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The LTV® 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5kg (11 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (via endotrach tube or trach tube) or non-invasively (via mask or nasal prongs). Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. The ventilator is suitable for use in institutional, home, or transport settings. The MR Conditional LTV® 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. Breath types including Volume, Pressure Control and Pressure Support. The modification intended to be cleared by this submission is: The "Indications for Use" is being expanded to label the LTV 1200 as MR Conditional. The LTV 1200 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modification.

This is a 510(k) summary for the LTV 1200 MR Conditional Ventilator, which is an expansion of the "Indications for Use" to label the device as MR Conditional. It is not a study that uses AI/algorithm. Therefore, I cannot provide the specific information requested in the prompt, as it is not applicable to this document.

However, I can extract information related to the device and its intended use:

Device Description:
The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation. It is suitable for use in institutional, home, and transport settings. It is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.) and supports positive pressure ventilation (invasive or non-invasive) in Assist/Control, SIMV, CPAP, or NPPV modes, with breath types including Volume, Pressure Control, and Pressure Support.

Modification for Clearance:
The modification for this 510(k) is to expand the "Indications for Use" to label the LTV 1200 as MR Conditional.

Intended Use (MR Conditional Version):
The MR Conditional LTV 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners.

Equivalence to Predicate Device:
The LTV 1200 MR Conditional ventilator was found to be substantially equivalent to the predicate device:

• Predicate Device: iVent 201 MR Conditional Portable Ventilator
• 510(k) Clearance: K073694
• Manufacturer: Versamed Corporation

The document states that "Testing conducted in the MR environment has demonstrated that the LTV 1200 MR Conditional ventilator is substantially equivalent to the predicate device listed below." This implies that the acceptance criteria for being "MR Conditional" were met through testing, and the performance of the LTV 1200 in the MR environment was deemed comparable to the predicate device. However, the specific acceptance criteria, reported performance values, or details of the study (like sample size, ground truth, etc.) are not provided in this 510(k) summary.

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PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.

PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.

Federal law (USA) restricts the sale of this device except by or on the order of a physician.

The PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.

The PTV platform provides for the following features:

• . High performance ventilation in a small lightweight package
• A range of maneuvers including Inspiratory and Expiratory hold . and synchronized Nebulization (touch screen models only)
• . Internal flow generator, allowing the PTV to operate without an external compressed gas source
• . Four distinct breath types offering a range of treatment options. CPAP with optional Pressure Support 1, SIMV2, Control, Assist / Control
• Configurable Apnea back-up ventilation .
• NPPV3 ventilation, providing an alarm package suitable for . mask ventilation of patients whose needs do not extend to life support
• Volume Control, Pressure Control and PRVC4 ventilation modes t
• Adjustable alarm settings including High Peak Pressure. Low . Peak Pressure, Low Minute Volume, and Apnea
• Oxygen blending from a high-pressure oxygen source (optional) . or low-pressure oxygen bleed-in
• Lockable front panel controls .
• A wide range of monitors including Breath Rate (f), I:E Ratio . (Measured), MAP, Exhaled Minute Volume (VE), PEEP, PIP and Tidal Volume (Vte)
• Dynamic waveform and loop displays .
• . Graphic trending histogram display
• Real-time patient circuit pressure display .
• . Variable termination options for Pressure Support breaths, including maximum inspiratory time and percentage of peak flow
• . Selectable Percentage of Peak Flow termination for Pressure Control breaths
• Leak Compensation to improve patient triggering when a circuit . leak is present
• . Operation from a variety of power sources including AC power. removable battery and external DC power sources
• . Optional FIO2 sensor package.
• . Optional Oximetry module

Here's an analysis of the provided text regarding the acceptance criteria and study for the PALMTop PTV Models 8/10 ventilator, formatted to answer your questions:

Acceptance Criteria and Study Analysis for PALMTop PTV Models 8/10

The provided 510(k) summary for the PALMTop PTV Models 8/10 describes the device and its intended use, and states that performance testing (Bench testing) was conducted to verify that the device meets specified performance requirements and is substantially equivalent to predicate devices.

However, the document does not explicitly provide a table of acceptance criteria with numerical thresholds, nor does it detail a specific clinical study with human subjects, ground truth establishment, or expert adjudication that would typically be associated with AI/ML-driven medical devices. The testing described appears to be traditional engineering performance verification against specifications, rather than a statistical study comparing device output to expert-established ground truth in a diagnostic or predictive context.

