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Under the supervision of a qualified physician trained in ECG interpretation, Atria can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures.

This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient's heart but rather provide an effective beginning for evaluation of adult and pediatric patients with cardiac abnormalities.

The Atria 3100 and 6100 are 12 lead electrocardiographs designed to record the electrical activity of the heart. They can display, print, electronically send and save ECG recordings. The Atria 6100 features a full alpha numeric keyboard and color display for data entry, waveform review and editing machine settings. The unit provides the ability to store 150 ECGs, print rhythm strips manually or automatically, and provides an optional interpretation. Advanced communications options allow the unit to fax, email and upload results to shared network drives via wired Ethernet, wireless 802.11 and modem.

The differences between the Atria 3100 and 6100 are as follows:

1. Screen Size:
   Atria 3100 = 2 x 40 character display for data entry only (no waveform . viewing)
   Atria 6100 = 640 x 480 color TFT VGA preview screen for waveform . viewing
2. Storage:
   . Atria 3100 = 50 records
   Atria 6100 = 150 records .
3. The Atria 6100 has a slightly different keyboard to accommodate navigation in the User Interface.

Here's an analysis of the provided information regarding the Atria 3100 and Atria 6100 electrocardiographs, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary and the FDA's clearance letter. It primarily describes the device, its intended use, and argues for substantial equivalence to predicate devices. It does NOT contain detailed information on specific acceptance criteria or the studies that would typically prove a device meets those criteria in a rigorous fashion (e.g., performance metrics, sample sizes for test sets, ground truth establishment, MRMC studies, or standalone algorithm performance).

Therefore, I will extract relevant information where available and explicitly state when information is not present in the provided text.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Its clearance is based on substantial equivalence to predicate devices. This means the FDA determined the new device is as safe and effective as a legally marketed device (predicate device) and does not raise new questions of safety and effectiveness.

The document states the "intended use, indication for use and principle of operation are substantially equivalent to the predicate devices, and do not raise any new types of safety and effectiveness questions." This is the core "acceptance criteria" from a regulatory perspective for a 510(k) submission, rather than specific performance numbers.

Predicate Devices:

• PageWriter Trim Series Cardiograph - Phillips Medical Systems (K031422)
• CP 100 and CP 200 - Welch Allyn, Inc. (K050074)

Detailed Study Information (Based on Available Text)

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated as quantifiable performance metrics in the provided text. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to existing predicate devices regarding safety and effectiveness, and not raising new safety/effectiveness questions.
   • Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity for ECG interpretation) are reported in this document. The device "can display, print, electronically send and save ECG recordings" and "provides an optional interpretation." The document repeatedly states it's "not designed to produce a definitive interpretation nor exhaustive evaluation" but rather "provide an effective beginning for evaluation."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided in the document. The 510(k) summary focuses on device description and substantial equivalence, not detailed clinical study results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not provided in the document. No information on ground truth establishment for any test set (since no test set is described).

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

   • Not provided in the document. No information on adjudication methods.

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 provided in the document. This type of study is not mentioned as part of the 510(k) submission, likely because the primary claim is not about improved human performance with AI assistance, but rather the device's basic functionality and equivalence. The "optional interpretation" is mentioned, but its performance or impact on human readers is not detailed.

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

   • Not provided in the document. While the device offers "optional interpretation," the document specifically states it's "not designed to produce a definitive interpretation nor exhaustive evaluation." This implies that a standalone, definitive diagnostic performance study was likely not part of this 510(k) given its intended use as an initial evaluation tool.

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

   • Not provided in the document. No information on ground truth, as no specific performance study is detailed.

8. The sample size for the training set

   • Not provided in the document. No information on any training set, as the document doesn't detail the development or validation of the "optional interpretation" algorithm.

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

   • Not provided in the document.

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