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The Medtronic Model 9525 Reveal Insertable Loop Recorder is an implantable, patientactivated monitoring system that records subcutaneous ECG and is designed for diagnostic evaluation of patients who experience transient symptoms that may suggest a cardiac arrhythmia.

The Reveal ILR system is designed to record and store subcutaneous electrocardiogram (ECG) during symptomatic events. The system consists of the Model 9525 implanted recorder and the Model 6190 Activator. A Medtronic Model 9790 programmer equipped with a Medtronic Model 9766A radio frequency telemetry head and Model 9802E software is required for programming and retrieving data from the recorder.

Here's an analysis of the acceptance criteria and study information for the Medtronic Reveal™ Insertable Loop Recorder (K972242), based on the provided text:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a dedicated section with specific numerical targets. Instead, it describes a series of tests performed to ensure the device meets its design and performance requirements, and then concludes with a statement of substantial equivalence to predicate devices. The "performance" is implicitly demonstrated by the successful completion of these tests.

Therefore, the table below will list the types of testing performed and the reported outcome.

Study Information Details

The provided 510(k) summary focuses on demonstrating substantial equivalence through in vitro and in vivo animal testing, rather than a clinical trial with human subjects from a "test set" in the typical sense for algorithm performance.

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

   • In Vitro/Bench Testing: The sample sizes for these tests are not specified but would typically involve multiple units of each component (recorder, activator, packaging) tested under various conditions to ensure robustness and adherence to specifications. The data provenance is internal laboratory testing by Medtronic.
   • In Vivo Canine Testing: "Two comparative studies of the Reveal ILR system were performed with canines." The exact number of canines is not specified. The data provenance is animal (canine) studies, presumably conducted by Medtronic or a contracted research organization.

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

   • For the canine studies, the "ground truth" for ECG information was likely established by the "surface ECG monitor" used as a comparator device and interpreted by veterinary or medical professionals with expertise in cardiac electrophysiology, though their specific number and qualifications are not mentioned. For the bench testing, the ground truth would be engineering specifications and standards.

3. Adjudication method for the test set:

   • Not applicable as the reported studies are primarily technical performance evaluations and animal comparative studies, rather than human clinical trials requiring complex adjudication of diagnostic outcomes.

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, an MRMC comparative effectiveness study was not done. This submission predates widespread AI integration in such devices and focuses on the fundamental function and safety of the recording system, not on human interpretation assistance.

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

   • The "Reveal™ Insertable Loop Recorder" acts as a recording system. Its "performance" is in accurately capturing and storing ECG data. The device itself (the implanted recorder) and its associated software for displaying waveforms do not appear to have an independent "algorithm" for automated diagnosis or interpretation. Its function is to provide raw ECG data for a clinician to analyze. Therefore, a standalone algorithm performance study, as understood in an AI context, is not applicable. The device's 'standalone' performance is its ability to record and store ECG signals reliably.

6. The type of ground truth used:

   • In vitro/Bench Testing: Engineering specifications, industry standards, and functional requirements.
   • In vivo Canine Testing: The ground truth for the ECG information was established by simultaneously recorded data from a "surface ECG monitor" which serves as a established standard for cardiac electrical activity.

7. The sample size for the training set:

   • Not applicable. This device is a diagnostic recording system, not a machine learning algorithm that requires a "training set" in the AI sense. Its development would involve engineering design, manufacturing standards, and rigorous testing on physical devices.

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

   • Not applicable, as no training set for an AI algorithm was involved.

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The Pikos LP 01/LP B01 models, like the Pikos 01/E01 models, are indicated for use in the following conditions:

• · Sinus node arrest or bradycardia with or without AV conduction disorder.
• · Intermittent or complete AV conduction block.
• · Brady/tachy syndrome or other manifestation of sick sinus syndrome which results in symptomatic bradycardia.
• · Atrial fibrillation and ventricular bradyarrhythmia.

The Pikos LP 01/LP B01 is a multi-programmable single chamber pulse generator which is designed and recommended for use with atrial or ventricular leads. The Pikos LP 01/LP E01 models offer a limited number of programmable options compared to those of the Pikos 01/E01 models.

This 510(k) submission (K945627) for the Pikos LP 01/LP B01 Implantable Pacemaker Pulse Generators focuses on demonstrating substantial equivalence to a predicate device (K914109/A, Pikos 01 and Pikos H01) rather than establishing new acceptance criteria through a clinical study. Therefore, most of the requested information regarding a study proving acceptance criteria will not be present.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define a table of new acceptance criteria and corresponding performance metrics from a distinct study for this device. Instead, it relies on demonstrating that the new device performs equivalently to a predicate device (Pikos 01/E01 models) based on pre-established performance of that predicate.

The qualification testing mentioned is primarily for design verification and validation of components and modifications, not for proving clinical performance against new acceptance criteria.

• Self-Sealing Header: "qualification reports describing the testing conducted for validation... included vibration, shock, temperature and transport tests meeting the applicable IS-1 requirements; header leakage resistance tests. Sterilization... was validated."
• Hybrid Circuit Modifications: "qualified with complete electrical and mechanical testing." (Implies meeting internal design specifications and performance standards). |
  | Safety and Effectiveness: | "The product labeling includes instructions for use adequate to assure safe and effective operation of the device." (Relies on the established safety and effectiveness of the predicate device and verification of modifications). |

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

No specific "test set" in the context of clinical data for proving new acceptance criteria is described. The "qualification testing" refers to engineering and bench testing.

• Sample Size: Not applicable in the context of a clinical test set from human subjects for this submission. The "sample" likely refers to components or finished devices subjected to various engineering tests (e.g., a certain number of self-sealing headers tested for leakage). These numbers are not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data. The qualification testing data would be generated in-house by BIOTRONIK GmbH & Co.

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

Not applicable. This submission is for a medical device that relies on engineering qualification and demonstrated equivalence, not a diagnostic algorithm requiring expert-established ground truth from a test set of human data.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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 no MRMC study or AI components are mentioned.

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

Not applicable for the reasons stated above.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the qualification testing of components and modifications (e.g., self-sealing header, hybrid circuits), the "ground truth" would be engineering specifications, international standards (like IS-1 mentioned for the header), and internal design requirements.

For the substantial equivalence claim, the "ground truth" is effectively the established safety and effectiveness profile and performance characteristics of the predicate device (Pikos 01/E01).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

In summary: This 510(k) submission is for an implantable pacemaker pulse generator that relies on demonstrating substantial equivalence to an already approved predicate device. The "qualification testing" described is for verifying the design and manufacturing of the new device and any modifications, ensuring it meets engineering standards and is comparable to the predicate. It does not involve a clinical study with human subjects designed to establish new performance acceptance criteria for a novel device.

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