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The device is intended to be used as a radiofrequency physiological signal transmitter and receiver to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another. The received signal is reconditioned by the device into its original format so that it can be displayed.

The Ambulatory X-12 Telemetry Module, designed and manufactured by Mortara Instrument. Inc. represents the state-of-the-art in Wireless Electrocardiographic Technology. Design innovations implemented in the Ambulatory X-12 Telemetry Module achieve real-time acquisition, RF transmission of simultaneous 12-lead ECG data with diagnostic quality to the Mortara Receiver Module while allowing the patient to be ambulatory.

The Ambulatory X-12 Telemetry Module combines unparalleled accuracy, flexibility, and ease of use in a small light-weight Ambulatory X-12 (transmitter) unit worn by the patient. The patient cable used in conjunction with the Ambulatory X-12 is a light-weight flexible design, which plugs into a polarized connector on the side of the transmitter. The cable is worn by the patient in a standard torso 12-lead hook-up, and connects directly to snap type electrodes.

The Large LCD screen clearly displays each lead's status or lead fault. Two letter codes for Power On(On) and Low Battery (Lb) are displayed during normal operation, with the ON/OFF switch located inside the battery compartment, to prevent transmitter from being inadvertently turned off during normal use. When turned ON, the power to the Ambulatory X-12 is supplied by two size AA Alkaline batteries.

Lead Check Mode is initiated by the TEST button and the CALL button is used to select individual leads. Once in Lead Check Mode an LC code is displayed along with a flashing torso lead indicator of the lead being tested and a bar graph indicating the lead quality.

ECG data is gathered and transmitted on a low power, FM modulated carrier using a proprietary encoding scheme. An electrocardiograph containing the Mortara Receiver Module demodulates and decodes the data. The Ambulatory X-12 Telemetry Module affords the patient complete freedom of movement. Unlimited range can also be obtained with the addition of the Mortara Antenna Network Box(s).

Here's an analysis of the provided text regarding the Ambulatory X-12 Telemetry Module, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which is a regulatory submission for medical devices. It details the device's characteristics and its equivalence to previously approved devices. It does not typically contain detailed reports of clinical trials or specific performance studies proving acceptance criteria in the same way a research paper would. Instead, it relies on demonstrating adherence to recognized standards and comparison to predicate devices. Therefore, some information, especially regarding specific "studies" with detailed sample sizes, expert qualifications, and adjudication methods for proving acceptance criteria, may not be explicitly present or will be inferred from the stated compliance with standards.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Ambulatory X-12 Telemetry Module are primarily established by its compliance with various national and international standards for electrocardiographic devices and medical electrical equipment. The device's performance is reported implicitly by stating its features and specifications that meet or exceed these standards, and by comparison with predicate devices.

Study Details (Based on available 510(k) Summary Information)

The 510(k) summary primarily refers to non-clinical performance data and compliance with recognized standards rather than a single, specific clinical study to "prove" the device meets acceptance criteria. The "study" here refers to the process of verification and validation against these standards.

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

   • Test Set Sample Size: Not explicitly stated as a number of patients or ECGs. The "test set" for this type of device would involve laboratory testing and performance verification against the specified standards (e.g., AAMI EC 11, AAMI EC 38). These standards define test methods and acceptance limits (e.g., frequency response, noise, common mode rejection, input impedance, etc.), and the device would be tested against these physical and electrical parameters.
   • Data Provenance: The data provenance is from the device manufacturer's internal verification and validation processes ("To ensure the safety and effectiveness of the Ambulatory X-12 Telemetry Module, verification and validation were performed in accordance with the following standards"). This is therefore primarily retrospective in the sense that it's reported after the testing has been completed by the manufacturer as part of their device development and regulatory submission. No country of origin for patient data is mentioned as this isn't a patient-based clinical study summary.

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

   • Number of Experts & Qualifications: Not applicable or explicitly stated in a 510(k) summary of this type. For performance characteristics like those governed by AAMI/IEC standards (e.g., frequency response, noise, amplitude accuracy), the "ground truth" is typically defined by the standard's specifications and measurements are taken using calibrated equipment. This is not a diagnostic AI device requiring expert adjudication of ground truth labels on medical images or waveforms for diagnostic accuracy.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. As noted above, this summary details compliance with technical standards rather than an interpretation study requiring expert adjudication of clinical outcomes or diagnoses. Device performance is determined by meeting objective, measurable criteria defined within the referenced standards.

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:

   • MRMC Comparative Effectiveness Study: No. This device is a data acquisition and transmission module for ECG data, not an AI-powered diagnostic tool, nor does it involve human readers interpreting AI output. Therefore, an MRMC study and effect size of AI assistance are not relevant or discussed.

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

   • Standalone Performance: The device itself, as an ECG acquisition and transmission system, is a "standalone" system in its function. It gathers and transmits ECG data. Its "performance" is evaluated by how accurately and reliably it acquires and transmits the electrical signals according to the specified signal integrity and transmission characteristics defined by the relevant standards. This is not an "algorithm only" in the sense of a software-only diagnostic AI.

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

   • Type of Ground Truth: The "ground truth" is defined by the specifications and performance requirements within the referenced standards (e.g., AAMI EC 11-1991, AAMI-EC 38-1994, IEC-601 series). These standards specify acceptable ranges for electrical performance, noise levels, frequency response, common mode rejection, input impedance, safety, and electromagnetic compatibility. The device's measured performance against these defined limits serves as the ground truth for its compliance.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This device is hardware for signal acquisition and transmission, not a machine learning or AI algorithm that requires a "training set" of data.

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

   • Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

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