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Indications for Use: Physiological purpose: To aid the clinician deciding whether to administer thrombolytic therapy or to provide another avenue of treatment; Condition: Patient is a potential candidate for thrombolytic therapy; Patient Population: adult (35 to 75 years) patients diagnosed as having symptoms of Acute Myocardial Infaction: Body or type of tissue interacted with: No body or tissue contact; Prescription versus over-the-counter: HP TPI is a prescription device.

HP TPI is an accessory software device that provides probability indices to aid the clinician deciding whether to administer thrombolytic therapy or to provide another avenue of treatment. HP TPI can only be installed in prescription host devices that meet the HP TPI interface and computing platform requirements.

The provided document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria in the format requested. The document is primarily a 510(k) submission summary for "HP TPI Application" (Thrombolytic Predictive Instrument), outlining its purpose, regulatory information, and general claims of safety and effectiveness.

Here's an analysis based on the information available:

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

The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a table of reported device performance metrics against such criteria. It generally states: "Documented test results obtained from extensive testing coupled with detailed user documentation of HP TPI and host devices produces a very high confidence level that the device is safe and effective when used as intended."

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

This information is not provided in the given text.

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)

This information is not provided in the given text.

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

This information is not provided in the given text.

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 document refers to the device as an "accessory software device that provides probability indices to aid the clinician deciding whether to administer thrombolytic therapy or to provide another avenue of treatment." This implies human-in-the-loop use. However, no details about an MRMC study or effect size of human improvement with AI assistance are provided.

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

The document describes the device as providing "probability indices to aid the clinician," indicating it's not intended for standalone use. No standalone performance study details are provided.

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

This information is not provided in the given text. The device's purpose revolves around aiding decisions for "Acute Myocardial Infarction," which would typically involve clinical diagnosis and outcomes, but the specific ground truth methodology is not detailed.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text.

Summary of what is available:

• Device Name: Model M1792A Thrombolytic Predictive Instrument (HP TPI Application)
• Intended Use: To aid clinicians in deciding on thrombolytic therapy or alternative treatments for adult patients (35-75 years) with symptoms of Acute Myocardial Infarction.
• Algorithm: Uses ECG measurement information from the host cardiograph and patient data input by the operator to calculate risk indices.
• Verification and Validation: States that "HP TPI software operates properly with no known safety related defects," "the algorithm embodied in the software performs the same as the algorithm used during clinical testing," "identified hazards have been mitigated," and "host cardiograph performance has not been compromised." This is a high-level verification statement without specifics on the "clinical testing."

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