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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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The LTV1000 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 10 kg (22 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 and transport settings.

The LTV 1000 is a self-contained mechanical ventilator suitable for continuous life support in institutional and attended transport settings. The ventilator is slightly larger than a "laptop computer" and is selfcontained in that it can be operated without the need for externally supplied compressed air. The unit may be operated from external AC power through the use of an external AC/DC converter, or may be operated for approximately one hour using an internal rechargeable battery pack.
The following major features are included:

• Modes: Assist/Control, SIMV, CPAP, Apnea Backup .
• Breath Types: Volume Control, Pressure Control, Pressure Support, Spontaneous .
• Flow Triggering .
• Oxygen Blending
• PEEP
• Monitors: Calculated Peak Flow, Exhaled Tidal Volume, I:E Ratio, Mean Airway Pressure, Real Time . Airway Pressure, Peak inspiratory Pressure, PEEP, Total Breath Rate, Total Minute Volume
• Alarms: Apnea, High Pressure Limit, Low Peak Pressure, Low Minute Volume, Disconnect, Low & . Lost External Power, Low & Empty Internal Battery, Oxygen Inlet Pressure
  The ventilator uses an internal flow generator to provide the pressurized gas source. All breath types are delivered by an electromechanical inspiratory flow valve. An oxygen blender meters oxygen as required to meet the current setting of the O2% control. Mechanical valves are provided internally for overpressure relief and sub-ambient relief functions.
  The patient circuit is comprised of a single leg inspiratory tube connected to an exhalation system located proximal to the patient connection. The exhalation valve system will consist of a piloted exhalation valve, a PEEP valve, and a flow transducer combined in a compact package. Additional small bore tubing is included to transmit the flow, pressure and exhalation drive signals.

The provided document is a 510(k) premarket notification for a medical device, the LTV 1000 Ventilator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. Therefore, several requested elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in terms of quantitative performance metrics with pre-defined thresholds. Instead, it describes a non-clinical performance testing program designed to ensure the device met its "stated specifications" and demonstrated "functional and technical equivalence" to the predicate device. The "reported device performance" is essentially that the ventilator "was found to perform to specifications."

Note: The document explicitly states: "A validation report was written that summarizes the results of these tests. The ventilator was found to perform to specifications with exceptions as noted in the validation report. If a parameter was found to be non-compliant, a procedure was described in the report to ensure the anomaly does not present a hazard to the patient or user." This suggests that any deviations from specifications were either minor or had a documented mitigation plan.

Study Details

The study described is a non-clinical performance testing program aimed at demonstrating substantial equivalence to a predicate device (TBird Ventilator, K950484).

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

   • Sample Size: The document states that test procedures were written specifying the "number of units to be tested." However, the exact number is not specified in this document. It only mentions "In general, test procedures were written to test each parameter over the entire range of operation while varying other relevant parameters such as patient lung condition and environment."
   • Data Provenance: The testing was retrospective in the sense that it was conducted on the manufactured device to verify its specifications. The data origin is internal testing by Pulmonetic Systems, Inc. There is no mention of external data or patient data from a specific country.

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

   • Not applicable / Not specified. This was a non-clinical technical performance study. "Ground truth" in this context refers to the defined specifications and standards (e.g., ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care). The "experts" involved would be the engineers and quality assurance personnel who designed the tests and evaluated the results against the established specifications. Their specific number and qualifications are not mentioned.

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

   • None specified. As this was a technical validation against specifications, an adjudication method in the clinical sense (e.g., for image interpretation) is not relevant. The validation report would likely have involved review and approval by relevant engineering and quality management personnel.

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:

   • No. This device is a mechanical ventilator and does not involve AI or human "readers" in the context of diagnostic interpretation. Therefore, an MRMC study is not applicable.

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

   • Yes, analogous to standalone performance. The non-clinical performance testing assesses the device (including its software and mechanical components) in isolation, against its stated specifications and relevant standards. This is essentially a standalone performance evaluation of the device's functional and technical characteristics.

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

   • The "ground truth" for this non-clinical study consists of:
     • System Specifications: Internal design requirements.
     • Software Requirements Specifications: Internal software design requirements.
     • System Hazards Analysis: Requirements derived from risk assessment.
     • ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care: External, recognized industry standard for ventilator performance.

7. The sample size for the training set:

   • Not applicable / Not specified. This device is a mechanical ventilator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The development of the device would have involved engineering design, prototyping, and iterative testing, but not a "training set" for an algorithm.

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

   • Not applicable. As there is no "training set" for an algorithm, this question is not relevant. The ground truth for the testing related to device specifications was established through internal design requirements (System, Software Requirements, Hazards Analysis) and external industry standards (ASTM F 1100-90).

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