(157 days)
The DETECT™ Surgical Pacing and Mapping Tool is a handheld, single use device designed to provide temporary cardiac pacing or monitoring.
The Medtronic® Detect™ Temporary Pacing and Mapping Device Description: Electrode Probe consists of a handle, a malleable stainless steel shaft with a flouropolymer sheath ending in a textured ball tip electrode, and a cable for connection to diagnostic device. Sterile, Nonpyrogenic, Disposable, Single use only.
The Grounding Electrode consists of a needle and a cable for connection to a diagnostic device. Sterile, Nonpyrogenic, Disposable, Single use only.
The Detect™ Electrode Probe is compatible with the Medtronic External Temporary Pacemaker (Model 5388), and the Medtronic Programmer/ Analyzer (Model 2090/2290).
The provided 510(k) summary does not contain detailed acceptance criteria and a study proving the device meets them in the way a modern AI/ML device submission would. This document pertains to a medical device (a temporary pacing and mapping tool) from 2004, which predates the widespread regulatory frameworks for AI/ML-driven devices.
The "study" referenced is a regulatory review for substantial equivalence to a predicate device, rather than a performance study with detailed metrics and statistical significance for a novel AI algorithm.
However, based on the provided text, I can infer and extract information to address your points as best as possible within the context of a 2004 medical device submission.
Here's an analysis of the provided text in response to your questions:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for specific quantitative performance metrics of a novel algorithm. Instead, the acceptance is based on the device being deemed "safe and effective" and "substantially equivalent" to a predicate device, primarily through compliance with established medical device standards and preliminary guidance.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (Inferred) |
|---|---|
| Safety and Effectiveness: Meets general requirements for medical devices. | The device has been "tested and are considered safe and effective." |
| Substantial Equivalence: Similar in principle and intended use to a predicate device. | The device is deemed "substantially equivalent" to legally marketed predicate devices (specifically, the Medtronic® Model 6494 Unipolar Temporary Myocardial Pacing Wire). |
| Compliance with Standards: Adheres to relevant international and FDA guidance documents.** | The device meets standards set by: |
- "Electrode Recording Catheter Preliminary guidance" (FDA, 1995)
- IEC 60601-1
- IEC 60601-27 |
| Intended Use Fulfilled: Capable of temporary cardiac pacing or monitoring. | The device is designed and demonstrated to provide "temporary cardiac pacing or monitoring." |
| Compatibility: Works with specified Medtronic devices. | Compatible with Medtronic External Temporary Pacemaker (Model 5388) and Medtronic Programmer/ Analyzer (Model 2090/2290). |
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 describe a "test set" in the context of an AI/ML algorithm's performance evaluation using patient data. It refers to testing of the physical device for safety and effectiveness, which would typically involve bench testing, biocompatibility testing, electrical safety testing, and potentially some limited animal or human clinical data for a novel device, but not a "test set" for an algorithm.
Therefore, this information is not applicable or available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As there is no mention of a "test set" for an algorithm's performance, there is no discussion of experts establishing ground truth for such a set. The "ground truth" here is the regulatory assessment of device safety and effectiveness and substantial equivalence by regulatory bodies (FDA) based on submitted data and adherence to standards.
Therefore, this information is not applicable or available in the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Similarly, since there's no "test set" for algorithm performance described, there's no adjudication method mentioned.
Therefore, this information is not applicable or available in the provided text.
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
The document does not describe an MRMC comparative effectiveness study or any study involving human readers interacting with an AI system. This is a physical device (an electrode probe), not an AI diagnostic or assistive tool.
Therefore, this information is not applicable or available in the provided text.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an AI algorithm's performance. The device described is a physical medical tool, not an AI algorithm.
Therefore, this information is not applicable or available in the provided text.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of traditional medical device, the "ground truth" for regulatory approval would be established through a combination of:
- Bench Testing Data: Verification of electrical performance, mechanical integrity, material compatibility, and sterile barrier integrity against predefined specifications.
- Biocompatibility Testing: Data demonstrating the device's materials do not cause adverse biological reactions.
- Performance Data: Evidence (often from preclinical studies or, if applicable, limited clinical data) that the device performs its intended function (pacing or monitoring) effectively and safely.
- Comparison to Predicate: The predicate device itself serves as a "ground truth" reference for safety and effectiveness, meaning the new device must demonstrate comparable performance characteristics.
The studies mentioned in the document are compliance with IEC standards, which cover aspects like electrical safety and electromagnetic compatibility.
No human expert consensus, pathology, or specific outcomes data for defining an "algorithm ground truth" is mentioned.
8. The sample size for the training set
The concept of a "training set" is specific to machine learning algorithms. This document describes a physical medical device, not an AI/ML algorithm.
Therefore, this information is not applicable or available in the provided text.
9. How the ground truth for the training set was established
As there is no "training set" for an AI/ML algorithm, the method for establishing its ground truth is not applicable.
Therefore, this information is not applicable or available in the provided text.
In summary: The provided 510(k) summary is for a traditional physical medical device from 2004 and does not address the criteria typically associated with AI/ML device submissions (e.g., test sets, training sets, AI performance metrics, expert adjudication for algorithms). The "proof" for this device lies in its substantial equivalence to a legally marketed predicate and its compliance with established safety and performance standards.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.