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The EndoPATx device is a non-invasive device intended for use as a diagnostic aid in the detection of coronary artery Endothelial Dysfunction (positive or negative) using a reactive hyperemia procedure.

The EndoPATx has been shown to be predictive of coronary artery Endothelial Dysfunction in the following patient population: patients with signs or symptoms of ischemic heart disease, who are indicated for coronary artery angiography, but who lack angiographic evidence of obstructive coronary artery disease. The device is intended to be used in a hospital or clinic environment by competent health professionals.

The EndoPATx device is not intended for use as a screening test in the general patient population. It is intended to supplement, not substitute, the physician's decision-making process. It should be used in conjunction with knowledge of the patient's history and other clinical findings.

The EndoPATx is a non-invasive system for assessing vascular endothelial function. It is based on the use of Peripheral Arterial Tone (PAT) technology which measures post-ischemic vascular response following arm blood flow occlusion.

It is intended for use as a diagnostic aid in the detection of presence coronary artery Endothelial Dysfunction using a reactive hyperemia procedure in the following patient population: patients with signs or symptoms of ischemic heart disease, who are indicated for coronary artery angiography, but who lack angiographic evidence of obstructive coronary artery disease. The device is intended to be used in a hospital or clinic environment by competent health professionals.

It is not intended for use as a screening test in the general patient population. It is intended to supplement, not substitute, the physician's decision-making process. It should be used in conjunction with knowledge of the patient's history and other clinical findings.

The provided FDA 510(k) summary for the EndoPATx device does not contain a detailed study proving the device meets specific acceptance criteria in the manner typically presented for clinical performance studies of AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device (EndoPAT2000) through functional, safety, and performance testing, emphasizing that the underlying technology and algorithms are identical, with the EndoPATx being a "modern replica" with updated hardware and user interface.

Therefore, many of the requested elements (sample size for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance details, and specific acceptance criteria with reported performance) are not explicitly described in this document. This is common for 510(k) submissions where the device builds directly upon a previously cleared predicate and primarily involves hardware or usability updates, rather than a new clinical algorithm requiring extensive de novo validation.

However, based on the information provided, I can construct a response addressing what is present and noting what is absent.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Given that the EndoPATx device is seeking clearance through substantial equivalence to its predicate device (EndoPAT2000) and states that "The principles of operation of the EndoPATx are identical to those of the predicate... Both the predicate device and the subject device use the same analysis algorithms and the same scores are calculated in both devices," the acceptance criteria are implicitly tied to demonstrating that the changes in the EndoPATx do not negatively affect the performance or introduce new questions of safety or effectiveness compared to the already cleared predicate.

The "performance data" provided relates to this equivalency, rather than establishing de novo clinical performance metrics against a defined ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

The overall conclusion is that "The testing above demonstrated that the EndoPATx is substantially equivalent to its predicate and the proposed modifications do not raise any different questions of safety or effectiveness."

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

The document does not specify a sample size for a "test set" in the context of clinical performance evaluation with patient data. The equivalency testing mentioned ("PAT signal acquisition input/output equivalency tests; Scoring equivalency tests") refers to technical tests comparing the new device's output to the predicate's, likely using simulated or previously collected signals rather than a new clinical test set with human subjects.

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely relates to internal technical validation data rather than a new clinical dataset from patients. Given the predicate's established use, it's implied that the original predicate's performance was proven with clinical data, and this submission leverages that.
• Retrospective or Prospective: Not stated for this equivalency testing; however, if it involved patient data, it would likely be retrospective given the nature of demonstrating equivalence to an existing device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not specified. The ground truth for direct clinical performance is not explicitly established or re-established for this 510(k) submission, as the device is leveraging substantial equivalence. The claim is that the device's technical performance for PAT signal acquisition and scoring is equivalent to the predicate, which presumably had its own clinical validation and ground truth established during its initial clearance (K032519).

4. Adjudication Method for the Test Set

Not applicable/Not specified. There is no mention of a human-reviewed "test set" requiring adjudication in this 510(k) summary for the new device's clearance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study was not conducted for this 510(k) submission. This type of study is typically performed to evaluate the impact of an AI/ML device on human reader performance, which isn't the focus when demonstrating substantial equivalence of a device with identical algorithms to its predicate.

6. Standalone (Algorithm Only) Performance

The EndoPATx relies on the same core analysis algorithms as its predicate, EndoPAT2000. The document states: "Both the predicate device and the subject device use the same analysis algorithms and the same scores are calculated in both devices."
Therefore, its "standalone" performance is considered to be identical to that of the predicate. The document does not provide new standalone performance metrics for the EndoPATx, but implies it has the same standalone performance as the predicate due to identical algorithms.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for the equivalency testing. For the original EndoPAT2000, the "ground truth" for "coronary artery endothelial dysfunction" would typically be established via a gold standard clinical procedure, such as coronary artery angiography (as mentioned in the Indications for Use, "who lack angiographic evidence of obstructive coronary artery disease" implies correlation to angiographic findings for patient selection). However, for this 510(k), the "ground truth" for the equivalency study is implicitly the output of the predicate device (EndoPAT2000) for PAT signal acquisition and scoring, as the objective is to show the new device produces the same results.

8. Sample Size for the Training Set

Not applicable/Not specified. This 510(k) is for a device which uses established, identical algorithms as its predicate. There is no mention of a new "training set" for an AI/ML algorithm in this submission. The algorithms are already developed and proven via the predicate.

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

Not applicable/Not specified. As there is no new training set mentioned, the establishment of ground truth for a training set is not pertinent to this submission.

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