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The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Physio Control, Zoll, and "Anderson" adapted models of monophasic and bi-phasic defibrillators.

These are single use, sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = Conductive Area: 195.98 Sq.cm. They are radiotransparent. They come in three connector styles to match the specific defibrillator. The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

The provided 510(k) summary for K131550 describes Sterile Defibrillator Pads. This submission focuses on demonstrating substantial equivalence to a predicate device (K080421, Heart Sync C-100/T-100) for a sterile version of an already marketed product. Therefore, the "study" described is primarily a non-clinical bench testing and biocompatibility study to confirm that the new sterile version performs equivalently to the non-sterile predicate and meets relevant standards.

Here's an analysis of the provided information, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "Various different lots containing multiple samples each were subjected to the AAMI tests..." It does not specify an exact numerical sample size for the test set.

• Data Provenance: The testing appears to be prospective bench testing conducted by Heart Sync, Inc. The country of origin for the data is not explicitly stated but can be inferred as the United States, given the company's location and FDA submission.

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

Not applicable (N/A). This submission pertains to a medical device (defibrillator pads), not an AI or diagnostic imaging device that requires expert ground truth establishment for a test set. The "ground truth" here is defined by objective engineering standards (AAMI, FDA, ISO) and laboratory measurements, not human interpretation.

4. Adjudication Method for the Test Set

Not applicable (N/A). Since the testing involves objective measurements against engineering standards, there is no need for adjudication by multiple human experts. The pass/fail criteria are defined by the standards themselves.

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

No, a MRMC comparative effectiveness study was not done. This type of study is typically conducted for AI-powered diagnostic tools to assess the impact of AI on human reader performance. Defibrillator pads are a therapeutic device, not a diagnostic one that involves human image or data interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable (N/A). This device does not involve an algorithm. Its performance is assessed through physical and electrical bench testing, and its function is to provide a conductive interface for defibrillation and pacing, not to perform an algorithmic function.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective engineering and biocompatibility standards.

• AAMI Standard ANSI/AAMI DF80:2003: Performance criteria for defibrillator electrodes.
• FDA Performance Standard for Touch-Proof ECG Connectors: Safety and performance criteria for connectors.
• ANSI/AAMI/ISO 11137-2: Sterilization validation standard.
• Biocompatibility testing against established biological safety criteria.
• Direct comparison to the predicate device for attenuator system performance.

8. The Sample Size for the Training Set

Not applicable (N/A). This device is not an AI or machine learning algorithm, so there is no concept of a "training set."

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

Not applicable (N/A). As there is no training set for an algorithm, there is no ground truth to establish for it.

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Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. Heart Sync T-Cardiac Science AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T-Cardiac Science AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours)

These are single use. non-sterile, self-stick defibrillator electrodes packaged in pairs. Effective electrode area = 170 Sq. cm. They are Radiotranslucent. They come in an Anderson connector to match the specific defibrillator. The construction and materials employed are similar to the predicates. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate device. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

The provided text describes a 510(k) premarket notification for the "T-CardiacSci-AED™ Pads." This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested elements for a study proving device meets acceptance criteria (e.g., sample size for test set, expert ground truth, MRMC study, training set details) are not applicable to this specific submission.

The "acceptance criteria" here relate to engineering and performance standards for defibrillator pads, as well as demonstrating equivalence in design and materials to a legally marketed predicate device.

Here's an analysis based on the provided text, addressing the points where applicable:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for defibrillator pads, the acceptance criteria are primarily related to meeting established performance standards for such devices and demonstrating material and functional equivalence to a predicate. The "study" proving this is the non-clinical bench testing.

Study Details (Bench Testing)

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

   • Sample Size: "Various different lots containing multiple samples each" were subjected to AAMI tests and accelerated shelf-life testing. Specific numbers are not provided in the text.
   • Data Provenance: The testing was conducted internally by the manufacturer (Heart Sync, Inc.) or a third-party lab contracted by them. The country of origin for the data is implicitly the USA, as Heart Sync is located in Ann Arbor, MI. The data is prospective in the sense that it was generated specifically for this submission.

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

   • This is Not Applicable (N/A). The "ground truth" for this device is based on objective engineering and material standards (AAMI, FDA performance standards) and direct comparison to a predicate device's characteristics. There's no subjective expert interpretation of, for example, medical images.

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

   • N/A. Adjudication methods are typically used in clinical studies involving subjective assessments (e.g., image interpretation). For bench testing against objective standards, the outcome is pass/fail based on measured parameters.

