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The IQSense Flow Sensor Mouthpiece is intended to be used as a disposable pneumotach mouthpiece for the Midmark (formerly Brentwood) IQspiro Digital Spirometer.

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I am sorry, but the provided text from the FDA 510(k) K150515 for the "IOSense Flow Sensor Mouthpiece" is a clearance letter and an "Indications for Use" statement. It does not contain information about the acceptance criteria, study details, or performance data of the device.

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

To answer your request, I would need a document such as the 510(k) summary or the full 510(k) submission, which typically includes detailed study reports and performance data.

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The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.

The AstraSonic Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses an ultrasonic transducer that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.

The document describes a 510(k) submission for the SDI AstraSonic Diagnostic Spirometer. The study performed aims to demonstrate substantial equivalence to a predicate device, the ndd Medical Technologies EasyOne Spirometer.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state acceptance criteria in a quantitative table. Instead, it describes a comparison methodology to establish equivalence. The core "acceptance criterion" is that the AstraSonic spirometer's measurement accuracy for flow should be equivalent to the predicate device.

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

• Sample Size for Test Set: The study utilized 26 waveforms. This refers to a standardized set of waveforms defined by the American Thoracic Society (ATS) for evaluating spirometer performance. These are likely simulated waveforms, not real patient data.
• Data Provenance: The 'data' (waveforms) are predefined standards from the American Thoracic Society, not originating from a specific country or collected retrospectively/prospectively. They represent a standardized, objective input for testing.

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

This information is not provided in the document. The "ground truth" for the test set (the 26 ATS waveforms) is inherent in the definition of those waveforms themselves as a benchmark for spirometer accuracy, not established by human experts in this context.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of using standardized ATS waveforms, there wouldn't typically be a need for expert adjudication in the way it's applied to, for example, image interpretation. The device's measurements would be compared against the known characteristics of the input waveforms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance is affected by an AI system. The AstraSonic spirometer is a diagnostic device for measuring lung function, not an AI system assisting human readers with clinical interpretation.

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

Yes, a standalone performance evaluation was the primary method. The study involved a "direct comparison of the Astrasonic spirometer and the predicate device... using the 26 waveforms described by the American Thoracic Society." This means the device's algorithmic and mechanical performance was tested independently against a known standard, without human-in-the-loop interaction for performance evaluation.

7. The Type of Ground Truth Used

The ground truth used was standardized scientific benchmarks/specifications, specifically the 26 waveforms described by the American Thoracic Society.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Spirometers like the AstraSonic typically do not employ machine learning models that require "training sets" in the conventional sense. Their function relies on established physical principles (ultrasonic measurement of flow) and algorithms (to derive values from this flow).

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

This information is not applicable for the reasons stated above (no typical "training set" for this type of device).

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The SDI Astra 300 Spirometer is a freestanding laboratory instrument for performing basic lung function tests and oximetry in people of all ages. It is intended to be used by physicians or professional medical personnel for testing in any setting.

The ASTRA 300 Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses a turbine transducer that measures flow via infrared interruption. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display. With the optional Pulse Oximeter module, the specific patient parameters oxygen saturation in the blood (SpO2) and pulse rate, both relating to the patient's pulmonary condition, may be measured and displayed.

The provided text lacks specific details about acceptance criteria, a detailed study design, and the performance characteristics of the SDI ASTRA 300 Diagnostic Spirometer that would allow for a comprehensive answer to your request. The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results.

However, based on the information available, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Study Details (Based on available information and assumptions about typical 510(k) submissions for such devices)

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

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified. For 510(k) substantial equivalence, data might come from internal testing, comparisons to predicate devices, or adherence to recognized standards. It's likely involved a combination of bench testing and potentially clinical data, but the specifics are absent.

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

• Not specified. This type of information is typically not included in a 510(k) summary for a diagnostic spirometer, as the "ground truth" for spirometry measurements is usually established by highly calibrated reference devices and standardized test gases/flows rather than expert interpretation of patient data in the same way it would be for imaging diagnostics.

