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The Flexible Bronchoscopes have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Flexible Bronchoscope is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.

The Flexible Bronchoscope (Model: BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) is intended to be used with the Portable Video Processor (cleared via K243497). The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during bronchoscopy, and when used with the compatible video processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Bronchoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a push button for suction, a connector for suction tubing, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the video processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the video processor, optical fibers for transmitting illumination from the LED inside the handle, and the distal opening of the working channel. The Endoscope Connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection).

This document is an FDA 510(k) clearance letter for a Flexible Bronchoscope, indicating substantial equivalence to a predicate device. However, it does not contain the level of detail requested regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The provided text focuses on the physical and performance characteristics of the bronchoscope itself, its intended use, technological comparison to a predicate device, and various non-clinical tests (electrical safety, photobiological safety, mechanical/optical performance, biocompatibility, sterilization, shelf life, and package validation).

There is no mention of an AI component, an algorithm, or any study involving human readers, ground truth establishment, or performance metrics like sensitivity, specificity, or AUC. The "device performance" in this context refers to the bronchoscope's mechanical and optical functionality, not the diagnostic accuracy of an AI algorithm.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to answer based on the provided text, highlighting what is missing:

1. Table of acceptance criteria and reported device performance

The document does not present a formal table of "acceptance criteria" for a diagnostic algorithm with corresponding "reported device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, AUC). Instead, it states that various non-clinical tests were performed to demonstrate compliance with recognized standards and that the device is "as safe, as effective, and performs as well as the legally marketed device identified above."

Below is a table summarizing the types of tests and the general conclusion, but without specific quantitative acceptance criteria or performance metrics related to diagnostic accuracy.

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

• Sample Size for Test Set: Not applicable/Not mentioned. This document describes a medical device (bronchoscope) itself, not an AI algorithm performing a diagnostic task on a dataset. The "tests" mentioned are non-clinical engineering and biological safety tests, not tests on a dataset.
• Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/Not mentioned.

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

• Not applicable. There is no mention of "ground truth" in the context of an AI algorithm's diagnostic performance for which experts would be needed. The "ground truth" for the non-clinical tests would be the established performance specifications and standards for a bronchoscope.

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

• Not applicable. As no expert ground truth establishment for a diagnostic AI is mentioned, no adjudication method would be relevant.

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. This document describes the clearance of a flexible bronchoscope, a physical medical device. It does not mention any AI component or a MRMC study.

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

• Not applicable. There is no mention of an algorithm in this document that would perform as a standalone device.

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

• Not applicable. Ground truth in the context of diagnostic AI is not mentioned. For the non-clinical tests, the "ground truth" is compliance with established engineering and safety standards.

8. The sample size for the training set

• Not applicable. There is no mention of an AI model or a training set.

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

• Not applicable. There is no mention of an AI model or a training set.

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aScope™ 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope™ 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Broncho System is a combination of a displaying unit, the Ambu® aBox™ 2, and a compatible endoscope, Ambu® aScope™ 5 Broncho.

Ambu® aScope™ 5 Broncho is a sterile, single-use flexible bronchoscope designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The endoscope is available in two size confiqurations: Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 2.7/1.2. Apart from the size, the endoscopes share a similar design. The insertion portion is inserted into the patient airway through the mouth, nose, endotracheal tube, tracheostomy tube, etc. There is a working channel system within the endoscope for use with endotherapy instruments or instillation of fluids. An introducer (luer lock adaptor), which is supplied together with the endoscopes, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from airway is possible through the suction system.

Ambu® aScope™ 5 Broncho features an integrated camera module with built-in dual LED illumination. The image module provides a cropped 400x400 pixels signal from the 160 Kpixel sensor.

The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.

The Ambu® aBox™ 2 has the following physical and performance characteristics:

• Displays the image from Ambu® aScope™ 5 Broncho endoscope . on the screen
• . Can record snapshots or video of image from Ambu® aScope™ 5 Broncho endoscope
• Can connect to an external monitor .
• . Is a reusable device

Here's an analysis of the provided text regarding acceptance criteria and study details for the Ambu® aScope™ 5 Broncho System.

