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The Salter Labs Trach-Vac endotracheal tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.

The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyurethane) and The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyvinylchloride) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. They are made primarily of polyvinylchloride with either a polyurethane (PU) or PVC cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization.

The provided text describes a 510(k) premarket notification for a medical device, the Salter Labs Trach-Vac Endotracheal Tube. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this document.

However, I can extract information related to the device's technical specifications and how its performance was evaluated to demonstrate substantial equivalence for a non-AI/ML medical device.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the way an AI/ML study would define performance metrics and thresholds. Instead, it demonstrates performance by showing compliance with recognized standards and similarity to a predicate device. The "reported device performance" is essentially the device meeting these standards and exhibiting similar characteristics to the predicate.

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The bubble humidifier is intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice.

The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.

The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410 mbars) safety valve is an empty, disposable, non-sterile, not made with natural rubber latex, device intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is provided with a 6 pounds per square inch (PSI) safety valve and can operate within flow rates of 6 to 15 liters per minute (LPM). The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks or cannulas, and use of optional oxygen tubing and water traps (face masks, 21 CFR 868.5580: nasal cannulas, 21 CFR 868.5340; oxygen tubing, 21 CFR 868.5860 and water traps, 21 CFR 868.5995 are 510(k) exempt).

This device is a passive device and is not a cascade humidifier, is not heated and is not prefilled.

The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located at the end of a PVC diffuser tube inside the humidifier bottle. The diffusor is designed to uniformly disperse the gas throughout the water. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The bottle is permanently marked with "minimum/maximum" water levels. The lid is marked with minimum source pressure, flow ranges and pressure value of the safety valve.

The provided document describes a 510(k) premarket notification for a medical device, specifically a "Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the device acceptance criteria and study information provided are tailored to this regulatory pathway, primarily involving performance testing and biocompatibility assessments related to a material change.

The document does not describe the development or evaluation of an Artificial Intelligence (AI) device. Consequently, several of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size, and ground truth for training set) are not applicable to this submission.

Here's an analysis of the provided information, addressing the relevant points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance specifications of the predicate device and relevant international standards. The "Performance Data" section indicates that the focus was on verifying that the material change did not adversely affect performance.

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

The document does not explicitly state the sample size for the performance tests conducted on the modified device (e.g., bond strength, cleaning, useful life studies). However, such tests would typically involve a statistically relevant number of units.

• Data Provenance: The tests were conducted internally by Salter Labs, the manufacturer. No country of origin for test data is specified beyond the manufacturer's location in Carlsbad, California, USA. The studies are prospective in the sense that they were designed and executed to evaluate the modified device.

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

This question is not applicable. The studies involved physical and chemical testing of the device, not the establishment of ground truth by human experts, as would be the case for diagnostic AI.

4. Adjudication Method for the Test Set

This question is not applicable. The tests involved objective physical and chemical measurements against predetermined specifications, not subjective interpretation requiring 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

This question is not applicable. This is not an AI device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This question is not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Established Performance Specifications: For parameters like flow rate, pop-off pressure, and mechanical integrity (bond strength), the "ground truth" refers to the pre-defined engineering and performance specifications that the device must meet, often derived from the predicate device's performance or relevant industry standards.
• International Standards (Biocompatibility): For biocompatibility, compliance with ISO 10993 standards (e.g., negative cytotoxicity, no irritation/sensitization) serves as the "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI device; therefore, there is no AI model requiring a training set.

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

This question is not applicable. There is no training set for an AI model.

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The BiNAPS Nasal Airflow Pressure and Snore Transducer (using the pressure transducer) is an accessory intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and amplifying breathing signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula. This device is intended for adult and pediatric (excluding neonatal and infant) use.

The ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is a thermal resistive thermistor designed to monitor oral/ nasal thermal airflow temperature and pressure changes during sleep studies. The ThermiSense is intended for use with a nasal cannula and polysomnography headbox or pressure transducers, such as, BiNAPS Nasal Airflow Transducer. This device is intended for adult and pediatric (excluding neonatal and infant) use.

