Search Results

ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.

In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air.

By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech.

The entire device is for single patient use and the HME-part is for single use.

Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10kg in weight) using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.

Environment of Use: Hospitals, ICU, sub-acute care institutions and home.

The Speaking Valve, the HME DigiTop and the HME DigiTop O2 (sold separately) are all used to enable speaking. They will therefore be referenced to as "speaking devices".

Speaking Valve and HME 15 / 22

The reusable Speaking Valve is used with a single use 15 mm or 22 mm Heat and Moisture Exchanger (HME). The HME is placed so that it prevents direct contact between the Speaking Valve and the airways. This prevents the Speaking Valve from being clogged or soiled by mucus.

The Speaking Valve has two modes: speaking mode and HME mode.

In speaking mode, a flexible membrane is positioned in the airflow openings and acts as a one way valve. It opens during inhalation so the patient can inhale through the device. During exhalation, the membrane remains closed and the air is re-directed through the upper airways and the vocal folds. Thereby the patient is able to speak. In speaking mode the inhaled air does not get conditioned since the exhaled air goes out through the upper airways.

In HME mode the membrane is moved out of the airflow so that the patient both inhales and exhales through the device. The inhaled air is conditioned by the heat and moisture that is retained from the exhaled air in the impregnated HME mode, speaking is not possible. The device is switched between the modes by rotating the lid of the Speaking Valve until it clicks into the desired position.

HME DigiTop and HME DigiTop O2

The HME DigiTop and the HME DigiTop O2 enable use of the HME without the Speaking Valve, and can manually be occluded to enable speaking.

The provided text is a Premarket Notification (510(k)) for a medical device called "ProTrach DualCare." This document is a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices. It focuses on comparing the new device to existing ones and presenting non-clinical studies to support safety and performance.

The document does not contain information about studies involving human subjects, clinical efficacy, or the statistical metrics often associated with AI/ML device performance (like sensitivity, specificity, AUC) from a test set with corresponding ground truth established by experts. Therefore, many of the requested items cannot be directly extracted from this document.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its performance and substantial equivalence.

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

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

The document provides a comparison table between the ProTrach DualCare and its predicate device (SPIRO Speaking Valve) for several performance attributes. While explicit "acceptance criteria" (numerical thresholds) are not always stated, the comparison implies that "same" or "better" performance is the acceptance criterion for substantial equivalence.

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 provided in the document. The studies mentioned are primarily non-clinical engineering and biocompatibility tests. There is no mention of "test sets" in the context of clinical data or human subjects.

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 as the document does not describe studies involving expert-established ground truth for a clinical test set. The ground truth for the non-clinical tests (e.g., moisture loss, dead space) would be established by the measurement instruments and methodology prescribed by relevant engineering standards.

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

This information is not provided as there is no mention of a human-reviewed "test set" and thus no need for an adjudication method.

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 was not done. This submission is for a physical medical device (speaking valve/HME) and does not involve AI or human readers.

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

This is not applicable as the device is not an AI algorithm.

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

For the non-clinical tests: The "ground truth" for reported performance metrics like moisture loss, airflow resistance, leakage, and dead space would be derived from standardized physical measurements using laboratory equipment, following recognized testing standards (e.g., those related to HMEs and tracheostomy accessories). For biocompatibility, the ground truth is established by the results of biological tests according to ISO 10993 series.

8. The sample size for the training set

This information is not applicable/not provided. This device does not use a "training set" in the context of AI/ML.

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

This information is not applicable/not provided.

Ask a specific question about this device

The Provox FreeHands FlexiVoice combines pulmonary rehabilitation using a Heat and Moisture Exchanger with voice rehabilitation using an Automatic Speaking Valve or Manual Occlusion, in laryngectomized patients using a voice prosthesis.

The entire device is for single patient use and the HME-part is for single use, i.e, it has to be exchanged at least every 24 hours.

Environments of use include: Hospitals, ICU, sub-acute care institutions and home.

The Provox FreeHands consists of two functional units that work together, a speech valve unit in a reusable housing and a disposable Provox FreeHands HME Cassette, which is connected to the lower part of the valve housing before it is ready to use.

The speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It has three interchangeable membranes (Light, Medium and Strong).