Much of the information requested, particularly regarding specific numerical acceptance criteria and the detailed outcomes of human-in-the-loop studies (MRMC), is not explicitly present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence through design and performance testing against recognized standards and a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and overall conclusions but does not provide a table with specific numerical acceptance criteria alongside reported numerical performance for each. Instead, it generally states that the device "performed as expected and met the test specifications set."

Note: For the optical performance marked with an asterisk, the document states these were compared to a reference device (Ambu® aScope™ 4 Broncho) to demonstrate substantial equivalence, rather than directly stating a specific numerical acceptance criterion was met against a pre-defined threshold.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for the various performance and verification tests. It lists the types of tests performed (e.g., optical performance tests, mechanical tests) but not the number of units or data points included in each test.

The provenance of the data is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device and the types of tests listed (bench testing, sterilization validation, biocompatibility), these are typically prospective laboratory and bench studies conducted by the manufacturer.

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

This information is not provided in the document. The listed tests are primarily objective engineering and performance evaluations. There is no mention of expert human assessment or ground truth establishment in the context of diagnostic performance or clinical interpretation, as this device primarily provides visualization.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The listed tests are primarily objective performance evaluations (e.g., measuring dimensions, suction flow, optical parameters) and do not involve human adjudication for establishing ground truth from subjective observations.

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

No, an MRMC comparative effectiveness study is not mentioned in the document. The device (Ambu® aScope™ 5 Broncho System) is an endoscope and display unit for visualization and therapeutic interventions. Its primary function is to provide images for a clinician to interpret and act upon. The document focuses on the device's technical performance and safety, not on human interpretive performance with or without AI assistance.

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

No, a standalone algorithm-only performance study is not mentioned or applicable. This device is an imaging tool used by a human operator; it does not contain AI algorithms that would operate standalone for diagnostic purposes.

7. The Type of Ground Truth Used

For the various performance tests (e.g., dimensions, optical parameters, suction, electrical safety), the ground truth is established by objective measurements against engineering specifications and international standards (ISO, IEC). These are not clinical "ground truths" in the sense of pathology or outcomes but rather engineering and performance "ground truths" defined by validated measurement methods.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As explained, this device does not contain AI/ML components that would require a "training set" for an algorithm.

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

This information is not applicable and therefore not provided, as there is no mention of a training set for an AI/ML algorithm.

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The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.

The Digital Video Monitor is specially designed to be used with endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.

The Vathin® Video Rhinolaryngoscope System consists of Single-use flexible Rhinolaryngoscope (eight models shown in below) and Digital Video Monitor (model: DVM-A1, DVM-A2, DVM-B1, DVM-B2) for clinical image processing and display.

The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.

The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.

Single-use flexible Rhinolaryngoscope is a sterile single Rhinolaryngoscope. Digital Video Monitor is a reusable monitor.

The light emitted by the LED cold light source of the Single-use flexible Rhinolaryngoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Digital Video Monitor via the encoding circuit. The Digital Video Monitor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.

Single-use flexible Rhinolaryngoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user .
• Flexible insertion cord .
• Camera and LED light source at the distal tip .
• . Sterilized by Ethylene Oxide
• For single use

The differences between the Single-use flexible Rhinolaryngoscope models are as follow:

• . Have or haven't working channel
• . Working channel inner diameter
• . Insertion tube outer diameter
• . The length of insertion tube

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information:

Device: Vathin® Video Rhinolaryngoscope System (includes Single-use Flexible Rhinolaryngoscope and Digital Video Monitor)

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

The provided document describes the device's technical specifications and reports that all evaluation acceptance criteria were met for the non-clinical tests. However, it does not explicitly state numerical acceptance criteria for each performance parameter, nor does it provide a direct comparison table of "acceptance criteria vs. reported performance" in a quantitative manner. Instead, it lists the tests performed and implies compliance.

Below is a table summarizing the reported device performance characteristics where numerical values are given, and notes where general compliance is stated without specific numerical acceptance criteria.