The Salter Labs BiNAPS Nasal Airflow Pressure and Snore Transducer is a two output channel device used to acquire respiratory low pressure waves and low air flow that are sensed through a Nasal Cannula typically worn by a subject during a sleep diagnostic session. It is used to convert changes in air pressure and flow, occurring during sleep, into electrical signals that can be measured by polysomnography equipment. The Nasal Cannula directs the airflow and pressure waves generated by breathing and snoring from the nares and mouth of a patient through a luer lock fitting and then into a cup shaped plastic cylinder chamber sealed closed at the open end by a fitting and then into a cup shaped plastic cylinder chamber sealed closed at the open end by a piezo-electric ceramic element. The piezo element, when flexed by the impinging air pressure changes, generates a proportional electric voltage. This voltage is attenuated and filtered by subsequent passive electronic circuitry composing the sensor. The Salter Labs Airflow Pressure Transducer does not require a power source.

ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is composed of a Thermistor as the element which changes resistance as airflow from the patient is delivered across the element of the thermistor. The thermistor elements are located directly underneath the nares and in the airflow of the mouth. In both cases the element is kept from touching the skin of the patient in order to be the most effective change in temperature.

The Thermistor is mounted in the Cannula to position the thermistor properly under the nares and in the airflow path of the mouth. The Thermistor is covered with a heat shrink tubing to protect it from moisture from the patient. The Thermistor requires a battery source in order to derive a current flow through the circuit. This battery source is located in a small container called a signal-conditioning unit. This unit has circuitry that will remove noise, display a smooth signal and is an added feature test for wire continuity.

The provided text describes the acceptance criteria and the study conducted for the BiNAPS Nasal Airflow Pressure and Snore Transducer and the ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal. This document is a 510(k) summary submitted to the FDA, focusing on demonstrating substantial equivalence to predicate devices, primarily due to a material change in the cannulas.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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The intended use is to deliver oxygen to the patient nasally, controlled by a demand system.

The demand cannula is a special cannula designed to give adult and pediatric users of dual port oxygen conservation delivery system all the comfort and conveniences of a Salter-Style® cannula. Unique dual tubing delivers oxygen on demand through one tube while inspiratory / expiratory effort is also sensed through the other tube. Meets dual port device manufacturers' specifications.

The provided document describes the acceptance criteria and a study to demonstrate substantial equivalence for the NOP Demand Nasal Oxygen Cannula and NOP Modified Demand Nasal Oxygen Cannula.

Here's the breakdown of the requested information:

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

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

• Sample Size: A minimum required sample size of 29 was used for the performance testing.
• Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study conducted by the manufacturer (Salter Labs) to demonstrate substantial equivalence for a material change.

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 document. The study focuses on direct physical and performance testing of the device, not on expert evaluation or consensus for a "ground truth" as might be relevant for diagnostic or AI-based devices.

4. Adjudication method for the test set

This information is not applicable/provided as the study did not involve expert adjudication for establishing ground truth. The testing involved objective measurements against predefined criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a nasal oxygen cannula, not an AI-based diagnostic tool, so an MRMC study is not relevant.

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

This information is not applicable. The device is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

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

The concept of "ground truth" as typically defined for diagnostic or AI studies is not directly applicable here. Instead, the study establishes "truth" through direct physical performance measurements (e.g., back pressure, bond strength, temperature resistance) against specified engineering and product design criteria.

8. The sample size for the training set

This information is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

This information is not applicable. As there is no training set, there is no ground truth for it. The study established performance data through direct physical testing.

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The Nasal CO2 Sample Line is intended to be used to sample exhaled gas.

The O2 Delivery / CO2 Sampling Nasal Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.

The Oral / Nasal CO2 Sampling Cannula is intended to be used where exhaled gas is monitored.

The O2 Delivery with Oral / Nasal CO2 Sampling Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.

The Divided O2 Delivery / CO2 Sampling Nasal Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.

The Sample Lines are intended to be used where exhaled gas is monitored.

Environment of use - hospital, sub-acute, and pre-hospital settings.

Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.