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

• Not specified. Given the nature of a spirometer, adjudication methods like 2+1 or 3+1 are generally not applicable. Performance is assessed against objective flow and volume 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:

• No, an MRMC comparative effectiveness study was likely not performed. This device is a diagnostic spirometer, which directly measures physiological parameters (flow and volume). It does not involve "readers" in the context of interpreting complex images or data that require AI assistance for improved human performance. The device provides raw and calculated spirometric values.

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

• The device inherently operates as a standalone diagnostic tool. The algorithms determine values based on flow measurement. Its performance would be evaluated in a standalone manner against a gold standard for spirometry. The 510(k) process typically requires demonstrating that the device alone performs comparably to its predicate.

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

• The ground truth for spirometers is typically established using highly accurate and calibrated reference spirometers, flow meters, or syringes that deliver known volumes and flows. Performance is then compared against these physical standards according to international guidelines (e.g., ATS/ERS).
  • For the pulse oximetry function, ground truth would involve co-oximetry readings from arterial blood samples.

8. The sample size for the training set:

• Not applicable/Not specified. This device primarily uses algorithms based on physics principles (flow measurement via turbine transducer and infrared interruption) and established spirometric calculations, rather than machine learning models that require large training datasets in the traditional sense. Therefore, a "training set" as understood in AI/ML is unlikely to have been used or reported.
  • If any modeling or calibration was done, it would be based on engineering principles and calibration data, not a "training set" of patient data.

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

• Not applicable (see point 8).

Summary of Limitations:

The provided document, being a 510(k) summary, focuses on establishing "substantial equivalence" to predicate devices (SDI Spirolab II Spirometer and Motion Media Technology CareStation 126S). It does not contain the detailed performance study results, specific acceptance criteria with numerical targets, or comprehensive methodologies that would be found in a full technical report or peer-reviewed publication. Its purpose is to demonstrate that the new device is as safe and effective as a legally marketed device, not to present a detailed scientific validation study in the way you might find for a novel AI diagnostic.

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The AstraGuard Pulmonary Function Filter is intended for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.

The SDI AstraGuard Pulmonary Function Filter is an electrostatic polypropylene medium enclosed in a molded polystyrene shell. The highly efficient medium is ultrasonically welded to the shell body.

The provided 510(k) summary for the SDI AstraGuard Pulmonary Function Filter does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against them. The document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's technical specifications and intended use.

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

Here's an attempt to answer your questions based only on the provided text, recognizing significant gaps:

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

The provided text does not explicitly state specific acceptance criteria (e.g., a minimum filtration efficiency percentage for particles of a certain size) nor does it report the device's performance against such criteria in a quantitative table.

The device description mentions: "The highly efficient medium is ultrasonically welded to the shell body." This implies a claim of efficiency, but no specific performance metric is given.

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

This information is not available in the provided 510(k) summary. There is no mention of a test set, sample sizes, or data provenance for performance evaluation.

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 available in the provided 510(k) summary. As no explicit performance study with a test set generating "ground truth" is described, there's no mention of experts or their qualifications.

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

This information is not available in the provided 510(k) summary. No details about adjudication methods are present.

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 mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This device is a physical filter, not an AI diagnostic tool.

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

This question is not applicable as the device is a physical filter, not an algorithm or AI.

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

This information is not available in the provided 510(k) summary. As no explicit performance study with a test set generating "ground truth" is described, there's no mention of the type of ground truth. For a filter, "ground truth" would likely relate to objective measurements of filtration efficiency for specific microorganisms or particle sizes, rather than expert consensus on images or pathology.

8. The sample size for the training set

This information is not available in the provided 510(k) summary. As this is not an AI/machine learning device, the concept of a "training set" in this context is not applicable.