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:

   • N/A. This device is a defibrillator pad, not an AI-assisted diagnostic tool. No MRMC study was performed or required. The text explicitly states: "Clinical tests are not required to establish substantial equivalence."

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

   • N/A. This refers to AI algorithm performance. This device is not an AI algorithm.

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

   • The "ground truth" for device performance is defined by recognized industry standards (AAMI), regulatory performance standards (FDA for connectors), and direct comparison/equivalence to the established characteristics of the predicate device. For biocompatibility, the ground truth is established by recognized biocompatibility testing protocols (e.g., ISO 10993).

7. The sample size for the training set:

   • N/A. This concept applies to machine learning models, but this submission is for a physical medical device. There is no "training set" in the AI sense.

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

   • N/A. As above, there is no training set. The "ground truth" for the device's design and manufacturing processes is established through engineering design specifications, material selections, and manufacturing quality control, all benchmarked against the predicate device and relevant standards.

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Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation. Used to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55 Ibs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = Conductive Area: 92 Sq. cm. They are radiotranslucent. They come in two connector styles to match the specific defibrillator. The construction and materials employed are similar to the predicates. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

Here's an analysis of the provided text regarding the Heart Sync Pediatric AED Pad, formatted to describe acceptance criteria and study details.

Please note: The provided text is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to predicate devices through non-clinical (bench) testing. It does not contain information about clinical trials, human reader studies, or AI performance, as the device is a medical accessory (defibrillator pads) and not an AI algorithm. Therefore, many sections of your requested output will be marked as "Not Applicable" (N/A) or "Not Provided in Document."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Various different lots containing multiple samples each" were subjected to AAMI tests. No specific numerical sample size is provided.
• Data Provenance: Not explicitly stated, but assumed to be from manufacturing and laboratory testing conducted by Heart Sync, Inc. or its contracted labs. This is retrospective in nature (testing manufactured units). No country of origin of data is specified beyond the submitter's location (Ann Arbor, MI, USA).

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

• Not Applicable. The "ground truth" for this device's performance is based on established engineering and medical device standards (AAMI, FDA performance standards) and direct measurements from bench tests, not expert interpretation of cases or data.

4. Adjudication Method for the Test Set

• Not Applicable. As the testing is bench-top and objective against defined standards, there is no need for expert adjudication.

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

• No. This device is a passive accessory (defibrillator pad) and does not involve AI or human interpretation for its function. Therefore, no MRMC study was performed.

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

• Not Applicable. This device is a medical accessory, not an algorithm.

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

• The "ground truth" for this device's performance is based on defined technical specifications and validated test methods from standards bodies (AAMI) and regulatory agencies (FDA). For instance, the "ground truth" for impedance is a specific numerical range defined by the standard.

8. The sample size for the training set

• Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

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

• Not Applicable. See point 8.

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The Heart Sync Pediatric Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on pediatric patients whose weight is less than 25 kg. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.

The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. Heart Sync electrodes can be used on Physio Control, Zoll, Hewlett-Packard, Philips and Welch-Allyn makes and models of monophasic and bi-phasic defibrillator. Radiotranslucent "One Pad System" enables the pads to stay with the patient as they move through departments. Heart Sync has an electrode for any clinical need or patient situation. Heart Sync can provide onsite conversion of current cables to accept the Heart Sync electrodes. The polymer adhesive gel provides contact for uniform current distribution and more effective defibrillation and pacing.

The provided text describes the 510(k) summary for the "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes, model # Pediatric-100. The device's acceptance criteria are based on its substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Heart Sync device are primarily based on its substantial equivalence to the predicate device, Pad Pro K020288. Therefore, the "performance" is demonstrated by meeting the same standards and having comparable features and indications for use.

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

The provided text does not describe an explicit "test set" in the context of a clinical performance study with a defined sample size. The submission for the Heart Sync device relies on demonstrating substantial equivalence to a predicate device (Pad Pro K020288). This means that its performance is argued to be equivalent because its design, materials, and intended use are similar to a device already cleared by the FDA, and it meets the same recognized standards.

Therefore, there is no mention of a specific sample size, country of origin, or retrospective/prospective nature of data for a "test set" for the Heart Sync device itself. The "data provenance" would refer to the standards cited (e.g., 21CFR 898.12, ANSI/AAMI DF-39) which are generally established through extensive research and validation studies in the broader medical device industry.

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

As there is no described "test set" or clinical study with independent ground truth establishment, this information is not applicable or available in the provided document. The ground truth for the predicate device would have been established through its own clearance process, but that information is not detailed here.