The devices are non-sterile, disposable, single patient use cannulas and sample lines intended for sampling exhaled gases and/or delivering supplemental oxygen. Specific descriptions for each device type are provided: Nasal CO2 Sample Line, O2 Delivery / CO2 Sampling Nasal Cannula, Oral / Nasal CO2 Sampling Cannula, O2 Delivery with Oral / Nasal CO2 Sampling Cannula, Divided O2 Delivery / CO2 Sampling Nasal Cannula, and Sample Lines.

This document describes the equivalence of several CO2 sampling cannulas and lines (referred to as "Modified ETCO2 Devices") to previously cleared predicate devices. The primary change in the new devices is the material formulation.

Here's an analysis based on your requested information:

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

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

The document does not specify the exact sample sizes used for the performance tests (back pressure, bond strength, biocompatibility). It states "The test results demonstrate that the device is substantially equivalent" and "The materials passed all parameters" without providing numerical sample sizes.

The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted by Salter Labs for FDA clearance in the USA. The tests appear to be prospective in nature, performed on the newly modified devices.

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

This information is not applicable to this type of device and study. The "ground truth" here is based on quantifiable engineering and material performance standards (e.g., specific psi for back pressure, lbs for bond strength, and established biocompatibility testing protocols), not expert interpretation of clinical data or images.

4. Adjudication method for the test set:

Not applicable. This is a technical performance study, not a study requiring adjudication of human interpretation.

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 describes material and mechanical performance testing of a medical device (CO2 sampling cannibal/line), not an AI algorithm or a study involving human readers.

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

Not applicable. This document is not about an algorithm.

7. The type of ground truth used:

The ground truth used for this study is based on engineering specifications and established material safety standards.

• For back pressure and bond strength, the ground truth is the numerical threshold values (e.g.,

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CPAP Cannulaide is indicated to aid in securing and positioning the nasal interface for neonates and infants undergoing non-invasive ventilation in an acute care setting.

CPAP Cannulaide is a disposable device and is for single patient use only.

The CPAP Cannulaide® is a die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface for non-invasive ventilation. The Cannulaide® is applied above the lip and over the nose to provide a protective barrier between the nasal cannula and the patient's skin. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on neonates and infants. It is a non-sterile, single-patient use, disposable device.

The provided document describes a 510(k) premarket notification for the "CPAP Cannulaide®" device and focuses on establishing substantial equivalence to a predicate device. It is not a study report demonstrating the device meets specific acceptance criteria based on performance metrics as typically seen in AI/ML validation studies.

Therefore, many of the requested details about acceptance criteria, study methodologies, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not present in this type of regulatory submission. This document primarily outlines the device's intended use, features, and how it compares to existing, legally marketed devices to demonstrate that it does not raise new questions of safety or efficacy.

However, I can extract the information that is available and explain why other information is missing.

Device: CPAP Cannulaide®
Regulation Number: 21 CFR 868.5905 (Noncontinuous Ventilator (IPPB) Accessory)
Regulatory Class: Class II
Product Code: BZD
Predicate Device: K100011, headgear accessory as part of Patient Nasal Interface of Fisher & Paykel Bubble CPAP System
Reference Device: K903539, Salter Labs Model # 1015 (Tender Grip)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for an AI/ML algorithm. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

The "reported device performance" is described through non-clinical performance testing intended to show that differences from the predicate device do not raise new safety or efficacy concerns. These are typically engineering and materials tests, not clinical performance metrics against a "ground truth" derived from patient data for diagnostic or treatment-guidance AI.

• Tests performed: Cytotoxicity, Sensitization, Irritation.
• Additionally, exhaustive Extractable and Leachable testing including a risk-based assessment.
• Result: Materials found to be biocompatible and have limited reactivity. Supports no new safety/efficacy concerns compared to predicate. |
  | Securement Performance: Ability to secure nasal interface. | - Comparative securement (peel) testing performed.
• Result: Testing done to demonstrate changes do not raise new safety or efficacy concerns and support claims. (Specific peel force values are not provided in this summary but would have been in the full submission).
• Claim: Helps to prevent movement of the interface to maintain proper positioning. |
  | Sealing Performance: Ability to aid in sealing nasal prongs. | - Comparative sealing of nasal prongs testing performed.
• Seal maintenance testing performed.
• Result: Testing done to demonstrate changes do not raise new safety or efficacy concerns and support claims. (Specific seal metrics are not provided).
• Claim: Provides a secondary seal around the nasal prongs. |
  | Durability/Shelf-Life: Device maintains performance over time. | - Age / Shelf-life for 2 years testing performed.
• Performance in high humidity conditions testing performed.
• Result: Testing done to demonstrate changes do not raise new safety or efficacy concerns. (Specific stability data not provided). |
  | Overall Equivalence: Device is as safe and effective as the predicate. | - Substantial Equivalence Conclusion: The CPAP Cannulaide® based upon testing has been found to be substantially equivalent to the predicate accessory bonnet and straps of the F&P Infant Interface (K100011). The differences do not raise new questions of safety or efficacy. |

