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The Sleuth AT system is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:

• . Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• Patients who experience transient symptoms that may suggest a cardiac . arrhythmia

The Sleuth AT Implantable Cardiac System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth AT Implantable Cardiac System comprises three interrelated components: Implantable Loop Recorder (ILR), Personnel Diagnostic Manager (PDM) and Base Station,

The PDM software was updated from Version 4.2 to Version 4.3. The Version 4.3 software incorporates a Service Menu in the PDM and minor software bug fixes. The Service Menu includes time zone set-up, data review option and transfer log. No other changes to the system were made.

The provided text describes a 510(k) submission for the Sleuth AT Implantable Cardiac Monitoring System. The submission is a "Special 510(k)" indicating minor changes to an already cleared device, where the changes do not affect the intended use or fundamental scientific technology.

Based on the provided information, the following answers can be given:

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

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

The document does not provide details on the sample size used for the test set or the data provenance. This submission is for a software update with minor bug fixes and a new "Service Menu," not for a new device requiring extensive clinical or performance data. The "test set" here refers to software verification and validation, not a clinical study on patients.

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)

The document does not provide information on the number or qualifications of experts used to establish ground truth for any testing. Given the nature of a Special 510(k) for a software update and bug fixes, expert review would likely be internal (e.g., software engineers, quality assurance personnel) rather than external clinical experts.

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

The document does not provide information on any adjudication method used for a test set. This type of detail is typically relevant for clinical studies involving interpretation of medical images or data by multiple readers.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an Implantable Cardiac Monitoring System, and the submission pertains to a software update, not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers improving with AI assistance.

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

The provided text does not describe a standalone algorithm performance study. The device is an "Implantable Cardiac Monitoring System" with continuous ECG monitoring and recording capabilities. The "performance" described relates to software functionality and substantial equivalence to a predicate device, not an algorithm's standalone diagnostic accuracy.

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

The document does not explicitly state the type of "ground truth" used. For software verification and validation, ground truth would typically refer to expected software behaviors, defined specifications, and absence of identified bugs, rather than clinical outcomes or pathology.

8. The sample size for the training set

The document does not provide information on a training set sample size. This submission is for a software update and bug fixes, not for a newly developed machine learning or AI algorithm that would typically involve a "training set."

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

The document does not provide information on how ground truth for a training set was established, as a training set for a new algorithm is not relevant to this Special 510(k) submission.

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The Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:

• Patients with clinical syndromes or situations at increased risk of cardiac . arrhythmias
• Patients who experience transient symptoms that may suggest a cardiac . arrhythmia

The Sleuth Implantable ECG System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth Implantable ECG System comprises three interrelated components: Implantable Monitoring Device (IMD), Activator and Base Station.

The modification described in this Special 510(k) is the addition of an 8 cm Antenna Accessory Kit option (Model 3000-08) for use with the IMD, Model 2010.

The 8 cm antenna gives the physician an additional option. The Accessory Kit contains an 8 cm antenna and torque wrench. No changes have been made to the torque wrench.

The only difference between the original 6 cm antenna and the 8 cm antenna is the length. The antenna measures 8 cm from the IS-1 connector to tip.

The provided document is a 510(k) summary for the Transoma Medical Model 3000-08 Antenna Accessory Kit, which is an accessory to the Sleuth Implantable ECG System. This submission is for a modification to an existing device, specifically the addition of an 8 cm antenna. The summary focuses on demonstrating substantial equivalence to a predicate device (Sleuth Implantable ECG System K063035 with a 6 cm antenna). As such, the study design described is primarily non-clinical bench testing to prove the accessory's safety and performance and its substantial equivalence to the previously cleared device.

Therefore, many of the typical elements of a study proving a new device meets acceptance criteria, particularly clinical performance metrics, reader studies, and ground truth establishment, are not applicable in this context. The document aims to show that the new 8 cm antenna has comparable features and performance to the 6 cm antenna through engineering and physical tests.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for each bench test conducted. Non-clinical bench tests often involve testing a small batch of devices (e.g., 3-5 units) per test, but this information is not explicitly stated.
• Data Provenance: The data is generated from non-clinical bench testing. The tests were likely performed in a laboratory setting by the manufacturer, Transoma Medical, Inc., located in Arden Hills, MN. This is prospective data generation for the purpose of this 510(k) submission. No specific country of origin for patients or previous data is applicable here as it's a bench test for an accessory.

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

This information is not applicable as the evaluation is based on non-clinical bench testing against established engineering and regulatory standards, not on clinical assessment by medical experts to establish a "ground truth" for diagnostic accuracy. The "ground truth" for these tests would be the established performance characteristics and safety standards for medical device accessories, as demonstrated by the predicate device.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies when multiple human readers interpret data that might be subjective. For bench testing, results are typically objective measurements or pass/fail criteria against a specification, not subject to adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is used to evaluate the impact of a device (often AI) on human reader performance for diagnostic tasks. Since this 510(k) is for an antenna accessory and relies on bench testing for substantial equivalence, such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device (an antenna accessory) does not involve an algorithm. The "standalone performance" concept usually applies to AI/software as a medical device. Here, the performance is evaluated through physical and electrical characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the engineering specifications and safety standards that the predicate 6 cm antenna successfully met, and the regulatory requirements for medical devices. The new 8 cm antenna needed to demonstrate compliance with these same non-clinical performance benchmarks to establish substantial equivalence. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or algorithms that require a "training set." The performance evaluation is based on direct measurement and testing of the physical accessory.

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

Not applicable as there is no training set for this device.

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