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510(k) Data Aggregation
(439 days)
The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 lbs).
The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: ACMV Volume, Pressure or PRVC, SIMV Volume, Pressure or PRVC, PSV/SPONT mode with Pressure Support and Volume Guarantee, Bi-Level (APRV). It can be pressure, flow or time triggered; volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure.
The FLIGHT 60 may be powered by external power (100 - 240 VACS or 12 - 15 VDC) or by its two internal Li Ion rechargeable batteries, which power the ventilator for up to 12 hours when fully charged.
The electrical system is comprised of three primary boards: the Main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU, the Power board, which holds the power subsystem and internal communication functions, and the Communication board, which holds internal communication and external communication connectors.
The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides built in PEEP.
A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
Here's an analysis of the acceptance criteria and study information for the FLIGHT 60 Ventilator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on establishing substantial equivalence to predicate devices and adherence to medical device standards. It does not present specific quantitative acceptance criteria alongside corresponding performance metrics in a direct table format for the FLIGHT 60 Ventilator itself. Instead, it makes a general statement about meeting "applicable device specification" and compliance with recognized standards.
However, we can infer the "acceptance criteria" through the mentioned standards and the general statement about meeting design verification criteria. The "reported device performance" is essentially the statement of compliance.
| Acceptance Criteria (Inferred from Standards & General Statements) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:1998 (+A1:1991+A2:1995) (Medical electrical equipment - Part 1: General requirements for safety and essential performance) | Device is compliant with this standard. |
| Compliance with IEC 60601-1-2:2007 (Electromagnetic compatibility. Requirements and tests) | Device is compliant with this standard. |
| Compliance with IEC 60601-1-8:2006 (General requirements, tests and guidance for alarm systems in medical equipment and medical electrical systems) | Device is compliant with this standard. |
| Compliance with IEC 60601-2-12:2001 (Particular requirement for the safety of lung ventilators -- Critical care ventilators) | Device is compliant with this standard. |
| Compliance with ASTM F 1246-91 (Standard Specification for Electrically Powered Home Care Ventilators Part 1-Positive-Pressure Ventilators and Ventilator Circuits) | Device is compliant with this standard. |
| Meeting all applicable device specifications (general statement) | Device met required design verification criteria. |
| Acceptable performance when used in accordance with its labeling | Device has acceptable performance when used as intended. |
| Performance parameters comparable to referenced predicate devices | Performance parameters are comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance data. The "Performance Data" section merely states: "FLIGHT 60 Ventilator meets all applicable device specification... Verification of compliance with recognized standard has been made to support use of the device for its intended use and in its intended environment." This suggests testing was conducted, but the specifics of the test set are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set. This type of evaluation is common for diagnostic/AI devices, but for a ventilator, performance is typically assessed against engineering specifications and international standards, often through bench testing and simulated use, rather than requiring expert interpretation of results.
4. Adjudication Method for the Test Set
Since the document does not describe a study involving a "test set" in the context of expert review or clinical outcomes requiring adjudication, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is more relevant for diagnostic imaging devices where human readers interpret medical images, and the performance of AI-assisted reading is compared to unassisted reading. The FLIGHT 60 Ventilator is a treatment device, not a diagnostic one in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone performance" typically applies to AI algorithms that provide a diagnostic or predictive output without human intervention. The FLIGHT 60 Ventilator is a physical medical device. Its "performance" is inherently standalone in that it functions independently according to its design and specifications. There's no AI algorithm in the sense of a diagnostic one being evaluated for standalone performance here. The document states it is "microprocessor controlled" but doesn't imply an AI component requiring this type of assessment.
7. The Type of Ground Truth Used
For medical devices like ventilators, the "ground truth" for performance evaluation is typically established through:
- Engineering specifications and design requirements: The device's output (e.g., delivered volume, pressure, flow) is measured and compared against its programmed settings and acceptable tolerances.
- International standards conformance: Performance is assessed against the requirements of relevant ISO and IEC standards (as listed), which define acceptable ranges and behaviors for medical electrical equipment and specific device types.