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable/Not provided. This document describes engineering and biocompatibility testing for a medical device (a physical product), not a data-driven AI/ML model that would have a "test set" of patient data in the conventional sense. The "performance testing" refers to physical tests on the device's material properties and mechanical function, not a dataset of patient cases.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. As above, there isn't medical "data" in the context of patient images or clinical records for an AI/ML model. The tests are on the device itself.

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

• Not applicable. There is no "ground truth" established by experts for a "test set" in the context of an AI/ML algorithm's diagnostic or predictive performance. The ground truth for biocompatibility is established by adherence to ISO standards and laboratory testing. The ground truth for mechanical performance (e.g., peel strength, seal integrity) is established through engineering test methods.

4. Adjudication Method for the Test Set:

• Not applicable. No expert adjudication method is mentioned, as there is no human interpretation of a "test set" to establish ground truth for an AI/ML clinical application.

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

• No. An MRMC study is not relevant for this type of physical medical device. MRMC studies are typically performed to assess the impact of an AI/ML system on human reader performance for diagnostic tasks (e.g., radiologists reading images).

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

• Not applicable. This device is a physical product, not a standalone algorithm.

7. The Type of Ground Truth Used:

• Biocompatibility: Established by published international standards (ISO 10993-1) and laboratory testing methods (e.g., cytotoxicity assays, sensitization studies).
• Performance: Established by engineering test methods (e.g., peel force measurements, seal integrity tests) designed to quantify the physical properties and functional aspects of the device against predefined specifications (though the numerical specifications themselves are not in this summary).

8. The Sample Size for the Training Set:

• Not applicable/Not provided. This is a physical device, not an AI/ML model that is "trained" on a dataset.

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

• Not applicable. As above, no training set or associated ground truth.

Summary of Device and its Role:

The CPAP Cannulaide® is a disposable, non-sterile device for neonates and infants undergoing non-invasive ventilation. Its purpose is to aid in securing and positioning the nasal interface and provide a protective barrier between the nasal cannula/interface and the patient's skin. It utilizes a hydrocolloid-coated polyurethane film with an integral hook strip.

The document demonstrates substantial equivalence to predicate devices by comparing:

• Indications for Use
• Environment of Use
• Patient Population
• Technology
• Materials
• Non-clinical performance testing (material biocompatibility, comparative securement, comparative sealing, seal maintenance, age/shelf-life, performance in high humidity).

The core of this 510(k) submission is to ensure the safety and effectiveness of this new physical device in its intended use, primarily through demonstrating that its materials and mechanical function are equivalent to or do not raise new concerns compared to legally marketed devices. It is not an AI/ML software device requiring performance metrics based on analysis of clinical data.

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To swaddle infants during neonatal phototherapy in the hospital or home setting. Single patient use only.

The Luma Wrap™ by Beevers Manufacturing & Supply, Inc./Salter Labs is a translucent, highly breathable, phototherapy-compatible, disposable infant swaddling blanket. It is made of spun bond polypropylene non-woven fabric that is more than 90% light-permeable. The Luma Wrap™ provides centered and comfortable boundaries to benefit many babies who exhaust themselves with their hyper-reactive, frantic movements while receiving phototherapy. The Luma Wrap™ is a stand-alone device and has no accessories. It is available in two designs: a square and a shape similar to baseball's home plate. A 2" strip of self-adhesive is an added optional convenience feature to assist the user in positioning the device by adhering two parts of the device together.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Luma Wrap™ device.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical efficacy or diagnostic accuracy for an AI/algorithm-driven device. Therefore, many of the typical AI study components like training sets, ground truth establishment for AI, expert adjudication, or MRMC studies are not applicable here.

