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HC1000P software analyzes ECG and pulse oxygen saturation data acquired from a sleeping patient. It may be used as an aid in the diagnosis of sleep and sleep related breathing disorders.

HypnoCore's HC1000P is a sleep diagnosis software application. This software is used as an aid in the diagnosis of sleep and sleep related breathing disorders. The HC1000P is able to acomplish this by analyzing continuous ECG and pulse oxygen saturation data acquired from a sleeping patient. The interpretation of the results provided by the HC1000P software package is performed in conjunction with clinical information and examination of the patient obtained by a trained professional familiar with sleep medicine.

Here's an analysis of the provided 510(k) summary for the HC1000P Sleep Diagnosis Software System, outlining the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of target performance metrics (e.g., minimum sensitivity, specificity, or accuracy values). Instead, it states that the device's results are "valid when compared against the gold standard and its predicate devices" and that this was "statistically confirmed through a retrospective analysis against a clinical study."

Therefore, I cannot populate a table with specific acceptance criteria and reported numerical performance. The "acceptance criterion" in this context appears to be demonstrating statistical equivalence or validity against a gold standard in a retrospective clinical study.

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

• Sample Size: The document does not specify the exact sample size for the test set used in the retrospective analysis. It refers generally to "a clinical study."
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: The study was a "retrospective analysis."

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

This information is not provided in the given 510(k) summary. It mentions that "the interpretation of the results provided by the HC1000P software package is performed in conjunction with clinical information and examination of the patient obtained by a trained professional familiar with sleep medicine," but this refers to the intended use context, not the ground truth establishment for the validation study. The summary also refers to validation against a "gold standard" but does not specify how this gold standard was established or by whom.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for establishing the ground truth of the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

• MRMC Study: The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The study described is a retrospective analysis comparing the device's output to a "gold standard."
• Effect Size: Consequently, no effect size for human reader improvement with AI assistance is provided.

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

Yes, a standalone performance assessment was conducted. The description states: "This was statistically confirmed through a retrospective analysis against a clinical study" to show the device's results are "valid when compared against the gold standard." This implies the algorithm's performance was evaluated independently against an established gold standard. The device is intended as an "aid in the diagnosis" and a "decision support system," with final interpretation by a "trained professional," but the validation described is of the software's output itself.

7. The Type of Ground Truth Used

The ground truth used was referred to as the "gold standard" from a "clinical study." While the specific nature of this "gold standard" is not explicitly detailed (e.g., expert consensus based on polysomnography, pathology), the context of "sleep and sleep related breathing disorders" strongly suggests that the gold standard would likely involve conventional polysomnography (PSG) studies interpreted by board-certified sleep specialists.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. The study described is a retrospective analysis for validation, not a description of the model development process.

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

The document does not provide any information on how the ground truth for a training set (if one was used) was established.

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