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The Blom-Singer® FirstFit™ Surgical Kit (FFSK) is indicated for use during surgical creation of primary or secondary tracheoesophageal puncture, dilation of the tracheoesophageal wall, and to guide the placement of the voice prosthesis for tracheoesophageal voice restoration following total laryngectomy.

The FFSK contains a sterile single use indwelling Blom-Singer® Indwelling Voice Prosthesis device 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.

The FirstFit Surgical Kit (FFSK) is a kit for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Blom-Singer® Indwelling Voice Prosthesis, cleared in K082206.

The FFSK is for transient use as an aid to a surgical operation to puncture and stent the tracheoesophageal septum. The FFSK is provided sterile (by ethylene oxide) in a sealed tray, ready to be introduced into the surgical field. Additionally, it is used to guide voice prosthesis placement in a total laryngectomized patient as a primary or secondary procedure. Puncture and placement should take place in a sterile field with the patient being under anesthesia.

The FFSK is designed for primary or secondary tracheoesophageal puncture (TEP) with retrograde voice prosthesis insertion. This kit includes: one (1) 13-gauge curved core puncture needle, one (1) 36-inch guidewire with rounded tips, one (1) pharynx protector tool with handle and notched cylinder, one (1) voice prosthesis inserter pre-loaded with a Blom-Singer® Indwelling Voice Prosthesis of the diameter and length specified on the package label.

The Blom-Singer® Indwelling Voice Prosthesis devices (VP) are indwelling devices primarily made of silicone, designed to provide voicing after total laryngectomy. The voice prostheses are placed in a surgically created fistula between the trachea and esophagus in order to divert air through the prosthesis valve to create voicing. The use of an indwelling device means that routine removal for cleaning by the patient is not necessary, thus making it easier for the patient to maintain the device the risk of accidental dislodgment of the device.

The provided FDA 510(k) summary does not contain information on rigorous acceptance criteria and a detailed study proving the device meets those criteria in the context of an AI/software medical device, as the device is a physical surgical kit (FirstFit Surgical Kit). Therefore, the requested information regarding AI model performance (e.g., sample sizes for training/test sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications) is not applicable to this submission.

However, I can extract the relevant performance testing and findings for the physical device as described in the summary:

Device Name: FirstFit Surgical Kit
Regulation Name: Laryngeal Prosthesis (Taub Design)
Regulatory Class: Class II
Product Code: EWL

Here's a breakdown of the performance testing that serves as the "study" for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the submission)

For a physical surgical kit, the "acceptance criteria" are generally related to its ability to perform its intended surgical functions safely and effectively. The submission describes a cadaver study as the primary performance evaluation.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 15 users performing 2 punctures & placements each on fresh cadaver tissue. The exact number of cadavers is stated as "37 cadavers" needing additional instrumentation for dilation out of an unstated total number of cadavers used. However, the primary performance data seems to be derived from the "15 users performing 2 punctures & placements each".
• Data Provenance: Fresh cadaver tissue. The country of origin is not specified. This was a prospective "usability validation testing methodology."

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth Establishment: For a physical device, "ground truth" usually refers to the successful and safe execution of the surgical procedure. In this case, the "usability engineering" study was conducted by "users" (presumably surgeons or medical professionals who would use the device). The document does not specify if these users were considered "experts" for establishing ground truth, nor does it explicitly state their qualifications (e.g., number of years of experience). The assessment of "no tissue damage" would likely have been made by the study observers or the users themselves.

4. Adjudication Method for the Test Set

• The document does not describe a formal "adjudication method" in the sense of multiple reviewers arbitrating discrepancies. The study observed the performance of the 15 users.

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

• No. This is a physical surgical kit, not an AI/software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance (Algorithm Only)

• N/A. This is a physical surgical kit. There is no algorithm to test in standalone mode.

7. Type of Ground Truth Used

• Observed Performance on Cadaveric Tissue: The "ground truth" was the observed successful (or, in 3 cases, difficult) completion of the surgical steps (puncture, dilation, prosthesis placement) and the absence of tissue damage in the simulated-use cadaver study. It's a pragmatic assessment of procedural success and safety.

8. Sample Size for the Training Set

• N/A. This is not an AI/machine learning device that requires a "training set."

9. How Ground Truth for the Training Set Was Established

• N/A. Not applicable for a physical device.

In summary, the "study" for this device was a usability engineering study conducted on cadavers to demonstrate the safe and effective performance of the FirstFit Surgical Kit in creating tracheoesophageal punctures, dilating them, and guiding voice prosthesis placement. The primary finding was that the device met its functional goals, with an important caveat regarding potential tissue stiffness in cadavers leading to a labeling update for real-world use.