Acceptance Criteria and Device Performance for Luma Wrap™

The Luma Wrap™ is a neonatal phototherapy unit (specifically, an infant swaddling blanket). The primary acceptance criteria revolve around its physical properties and performance in allowing phototherapy light to pass through, as well as its safety features.

1. Table of acceptance criteria and the reported device performance

• Test 1 (Lab, Overhead LED): 92.0%
• Test 2 (Lab, Overhead LED): 93.7%
• Test 3 (Hospital, Overhead Halogen): 94.0%
• Test 4 (Hospital, Beneath-the-infant Fluorescent): 97.7%

Double- and Triple-Layers: "light transmittances are still quite high" (No specific numeric value provided, but implied to meet an unstated internal acceptance criteria given the overall conclusion of substantial equivalence). |
| Adhesive Pull Strength | Adhesive pull strength to meet performance specification (specific value not explicitly stated as an "acceptance criteria" but implied by meeting the spec) | On average, 200g (measured with a force gauge pulled perpendicular to the adhesive). This "met the performance specification." |
| Adhesive Cycling / Reliability | Adhesive could be opened and closed at least 20 times (to verify functionality) | Adhesive cycle test verified that the adhesive could be opened and closed at least 20 times. |
| Air Flow Resistance (Safety) | Did not exhibit substantial resistance to air flow at rates of 1-12 lpm (to ensure infant's breathing is not impaired if device covers nose/mouth). | For two layers of fabric with an air flow of 8 lpm, resistance was 0.066 mmH2O/sq cm. This "met the device's performance specification and confirmed that an infant's breathing is not impaired if the device slips over the infant's nose and/or mouth." |

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

• Sample Size: Not explicitly stated for each test. The light transmittance tests refer to "Test #" (1-4), suggesting multiple measurements were taken for each. The adhesive pull strength mentions "on average, 200g," implying multiple measurements. The adhesive cycle test is for "the adhesive" (singular, but refers to the general feature). Air flow resistance is a single reported value for "two layers of fabric."
• Data Provenance: The tests were bench tests and performed in a laboratory and an empty hospital room. This is entirely simulation/controlled environment data, not patient-derived data.

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

This is not applicable. The device is not an AI/diagnostic device that relies on expert interpretation or ground truth establishment in a human sense. The "ground truth" here is the physical measurement of material properties (light transmittance, strength, air flow) using calibrated equipment.

4. Adjudication method for the test set

Not applicable, as this refers to expert review processes for AI/diagnostic outputs. The tests here are physical measurements.

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 physical product (a blanket), not an AI system. No MRMC study was performed.

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

Not applicable. This is not an algorithm/AI device. The "standalone" aspect refers to the device itself as a physical product, acting without human input for its core function (e.g., transmitting light). The tests performed are analogous to standalone performance tests of the physical properties.

7. The type of ground truth used

The ground truth used for these performance tests is objective physical measurement against established standards and specifications. For example, for light transmittance, it's the measured light passing through the material compared to the light without the material. For adhesive strength, it's the force required to pull it apart. For air flow, it's the measured resistance using specialized equipment.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this physical device.

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The bubble humidifier is a device that is intended to add moisture to breathing gases for administration to a patient. The bubble humidifier is indicated for use with oxygen concentrators or gas sources in homecare, hospital, extended care facilities and hospice environments. The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.

The Salter Labs Bubble Humidifier (High Flow) is an empty, disposable, non-sterile device that is intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (High Flow) is provided with a 6 PSI safety valve and can operate within flow rates of 6 to 15 LPM. The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks and cannulas, and use of optional oxygen tubing and water traps. The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle and houses the different interface connectors, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located inside the humidifier bottle that is designed to uniformly disperse the gas throughout the water. The 360° diffuser ports also provide quiet operation and minimize system backpressure. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The jar is permanently marked with minimum/maximum water levels.