- Simulated physiological models: Ventilator performance can be tested using lung simulators that mimic various patient conditions.
The document explicitly states that "Verification and validation activities were conducted to establish the performance characteristics of the FLIGHT 60 Ventilator" and that "All testing demonstrated that the FLIGHT 60 Ventilator met required design verification criteria and has acceptable performance when used in accordance with its labeling." This indicates that the ground truth was based on pre-defined engineering standards and specified performance parameters.
8. The Sample Size for the Training Set
The document does not mention a "training set." This term is specific to the development and evaluation of machine learning or artificial intelligence algorithms. The FLIGHT 60 Ventilator is a microprocessor-controlled device, but the context provided does not indicate it uses a machine learning model that would require a distinct training set for its core functionality.
9. How the Ground Truth for the Training Set Was Established
As no "training set" for a machine learning algorithm is discussed, there is no information on how its ground truth might have been established.
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(197 days)
FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray images of the liver arterial tree. Its output is intended as an adjunct means to help identify arteries leading to the vicinity of hypervascular lesions in the liver. This adjunct information may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during embolization procedures.
FlightPlan for Liver is a post-processing software application for use with interventional fluoroscopy procedures, using 3D rotational angiography images as input. It operates on the AW VolumeShare 4 [K052995] and AW VolumeShare 5 [K110834] platform. It is an extension to the Volume Viewer application [K041521] utilizing the rich set of the 3D processing features of Volume Viewer. FlightPlan for Liver delivers post-processing features that will aid physicians in their analysis of 3D X-ray images of the liver arterial tree. Additionally FlightPlan for Liver includes an algorithm to highlight the potential vessel(s) in the vicinity of a target.
Here's an analysis of the provided text regarding the acceptance criteria and study for the FlightPlan for Liver device:
Acceptance Criteria and Device Performance
There is no explicit table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device and confirming that the software functions as required and fulfills user needs.
The "Performance testing" mentioned is described as "computing time of algorithm on several data," implying it's a speed or efficiency metric rather than a diagnostic performance metric. The "Verification confirms that the Design Output meets the Design Input (Product Specifications) requirements" and "Validation confirms that the product fulfills the user needs and the intended use under simulated use conditions," but specific, quantifiable acceptance criteria are not detailed.
The "Summary of Clinical Tests" states that the study "demonstrate[d] the safety and effectiveness of FlightPlan for Liver" and compared its output "to a reference reading established by two senior interventional oncologists." However, the exact metrics used for comparison and the "acceptance criteria" for those metrics are not provided. The key takeaway is that the clinical data was not intended to support a claim of improved clinical outcomes.
Study Details
Here's what can be extracted about the study that proves the device meets the (unspecified quantitative) acceptance criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicit/General) | Reported Device Performance |
|---|---|---|
| Functional Verification | Application works as required; Risk mitigations correctly implemented. | "Verification tests... performed to check whether the application works as required and whether the risk mitigations have been correctly implemented." |
| Performance Testing | Algorithm computing time (specific targets not provided). | "Performance testing consists of computing time of algorithm on several data." |
| Design Validation | Product fulfills user needs and intended use under simulated use conditions. | "Validation tests consist of typical use case scenario described by the sequence of operator actions. The Design Validation confirms that the product fulfills the user needs and the intended use under simulated use conditions." |
| Clinical Effectiveness | Output provides adjunct information to aid physicians in evaluating hepatic arterial anatomy; output compared to reference reading. | Output was compared to a reference reading established by two senior interventional oncologists. No specific quantitative performance metrics (e.g., accuracy, precision) are provided, nor are numerical results of this comparison. |
| Substantial Equivalence | Functionality, safety, and effectiveness are comparable to the predicate device. | "GE Healthcare considers the FlightPlan for Liver application to be as safe and as effective as its predicate device, and its performance is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance
- Test Set Size: 44 subjects, representing a total of 66 tumors.