The HME unit of the Provox® FreeHands HME® is a full heat-and-moisture-exchanger, which is used for partial restoration of the lost upper airway functions. It also separates the speech valve from direct contact with the airway and, thus, prevents mucous from being coughed into the valve part of the device. It also reduces the risk of inhalation of small particles, e.g., coming from a defective valve.

After proper adjustment and attachment of the speech valve unit and HME cassette, the completed Provox FreeHands HME is inserted into either Provox Adhesive base plate or Provox LaryTube with ring.

This document describes the non-clinical testing for the Provox FreeHands FlexiVoice device, comparing it to a predicate device, the Atos Medical - Provox FreeHands HME (K022125).

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

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

The document does not explicitly state numerical acceptance criteria. Instead, it describes general performance characteristics that were verified and then makes a comparative statement that the new device's performance is "very similar" or "a bit lower" (which is presented as an improvement in flow resistance).

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

The document does not specify the sample sizes used for any of the non-clinical tests. It also does not provide information about the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are described as non-clinical, suggesting they were likely conducted in a lab setting rather than with human subjects.

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. The non-clinical testing described focuses on device performance parameters rather than diagnostic accuracy requiring expert panel review. While a "usability study" was conducted, details about experts involved or ground truth establishment are absent.

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

This information is not applicable and therefore not provided in the document the studies were non-clinical verification and validation tests rather than clinical trials requiring adjudication of human observations.

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 a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The device is a medical prosthesis, not an AI-assisted 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 medical prosthesis, not an algorithm. Therefore, standalone algorithm performance is not relevant.

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

For the non-clinical performance tests (closing flow, moisture loss, etc.), the "ground truth" would be the measured physical properties of the device under specific test conditions, consistent with engineering and materials science standards. For the simulated use/usability study, the ground truth would be based on user feedback and observations of proper device function. There is no mention of complex ground truth types like pathology or outcomes data.

8. The sample size for the training set

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

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

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

Ask a specific question about this device

Provox® Vega™ Puncture Set is a device for performing a primary or secondary tracheoesophageal (TE) puncture in laryngectomized patients, with integrated placement of a Provox Vega voice prosthesis.

The Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ.

Environments of use include;

• Provox® VegaTM Puncture Set hospitals and sub-acute care institutions.
• Provox® Vega Voice Prosthesis hospitals, sub-acute care institutions and home.

The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device.

The Provox Vega Puncture Set is intended for single use only and the package contains the following sterile items in a blister package:

• · 1 Pharynx Protector (Fig. 1:1) made of transparent thermoplastic,
• · 1 Puncture Needle (Fig. 1.2) made of surgical stainless steel.
• · 1 Guidewire (Fig. 1.3) made of pre-colored fluoroplastic.
• · I Puncture Dilator with I preloaded Provox Vega voice prosthesis (Fig. 1.4). The Puncture Dilator is made of thermoplastic elastomer and polypropylene; and the Vega voice prosthesis is made of medical grade silicone rubber and fluoroplastic.

The set also includes the following non-sterile items:

• · 1 Instructions for use Provox Vega Puncture Set,
• · 1 Provox Vega Patient's Manual,
• · 1 Provox Brush of a size corresponding to the voice prosthesis,
• · 1 Provox Brush Instructions for Use.
• · I Provox Plug of a size corresponding to the voice prosthesis,
• · 1 Provox Plug Instructions for Use.
• · 1 Emergency Card

The provided text describes the Provox® Vega™ Puncture Set and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through empirical testing.

The submission focuses on demonstrating that the proposed device is as safe and effective, and performs as well or better than the predicate devices based on:

• Identical indications for use (for the voice prosthesis component)
• Similar materials
• Similar design
• Similar operating principles

Essentially, the argument for equivalence is based on the lack of significant differences in these aspects between the new device and previously cleared devices, rather than a standalone performance study with predefined acceptance criteria.

Therefore, many of the requested sections about acceptance criteria, reported performance, sample sizes, ground truth, expert adjudication, or MRMC studies cannot be extracted from this document because such a study is not detailed.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or report performance metrics from a formal study. The conclusion is based on substantial equivalence to predicate devices, implying that if the predicate devices meet their acceptance criteria, the new device will too due to its similarity.