Here's a breakdown of the acceptance criteria and study information for the Salter Lab Bubble Humidifier (High Flow), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "sample size for the test set" or the "country of origin of the data" or whether the testing was "retrospective or prospective." The non-clinical testing appears to be a series of laboratory tests performed on the device itself against established standards.

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

This information is not applicable to a physical medical device like a humidifier, where performance is measured against technical specifications and industry standards rather than being subject to expert interpretation for ground truth.

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

This information is not applicable to the non-clinical testing of a physical medical device against performance standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a bubble humidifier, not an AI-powered diagnostic tool requiring human reader studies.

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

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

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

The "ground truth" for this device's performance is based on established industry standards and regulatory requirements, specifically:

• ASTM F1690-96 (Reapproved 2004), "Standard Specification for Humidifiers for Medical Use-Part 1: General Requirements for Active Humidification Systems" for safety and performance and humidifier output.
• ISO 10993, "Biological Evaluation of Medical Devices" for biocompatibility.
• The 6 PSI pressure relief valve specification.
• The presence of an audible occlusion notification.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

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The Salter Labs Oral/Nasal Thermal Airflow Sensor is used as a cannula accessory with existing recording devices and data acquisition systems in a sleep laboratory setting to support the diagnostic recording of nasal and/or oral airflow. The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of airflow for use as an accessory component to a polysomnography recorder. The target population is adult and pediatric patients during a sleep study in a sleep laboratory.

The modified device has a minor construction change from that of the predicate device where a series of connected thermocouples replace a series / parallel connection of thermistors. Both elements are placed at the bridge of the nose to measure the same temperature changes during breathing from each nare and from the mouth. The lower cost thermocouples provide a lowcost single-use replacement for the more expensive thermistor device already cleared.

This document describes a Special 510(k) for a modified device, the Salter Labs Thermocouple (PneumoTherm), which replaces a thermistor-based thermal airflow sensor. The submission focuses on demonstrating substantial equivalence to the predicate device (K080922 Salter Labs Thermal Airflow Sensor) due to a minor construction change.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the acceptance criterion appears to be qualitative: demonstrating that the modified device is "sensitive enough to provide an adequate signal" and is "sensitive and timely enough to record a substantial signal" compared to other physiological respiratory events, and that it "performs as well or better as the predicate."

Since there are no numerical acceptance criteria, a direct comparison table is not possible in the traditional sense. However, based on the provided text, the performance can be summarized as:

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

• Sample Size: The document does not specify the sample size for the clinical testing. It simply refers to "Clinical Testing."
• Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the FDA (USA), it's highly probable the testing occurred in the USA or a region with similar clinical practices. The study is described as "Clinical Testing," implying it was prospective in nature, as it was conducted to demonstrate the functionality of the new device for this premarket notification.

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

• The document does not provide any information regarding the number of experts or their qualifications used to establish ground truth.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method. It simply states "Clinical Testing was simply down to show that the Thermocouple device was not only sensitive enough to provide an adequate signal... but that it was sensitive and timely enough to record a substantial signal compared to that of other physiological respiratory events." This suggests observation and comparison rather than a formal adjudication process for interpreting complex results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, an MRMC comparative effectiveness study was not done. The study's purpose was to demonstrate the function and safety of the device compared to a predicate, not to assess reader performance or the improvement with AI assistance (as this is not an AI device).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• This is not an AI/algorithm-based device. It is a physical sensor (thermocouple). Therefore, the concept of a standalone algorithm performance study is not applicable. The "device function" section describes its direct physical detection capabilities.

7. The Type of Ground Truth Used

• The ground truth can be inferred as physiological respiratory events observed and recorded by a Polysomnograph system. The document states clinical testing aimed to show the device's signal was "substantial compared to that of other physiological respiratory events." This implies that the standard polysomnography system provides the reference for what constitutes a "substantial signal" for breathing.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, and therefore, 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 type of device.

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The Salter Labs Oral/Nasal Thermal Airflow Sensor is used as a cannula accessory with existing recording devices and data acquisition systems in a sleep laboratory setting to support the diagnostic recording of nasal and/ or oral airflow. The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of ariflow for use as an accessory component to a polysomnography recorder.

