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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.

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