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

• Cannot be provided. No specific test set or study involving human subjects or data is described. The comparison is primarily regulatory and technical, based on device specifications and intended use.

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

• Cannot be provided. No ground truth establishment activity is mentioned for a test set.

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

• Cannot be provided. No test set or adjudication process is described.

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

• Cannot be provided. This device is a medical instrument (voice prosthesis and puncture set), not an AI/imaging device. Therefore, MRMC studies or AI improvement metrics are not relevant or discussed.

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

• Cannot be provided. Not applicable as this is not an algorithm/AI device.

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

• Cannot be provided. No ground truth is established for a performance study. "Ground truth" here is effectively the accepted safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Cannot be provided. Not applicable as this is not an algorithm/AI device that requires a training set.

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

• Cannot be provided. Not applicable.

Summary of Substantial Equivalence Information (relevant to the document's purpose):

The document aims to demonstrate substantial equivalence to predicate devices rather than report on a new performance study with explicit acceptance criteria.

• Predicate Devices:

  • Atos Medical - Provox® Vega™ Voice Prosthesis with SmartInserter - (K090455)
  • Atos Medical - Provox Voice Prosthesis - (K940638)

• Basis for Equivalence:

  • Indications for Use: The Provox Vega Puncture Set's voice prosthesis component has identical indications to the predicate Provox® Vega™ Voice Prosthesis (K090455). The puncture set's overall function is for performing TE puncture with integrated placement of the voice prosthesis.
  • Materials: Stated as "Identical" for the Voice Prosthesis (medical grade silicone rubber and fluoroplastic) compared to the predicate Vega voice prosthesis. Components like the Guidewire, Puncture Needle, and Pharynx Protector are described as "modifications" of previously cleared or exempted accessories from predicate devices, with materials like pre-colored fluoroplastic, thermoplastic elastomer, surgical stainless steel, and transparent thermoplastic.
  • Design: The Provox Vega™ Voice Prosthesis included in the Puncture Set is stated to be "identical in every aspect" to the voice prosthesis in the predicate K090455. Other components are modifications of existing accessories.
  • Operating Principles: Not explicitly elaborated in detail beyond component function but implied to be similar due to comparable design and intended use.

The conclusion by Atos Medical AB is that "There are no significant differences between the Provox Vega Puncture Set compared to the predicate devices in terms of indications, materials, design and operating principles. Information presented in this submission supports that Provox Vega Puncture Set is as safe and effective, and performs as well or better than the predicate devices." This is the core "proof" presented for regulatory acceptance.

Ask a specific question about this device

Ask a specific question about this device

The Provox® Vega Voice Prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is handled by the Patient while it remains in situ.

The Provox SmartInserter is a sterile single use device intended for anterograde replacement of the Provox Vega Voice Prosthesis. This replacement procedure is carried out by a medical doctor or a trained medical professional in accordance with local or national guidelines.

The Provox SmartInserter is not intended to be used for insertion of a voice prosthesis in a freshly made puncture.

Environments of use for the Provox® Vega. Voice Prosthesis include - hospitals, subacute care institutions and home.

For the Provox SmartInserter environments of use include - hospitals and sub-acute care institutions.

The Provox Vega is a one-way valve (prosthesis) that keeps a TE-puncture open for speech, while reducing the risk of fluids and food entering the trachea. The Provox Vega voice prosthesis is not a permanent implant, and needs periodic replacement. The prosthesis is available in different diameters and several lengths. The device is made of silicone and fluoroplastic.

The Provox Vega package contains the following items:

• · 1 Provox Vega voice prosthesis pre-loaded in a single-use SmartInserter, sterile
• · 1 Provox Brush of a size corresponding to the voice prosthesis, non-sterile
• · 1 Clinician Manual
• · 1 Patient Manual
• · 1 Provox Brush Instructions for Use

The provided text describes the Provox® Vega™ voice prosthesis but does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. This document is a 510(k) summary for a medical device, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance criteria and the results of a specific clinical study against those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document mentions that there are "no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices," which is the basis for its substantial equivalence determination, but it does not report on specific performance metrics or trials against predefined acceptance criteria for the Provox® Vega™ itself.

