicate device, rather than a claim of meeting specific performance acceptance criteria based on a study with predefined metrics.

Therefore, the document does not contain an acceptance criteria table or a study that "proves the device meets the acceptance criteria" in the way one might expect for a de novo or PMA submission. Instead, the document establishes equivalence through a comparison of characteristics and performance with predicate devices.

Here's an analysis of the provided information based on your request, highlighting what is present and what is absent:

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

This information is not present in the document as specific acceptance criteria with defined numerical targets for performance and a direct reporting of how the device met those criteria.

However, the document does contain a "Comparison Table" (Section 10) which implicitly serves a similar purpose by comparing key characteristics and stating if the new device's performance or features are "Similar/Different" from the predicate devices. The goal is to demonstrate that any differences do not raise new questions of safety or effectiveness.

Below is an adapted table from the provided text, re-framing the "Characteristic" columns to reflect a comparison rather than explicit acceptance criteria. The "Reported Device Performance" for the Hans Rudolph 7600 Series is derived directly from the "7600 Series Reusable Full-Face CPAP/NIPPV Masks" column and the "Similar/Different" column in the original document.

| # | Characteristic (Implicit Criteria from Predicate) | Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks (Reported Device Performance) | Notes from "Similar/Different" Column |
|---|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | Connect adult patients to single and dual level CPAP devices and to non-invasively connect adult patients to blower-operated respiratory support ventilators | Similar |
| 2 | Indications | Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support | Similar |
| 3 | Environment | Homes, hospitals, and other clinical settings | Similar |
| 4 | Personnel Education and Training | Individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect | Similar |
| 5 | Reuse | Single patient multi-use | Similar (to ResMed and Respironics Reusable); Different (from Respironics Disposable) |
| 6 | Safety Mechanisms | Safety breathe-out valve to guard against loss of flow source; mask pull-string release feature to guard against aspiration or suffocation; mask vent holes to prevent CO2 buildup | Similar |
| 7 | Anti-suffocation Valve Threshold | 3.0 cm H2O minimum | Similar |
| 8 | Fastening Means | Mounting head gear straps | Similar |
| 9 | Mask Sizes | Five sizes (petite, extra small, small, medium, & large) fit a range of adult patients | Model 7600 series has one more size than Respironics and two more sizes than ResMed to ensure a good fit. Different |
| 10 | Mask Material in Contact with Face | Soft biocompatible silicone rubber (latex-free) | Similar (to ResMed and Respironics Reusable); Different (from Respironics Disposable which uses vinyl) |
| 11 | Cleaning Instructions | Yes | Similar (to ResMed and Respironics Reusable); Different (Respironics Disposable has none) |
| 12 | Validated Disinfection Instructions | Model 7600 series has validated disinfection instructions for all reusable mask components | Different (Predicate devices either have unknown validation or only for specific components) |
| 13 | Validated Sterilization Instructions | Model 7600 series has validated sterilization instructions for all reusable mask components | Different (Predicate devices either have none known or only for specific components) |
| 14 | Sterility at Shipment | Provided clean, non-sterile | Similar |
| 15 | Contraindications Listed in Labeling | More contraindications are recognized and these should also apply to predicates | Different (States more comprehensive list of contraindications than predicates, implying a more robust understanding of safety considerations) |
| 16 | Complications Listed in Labeling | More details are given on complications and these should also apply to predicates | Different (States more detailed list of complications than predicates, implying a more robust understanding of safety considerations) |
| 17 | Assemblies | Mounting head gear; face piece with vent holes; and swivel port assembly (includes mask adapter, elbow with anti-asphxyia valve, and 22 mm swivel port) | Similar |
| 18 | Material of Mask Shell & other pieces not in contact with face (excludes anti-suffocation valve) | Transparent polysulfone | Different (Predicate devices use polycarbonate or acrylic) |
| 19 | Service Life | 2 years | Different (Predicate devices' service life is unknown) |
| 20 | Maximum Operating Pressure | Model 7600 is capable of meeting all its specifications while operating at a maximum pressure of 40 cm H2O | Different (Equal to highest predicate; higher than one predicate's listed rating) |
| 21 | Carbon Dioxide Rebreathing | Built-in air leak provided by series of holes in mask near nose flushes CO2 out of mask | Similar |

Study that proves the device meets (implicit) acceptance criteria:

The document mentions that the manufacturer, Hans Rudolph, Inc., "has complied with these Design Control Procedures for all of the verification and validation (V & V) data generated to support the equivalency of this device."

The types of V & V data generated include:

• (a.) risk assessment and reduction analysis
• (b.) laboratory studies comparing the performance of the 7600 Series Masks with predicates
• (c.) human factors studies
• (d.) laboratory performance verification and validation

While these general categories are listed, specific details about the methodologies, sample sizes, or results of these studies are not provided in the publicly available 510(k) summary. The summary only states that these studies were conducted to support the claim of substantial equivalence.

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

This information is not provided in the 510(k) summary. The summary broadly states that "laboratory studies" and "human factors studies" were conducted. It does not mention sample sizes for any test sets or the provenance (country, retrospective/prospective) of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. Given the device type (a full-face mask for CPAP/NIPPV) and the nature of a 510(k) submission, "ground truth" as typically used in AI/image analysis studies with expert annotation is not directly applicable here. The "ground truth" for this device would relate to its physical and functional performance, potentially measured objectively in laboratory settings or subjectively through human factors evaluations.

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

This information is not provided in the 510(k) summary. Adjudication methods are typically relevant for studies involving subjective human interpretation (e.g., medical image reading) where disagreement among experts needs resolution. This is not the primary type of evaluation documented here.

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

An MRMC comparative effectiveness study is not mentioned and would not be relevant for this type of device (CPAP/NIPPV mask). MRMC studies are typically used to evaluate diagnostic imaging devices or AI tools that assist in interpretation. This device is a physical accessory for respiratory support, not an AI or diagnostic tool.

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

This is not applicable as the device is a physical medical accessory, not an algorithm or AI system.

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

For a physical device like a CPAP/NIPPV mask, "ground truth" would generally refer to objective measurements of physical properties (e.g., pressure, leak rate, CO2 washout as described in the comparison table) and performance against established safety and essential performance standards (e.g., biocompatibility, materials testing, functionality of safety valves). The document mentions:

• "laboratory studies comparing the performance of the 7600 Series Masks with predicates"
• "human factors studies" (likely subjective user feedback and fit assessments)
• "laboratory performance verification and validation"
• "Biocompatibility Testing"
• "Risk Assessment Analysis"
• "Comparative Testing"

These activities collectively contribute to understanding the device's "truth" or performance. However, explicitly defining "ground truth" as you might for a diagnostic AI is not directly addressed.

8. The sample size for the training set

This is not applicable as the device is a physical medical accessory and does not involve a "training set" in the context of machine learning or AI models.

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

This is not applicable for the same reasons as #8.

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Ask a specific question about this device

Ask a specific question about this device