(30 days)
The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, nonsterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.
The HeartSine Samaritan® PAD PAK pads are single use, non-sterile, hydrogel polymer self-adhesive electrode pads. The Samaritan® PAD PAK pads will be used in conjunction with Samaritan® PAD low energy semi-automatic external defibrillator (AED). The pads are sealed in a pouch to prevent drying out and to maintain their integrity throughout the duration of the shelf life.
The provided text describes the 510(k) summary for the HeartSine Samaritan® PAD PAK Defibrillation Electrodes. It focuses on the device's substantial equivalence to predicate devices and its intended use, rather than presenting detailed acceptance criteria and a specific study proving device performance against those criteria in a format with numerical targets and reported outcomes.
Here's an analysis based on the information provided, highlighting what can be extracted and what is missing for a comprehensive answer to your request:
Acceptance Criteria and Study Details for HeartSine Samaritan® PAD PAK Defibrillation Electrodes
The provided document (510(k) Summary) describes the general performance and biocompatibility testing undertaken for the HeartSine Samaritan® PAD PAK Defibrillation Electrodes, but it does not specify quantitative acceptance criteria or detailed study results in a table format. Instead, it makes general statements about compliance with standards and internal specifications.
Based on the information, the following can be inferred and what is missing is noted:
1. Table of Acceptance Criteria and Reported Device Performance
A specific table with quantitative acceptance criteria and corresponding reported device performance values is not provided in the document. The document states:
- "The PAD PAK pads comply with the requirements of AAMI/ANSI DF80. ISO 10993, and FDA Memorandum G95-1, and with HeartSine Technologies, Inc. internal specifications for a single use, ECG monitoring & defibrillation pad."
- "The testing of the PAD PAK pads demonstrate that the PAD PAK Pads function as intended."
- "The results of the testing have also shown the Samaritan® PAD PAK pads do not raise any new questions of safety or effectiveness."
To create the requested table, one would need to refer to the specific standards (AAMI/ANSI DF80, ISO 10993, FDA Memorandum G95-1) and the manufacturer's internal specifications, which are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally mentions "Testing and performance documentation has been submitted with the 510(k) submission."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The device is an electrode for monitoring and defibrillation, not an interpretative AI device that requires expert ground truth for its core function. Testing would involve electrical performance, biocompatibility, and physical integrity, not diagnostic accuracy based on expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not applicable to this device. This type of study is typically done for diagnostic imaging or interpretation devices where human readers are involved in assessing cases. The device here is an electrode, and its performance would be assessed through technical, electrical, and biological testing, not by comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable to this device. As an electrode, there is no "algorithm only" performance or "human-in-the-loop" concept in the way it applies to AI-driven diagnostic devices. The device's function is physical and electrical.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data, expert consensus) is not applicable here. For an electrode, "ground truth" would refer to established electrical measurement standards, biological safety standards, and physical performance specifications. The document states the device complies with AAMI/ANSI DF80, ISO 10993, FDA Memorandum G95-1, and internal specifications. These standards define the "ground truth" for electrical performance, biocompatibility, and physical characteristics.
8. Sample Size for the Training Set
This information is not applicable and not provided. The Samaritan® PAD PAK electrodes are a hardware device, not an AI/ML algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as #8.
Summary of what can be extracted from the provided text for acceptance criteria and study:
- Acceptance Criteria (General): Compliance with AAMI/ANSI DF80, ISO 10993, FDA Memorandum G95-1, and HeartSine Technologies, Inc. internal specifications. The device should "function as intended" and "not raise any new questions of safety or effectiveness."
- Study (General): "Testing and performance documentation has been submitted with the 510(k) submission." This testing demonstrated compliance with the aforementioned standards and internal specifications.
- Device Function: Single use, non-sterile, self-adhesive hydrogel pads, intended for ECG monitoring and external defibrillation, to be used with the Samaritan® PAD Automated External Defibrillator on patients 8 years and older.
Missing Information:
Crucially, the document lacks the specific quantitative acceptance criteria, the detailed results from the performance and biocompatibility tests, and any sample sizes used for these tests. The 510(k) summary is a high-level overview, not the detailed technical report of the studies themselves.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.