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

The document comprehensively lists various non-clinical tests conducted (Biocompatibility, Electrical Safety/EMC, Performance testing including Appearance, Dimensions, Weight, and Functional Performance). However, it does not specify the sample size used for any of these test sets, nor does it provide information on the country of origin of the data or whether the studies were retrospective or prospective. These were non-clinical, bench-top tests.

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)

The document describes non-clinical, bench-top testing. For such tests, the "ground truth" is typically established by industry standards, engineering specifications, and validated measurement methods, rather than by human expert consensus or qualifications in the medical sense for diagnostic performance. Therefore, no information on the number or qualifications of experts for establishing ground truth is provided or relevant in this context.

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

Since the study described involves non-clinical engineering and performance testing, rather than human interpretation of medical data, the concept of an "adjudication method" (like 2+1 or 3+1 for resolving discrepancies in expert interpretations) is not applicable and not mentioned.

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 comparative effectiveness study was mentioned or performed. This submission is for a medical device (endoscope system) and not an AI-powered diagnostic tool. The focus is on the substantial equivalence of the hardware's performance and safety.

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

No standalone algorithm performance study was mentioned or performed. This device is a physical Rhinolaryngoscope and Digital Video Monitor, not a software algorithm.

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

For the non-clinical tests conducted:

• Biocompatibility: Ground truth was established by adherence to ISO 10993-1:2018 standards and validated laboratory tests (Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity).
• Electrical Safety and Electromagnetic Compatibility (EMC): Ground truth was established by compliance with international standards (IEC 60601-1, IEC60601-2-18, IEC 60601-1-2).
• Performance Testing (Appearance, Dimensions, Weight, Functional Performance): Ground truth was established by engineering specifications and validated measurement methods as defined in the test protocols (e.g., measuring angles, lengths, diameters, image quality parameters).

8. The sample size for the training set

Not applicable. This submission describes a hardware medical device, not a machine learning or AI model that requires a "training set."

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

Not applicable. As above, no training set was used.

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Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.

Ambu® aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing endotherapy instruments via its working channel.

The Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Broncho HD system is a combination of the displaying unit, Ambu® aView™ 2 Advance, and a compatible Ambu endoscope, the Ambu® aScope™ 5 Broncho HD 5.0/2.2 or the Ambu® aScope™ 5 Broncho HD 5.6/2.8. The Ambu® aScope™ 5 Broncho HD bronchoscopes are the same devices as cleared in K220606. The only change is that the bronchoscopes are now also compatible to Ambu® aView™ 2 Advance.

The Ambu® aScope™ 5 Broncho HD endoscopes are single-use endoscopes designed to be used with Ambu displaying units, endotherapy instruments and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The insertion portion is inserted into the patient airway through the mouth, nose, or a tracheostomy. It is lubricated with a water-soluble medical grade lubricant to ensure the lowest possible friction when inserted into the patient. There is a working channel system within the endoscope for use with endotherapy instruments. An introducer (luer lock adaptor), which is supplied together with the endoscope, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from the airway is possible through the suction system.

Ambu® aScope™ 5 Bronco HD features an integrated camera module, with built-in dual LED illumination. The image module provides a cropped 800x800 Pixels signal from the 1280x800 (1 megapixel) sensor.

The Ambu® aView™ 2 Advance, also referred to as displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8" LCD screen. The device is powered through a Lithium-ion (Li-ion) battery or a separate power adapter.

Ambu® aView™ 2 Advance displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 5 Broncho HD endoscope on the screen.
Can record snapshots or video of image from Ambu® aScope™ 5 Broncho HD endoscope.
Can connect to an external monitor.
Reusable device.

The provided text is a 510(k) summary for the Ambu® aScope™ 5 Broncho HD system. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, this document does not detail a study proving the device meets an acceptance criterion for an AI/ML-driven medical device, nor does it provide a table of acceptance criteria and reported device performance in the context of an AI/ML study.