Based on the provided information, I can fill in what is available and clarify what is not.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific numerical acceptance criteria (e.g., accuracy > X%, sensitivity > Y%, etc.) or corresponding reported device performance metrics in a quantitative manner. Instead, it broadly states that "Performance testing (Bench testing) verified that the Palmtop Models PTV 8/10 meet specified performance requirements and that the devices are substantially equivalent to the predicate devices listed below."

Therefore, no direct table can be generated from the given text.

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

The document describes "Performance testing (Bench testing)", which implies laboratory or engineering testing of the device's functionality rather than a test set of patient data. As such:

• Sample Size for Test Set: Not applicable or not specified in terms of patient data. The testing involved the device in a benchtop environment.
• Data Provenance: Not applicable, as there is no patient data described as part of the performance verification.

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

This information is not provided. Given that the testing involved "Bench testing," it's likely that ground truth was established by engineering specifications, calibration standards, and established medical device performance parameters, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. Since there's no mention of a test set involving human data or interpretations, an adjudication method like 2+1 or 3+1 would not be relevant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, there is no indication that an MRMC comparative effectiveness study was done. The device is a ventilator, a life-support system, and the "Bench testing" described focuses on its mechanical and functional performance, not on interpretation of medical images or signals by human readers assisted by AI.

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

The device, a ventilator, is a therapeutic and monitoring device, not an AI algorithm. Its performance is inherent in its operation (e.g., delivering specified pressures or volumes). The "Bench testing" would assess this standalone functional performance. However, there's no "algorithm only" performance reported in the context of diagnostic AI.

7. The Type of Ground Truth Used

The ground truth for the "Bench testing" would have been based on:

• Engineering Specifications: The pre-defined parameters and operational ranges the ventilator is designed to achieve.
• Calibration Standards: Reference measurements to ensure the device's sensors and outputs (e.g., pressure, flow, volume) are accurate.
• Predicate Device Performance: Comparison to the established performance of the legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The PALMTop PTV Models 8/10 is a traditional medical device (a ventilator), not a machine learning or AI-driven system that would require a "training set" of data in the common sense of AI development.

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

Not applicable, as there is no "training set" in the context of an AI/ML device described for this product.

In summary: The provided document describes the regulatory submission for a ventilator, a traditional medical device. The "performance testing" mentioned refers to engineering validation and verification (bench testing) against predefined device specifications and predicate device performance, not a clinical study involving human data, expert adjudication, or AI algorithm training/testing. Therefore, many of the questions related to AI/ML device evaluation criteria are not applicable to this submission.

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The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilation is a restricted medical device intension of individuals who require incomment venture direction of a physician. Specifically, the ventilator is applicable for adult and petiative weighing at least 5 kg (1 1 lbs), who require the following types of ventilatory support:

• Positive Pressure Yentilation, delivered invasively (via ET tube) or non-invasively (via mask).
  Assist/Control, SIMV, CPAP, or NPPV modes of ventilation.
  The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
• Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. .
• Breath types including Volume, Pressure Control and Pressure Support. .
  The modifications intended to be cleared by this submission are:
• Incorporation of optional internal PEEP control, replacing the optional external 록 mechanical PEEP valve used with the previously cleared LTV 1000 Ventilator.
• 해 The addition of a Low PEEP alarm.
• The addition of optional Patient Setting Control Presets to assist clinicians in initially setting patient ventilation set parameters.
• I The addition of NPPV mode setting enhancements to assist the clinician in setting up NPPV mode ventilation.
• I The addition of externally accessibility to the device internal battery for trained service personnel battery replacement.
• g The designation of the modified LTV 1000 Ventilator as the VIASYS LTV 1200 Ventilator. (Note: The previously cleared Pulmonetic Systems LTV 1000 will continue to be marketed without the modifications listed in this submission).
  The LTV 1000 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modifications.

This 510(k) premarket notification (K060647) is for the Pulmonetic Systems, Inc. LTV 1200 Ventilator. The submission describes modifications to the previously cleared LTV 1000 Ventilator. However, the document does not contain information regarding specific acceptance criteria for performance metrics or a detailed study proving the device meets those criteria, as one would typically find for AI/ML-based medical devices.

