(303 days)
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No
The summary describes a device for measuring prothrombin time (PT) and INR, focusing on correlation with existing methods and user performance. There is no mention of AI, ML, or related concepts like image processing or complex algorithms beyond standard analytical calculations.
No.
The device measures coagulation (ProTime Microcoagulation System) for patient monitoring, but it does not directly administer therapy. The results are used to inform therapy adjustments made by a physician.
Yes
The device, the ProTime Microcogulation System, measures the performance by the correlation of its results to other lab results, including a reference lab, and assesses the accuracy of classification of patients within therapeutic ranges. It also states that test results can be communicated to a physician for therapy adjustments. This indicates that the device provides information used for diagnosis or to inform treatment decisions, which is the definition of a diagnostic device.
No
The summary describes a "ProTime Microcogulation System" which is used for home testing and involves a physical assay ("perform the assay"). This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Performance Studies: The description of the performance studies clearly indicates that the device is used to test patient samples (blood, based on the mention of INR and prothrombin time). These tests are performed in vitro (outside the body) to provide diagnostic information.
- Intended User/Care Setting: The mention of "home test," "healthcare worker," "anticongulation clinics," and "clinic" further supports the idea that this device is used for testing patient samples in various settings.
- Key Metrics: The metrics like "Correlation" and "Mean difference" are typical measures used to evaluate the performance of diagnostic tests against reference methods.
- Summary of Performance Studies: The entire section describes the evaluation of the device's ability to measure prothrombin time and INR, which are standard diagnostic tests for monitoring anticoagulant therapy.
The device is designed to analyze biological samples (likely blood) to provide diagnostic information about a patient's coagulation status, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance of the ProTime™ Microcegulation System was measured by the correlation of the results of the home lest to the results obtained by the cornelulion of the results of the home lest to the results obtained in the healthcare worker using the ProTime " System. Forty-five patients were selected from iour anticongulation clinics. The ProTime " System. Forty-five patients were selected from iour anticrospelation have cating und his health care professional with regard to the patient's suitability for home testing und hisher ability to perform the test procedure. Pulents who agreed to participate in the study received a 30 to 60 minute mainte session at the cince who agreed to explanation, demonstration and organice reforming the since which included required to demonstrate the ability to reforming the ass procedure. The palent was see for a nonemation and practice performing the assay prior to enrollment in the sudy.
The performance of the ProTime™ Microcogulation System was assessed using:
- Correlation of patient ProTime™ testics of concessional ProTime™ test
- Correlation of the ProTime™ results to the hospital lab and reference lab
- Companison of mean differences among PT methods
- Accuracy among methods of appropriale thempeutic classification of patients receiving in patients receiving in patients receiving in a oral anticoagulants.
Results of the patient self-lest and the INR generated by the healthoute processional were highly correlated (rad. 92) and the mean difference was small (-0.05 INR + 0.33). Significant and couvalent correlations were demonsmied between the reference in b INR and hospital and (red. B); the reference lab and the ProTime™ home uses (r=0.89); and the reference lab INR. cline ProTime™ test (re0.91). Accuracy was first.89); and the reference lab to th clinic ProTime test (rec.91). Accunity was further usessessed by comparison of mean differences between various INR test methods and the reference laboratory little and mean differences between various INR test methods and the reference laboratory in the man showed mean differences less than 0.2 INR unis. ANOVA computisons of mean differences for the laboratory cesults and the bone and clini: ProTimes of mean differences Secondary analysis examined the imment clinic ProTime™ test were not different Secondary analysis examined the impact on accuracy of the ProTime™ lest for subsers of the data set individual sites, children who tested themselves, und time effects. The uccuresy was equivalent for all subsets examined
The data was tested for agreement with the reference laboratory within the identified therupeutic range with respect to identifies. Home ProTime™ results agend with the reference laboratory with respect to identifiestion of patients in and out of thempeutic range. The accuracy of correctly classifying patients in above, or below the received in the many with the the my of others and the patient th, active, or below therepeatic rarge use in
Patients experienced some testing faults while using the ProTime™ System at home, but successfully repeated the test to obtain accume results. An eror messuge is generated in place a secure who when the was to bount accurate results. An except reasons in a In summary. the ProTime™ Microcogulation System has been shown to be equivalent to the the salety PT test Patients demonstrated the ability to learn the proper procedure to the the assay and were able to produce accurate results at home. Correlation studies and comparative and your of the ProTime™ result and reference laboratory result indicale that the Prolline - System is sale and effective within the boundates of current protrombin time test technology. Test results of patients aking only anticogedians could be residity communicated to the prescribing physician for appropriate adjustments to therapy. Patients rated ProTime™ System easy to use.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).