The document discusses performance tests for the medical device itself (bronchoscope and display unit), such as optical properties, mechanical performance, biocompatibility, and electrical safety. The "acceptance criteria" here refer to the device meeting these engineering and regulatory standards, not specifically to the performance of an AI/ML algorithm.

Therefore, I cannot answer your request based on the provided input text, as the information you are asking for (acceptance criteria and study details for an AI/ML device) is not present. The document focuses on the hardware aspects of a bronchoscope system.

To address your query, I would need a document that describes the development and testing of an AI/ML-based medical device.

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The EXALT Model B Single-Use Bronchoscope is intended for use with the EXALT Monitor for endoscopic procedures within the airways and tracheobronchial tree.

The EXALT Model B Single-Use Bronchoscope is a sterile, single-use bronchoscope available in three sizes (Slim, Regular, and Large). The proposed device facilitates examination of the airways and trachea. delivery of accessories (Regular and Large sizes only), and delivery of live video when connected to an EXALT Monitor.

This document is an FDA 510(k) summary for the EXALT Model B Single-Use Bronchoscope. It states that the proposed device is identical to its predicate device (EXALT Model B Single-Use Bronchoscope, K211030). The purpose of the Special 510(k) was only to revise the specifications for insertion tube stiffness. Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of device performance or clinical effectiveness.

Instead, it focuses on demonstrating substantial equivalence to a predicate device, which largely means showing that the new device has the same technological characteristics and indications for use as the predicate.

Here's a breakdown of why the requested information cannot be fully provided based on the given document:

• Acceptance Criteria and Reported Device Performance: This document states the device is identical to the predicate and only revised a specification for insertion tube stiffness. It does not provide performance metrics or acceptance criteria for clinical outcomes or device effectiveness.
• Study That Proves the Device Meets Acceptance Criteria: No such study is described for the proposed device. The only "testing" mentioned was on new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to establish insertion tube stiffness in commercial use, which informed the revised specifications for the EXALT Model B.
• Absence of specific information regarding clinical trials or performance studies for the EXALT Model B: The document explicitly states, "Performance testing was not required to establish a finding of substantial equivalence between the proposed device and the predicate device, since the device is unchanged."

Therefore, it is not possible to fill in the requested table or answer the specific questions about clinical performance, test sets, ground truth, experts, or MRMC studies based solely on this 510(k) summary.

Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided document):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical "test set" for performance evaluation of the EXALT Model B is described.
2. 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): Not applicable, as no such test set or ground truth establishment is described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 bronchoscope, not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding performance/testing:

• The proposed EXALT Model B Single-Use Bronchoscope is identical to its predicate device (K211030).
• The "special" nature of this 510(k) is to revise the specifications for insertion tube stiffness for the Slim, Regular, and Large sizes.
• Performance testing was NOT required to establish substantial equivalence for the EXALT Model B because it is "unchanged" from the predicate, except for the stiffness specification.
• "Performance testing was conducted on new, unopened samples of the original predicate device (Ambu aScope 4 Broncho, K173727) to establish the insertion tube stiffness seen in commercial use." This testing informed the new specifications for the EXALT Model B.

In essence, this FDA letter and summary confirm that the EXALT Model B is substantially equivalent to a previously cleared device, and the specific change addressed (insertion tube stiffness specifications) was supported by testing performed on the original predicate device, not the EXALT Model B itself as a new performance study.

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The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor.

The endoscope is intended for use in a hospital environment. It is designed for use in adults.

The Ambu® aScope™ 4 RhinoLaryngo Intervention is a sterile single use flexible endoscope for examination of the nasal lumens and upper airway anatomy.

Ambu® aScope™ 4 RhinoLaryngo Intervention has the following physical and performance characteristics:
Maneuverable tip controlled by the user
Flexible insertion cord
Camera and LED light source at the distal tip
Working Channel
Sterilized by Ethylene Oxide
For single use

The acceptance criteria and the study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates qualitative acceptance criteria by stating that "All tests were passed" for various performance characteristics when compared to recognized consensus standards and internal performance tests.