Instead, this submission is a typical medical device 510(k) for a hardware device with software components, focusing on demonstrating substantial equivalence to predicate devices and adherence to general controls and good manufacturing practices. The "acceptance criteria" discussed are implicitly related to the device functioning as intended for ventilation, meeting safety standards, and performing comparably to the predicate LTV 1000 and other listed ventilators (iVent 201 Portable Ventilator, AVEA Ventilator).

Here's a breakdown of the requested information based on the provided document, with notes on what is not applicable or not present in a traditional hardware device submission like this:

1. Table of Acceptance Criteria and Reported Device Performance

• Optional internal PEEP control
• Low PEEP alarm
• Optional Patient Setting Control Presets
• NPPV mode setting enhancements
• Externally accessibility to the device internal battery | The modifications are listed, and the 510(k) clearance implies that the FDA found these modifications do not raise new questions of safety or effectiveness and function as intended. However, specific quantitative performance data for these new features (e.g., alarm accuracy, preset efficacy) is not provided in this summary. |
  | Safety and Effectiveness: Device meets general safety and effectiveness requirements for ventilators for adult and pediatric patients (>5 kg) in institutional, home, and transport settings. | The FDA's clearance (K060647) indicates that after review, the device is deemed substantially equivalent, which includes an implicit determination of sufficient safety and effectiveness for its stated indications for use. Compliance with general controls and GMP is also required. |

Note: For a hardware device like a ventilator, acceptance criteria typically involve detailed engineering specifications, performance against recognized standards (e.g., ISO 80601-2-12 for critical care ventilators), and verification/validation testing covering aspects like:

• Pressure/volume/flow accuracy and stability
• Alarm performance (accuracy, response time)
• Battery life and management
• Durability and environmental testing
• Electromagnetic compatibility (EMC)
• Biocompatibility (if applicable to patient contact parts)
• Software validation (for embedded software)

This 510(k) summary does not include such detailed technical specifications or test results. It focuses on the regulatory aspect of demonstrating substantial equivalence.

The following information is not present in the provided 510(k) summary, as it is typically relevant for AI/ML-based medical devices or more specific clinical trials, which are not the focus of this hardware device submission.

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

• Not Applicable/Not Provided: This type of information is generally for studies involving data analysis, particularly for AI/ML models. For a ventilator, testing involves engineering verification and validation testing, not typically a "test set" in the context of data-driven models.

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)

• Not Applicable/Not Provided: This is specific to establishing ground truth for diagnostic or prognostic AI/ML applications. For a ventilator, "ground truth" is established by physical measurements and engineering standards, not expert consensus on data interpretation.

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

• Not Applicable/Not Provided: This relates to expert review processes for ground truth establishment in data-driven studies.

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/Not Provided: MRMC studies are used for evaluating diagnostic performance of AI-assisted human readers, which is not relevant for a ventilator's functional clearance.

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

• Not Applicable/Not Provided: This also pertains to AI/ML algorithm performance. The LTV 1200 is a device operated by a human, not a standalone diagnostic algorithm.

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

• Not Applicable/Not Provided, but inferred through engineering standards: For a ventilator, the "ground truth" for its performance is derived from physical laws of gas exchange, pressure/flow measurements, and established medical standards for ventilatory support. This is verified through engineering tests, rather than expert consensus on data labels, pathology, or outcomes data in the traditional sense of AI/ML studies.

8. The sample size for the training set

• Not Applicable/Not Provided: This refers to data used to train AI/ML models.

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

• Not Applicable/Not Provided: This also refers to AI/ML model training data.

Summary of the Study (as described in the 510(k) summary):

The "study" for the LTV 1200 Ventilator, as presented in this 510(k) summary, is not a clinical trial or a data-driven performance study in the AI/ML context. Instead, it is a regulatory submission process aimed at demonstrating substantial equivalence to legally marketed predicate devices (LTV 1000, iVent 201 Portable Ventilator, AVEA Ventilator).

• Evidence for Equivalence: The submission implicitly relies on:
  • Description of modifications: The document details the changes from the LTV 1000, which are primarily related to convenience, alarms, and internal components, not fundamental changes to the core ventilation mechanism.
  • Intended Use comparison: The intended use of the LTV 1200 is identical to the LTV 1000 (continuous or intermittent ventilatory support for adults and pediatric patients >5kg in various settings).
  • Technological Characteristics Comparison (implied): While not explicitly detailed in the summary, a full 510(k) submission would include a comparison of technological characteristics between the new device and the predicates, demonstrating that any differences do not raise new questions of safety and effectiveness. This often involves engineering verification and validation testing, which is assumed to have been performed even if not detailed in the public summary.