- Data Provenance: Retrospective study. The country of origin is not explicitly stated, but given the submitter's address (Buc, FRANCE) and the GE Healthcare global nature, it could be either European or multinational, but this is speculative.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Two.
- Qualifications: "Senior interventional oncologists." Specific experience (e.g., years) is not provided.
4. Adjudication method for the test set
- The ground truth was established by a "reference reading established by two senior interventional oncologists." While it states the two established the reference, it doesn't specify if this was by consensus, independent reads with adjudication, or another method. The phrasing "a reference reading established by two" suggests a single, agreed-upon ground truth, likely consensus or 2-reader agreement if initial reads differed.
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 comparing human readers with AI assistance vs. without AI assistance was not done. The study specifically states that the clinical data "was not designed nor intended to support a claim of an improvement in clinical outcomes of such procedures, and no such claim is being made." The study focused on comparing the device's output to an expert reference, not on human performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the clinical study appears to evaluate the algorithm's standalone performance compared to a "reference reading." The "output of FlightPlan for Liver was compared to a reference reading," indicating the algorithm's direct output was assessed. No mention is made of human interaction or interpretation of the algorithm's output as part of this comparison.
7. The type of ground truth used
- Type of Ground Truth: Expert consensus/reference reading. Specifically, "a reference reading established by two senior interventional oncologists."
8. The sample size for the training set
- The document does not mention the sample size for the training set. It only describes the clinical study as a "retrospective study" used for verification and validation, implying it was a test set. There's no information about the data used to train the "algorithm to highlight the potential vessel(s)."
9. How the ground truth for the training set was established
- This information is not provided since the document does not detail the training set or its ground truth establishment.
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(119 days)
The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 lbs).
The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: A/CMV Volume or Pressure Control, SIMV Volume or Pressure Control, Pressure Support & SPONT mode with Pressure Support. It can be pressure or time triggered; volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure.
The FLIGHT 60 may be powered by external power (100 - 240 VACS or 12 - 15 VDC) or by its two internal Li Ion rechargeable batteries, which power the ventilator for up to 12 hours when fully charged.
The electrical system is comprised of three primary boards: the Main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU, the Power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors.
The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP.
A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
Here's an analysis of the provided text regarding the FLIGHT 60 Ventilator, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a medical device (a ventilator). Unlike AI/ML-driven devices, traditional medical devices like ventilators do not typically have "acceptance criteria" in the same way an AI algorithm has performance metrics (e.g., sensitivity, specificity, AUC). Instead, they meet performance specifications and recognized standards to ensure safety and effectiveness. The "study" here refers to the verification and validation (V&V) testing.
Therefore, many of the requested categories (sample size for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable in the context of a ventilator's regulatory submission. This information is primarily relevant for AI/ML devices that make diagnostic or prognostic predictions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specifications/Standards) | Reported Device Performance |
|---|---|
| Applicable Device Specification Requirements for Performance Testing (as identified in FDA reviewer guidance for ventilators) | Met all applicable device specification requirements. |
| Compliance with Recognized Standards for safe use of the device in its intended environment. | Verification of compliance with recognized standards has been made. |
| Substantial Equivalence to Predicate Devices (Flight 60, K111683; Vela, K032451; Trilogy 100, K083526) without raising new safety or effectiveness concerns. | Demonstrated substantial equivalence without raising any new safety and/or effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as this is a physical medical device (ventilator), not a diagnostic algorithm. The "test set" for a ventilator would involve rigorous engineering and safety testing under various simulated and real-world conditions, rather than a dataset of patient information. The document refers to "performance testing" and "verification of compliance," which implies testing of the physical device's functionality and adherence to safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The "ground truth" for a ventilator's performance is objective physical measurements and safety standards (e.g., gas flow rates, pressure delivery, alarm functionality, battery life, power consumption). This does not involve expert consensus on medical images or diagnoses. Experts (e.g., engineers, clinicians) would be involved in designing the specifications and evaluating test results, but not in establishing a "ground truth" that is then compared against an algorithm's output.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretations, typically for establishing ground truth in diagnostic studies. For a ventilator, performance is objectively measured against specifications and standards, not subject to subjective adjudication in this way.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
This information is not applicable. MRMC studies are designed to assess the impact of an AI system on human reader performance, usually in image interpretation. This ventilator is a life-support device, not a diagnostic imaging aid. The "comparison" mentioned in the document is between the new FLIGHT 60 and its predicate devices to demonstrate substantial equivalence, not an assessment of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The FLIGHT 60 is a ventilator, a standalone medical device that performs a mechanical function. It's not an algorithm that makes diagnostic predictions. Its performance is its own operation, and it's designed to be used with human oversight, but not as an "AI-only" component.
