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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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Freehand is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use.

A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding gastric by pass nephrectomy radical prostatectomy anterior spinal fusion, decompression fixation wedge resection lung biopsy pleural biopsy, internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated examination of the evacuated cardiac chamber during performance of valve replacement or repair.

Freehand is a modification of Prosurgics EndoAssist. The Freehand is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery where a rigid laparoscope/endoscope is intended for use, and allows the surgeon directly to control movements of a rigid endoscope by head movements. Changes that have been made are to provide simpler control mechanisms that should result in greater reliability, as well as several convenience features. From the surgeon's point of view, the two devices are the same as far as their operation and functions are concerned.

The provided text describes a 510(k) submission for the "Freehand Endoscopic Camera Controller" and states that clinical tests were not necessary because the device uses the same technology as a predicate device. Therefore, there is no study provided that proves the device meets specific acceptance criteria based on clinical performance.

The acceptance criteria and device performance information would typically be derived from such clinical studies. Since no clinical study was performed or presented for K090340, the following points address the questions based on the available non-clinical data and the reasoning for not requiring clinical data.

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

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

• Sample size: Not applicable for clinical testing.
• Data provenance: Not applicable for clinical testing. The device was deemed substantially equivalent to a predicate based on technical specifications and intended use, not new clinical data.

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

• Not applicable as no clinical test set was used to establish ground truth.

4. Adjudication method for the test set

• Not applicable as no clinical test set was used.

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 MRMC or comparative effectiveness study was performed as no clinical tests were deemed necessary. This device is an endoscopic camera controller, not an AI-assisted diagnostic tool for "human readers."

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

• Not applicable. This device is a robotic camera controller, not an algorithm with standalone performance in a diagnostic context.

7. The type of ground truth used

• Not applicable for clinical validation. For non-clinical validation, ground truth would be defined by the standards of IEC 60601-1 and IEC 60601-1-2, which are engineering and safety standards.

8. The sample size for the training set

• Not applicable. There is no mention of a training set for an algorithm based on clinical data.

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

• Not applicable.

Summary of the study/non-clinical assessment:

The submission for K090340 (Freehand Endoscopic Camera Controller) did not include a clinical study to prove the device meets acceptance criteria. Instead, the manufacturer argued that clinical tests were unnecessary because the Freehand is a modification of a previously cleared device (Prosurgics EndoAssist, K043284) and uses the same core technology. The changes made were stated to be for "simpler control mechanisms that should result in greater reliability, as well as several convenience features." The safety and efficacy were demonstrated through non-clinical tests showing compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards. The substantial equivalence argument implied that the predicate device's established safety and efficacy extended to the Freehand due to the nature of the modifications.

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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 Leksell® Image Guidance Surgical System (LIGS) is intended for use in cranial and spinal neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools.

The Leksell® Image Guidance Surgical System (hereafter the LIGS System) which is the subject of this 510(k) Premarket Notification is a device System intended for use in neurosurgical procedures to provide image guidance based upon preoperative images which are visualized interactively with the aid of surgical tools. The LIGS System imports Computer Tomography (CT) and Magnetic Resonance (MR) images and provides a visual display of the images for pre-planning surgical paths. The images and pre-planned surgical paths can be viewed at a computer workstation in the operating room. The LIGS System is integrated with a Measurement System, which allows the patient in the operating room environment to be correlated with the diagnostic images obtained pre-operatively. The LIGS System may then be used for visual or instrumentation guidance during the surgical procedure.

The LIGS System is a modular System comprised of a set of components which may be used in conjunction with three basic Models of system configuration interfaced with a Measurement (position tracking) System:

1. The SurgiScope® Model is configured around a motorized ceiling mounted Integrated Tool Support System with integrated tool support software.
2. The ViewScope® Model is configured for use with a manual Floorstand Microscope System.
3. The FreeHand Model allows for the tracking of surgical tools without the use of a microscope.

The LIGS System consists of 6 major components that may be combined in different permutations in the SurgiScope®, ViewScope®, and proposed FreeHand Models. The six primary components of the LIGS System may be combined in various configurations, depending upon the features desired by the customer.

The provided document is a 510(k) Premarket Notification for the Leksell® Image Guidance Surgical System (LIGS). It describes the device, its intended use, and states that validation and verification studies were conducted. However, the document does NOT contain the detailed information necessary to fully answer all components of your request, specifically:

• Quantitative Acceptance Criteria: The document states that the system is "capable of safely and accurately performing the stated intended use" but does not define specific, quantifiable acceptance criteria (e.g., accuracy, precision metrics with numerical thresholds).
• Reported Device Performance: While it mentions studies were conducted, it does not provide the results of those studies in a quantifiable manner against any specific performance metrics.
• Sample Size and Provenance of the Test Set: No information is given about the number of patients or cases used for testing, nor where the data originated (country, retrospective/prospective).
• Number and Qualifications of Experts for Ground Truth: There is no mention of experts, their number, or their qualifications for establishing ground truth in any test set.
• Adjudication Method: No information is provided regarding adjudication methods (e.g., 2+1).
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that such a study was performed, nor any data on effect size for human readers with and without AI assistance.
• Standalone Performance: While the system is described, the document doesn't explicitly state "standalone performance" in the context of an algorithm without human-in-the-loop, likely because this system is inherently designed for human interaction.
• Type of Ground Truth: The document doesn't specify if ground truth was established by expert consensus, pathology, or outcomes data.
• Sample Size for Training Set: There is no information about a training set or its size.
• How Ground Truth for Training Set was Established: Since no training set is mentioned, there's no information on how its ground truth was established.

Based on the provided text, here is what can be extracted and what is missing:

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

Missing: Specific, quantifiable numerical acceptance criteria (e.g., accuracy +/- X mm, precision Y%) and the corresponding measured device performance values.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective nature of data).

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

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

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

• Adjudication Method: 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

• MRMC Study: Not mentioned as being conducted.
• Effect Size: Not applicable, as no MRMC study is mentioned.

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

• The LIGS system is described as an interactive image guidance system for use with surgical tools and a surgeon. The concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply directly to this type of device, as its core function is to provide guidance to a human during surgery. Therefore, a standalone performance study in the way it's typically understood for diagnostic AI wouldn't be relevant or detailed here.

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

• Type of Ground Truth: Not specified.

8. The sample size for the training set

• Sample Size: Not specified. This document is focused on regulatory submission and does not detail development or training data.

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

• Ground Truth Establishment: Not specified.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states: "Validation and verification studies were conducted to evaluate the performance characteristics of the Leksell® Image Guidance Surgical System. The results of these studies demonstrated that the Leksell® Image Guidance Surgical System is capable of safely and accurately performing the stated intended use."

The FDA's clearance letter confirms: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... You may, therefore, market the device..."

Missing: The specific details, methodology, results, and statistical analysis of these "validation and verification studies" are not provided in the publicly available 510(k) summary. These studies would contain the quantitative data to support the claims of safety and accuracy.

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