4. Adjudication Method for the Test Set

Since there is no described "test set" requiring expert review for ground truth, an adjudication method is not applicable or mentioned in the provided document.

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 device described is a physical medical device (defibrillator electrodes), not an Artificial Intelligence (AI) software. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable to this submission.

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

The device is a physical medical device (defibrillator electrodes), not an algorithm or AI software. Therefore, a standalone performance study of an algorithm is not applicable to this submission.

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

The "ground truth" in this context is implicitly established through compliance with recognized performance standards (21CFR 898.12, ANSI/AAMI DF-39) and the demonstrated substantial equivalence to a legally marketed predicate device. The predicate device's safety and effectiveness would have been established through its own clearance process, which likely involved pre-clinical testing, possibly some clinical data, and compliance with relevant standards. The provided document does not detail specific "ground truth" through direct clinical outcomes data for the Heart Sync device.

8. The Sample Size for the Training Set

As there is no described AI algorithm involved, a "training set" for machine learning is not applicable to this submission.

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

As there is no described AI algorithm involved, the establishment of ground truth for a "training set" for machine learning is not applicable to this submission.

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The Heart Sync Adult Radio Transparent Multi Function Electrodes and Heart Sync Adult Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.

The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. Heart Sync electrodes can be used on Physio Control, Zoll, Hewlett-Packard, Philips and Welch-Allyn makes and models of monophasic and bi-phasic defibrillator. Radiotransparent and or Radiotranslucent "One Pad System" enables the pads to stay with the patient as they move through departments. Heart Sync has an electrode for any clinical need or patient situation. Heart Sync can provide onsite conversion of current cables to accept the Heart Sync electrodes. The polymer adhesive gel provides contact for uniform current distribution and more effective defibrillation and pacing. All Heart Sync products are Latex free.

The provided text is a 510(k) summary for the "Heart Sync" C-100 and T-100 Multifunction Electrodes. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific performance metrics against acceptance criteria. Therefore, much of the requested information, such as detailed acceptance criteria, specific device performance data, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth, is not available in the provided document.

The document states that the device is "identical in function to the PadPro (K020203), and Katecho (K981737) and identical in design." It primarily relies on demonstrating compliance with recognized standards and similarity to these predicate devices.

However, I can extract and infer some information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be compliance with relevant standards and functional equivalence to predicate devices. Specific performance metrics for the Heart Sync electrodes are not reported in a quantitative manner but are stated to be "SAME" as the predicate devices in comparison areas.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The submission relies on comparative analysis and compliance with standards rather than a specific clinical test set with a defined sample size for the Heart Sync device itself.
• Data Provenance: Not applicable in the context of a clinical test set for the Heart Sync device. The comparison is made against existing predicate device specifications and recognized standards.

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

• Number of Experts: Not applicable. There is no mention of a test set requiring expert ground truth for the Heart Sync device in this document.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable. No test set requiring adjudication is described.

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

• MRMC Study: No. This device is an electrode for defibrillation, pacing, and monitoring, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant or described.

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

• Standalone Performance: Not applicable. The device is a physical medical device (electrodes), not an algorithm or AI system. Its performance is inherent to its physical properties and electrical conductivity, tested against physical standards.

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

• Type of Ground Truth: Not directly applicable to the Heart Sync device's evaluation in this document. The "ground truth" for the device's acceptable performance is defined by its compliance with industry standards (21CFR 898.12, ANSI/AAMI DF-80 2003) and its substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Sample Size: 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

• Ground Truth Establishment: Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study Proving Acceptance Criteria:

The "study" demonstrating the device meets acceptance criteria is primarily a comparative analysis against predicate devices and compliance with recognized standards.

• Comparison: The Heart Sync electrodes are compared to PadPro (K020203) and Katecho (K981737). The document explicitly states they are "identical in function" and "identical in design" to these predicates. The comparison table confirms that indications for use, where used, and basic features are "SAME" as the predicate devices.
• Standards Compliance: The Heart Sync electrodes are stated to meet the "Performance standard" 21CFR 898.12 and the "ANSI/AAMI DF-80 2003 standard, self-adhesive electrodes for monitoring and defibrillation."
• Conclusion of Substantial Equivalence: Based on the comparison and standards compliance, the conclusion is that the Heart Sync System Defibrillator Electrodes are "substantially equivalent to other electrodes that are legally marketed for this purpose" and "The device meets the standards referenced above." This determination of substantial equivalence (as indicated by the FDA's letter) serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance.

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