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JUN 23 '97 10:06 908 632 9299 ITC
Section VI. Safety and Efficacy Summary
Performance of the ProTime™ Microcegulation System was measured by the correlation of the results of the home lest to the results obtained by the cornelulion of
the results of the home lest to the results obtained in the healthcare worker using the ProTime " System. Forty-five patients were selected from iour anticongulation clinics.
The ProTime " System. Forty-five patients were selected from iour anticrospelation have cating und his health care professional with regard to the patient's suitability for home testing und hisher ability to perform the test procedure. Pulents who agreed to participate in the study received a 30 to 60 minute mainte session at the cince who agreed to
explanation, demonstration and organice reforming the since which included required to demonstrate the ability to reforming the ass procedure. The palent was see for a nonemation and practice performing the assay prior to enrollment in the sudy.
The performance of the ProTime™ Microcogulation System was assessed using:
- Correlation of patient ProTime™ testics of concessional ProTime™ test
- · Correlation of the ProTime™ results to the hospital lab and reference lab
- · Companison of mean differences among PT methods
- · Accuracy among methods of appropriale thempeutic classification of patients receiving in patients receiving in patients receiving in a oral anticoagulants.
Results of the patient self-lest and the INR generated by the healthoute processional were highly correlated (rad. 92) and the mean difference was small (-0.05 INR + 0.33). Significant and couvalent correlations were demonsmied between the reference in b INR and hospital and (red. B); the reference lab and the ProTime™ home uses (r=0.89); and the reference lab INR.
cline ProTime™ test (re0.91). Accuracy was first.89); and the reference lab to th clinic ProTime test (rec.91). Accunity was further usessessed by comparison of mean differences between various INR test methods and the reference laboratory little and mean
differences between various INR test methods and the reference laboratory in the man showed mean differences less than 0.2 INR unis. ANOVA computisons of mean differences
for the laboratory cesults and the bone and clini: ProTimes of mean differences Secondary analysis examined the imment clinic ProTime™ test were not different Secondary analysis examined the impact on accuracy of the ProTime™ lest for subsers of the data set individual sites, children who tested themselves, und time effects. The uccuresy was equivalent for all subsets examined
The data was tested for agreement with the reference laboratory within the identified therupeutic range with respect to identifies. Home ProTime™ results agend with the reference laboratory with respect to identifiestion of patients in and out of thempeutic range. The accuracy of correctly classifying patients in above, or below the received in the many with the the my of others and the patient th, active, or below therepeatic rarge use in
Patients experienced some testing faults while using the ProTime™ System at home, but successfully repeated the test to obtain accume results. An eror messuge is generated in place a secure who when the was to bount accurate results. An except reasons in a
In summary. the ProTime™ Microcogulation System has been shown to be equivalent to the the salery PT test Patients demonstrated the ability to learn the proper procedure to the the assay and were able to produce accurate results at home. Correlation studies and comparative and your of the ProTime™ result and reference laboratory result indicale that the Prolline - System is sale and effective within the boundates of current protrombin time test technology. Test results of patients aking only anticogedians could be residity communicated to the prescribing physician for appropriate adjustments to therapy. Patients rated ProTime™ System easy to use.
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