Ask a specific question about this device

The Provox® Micron HME™ is a specialized stoma cover that acts as a heat and moisture exchanger (HME) and air filtration device for laryngectomized patients. Provox® Micron HMETM partially restores lost breathing resistance due to laryngectomy.

For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

It is intended to be used with the Provox® HME System.

Environments of use include - hospitals, sub-acute care institutions and home.

The Provox® Micron HME™ is a device which covers the stoma of a laryngectomy pationt. It is dcsigned to heat and humidify inhaled air to reduce the drying out of the airway as well as it incorporates filter media to filter the inhaled air of bacteria, virus and particulate matter.

It also incorporates a feature whereby the user may close the device, diverting exhaled air through the esophagus to facilitate voicing. This feature is identical to the predicate, Provox® HME cassette (K014102) and Provox® FreeHands HME (K022125), the only difference between the proposed device and the predicates in the addition of filter media.

Here's an analysis of the acceptance criteria and the study information for the Provox® Micron HME™ device, 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

The provided text does not contain details about specific test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for the performance evaluations. The performance metrics listed are presented as single values, likely representing the results of a conducted test or series of tests, but the methodology and sample size for these tests are not described in this summary. The document focuses on demonstrating substantial equivalence to predicates through comparison of specifications.

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 the data provided. The performance metrics (moisture loss, filtration efficiency, pressure drop) are objective measurements typically determined through laboratory testing according to established standards (e.g., ISO 9360, ASTM F2101), not through expert consensus or interpretation of subjective data requiring ground truth establishment by human experts.

4. Adjudication method for the test set

This information is not applicable as the performance metrics are objective measurements, not subjective evaluations 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 information is not applicable. The device is a medical device (HME and filter for laryngectomized patients), not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in the way described.

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 the reported performance metrics would be laboratory measurements conforming to established international standards.

• HME function (Moisture loss): Measured according to ISO 9360.
• Filtration BFE/VFE: Measured according to ASTM F2101.
• Pressure drop: Measured under controlled airflow conditions.
  These standards define the precise methodology and equipment for obtaining these objective measurements.

8. The sample size for the training set

This information is not applicable. The Provox® Micron HME™ 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 for the same reason as #8.

Ask a specific question about this device

The Provox® NID™ Voice Rehabilitation System is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision.

The Provox NID is intended for single patient use.

The Provox® NID™ Rehabilitation System is a non-indwelling (Standard) voice prosthesis equipped with a safety medallion, an insertion tool and some accessories.

The Provox NID voice prosthesis is available in two outer diameters (17 and 20 French) and six different lengths, (6, 8, 10, 12, 14 and 18 mm). Each prosthesis comes individually packed with a re-usable inserter. The design of the device is based on the indwelling voice prostheses Provox1, Provox2 and ActiValve.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are not explicitly detailed in a quantifiable manner (e.g., specific thresholds for success, failure rates, etc.). Instead, the study's goal was to demonstrate that the device's performance satisfies its "design intent" and that it is "substantially equivalent" to predicate devices. The study results are reported qualitatively as supporting this conclusion.

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

• Sample Size for Test Set: 14 patients
• Data Provenance:
  • Country of Origin: Brisbane, Australia (Performed by Princess Alexandra Hospital)
  • Retrospective or Prospective: Prospective (implied by "participated in this clinical trail" and the approval by a Research Ethics Committee)

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set. It mentions the study was "Performed by Princess Alexandra Hospital," implying clinical oversight and assessment, but no specific number or roles of independent experts for ground truth establishment are provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

No. The document describes a clinical trial with patients using the device, but it does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device itself is a physical voice prosthesis, not an AI diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The Provox® NID™ Voice Rehabilitation System is a medical device (voice prosthesis), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The ground truth or evaluation standard implicitly revolves around clinical assessment of "voicing" effectiveness and the patient's ability to use the device as intended. The "functional equivalency test" for valve performance would likely involve objective measurements, but the specific type of ground truth for overall device performance is not detailed beyond demonstrating that it "satisfies the design intent" and is "substantially equivalent" to predicate devices. Prior to the study, patients were using the Blom-Singer Low Pressure Voice Prosthesis, suggesting a baseline for comparison in terms of patient experience or outcome.