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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.

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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.

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The Blom-Singer Indwelling TEP Occluder is indicated for anterograde placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of the indwelling occluder is performed by a qualified, trained medical professional. This device is for use with healed, intact tracheoesophageal puncture fistulas only.

The Blom-Singer Indwelling TEP Occluder is designed to provide fistula maintenance while preventing leakage of liquids from the esophagus into the trachea after total laryngectomy. The Indwelling TEP Occluder has been modified from its predicate devices by the inclusion of the Indwelling Low Pressure Voice Prosthesis design, and is now available in 16 and 20 fr. Sizes. In addition, this device will be offered in a large esophageal flange version. This version will be identical except for an esophageal flange which is greater in diameter to deter leakage around the device in individuals with unique physiology. These devices are manufactured from medical grade silicone and are latex-free.

Here's an analysis of the provided text regarding the Blom-Singer® Indwelling TEP Occluder, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a medical device, the Blom-Singer® Indwelling TEP Occluder, and references "functional equivalency tests" that demonstrate its performance. However, it does not explicitly state specific quantifiable acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalence to predicate devices by meeting their established performance characteristics.

The "reported device performance" is a qualitative statement of equivalency rather than measured individual performance metrics against predefined criteria.

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

The text describes "non-clinical tests" (Pressure Decay, Flange Retention Force, and Gel Cap Insertion method).

• Sample Size: The document does not specify the sample sizes used for these non-clinical tests.
• Data Provenance: The document does not provide information on the country of origin of the data, nor does it specify if the data was retrospective or prospective. Given these are "non-clinical tests," they likely involved laboratory testing of the devices themselves rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not provided in the document. As the tests were non-clinical, they likely involved engineers or technicians conducting laboratory measurements, rather than clinical experts establishing ground truth in a diagnostic context.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the non-clinical nature of the tests, an adjudication method for human interpretation (like 2+1 or 3+1) is not applicable. The tests likely involved direct measurement and comparison to established specifications or predicate device performance.

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

• A MRMC comparative effectiveness study was not done. The application describes non-clinical, functional equivalency tests comparing the device to predicate devices, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• A standalone performance study in the context of an algorithm's performance was not done. This device is a physical medical device, not an AI algorithm. The performance described relates to its physical and functional properties.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be established performance characteristics of the predicate devices and general safety/effectiveness standards for similar medical devices. The tests aimed to demonstrate that the new device's performance was "as well or better than the predicate devices" for the specific functional attributes (Pressure Decay, Flange Retention Force, Gel Cap Insertion method). This is a form of engineering or functional validation against existing benchmarks.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical medical component, not an AI model that requires a "training set" of data.

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

This information is not applicable and therefore not provided. This device is a physical medical component, not an AI model.

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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.

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The Blom-Singer Indwelling voice prosthesis is indicated for tracheoesophageal voice restoration following total laryngectomy, when placement, or replacement, of an indwelling voice prosthesis is performed by a qualified, trained medical professonal.

The Blom-Singer Dual Valve Indwelling Voice Prosthesis is provided for the same indications for use as the other Blom-Singer Indwelling Voice Prosthesis product lines. The Dual Valve Indwelling Voice Prosthesis has been modified from its predicate devices by the addition of a second valve intended to continue to function when leakage occurs in the primary valve.

The Blom-Singer Dual Valve Indwelling Prosthesis has been modified from its predicate devices by the addition of a second valve, consisting of a valve and valve seat, intended to continue to function when leakage occurs in the primary valve. The prosthesis is still primarily silicone. A second modification is the introduction of a slight tension in the voice prosthesis strap when loaded on the inserter with a gel cap containing the prosthesis' esophageal flange. When the gel cap dissolves the inserter moves forward, indicating flange deployment.

Accessory Devices: The device will be offered with the following accessories: inserter stick, flushing device, flange introducer, gel caps, and lubricant,

The provided document is a 510(k) summary for the Blom-Singer Dual Valve Voice Prosthesis. It does not contain information typically found in a study proving a device meets acceptance criteria, such as a detailed clinical study with specific acceptance criteria, sample sizes, expert involvement, or statistical analysis.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional equivalency tests.

Here's a breakdown of the requested information based on the provided text, and where the information is not available:

Acceptance Criteria and Device Performance Study Details (Blom-Singer Dual Valve Voice Prosthesis)

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance: The document explicitly states: "The conclusions drawn from the nonclinical tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices."