7. The Type of Ground Truth Used
The "ground truth" for a ventilator's performance is typically defined by:
- Engineering specifications: Precise measurements of gas delivery, pressure, oxygen concentration, flow rates, alarm thresholds, battery duration, power consumption, etc.
- Recognized national and international standards: Adherence to standards like ISO 80601-2-12 for critical care ventilators, or specific electrical safety standards.
- Biocompatibility testing: Ensuring materials are safe for patient contact.
- Electromagnetic compatibility (EMC) testing: Ensuring it doesn't interfere with or get interfered by other devices.
- Environmental testing: Performance under varying temperatures, humidity, and vibration.
It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.
8. The Sample Size for the Training Set
This information is not applicable. Ventilators do not have "training sets" in the context of machine learning. Their functionality is programmed and engineered, not "learned" from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no "training set" for a ventilator in the AI/ML sense, there's no ground truth to establish for it. The ventilator's operational parameters are based on scientific and medical principles, engineering design, and regulatory standards.
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(138 days)
The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 10kg (22 lbs). The Flight 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
The Flight 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: A/CMV Volume or Pressure Control. SIMV Volume or Pressure Control. Pressure Support & SPONT mode with Pressure Support. It can be pressure or time triggered volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure. The Flight 60 may be powered by external power (100 - 240 VACS or 12 -15 VDC) or by its two internal Li Ion rechargeable batteries, which power the ventilator for up to 12 hours when fully charged. The electrical system is comprised of three primary boards the Main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU, the Power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP. A comprehensive alarm system is built in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
This document is a 510(k) summary for the Flight 60 Ventilator, focusing on its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a specific algorithm or AI is not present.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document states: "The Flight 60 Ventilator meets all applicable device specification requirements for performance testing as identified in the FDA reviewer guidance for ventilators. Verification of compliance with recognized standards has been made to support safe use of the device for its intended use and in its intended environment." It also mentions a usability/human factors study.
While specific numerical acceptance criteria or performance metrics are not given, the overall acceptance criterion can be inferred as "meeting all applicable device specification requirements and recognized standards."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Meets applicable device specifications for performance testing | "The Flight 60 Ventilator meets all applicable device specification requirements for performance testing as identified in the FDA reviewer guidance for ventilators." |
| Complies with recognized standards for safe use | "Verification of compliance with recognized standards has been made to support safe use of the device for its intended use and in its intended environment." |
| User interface is simple and easy to use | "The results of the study demonstrated that the ventilator's user interface is simple and easy to use for the potential users." |
| Substantial equivalence to predicate devices | "comparison between the performance of the revised Flight 60 Ventilator (subject of this submission) with its predicate devices... demonstrated that the Flight 60 Ventilator is substantially equivalent to it predicate devices without raising any new safety and/or effectiveness concerns." |
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 mentions a "usability/human factors study" and refers to "users" being requested to use the ventilator.
- Sample size: Not specified.
- Data provenance: Not specified, but the applicant is "Flight Medical Innovations Ltd. 13 Hamelacha Street North Industrial Park Lod 71520, Israel," so presumably, the study was conducted there or relevant to their market. The study seems prospective in nature ("First users were requested to use the ventilator...").
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 because the "study" mentioned is a usability/human factors study, not a clinical study evaluating diagnostic accuracy or a similar measure that would require expert-established ground truth. The "ground truth" for a usability study would be user feedback and observed interactions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was a usability study focused on user experience, not a clinical trial with adjudicated outcomes from experts.