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

The document describes bench testing for various performance parameters, shelf-life, and biocompatibility. It also references conformity to ISO standards. However, it does not provide specific sample sizes for these tests. The data provenance is internal to the manufacturer ("Performance test reports," "Biocompatibility test reports") and relates to the device design and manufacturing process. There is no indication of clinical test sets with patient data.

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

Not applicable. The reported studies are primarily bench tests and conformity assessments, not clinical studies requiring expert ground truth establishment from patient data.

4. Adjudication method for the test set:

Not applicable. The reported studies are bench tests and conformity assessments, not clinical studies requiring expert adjudication of patient results.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical endoscope, and the submission focuses on its safety and performance characteristics compared to a predicate device, not on AI assistance for human readers.

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

No, a standalone algorithm performance study was not mentioned. The device is a physical endoscope for direct human use.

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

The "ground truth" for the reported studies appears to be based on:

• Established engineering principles and metrology: For performance tests like bending endurance, image sharpness, length, and suction.
• Recognized consensus standards: ISO 8600 series for optics, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC. These standards define criteria against which the device performance is measured.
• Predicate device characteristics: For demonstrating substantial equivalence, the technological characteristics of the predicate device (Olympus XENF-TP) serve as a comparative reference.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor.

The endoscope is intended for use in a hospital environment. It is designed for use in adults.

The Ambu® aScope™ RLS Slim is a sterile single use flexible endoscope for examination of the nasal lumens and upper airway anatomy.

Ambu® aScope™ RLS Slim has the following physical and performance characteristics:
• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use

The provided text describes the "Ambu® aScope™ RLS Slim" device, which is a sterile, single-use flexible endoscope. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

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

The document doesn't explicitly present a table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity). Instead, it lists various performance tests and regulatory compliances that the device underwent, with the universal result being "All tests were passed."

Here's a table summarizing the reported device performance based on the provided "Performance Data - Bench" section:

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

The document mentions "Performance test reports" for various physical and performance characteristics, shelf life, and biocompatibility, but does not specify the sample size for any of these tests.

Regarding data provenance, the tests were conducted to document the performance of the Ambu® aScope™ RLS Slim. It is implied these are pre-market tests performed by the manufacturer (Ambu A/S in Denmark, with contact details provided). There is no explicit mention of the country of origin of the data beyond the manufacturer's location, nor is it specified if the tests were retrospective or prospective, though performance tests are typically prospective.

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

The document does not mention the use of experts in the context of establishing ground truth for the performance tests. The tests described are primarily focused on the physical, mechanical, and safety characteristics of the device itself (e.g., bending angle, image sharpness, sterility) rather than a diagnostic performance where expert interpretation would typically establish ground truth.

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

Since experts were not mentioned as being used to establish ground truth for a diagnostic performance test, there is no mention of an adjudication method. The tests described appear to be objective measurements against predefined specifications or standards.

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

No MRMC comparative effectiveness study was done or mentioned. This device is a flexible endoscope for visualization, not an AI-powered diagnostic tool, so such a study would not be applicable in this context.

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

No standalone performance study of an algorithm was done. This device is a physical endoscope and does not contain artificial intelligence algorithms for standalone performance evaluation by itself.

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

The "ground truth" for the tests performed appears to be based on objective measurements against recognized industry standards and internal specifications. For example:

• ISO 8600-1, ISO 8600-3, ISO 8600-4 for optical instruments.
• IEC 60601-1-2 for electromagnetic compatibility.
• IEC 60601-1 and IEC 60601-2-18 for electrical safety.
• ISO 10993-1, ISO 10993-5, ISO 10993-10 for biocompatibility.
• Internal specifications for physical characteristics like length, diameter, bending angle, manipulator force, and image sharpness.

There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic accuracy claims.

8. The sample size for the training set:

Not applicable. This device is a traditional medical device (an endoscope), not a machine learning or AI algorithm, so there is no concept of a "training set."

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

Not applicable. As there is no training set mentioned, there is no discussion of how its ground truth was established.

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