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

• Sample Size for Test Set: Not specified. The document mentions "nonclinical tests" and "functional equivalency tests" but does not provide any numerical sample sizes for these tests.
• Data Provenance (Country of origin, retrospective/prospective): Not specified. These were likely bench tests conducted by the manufacturer, Helix Medical, LLC, which is based in Carpinteria, CA, USA. The nature of the tests (non-clinical) implies they are not human clinical data, and thus the terms "retrospective" or "prospective" as applied to clinical studies are not applicable.

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 as the document describes non-clinical, functional equivalency bench tests, not a clinical study requiring expert-established ground truth.

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

• This information is not applicable as the document describes non-clinical, functional equivalency bench tests, not a clinical study 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 voice prosthesis, not an AI or imaging diagnostic tool that would involve human readers or MRMC 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 (voice prosthesis), not an algorithm or software.

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

• The "ground truth" for the non-clinical functional equivalency tests would be established by engineering specifications and performance metrics derived from the predicate devices. The tests aimed to show that the new device's performance in specific areas (Airflow, Pressure Decay, Flange Retention Force, Valve Attachment Integrity, Inserter Deployment) was "equivalent" to the predicate devices.

8. The sample size for the training set

• This information is not applicable. The document describes the submission of 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 above, the device is not a machine learning model.

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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.

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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.

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The Blom-Singer Indwelling 2000 Voice Prosthesis is for voice rehabilitation following total laryngectomy where placement/replacement of the voice prosthesis is done by a clinician. The Blom-Singer Indwelling 2000 Voice Prosthesis may be placed at the time of surgery or may be placed at a later date secondary to the laryngectomy.

The design of the Blom-Singer Indwelling 2000 Voice Prosthesis is substantially equivalent to the current Blom-Singer Indwelling Low Pressure Voice Prosthesis. Both devices are manufactured sterile and nonsterile, out of medical grade silicone elastomer, and are comprised of a body with an outer esophageal flange and a tracheal flange with a strap. Both devices utilize a flap valve to control the passage of air through the device. The Blom-Singer Indwelling 2000 has the addition of an assembled cartridge, consisting of a valve seat, to optimize the valve performance and longevity. The valve now has an additive which has demonstrated antibacterial properties in in-vitro studies. To aid in placing the gel cap onto the device, the esophageal flange on the outer portion of the device has been modified. The esophageal flange now has contoured areas, which allow the flange to fold along the contours for easy insertion into a gel cap for atraumatic placement of the device.

The provided text is a 510(k) summary for a medical device called the "Blom-Singer Indwelling 2000 Voice Prosthesis." It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain a study or data proving the device meets specific acceptance criteria.

The document states that "Functional equivalency tests have been performed on the two Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the two designs." However, it does not provide any details about these tests, such as:

• Specific acceptance criteria: What metrics were used to define "equivalency of valve performance"? What were the thresholds for acceptance?
• Reported device performance: What were the results of these tests?
• Study design: What type of study was this? How many devices were tested? What was the methodology?
• Sample size and data provenance: How many devices were in the test set? Where did the data come from?
• Ground truth establishment: How was the "true" valve performance determined for comparison?
• Adjudication method, MRMC studies, or standalone performance: These concepts are not applicable to the type of "functional equivalency tests" alluded to for a device like this, which focuses on mechanical performance rather than diagnostic accuracy.
• Training set sample size and ground truth establishment: Not applicable as this is a mechanical device, not an AI/algorithm-based diagnostic tool.

Therefore, I cannot provide the requested table and detailed study information because the input document does not contain this specific data.

Here's what I can extract based on the available information:

1. Acceptance Criteria and Reported Device Performance:

The document states that "Functional equivalency tests have been performed on the two Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the two designs." This implies that the acceptance criterion was "equivalency of valve performance" between the new device and its predicate. However, no specific quantitative criteria or reported performance metrics are provided.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: The document only mentions "in-vitro studies" for antibacterial properties and "functional equivalency tests." No information is provided about the country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or specified. The "functional equivalency tests" would likely involve objective measurements of physical properties, not expert interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or 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: Not applicable. This is a medical device (voice prosthesis), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "functional equivalency tests," the ground truth would likely be established through objective physical measurements and engineering specifications, not expert consensus or clinical outcomes in the typical sense for diagnostic devices. No explicit details are given.

8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on establishing substantial equivalence for regulatory purposes based on design, materials, and intended use, rather than presenting detailed performance study data with specific acceptance criteria.

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