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

This information is not available in the provided 510(k) summary, as the concept of a training set and its ground truth is not applicable to this type of device.

Summary of what the document does indicate about meeting criteria/proving performance:

The basis for market clearance of the SDI AstraGuard Pulmonary Function Filter appears to be its substantial equivalence to existing predicate devices (K934509 SDI Pulmoguard Filter, K043148 Alliance Tech Medical All Flow Filter, K934475 Koko Disposable PFT Filter II).

The "study" proving the device meets acceptance criteria, in this context of a 510(k) for a medical device filter, would primarily involve:

• Bench testing: Demonstrating that the filter physically meets design specifications and potentially functional performance similar to or better than the predicates (e.g., flow resistance, dead space, and filtration efficiency against specified pathogens or particle sizes). While not explicitly detailed in this summary, these types of tests are standard for such devices. The statement "The highly efficient medium is ultrasonically welded to the shell body" alludes to design and manufacturing ensuring efficiency.
• Comparison to Predicate Devices: The 510(k) process focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics and intended use. The fact that the device uses an "electrostatic polypropylene medium enclosed in a molded polystyrene shell" suggests a similar construction to other filters on the market.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the "proof" the device met the regulatory acceptance criteria for market clearance under the 510(k) pathway. However, the details of the specific tests and their results that underpinned this substantial equivalence claim are not included in this provided summary.

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The Flosense II is intended to be used as a disposable pneumotach for the Puritan-Bennett Renaissance II Spirometers which currently use the Puritan Bennett FSII Flow Sensor.

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This document is a 510(k) clearance letter from the FDA, which states that the device, FloSense II, Model 29-8040, is substantially equivalent to a legally marketed predicate device.

It does not contain specific acceptance criteria, detailed device performance data from a study, or information about sample sizes, ground truth establishment, or expert involvement in a study. The letter itself is part of a regulatory process and refers to a premarket notification, but the notification details are not provided here.

Therefore,Based on the provided document, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: This document is the FDA's clearance letter, not the premarket notification submission itself. It states that the device is "substantially equivalent" to predicate devices, but does not provide specific performance criteria or a table of results.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size of how much human readers improve with AI vs without AI assistance: This information is not typically found in a 510(k) clearance letter, and is not present here. The device described is a spirometer accessory, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not available in this document. As above, this is a spirometer accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in this document.
8. The sample size for the training set: Not available in this document.
9. How the ground truth for the training set was established: Not available in this document.

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The spirotel spirometer is intended to be used by a patient under indications For 500. The opirator epiratory therapist to test lung function in people of all the matraction of a priyation of a single-patient device only and can be used in any setting - home, factory, hospital or physician's office.

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I am sorry, but the provided text from the FDA 510(k) summary for the Spirotel, Model 29-1020, does not contain the detailed information necessary to answer the questions about acceptance criteria and the specific study proving the device meets those criteria.

The document primarily focuses on the FDA's substantial equivalence determination, the regulatory classification of the device, and general compliance requirements. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes (test set, training set), data provenance.
• Information on experts used for ground truth, adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study.
• The type of ground truth used or how it was established for training or testing.

Therefore, I cannot generate the requested table and answer the specific study-related questions based on the input provided.

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The Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or trained technician to measure lung function in patients of all ages. It can be used in any setting, home, factory, hospital or physician's office.

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This document is a 510(k) clearance letter from the FDA for the SDI Spirolab II Spirometer. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

Therefore, I cannot answer your request based on the provided text.

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The Flosense is intended to be used as a disposable pneumotach for Puritan-Bennett spirometers which currently use the Puritan Bennett FS200 Flow Sensor.

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This is a traditional 510(k) clearance letter for a medical device (Flosense, Model 29-8010) and does not contain the detailed information about acceptance criteria and a study design that you've requested. These sections are typically found in the 510(k) submission itself or in a summary document (like a 510(k) summary or a clinical study report), not in the FDA's clearance letter. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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