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. The Flight 60 Ventilator is a hardware device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a hardware medical device (ventilator).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the usability/human factors study, the "ground truth" would be the subjective and objective feedback from the users regarding ease of use, and potentially observed performance during simulated tasks. For the overall device performance, the "ground truth" is compliance with recognized standards and device specifications, which would be verified through engineering and performance testing. There's no clinical "ground truth" in the sense of pathology or outcomes data presented here for efficacy.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI model.
9. How the ground truth for the training set was established
Not applicable, as this is a hardware device, not an AI model requiring a training set with established ground truth.
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(156 days)
The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 10kg (22 lbs).
The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: A/CMV Volume or Pressure Control, SIMV Volume or Pressure Control, Pressure Support & SPONT mode with Pressure Support. It can be pressure or time triggered; volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure. The FLIGHT 60 may be powered by external power (100 - 240 VACS or 12 - 15 VDC) or by its two internal Li Ion rechargeable batteries, which power the ventilator for up to 12 hours when fully charged.
The electrical system is comprised of three primary boards: the Main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU, the Power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP.
A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
The provided text is a 510(k) summary for the FLIGHT 60 Ventilator. While it discusses the device's intended use, classification, predicate devices, and general performance statements, it does not contain specific acceptance criteria or the details of a study that proves the device meets those criteria.
The relevant section, "Performance Data," states: "The FLIGHT 60 Ventilator meets all applicable device specification requirements for performance testing as identified in the FDA reviewer guidance for ventilators. Verification of compliance with recognized standards has been made to support safe use of the device for its intended use and in its intended environment."
This statement confirms that testing was conducted and standards were met, but it does not provide the specific data requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot populate the table or answer the specific questions because the information is not present in the provided text.
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(4 days)
The Flight Dental Systems A-Series Operative Units are intended to supply power und serve as a base for dental devices and accessories. The use intended is in the treatment of dental patients in the dental clinic/office environment. The units are for use only by trained dentists, dental hygienists, dental technicians and dental assistants.
The Flight A-Series Dental Operative Unit is a dental operating system. The device includes a patient chair, dentist's element, utility center and a floor box. The unit may also include a cuspidor, an assistant's element and a dental operating light. The doctor's element may be mounted on the patient chair or on a mobile cart. The unit is used to position the patient in a comfortable position and to provide the power to the dentist's instruments including dental handpieces.
This document describes the Flight Dental Systems A-Series Dental Operative Unit, cleared under K070196. This device is a dental operating system comprising a patient chair, dentist's element, utility center, and floor box, intended to supply power and serve as a base for dental devices and accessories in a dental clinic/office environment.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Sirona C8+ Dental Operative unit - K983242) rather than defining explicit, quantitative acceptance criteria for de novo performance. The acceptance criteria are implicitly met by demonstrating conformance to relevant standards and direct equivalence to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards Conformance) | Reported Device Performance |
|---|---|
| Safety: Device electrical safety, mechanical integrity, and biocompatibility. | Bench testing against various standards: |
| - Electrical Safety: Comply with IEC 60601-1 / UL 60601-1 and CAN/CSA-C22.2 No. 601.1 M90 for electrical medical equipment. | - Independent laboratory testing by Intertek Testing confirmed conformity with UL 60601-1 and CAN/CSA-C22.2 No. 601.1 M90. |
| - Mechanical Safety/Functional Standards: Comply with ISO 7494-1:1996 (Dentistry - Dental units - Part 1: General requirements and test methods) and ISO 7494-2:2003 (Dentistry - Dental units - Part 2: Water and air supply). | - Bench testing against local GB standards (GB9706.1-1995 and Y Y/T1043-2004) which are near equivalent to ISO 7494-2:2003 and ISO 7494-1:1996. Additional testing performed where local standards were not equivalent. |
| - Compatibility with Handpieces: Comply with ISO 9168:1991 (Dental handpieces - Coupling dimensions). | - Tested against ISO 9168:1991 and found to be in compliance. Device uses industry-standard 4-Hole handpiece tubings. |
| - Biocompatibility (Patient/Operator Contact Surfaces): Comply with ISO 7405:1997 (Dentistry - Evaluation of biocompatibility of medical and dental devices). | - Patient and operator contact surfaces tested and found to be in compliance with ISO 7405:1997. Device composed of materials with a long history of use. |
| Effectiveness/Performance: Ability to supply power and act as a base for dental devices and accessories, and to position the patient. | - Device description and comparison table assert "Equivalent" performance in all functional aspects (control of air and water, installation, components, accessories, power/utility supply, water system, cleaning system, activation, place of use, intended users) to the predicate Sirona C8. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The submission states that "Bench testing has been performed on a sample that is in all respects the same as the device to be marketed." This indicates a single device sample (or a very small number representing the manufactured article) was used for physical bench testing.