8. Sample Size for the Training Set

Not applicable. As this is a medical device (voice prosthesis) and not an AI/machine learning algorithm, 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 type of medical device.

Ask a specific question about this device

The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

The Provox® FreeHands system consists of two functional units that work together. The first unit is a reusable speech valve unit with two independent valves, and the second unit is a disposable HMET cassette. The speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It also describes the two valve positions, the "speaking position" and the "breathing position".

The provided text describes the "Provox® FreeHands HME™" device and references a clinical test. However, it does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. The document is primarily a 510(k) summary, focusing on substantial equivalence to predicate devices rather than a full performance study.

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

The document mentions a "clinical test" and states that "Test results support the conclusion that the actual device performance satisfies the design intent." However, the specifics of this "design intent" (i.e., the acceptance criteria) are not detailed with numerical thresholds.

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

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in quantitative terms within the provided text. The general statement is that "Test results support the conclusion that the actual device performance satisfies the design intent."
• Reported Device Performance: The document states that a comparison was made between the Provox® FreeHands HME™, Provox® HME Cassette, and Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap. The implication is that the Provox® FreeHands HME™ performed acceptably compared to these predicates, but specific performance metrics (e.g., heat/moisture retention percentages, speech clearness, breathability) are not provided.

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

• Sample size: Not specified.
• Data provenance: The clinical test was performed by the Netherlands Cancer Institute. It's described as a "clinical test," implying prospective collection, but not explicitly stated.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Not specified.

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 device is a physical medical device (HME with speech valve), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to "human readers improving with AI assistance" is not applicable.

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

• This device is a physical HME, not an algorithm. This question is not applicable.

7. The type of ground truth used

• Given it's a physical HME device, the "ground truth" would likely be objective measurements of HME performance (e.g., heat/moisture exchange efficiency), patient comfort, ease of speech, and potentially clinical outcomes related to respiratory health. However, the exact type of ground truth or specific metrics used in the "clinical test" are not detailed in the provided text.

8. The sample size for the training set

• The document describes a clinical test for evaluation, not a training/test set split as commonly found in machine learning/AI studies. Therefore, a "training set" in that context is not applicable.

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

• As above, a "training set" is not mentioned in the context of this device evaluation.

In summary, while a clinical test was conducted by the Netherlands Cancer Institute, the provided 510(k) summary is very high-level and lacks the detailed performance metrics, sample sizes, expert qualifications, and adjudication methods that would constitute a comprehensive description of acceptance criteria and the study proving it.

Ask a specific question about this device

The Provox HME system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by reclaiming heat and moisture from exhaled air in the device. For use by laryngectomees. The HME may also facilitate voicing.

The Provox HME system is a heat and moisture exchanger (HME)

This FDA document is a 510(k) clearance letter for the Provox HME System, not a study report or clinical trial. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving device performance.

The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide any performance metrics, study design, or results.

To answer your questions, one would need to access the actual 510(k) submission (K014102) itself, or any associated clinical study reports that were part of that submission, which are not provided in the text.

Ask a specific question about this device

The PROVOX Voice Rehabilitation System has exactly the same indications for use as the original PROVOX and is intended for use in prosthetic voice restoration after total laryngectomy. The prosthesis can be inserted at the time of laryngectomy (primary puncture), or at a later date (secondary puncture), or to replace another similar prosthesis.

The PROVOX Voice Rehabilitation System. Replacement is performed in an anterograde way, using the components accompanying the PROVOX2 device (Insertion tool). The development of an anterograde replacement method (through the tracheostoma) was a logical development since the retrograde replacement method (using a guide wire) is often discomfortable for the patient. The PROVOX2 can be used in primary or secondary TE-puncture procedures if it is used with the PROVOX GuideWire, the Trocar and Cannula, and the Pharynx Protector components of the PROVOX Voice Rehabilitation System.

The provided text is a 510(k) premarket notification letter from the FDA to Atos Medical regarding the Provox 2 Voice Prosthesis System. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the regulatory class and procode, and discusses general controls and regulations. The second page contains the "Indications for Use" for the Provox Voice Rehabilitation System.

Therefore, I cannot extract the requested information to fill in the table or answer the questions. The document you provided is a regulatory approval letter, not a clinical study report or a document detailing performance criteria and test results.

Ask a specific question about this device