The FDA's clearance (K060647) signifies that they reviewed the provided information and concluded that the LTV 1200 Ventilator, with its modifications, is substantially equivalent to the predicate devices and can therefore be marketed without requiring a premarket approval application (PMA) or more extensive clinical trials typical for novel devices.

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The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). .
• Assist/Control, SIMV or CPAP modes of ventilation. .

The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
• Assist/Control, SIMV, or CPAP modes of ventilation. .
• Breath types including Volume, Pressure Control and Pressure Support. .

The addition intended to be cleared by this submission is:

• The addition of the Automobile Lighter Power Cord to be externally attached . to the LTV Series to power the LTV Ventilator while operating in an automobile. The power cord is designed to connect to +12V automobile cigarette lighter or auxiliary power outlets capable of supplying as least 20 amperes of current.

The provided document is a 510(k) summary for the "Automobile Lighter Power Cord" for the LTV 1000 ventilator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against detailed acceptance criteria in the context of AI/ML or diagnostic applications.

Therefore, many of the requested elements (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance with AI, ground truth types) are not applicable to this particular submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for this specific 510(k) submission revolve around demonstrating substantial equivalence to an existing legally marketed device (the predicate device) and ensuring the new accessory (Automobile Lighter Power Cord) does not raise new questions of safety or effectiveness.

The "study" conducted for this submission is a comparison to a predicate device to establish substantial equivalence based on intended use and technical characteristics.

Additional Requested Information (Not Applicable or Not Provided in this Document)

The document is a 510(k) summary for a ventilator accessory, not a diagnostic device or an AI/ML-driven device. As such, information typically found in studies for AI/ML or diagnostic performance is not present.

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance or an AI/ML algorithm on a test set of data. The "test" is the comparison to a predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the context of diagnostic performance is being established for this type of device.
3. Adjudication method 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.
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. The "ground truth" for this submission is primarily the regulatory standard of substantial equivalence to a predicate device.
7. The sample size for the training set: Not applicable. There is no AI/ML algorithm being trained.
8. How the ground truth for the training set was established: Not applicable.

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The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
• Assist/Control, SIMV, or CPAP modes of ventilation. ●
• Breath types including Volume, Pressure Control and Pressure Support. ●
  The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
• . Assist/Control, SIMV, or CPAP modes of ventilation.
• Breath types including Volume, Pressure Control and Pressure Support. .
  The modification intended to be cleared by this submission is:
• The addition of Spontaneous Breathing Trial (SBT) function allowing the clinician to . more easily determine a patient's ability to be weaned from ventilation.

The provided 510(k) summary for the Pulmonetic Systems LTV 1000 Ventilator (K051767) primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a new "Spontaneous Breathing Trial (SBT)" function. This type of submission, for a ventilator modification, does not typically include detailed performance studies with acceptance criteria in the same way an AI/ML device would.

Based on the provided document, here's an analysis concerning acceptance criteria and study information:

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

The document doesn't present a table of quantitative acceptance criteria and reported 'performance' in the sense of a diagnostic or predictive device. Instead, it compares characteristics of the modified LTV 1000 Ventilator with its predicate devices to demonstrate equivalence.

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

This submission is for a modification to a medical device (ventilator software feature), not a diagnostic or AI/ML device that would typically involve a "test set" of patient data for performance evaluation in the way a clinical study would. Therefore, there is no specific sample size, test set, or data provenance mentioned in relation to proving the SBT function's performance. The evaluation is based on engineering design, comparison to predicate devices, and potentially internal validation/verification testing which is not detailed in this public summary.

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):

Not applicable. As this is not a diagnostic device relying on expert interpretation for ground truth, there's no mention of experts establishing ground truth for a test set. The statement about "Longer time duration is provided at the request of clinicians" suggests input from medical professionals informed the feature design, but not for establishing ground truth in a performance study.

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

Not applicable. There is no test set or adjudication method described in the context of this submission.

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

Not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI assistance effect size is mentioned.

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

Not applicable. The device is a ventilator with a software function. The "performance" is inherent to the function's design and operation, not an algorithm providing a diagnostic output independently.