- Data Provenance: The bench testing was performed against local GB standards in China. Additional independent laboratory testing was performed by Intertek Testing of Mississauga, Ontario, Canada. This is prospective testing of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This submission does not involve clinical data or expert evaluations for establishing ground truth in the context of image interpretation or diagnostic performance. Instead, ground truth is established by the compliance of the device with recognized international and national standards as assessed by engineering and testing professionals at the designated testing laboratories. Therefore, the "experts" are the qualified personnel at the testing facilities (e.g., Intertek Testing) who conducted the specified tests and verified compliance. Their specific qualifications are not detailed beyond their affiliation with the testing labs.
4. Adjudication Method for the Test Set:
- Not applicable. The testing described is objective bench testing against engineering standards, not subjective evaluation requiring adjudication among multiple human assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted devices that impact human clinical decision-making. This device is a physical dental operative unit.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a physical medical device, not an algorithm or software-only device. Its performance is inherent in its physical and electrical characteristics conforming to safety and performance standards.
7. Type of Ground Truth Used:
- The "ground truth" used for this submission is conformance to established engineering and safety standards (e.g., ISO, UL, CSA, GB standards), combined with direct comparison of technological characteristics to a legally marketed predicate device.
8. Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set.
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(14 days)
Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position.
The AIR, Inc. Model "Flight" mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The device can be easily folded for transport.
The provided 510(k) summary for the "Flight" mechanical wheelchair describes a performance study aimed at demonstrating substantial equivalence to a predicate device. This is largely based on compliance with voluntary standards rather than a typical clinical performance study for an AI-powered diagnostic device.
Here's an analysis of the acceptance criteria and the study, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Voluntary Standards (Performance) | ANSI/RESNA WC Vol 1: Applicable standards for mechanical wheelchairs | Meets applicable ANSI/RESNA standards | This is a general statement that the device meets the relevant standards. Specific numerical values for the standards are not provided in this document. |
| Voluntary Standards (Safety/Flammability) | ANSI/RESNA WC Vol 1, Section 16: Determination of flammability | Upholstery meets ANSI/RESNA WC Vol 1, Section 16 | Confirms compliance with a specific safety standard related to upholstery flammability. |
| Intended Use Equivalence | Same intended use as predicate device | "Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position." (Matches predicate) | The primary indication for use is identical to that of the predicate device, demonstrating functional equivalence. |
| Physical Characteristics Equivalence | Comparable weight bearing capacity | "Both devices have the same weight bearing capacity" | Directly states equivalence in a key performance aspect. |
| Functionality Equivalence | Foldable for transportation/stowage | "both devices are foldable for transportation or stowage" | Directly states equivalence in a key functional aspect. |
| Dimensional Similarity | Overall dimensions similar to predicate | "The overall dimensions are similar." | A qualitative assessment of similarity. |
| Safety Differences | Differences between new device and predicate are not safety-related | "The differences between the new device and the predicate are chiefly in the frame materials and in overall dimensions. These differences are not safety related" | A critical assertion for demonstrating substantial equivalence. |
Note: This 510(k) summary is for a mechanical wheelchair, not an AI/diagnostic device. Therefore, the concept of "device performance" here relates to meeting engineering and safety standards, and functional equivalence, rather than diagnostic accuracy metrics like sensitivity or specificity.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k). The "performance testing" described refers to engineering tests against specified standards rather than a clinical trial with a "test set" of patient data. The device itself (one or more units of the Flight wheelchair) would be the "test subject" for these engineering tests.
