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The Portable ECScope handheld, battery operated Multi channel electrocardiograph is intended to be used for evaluation of the cardiovascular system. The Portable ECScope will acquire, display and record Multi channel ECG signals. The Portable ECScope is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for specific clinical diagnosis. The clinical significance must be determined by a physician.

Portable ECScope is a multi channel electrocardiograph for the simultaneous acquisition of the 7 ECG leads i.e L1, L2, L3, aVR, aVL, aVF and one of the chest leads (V1-6), featuring 3-lead Display Unit, alphanumeric keyboard and an option to print the ECG data using the Print Tool on A4 Sheet Paper or Direct Printing through connected printer. Portable ECScope can record and store in its Database up to 200 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be reviewed, printed on the external printer using a PC.

The provided text is a 510(k) summary for the Portable ECScope device. It details the device's description, intended use, and comparison to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in detailed performance studies for AI/algorithm-based devices.

The document states:

"The Portable ECScope was subjected to safety and performance tests against regulatory standards. Final testing for the product included various performance tests as per ANSI/AAMI EC11: 1991 Guidance Document."

This indicates that the device underwent testing according to a recognized standard for electrocardiographs, but the specific acceptance criteria, test results, and details of how those results were obtained are not included in this summary.

Therefore, I cannot provide the requested information in the table or the detailed breakdown of study parameters because the provided text does not contain this information.

If this were an AI or algorithmic device submission, the 510(k) summary would typically include a dedicated section detailing performance data, acceptance criteria, ground truth establishment, and details of the study design. This document is a more traditional medical device submission for an ECG monitor, which relies on demonstrating adherence to established performance standards for hardware and basic functionality, rather than complex algorithmic performance metrics against a clinical ground truth.

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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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