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

Not applicable in the traditional sense of a diagnostic performance study. The "ground truth" for the SBT function would be its adherence to engineering specifications, correct implementation of the defined parameters (e.g., timing, mode switching), and safe operation in a simulated or actual clinical environment. This type of validation is typically conducted through internal engineering testing, which is not detailed here but implied by regulatory compliance.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that would require a 'training set'.

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

Not applicable. This is not an AI/ML device.

Summary:

The 510(k) summary for K051767 focuses on demonstrating "substantial equivalence" of a modified ventilator with a new Spontaneous Breathing Trial (SBT) function to previously cleared predicate devices. The "acceptance criteria" here are implicitly tied to ensuring the new function is safe, effective, and performs comparably or superiorly without introducing new risks compared to existing methods or devices. The "study" proving this largely relies on design comparison, engineering assessment of the software modification, and the assertion that it does not introduce new technology or patient risk. It does not involve a clinical performance study with patient data, ground truth establishment, or human reader evaluations as would be expected for a diagnostic or AI/ML device.

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The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11lbs.), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
• Assist Control, SIMV, or CPAP modes of ventilation. -

The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
• Assist/Control, SIMV, or CPAP modes of ventilation. .
• Breath types including Volume, Pressure Control and Pressure Support. .

The modification intended to be cleared by this submission is:

The addition of commercially available heated wire breathing circuit inspiratory/expiratory limbs manufactured and distributed by Allegiance Healthcare Corporation (K000697), as an option to the ventilator breathing circuits specified for use

This 510(k) submission (K040790) describes a modification to the LTV 1000 Ventilator, specifically the addition of commercially available heated wire breathing circuits. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel device requiring extensive performance testing against acceptance criteria in the traditional sense. Therefore, the details requested regarding a specific "study that proves the device meets the acceptance criteria" and related metrics are not explicitly provided in this document as it pertains to a new device.

However, based on the provided text, we can infer the implicit "acceptance criteria" and "device performance" in terms of establishing substantial equivalence and the testing methods typically involved for such modifications.

Inferred Acceptance Criteria and Reported Device Performance (Table 1)

Given that this is a 510(k) for a modification focused on incorporating existing, cleared components (heated wire breathing circuits) into a cleared ventilator system, the primary "acceptance criterion" is demonstating that the modified system maintains the safety and effectiveness of the predicate device and the added components when integrated. This is typically achieved through:

• Substantial Equivalence: The modified device performs as intended and is as safe and effective as the predicate device(s).
• Performance Testing: Verification of critical ventilator parameters and circuit performance within established engineering specifications and relevant standards. This might involve pressure, flow, volume delivery, temperature control (for the heated circuits), and alarm functionality.
• Biocompatibility: Ensuring that the materials of the new breathing circuits are biocompatible with patient contact.
• Electrical Safety and EMC: Compliance with relevant electrical safety and electromagnetic compatibility standards.

Since the document is a summary for a 510(k), explicit, detailed acceptance criteria values (e.g., "flow rate must be within ±5% of set value") are not laid out, nor are specific performance testing results presented as a report. Instead, the "reported device performance" is implied by the statement of substantial equivalence and the expectation that the combined system meets the performance of its cleared predicate components.

Detailed Study Information (Based on 510(k) Modification Context)

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a "test set" sample size in terms of patient data. For a 510(k) modification focused on component integration and substantial equivalence, testing would involve engineering verification and validation (V&V) on a sufficient number of device units (physical ventilators with the new circuits) to demonstrate performance against specifications and compliance with standards. The specific number of units tested is not provided in this summary.
   • Data Provenance: The data provenance would primarily be from internal engineering and quality testing conducted by Pulmonetic Systems, Inc. on their modified LTV 1000 Ventilator system. Additionally, the pre-existing clearance (K000697) of the Allegiance Airlife Heated Ventilator Breathing Circuits would draw upon its original test data. This is prospective testing related to the manufacturing and verification of the modified device before market entry. Country of origin for testing is implied to be the US (Minneapolis, Minnesota for Pulmonetic Systems, Inc.).

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

   • This question is largely not applicable in the context of this 510(k) modification. "Ground truth" established by external experts (like radiologists for imaging) is relevant for diagnostic devices or AI algorithms where clinical accuracy is being assessed. For a ventilator modification, the "ground truth" for performance is established by engineering specifications, international standards (e.g., ISO for ventilators), and existing predicate device performance. Device validation would be performed by qualified engineers and technicians, not typically by external clinical "experts" establishing a "ground truth" for a test set in the way this question implies. Clinical experts would inform requirements and user needs, but they wouldn't perform ground truth adjudication on device performance data in this manner.