- Data Provenance: Not applicable. The "data" comes from engineering tests performed on the physical device, not from patient populations or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth, in the context of a diagnostic device, typically refers to a definitive diagnosis or outcome. For a mechanical wheelchair, the "ground truth" for its performance is determined by whether it physically meets the specified engineering standards (e.g., strength, durability, flammability under controlled test conditions). This doesn't involve human expert interpretation of patient data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretation of clinical data. Since this involves engineering tests rather than clinical data interpretation, adjudication is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic devices to assess the impact of a new technology (like AI) on physician performance. The "Flight" wheelchair is a mechanical device, and its evaluation focuses on engineering compliance and functional equivalence, not on improving human reader performance.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a "standalone" evaluation was done. The "Flight" mechanical wheelchair was tested on its own to determine if it met the specified ANSI/RESNA standards. This is an evaluation of the device's inherent physical performance characteristics, independent of human interaction beyond operating the test equipment.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims of the "Flight" mechanical wheelchair is based on engineering standards and specifications. The device is tested against predefined metrics and procedures outlined in documents like ANSI/RESNA WC Volume 1, Section 16 (for flammability) and other applicable standards for mechanical wheelchairs. Successful completion of these tests, demonstrating compliance with the numerical and qualitative requirements of the standards, constitutes the "ground truth" that the device performs as intended and meets safety requirements.
8. The Sample Size for the Training Set
Not applicable. The "Flight" mechanical wheelchair is a physical product, not an AI algorithm that requires a "training set" of data to learn from. Its design and manufacturing are based on engineering principles and material science, not machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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(28 days)
Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers. Over the Counter
SSL's Medical Support Stocking is a compression stocking in the 14 -17mmHg range. It is composed of Polyamide / Elastane. A cotton feel Flight sock using air jet textured spun nylon.
The provided document describes a 510(k) premarket notification for a medical support stocking (Flight Sock), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.
However, I can extract the relevant information regarding the acceptance criteria and the study performed for this specific medical device.
Acceptance Criteria and Device Performance for SSL's Medical Support Stocking (Flight Sock)
The core "acceptance criteria" in this context is demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of physical characteristics and intended use. The study performed focuses on this comparison.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
| :--------------------------- | :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Compression Range | Equivalent compression in the 14-17 mmHg range to predicate devices. | The device is a compression stocking in the 14-17 mmHg range. Equivalent to predicate devices (Futuro's Venes Anti Embolism Stockings, K830696, and Jobst Travel Sock, K032325). |
| Composition | Equivalent materials to predicate devices. | Composed of Polyamide / Elastane (a cotton feel Flight sock using air jet textured spun nylon). Equivalent to predicate devices. |
| Intended Use | To help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers. | Same as the predicate devices. |
Study Information
-
Sample size used for the test set and the data provenance:
- The document implies a comparative equivalency study was performed against Futuro's Venes Anti Embolism Stockings (K830696).
- The specific number of samples (e.g., individual stockings or tests) for the equivalency testing is not specified in the provided text.
- Data Provenance: Not explicitly stated, but assumed to be internal testing by SSL Americas, Inc. (retrospective for the submission).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML study generating a diagnostic output. The "ground truth" here is the established characteristics and performance of the predicate device.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No human adjudication of results in the AI/ML sense. The equivalency was determined through direct comparison of physical properties (compression, composition).
-
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 is not an AI/ML device, so no MRMC study was performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the equivalency testing was the established characteristics and performance of the predicate devices (Futuro's Venes Anti Embolism Stockings and Jobst Travel Sock). This would involve physical measurements of compression and analysis of material composition.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable.
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