The target population is adult and pediatric patients during a sleep study in a sleep laboratory.

The Salter Labs Thermal Airflow Sensor is composed of a Thermistor as the element which changes resistance as aiflow from the patient is delivered across the element of the themistor. The thermistor elements are located directly underneath the nares and in the airflow of the mouth. In both cases the element is kept from touching the skin in the patient in order to be the most effective change in temperature.

The thermistor will be mounted in the Cannula to position the thermistor properly under the nares and in the airflow path of the mouth. The thermistor will be covered with a heat shrink tubing to protect it from moisture from the patient.

The thermistor will require a battery source in order to derive a current flow through the circuit. This battery source will be located in a small container called a signalconditioning unit. This unit has circuitry that will remove noise, display a smooth signal and is an added feature test for wire continuity.

This 510(k) summary for the Salter Labs Oral/Nasal Thermal Airflow Sensor (K080922) does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets them. This document is a summary for regulatory clearance based on substantial equivalence to a predicate device, not a detailed technical report of a performance study with specific acceptance criteria.

However, based on the provided text, I can infer some information and highlight what is missing.

Here's a breakdown of the available and missing information:

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

• Missing: Specific quantitative acceptance criteria (e.g., accuracy, precision, response time, specified drift, signal-to-noise ratio) are not provided. The document relies on qualitative equivalence to a predicate device. If a performance study was conducted, the detailed results against specific metrics are not included in this summary.

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

• Missing: This information is not provided in the 510(k) summary. Given that this is a substantial equivalence submission, it's possible no direct clinical or bench testing beyond what's needed to simply demonstrate equivalence to the predicate (which might not involve a "test set" in the sense of a standalone performance study) was required or reported in this summary. If any testing was done, the sample size and data provenance are not disclosed.

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

• Missing: Not applicable as a formal "ground truth" establishment for a test set in a human-in-the-loop diagnostic performance study is not described. The device is an accessory for diagnostic recording, not a diagnostic device itself.

4. Adjudication method for the test set

• Missing: Not applicable for the reasons stated above.

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

• Missing: Not applicable. This device is a thermal airflow sensor, not an AI-powered diagnostic tool. No MRMC study is mentioned.

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

• Missing: The document states, "The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of airflow for use as an accessory component to a polysomnography recorder." This implies it provides raw data rather than performing an "algorithm-only" interpretation or diagnosis. No standalone performance data is presented in this document. The "equivalent performance in all operating ranges" likely refers to bench testing or basic functional comparison against the predicate, not a clinical standalone study.

7. The type of ground truth used

• Missing: Not explicitly stated as a formal "ground truth" was likely not established for a clinical diagnostic performance study of the sensor itself. For a device like this, "ground truth" for proving performance would typically involve a reference standard for airflow measurement (e.g., spirometry, pneumotachograph) or comparison against the established performance of the predicate device under controlled conditions. This detail is not in the summary.

8. The sample size for the training set

• Missing: Not applicable. This is a hardware sensor, not a machine learning model, so there is no "training set."

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

• Missing: Not applicable for the same reason as above.

Summary of Study (Based on the 510(k) Summary):

The document does not describe a particular "study" that proves the device meets specific acceptance criteria in the way one might expect for a diagnostic device. Instead, it relies on a "Substantial Equivalence" claim.

The implicit "study" is a comparison to a predicate device (Braebon Medical Corp. Airflow Sensor K981445). The "proof" is the assertion from Salter Labs that their device is substantially equivalent based on:

• Same intended use.
• Same operating principle (thermistor changes resistance with airflow).
• Same technology.
• Similar manufacturing processes.
• Equivalent performance in all operating ranges.

The 510(k) process for this type of accessory device often involves demonstrating that the new device functions reliably and similarly to a legally marketed predicate, rather than conducting extensive de novo clinical or performance trials with strict, quantitative, pre-defined acceptance criteria published in the summary. The "equivalent performance in all operating ranges" statement without specific data means that the FDA reviewed internal company data (not provided in this summary) and agreed that the new device performs at a similar level to the predicate, making it substantially equivalent.

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