3. Adjudication method for the test set:

   • Not Applicable in the sense of clinical adjudication. Device performance testing against specifications typically involves defined measurement protocols, acceptance criteria, and verification by qualified test personnel. Discrepancies would be resolved through standard engineering and quality assurance processes, not a multi-reader, multi-case adjudication method.

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 ventilator device, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant to this submission.

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

   • Not Applicable. This is a hardware modification for a ventilator, not an algorithm or AI system.

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

   • The "ground truth" in this context is based on engineering specifications, compliance with recognized national and international standards for medical devices (specifically ventilators and breathing circuits), and the established safety and performance profile of the predicate devices. This includes physical and functional performance measurements, material biocompatibility, electrical safety, and electromagnetic compatibility.

7. The sample size for the training set:

   • Not Applicable. This is for a hardware modification, not a machine learning or AI algorithm development that requires a training set. The "training" for such a device would be the design and development process adhering to a quality management system.

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

   • Not Applicable. See point 7.

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The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
• Assist/Control, SIMV, or CPAP modes of ventilation. .
• Breath types including Volume, Pressure Control and Pressure Support. .

The ventilator is suitable for use in institutional, home and transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

• . Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
• Assist/Control, SIMV, or CPAP modes of ventilation. .
• Breath types including Volume, Pressure Control and Pressure Support. ●

The modifications intended to be cleared by this submission are:

• . The addition of a High Breath Rate Alarm to alert operators to a patient's high breath rate condition.
• . The addition of O2 cylinder duration monitoring to provide a reference indicator of the approximate remaining usable time of an external O2 cylinder based on operator entered input parameters.
• The addition of a 100% O₂ flush feature allowing the operator to elevate delivered FIO₂ . for a preset time period.
• The addition of Automatic High O₂ Switchover to alert operators that a high O₂ pressure . source is attached to the ventilator when a low O2 pressure source has been selected. In this condition, the ventilator will switch to a high O2 pressure source mode and set O2 delivery to 21% or room air.
• A change in maximum allowable oxygen input pressure from 70 psig to allow . broader compatibility with institutional oxygen sources.

The provided text describes a 510(k) summary for the LTV 1000 Ventilator, focusing on modifications to an existing device rather than a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance studies for a device which normally would involve data from human or phantom subjects, ground truth, expert opinions, or statistical analysis of algorithmic performance.

The text details:

• Device Trade Name: LTV 1000 Ventilator
• Common Name: Ventilator
• Classification Name: Ventilator, Continuous (Respirator) 868.5895
• Intended Use: To provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation (adult and pediatric patients weighing at least 5 kg). Suitable for institutional, home, and transport settings.
• Modifications: Addition of High Breath Rate Alarm, O2 cylinder duration monitoring, 100% O2 flush feature, Automatic High O2 Switchover, and improved maximum allowable oxygen input pressure.
• Equivalence to Predicate Devices: The modified LTV 1000 Ventilator is deemed substantially equivalent to the previously cleared LTV 1000 Ventilator (K032226) and the T-Bird AVS Ventilator (K981971).

Without information on a performance study specific to the modifications and their impact on clinical outcomes or diagnostic accuracy, I cannot fill out the requested table or answer the questions related to acceptance criteria, sample size, ground truth, or expert involvement.

The information provided in this 510(k) summary is focused on demonstrating substantial equivalence to a predicate device for device modifications, which is a regulatory pathway for marketing new medical devices in the US. This regulatory process typically relies on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, often through engineering tests and comparison of technical specifications, rather than new clinical effectiveness studies as would be seen for novel device types or those requiring PMA.

Ask a specific question about this device

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
• Assist/Control, SIMV, or CPAP modes of ventilation.

The ventilator is suitable for use in institutional, home, or transport settings.

Not Found

This document is an FDA 510(k) clearance letter for a medical device called the LTV 1000 Ventilator. It does not contain information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment for an AI/ML powered device.

The letter confirms that the FDA has reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. This type of clearance process primarily focuses on demonstrating equivalence to existing devices, rather than requiring new clinical trials that would generate performance metrics against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the input text.

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Ask a specific question about this device

Ask a specific question about this device