(108 days)
The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads. The AtriAmp also supports monitoring of intra-cardiac signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor.
The AtriAmp acts as a connection hub for these three systems (external pacemaker, patient contacting external pacemaker lead wires and cardiac monitor) to provide a real-time, continuous atrial electrogram to the cardiac monitor while simultaneously allowing pacing of the atriAmp is a sterile, single patient use device.
The provided text describes the regulatory clearance (K200674) for the AtriAmp device, which is an extension cable used with external pacemakers and ECG monitors. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific performance goal for an AI/ML algorithm. Therefore, many of the typical questions for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, and MRMC studies) are not applicable in this context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ANSI/AAMI EC53:2013 compliance | Compliance with applicable requirements of EC53:2013 for Cable and leadwire noise, performing the same as the predicate. | Pass: The AtriAmp complies with applicable requirements of EC53:2013 and performs the same as the predicate for Subclause 5.3.2 Cable and leadwire noise. |
| ANSI/AAMI ES 60601-1 and IEC 60601-2-31 compliance | Compliance with applicable requirements of ANSI/AAMI ES60601-1:2005 & A1:2012 and IEC 60601-2-31:2011. | Pass: The AtriAmp with accessory external pacemaker interface cables complies with applicable requirements of ANSI/AAMI ES60601-1:2005 & A1:2012 and IEC 60601-2-31:2011. |
| ES60601-1 Subclause 8.5.2.3 compliance (for 21 CFR Part 898) | Compliance with ES60601-1 Subclause 8.5.2.3 Patient leads or patient cables. | Pass: In support of 21 CFR Part 898 compliance, the AtriAmp complies with ES60601-1 Subclause 8.5.2.3 Patient leads or patient cables. |
| Sterility | Achieving a minimum Sterility Assurance Level (SAL) of $10^{-6}$ according to ISO 11137-1:2006(R)2015 & A1:2013 & A2:2018. | Pass: Sterilization of the subject device was validated according to ISO 11137-1:2006(R)2015 & A1:2013 & A2:2018, demonstrating the device is provided with a minimum sterility assumed level (SAL) of $10^{-6}$. |
| Sterile barrier integrity | The flexible pouch sterile barrier package must maintain integrity after terminal sterilization, simulated distribution, seal peel, and bubble emission testing. | Pass: The sterile barrier package is a flexible pouch. The methods applied to evaluate the sterile barrier package integrity included post terminal sterilization simulated distribution, seal peel and bubble emission testing. |
| Biocompatibility | Passing results for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2020), and Irritation (ISO 10993-10:2020). | Pass: The ISO 10993-5:2009 and ISO 10993-10:2020 test methods were applied, with passing results: for Cytotoxicity, Sensitization, Irritation. |
| Shelf life (two years) | Confirmation of device functional performance and sterile barrier pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) with accelerated aging and simulated distribution per ASTM 4169-16 and bubble leak (ASTM F2096). | Pass: Confirmation of device functional performance and sterile barrier pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) with accelerated aging and simulated distribution per ASTM 4169-16 and bubble leak (ASTM F2096). |
| Duration of use | Verification of use for up to 14 days. | Pass: Operation use was evaluated to verify use for up to 14 days. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical performance tests for the physical device (AtriAmp cable and accessories). These tests typically involve a sample of the manufactured device, but the specific number of units tested is not provided in this summary. The data provenance is not mentioned, but these are laboratory tests performed by the manufacturer to verify product specifications and regulatory standards. Given the nature of these tests, they are inherently prospective for the specific device being manufactured and tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests are for the physical and electrical characteristics, sterility, and biocompatibility of a medical device cable, not for an AI/ML algorithm requiring expert interpretation of medical images or data. The "ground truth" here is objective measurement against specified engineering and biological standards.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against established standards.
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 document is for a medical device (cable) and does not involve AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a medical device (cable) and does not involve an AI algorithm.
7. The type of ground truth used
The ground truth for these tests is based on established engineering and biological standards and test methods (e.g., ANSI/AAMI EC53, IEC 60601-1, ISO 11137-1, ISO 10993 series, ASTM F88, ASTM F2096, ASTM 4169-16). These are objective criteria for physical, electrical, and biological safety and performance.
8. The sample size for the training set
Not applicable. This document is for a medical device (cable) and does not involve an AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable. This document is for a medical device (cable) and does not involve an AI algorithm with a training set.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).