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The ECG Holter evaluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter ECG recordings. The Holter recordings are used for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.

The ECG Holter evoluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter EOG recordings. The Holter iscoralings are used for the diagnostics of symptomatic and asymptomatic arrhythings, i.e. bradyeardia, tachycardia, diagnastic of arthythinias in pattents with coraniary artery disease, in cardiomopathy, high blood pressure, long QT syndrome, A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of aliziniess or for controlling medical theraples, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic Ischemics. The software runs on Windows™ 95.

Here's a breakdown of the acceptance criteria and study information for the SCHILLER Microvit MT-200 Holter Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Arrhythmia Detection: The test set comprised "the AHA and MIT data bases." No specific number of records or patients is provided, but these are well-known, publicly available databases widely used for Holter ECG algorithm validation. The provenance is likely mixed, given the international nature of these databases, and typically retrospective, as they are pre-recorded and annotated datasets.
• ST-T Segment Analysis: The test set used "the ESC ST.T. database." Similar to the arrhythmia detection, no specific number of records is provided. This is also a well-known, typically retrospective database.

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

• Arrhythmia Detection: The ground truth for arrhythmia detection was established by "the annotations in the databases [AHA and MIT]." The number and qualifications of experts who created these annotations are not specified in this document. These databases are generally annotated by multiple expert cardiologists or electrophysiologists.
• ST-T Segment Analysis: The ground truth for ST-T analysis was established by "two independent observers." Their specific qualifications (e.g., "cardiologist with X years of experience") are not provided, only that they were "independent observers."

4. Adjudication Method for the Test Set

• Arrhythmia Detection & ST-T Segment Analysis: For arrhythmia detection, the MT-200's classifications were directly "compared with the annotated classifications of the data bases." For ST-T analysis, the MT-200's measurements were "compared to the deviations measured by two independent observers." This implies a direct comparison rather than an explicit arbitration or 2+1/3+1 adjudication method being used during the study. The ground truth itself, particularly for the well-established AHA/MIT/ESC databases, would have undergone rigorous expert consensus and adjudication during its creation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study is mentioned. The study focuses on evaluating the algorithm's performance against established ground truth rather than assessing human reader improvement with AI assistance.

6. Standalone Performance

• Yes, a standalone performance study was conducted. The document explicitly states: "The classifications given by the MT-200 were then compared with the annotated classifications of the data bases," and for ST-T analysis, "The STsegment deviations measured by the MT-200 were compared to the deviations measured by two independent observers." This demonstrates the algorithm's performance without human intervention in the loop during the reported tests.

7. Type of Ground Truth Used

• Arrhythmia Detection: Expert consensus, as represented by "the annotated classifications in the AHA and MIT databases."
• ST-T Segment Analysis: Expert consensus, as determined by "two independent observers" measuring ST-segment deviations.

8. Sample Size for the Training Set

• The document does not provide any information about the sample size used for the training set. The study focuses solely on the evaluation of the device's performance using established test databases.

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

• Since no information on a training set is provided, there is no mention of how its ground truth would have been established. This K973751 focuses on the validation of the developed software using known benchmark databases.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.

system consists of Endosseous implant implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for a dental implant system. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, manufacturing process, and intended use. It does not present performance data or clinical study results in the manner requested.

Therefore, I cannot provide the requested information.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for for the patient.

Endosseous implant system consists of implants, tools and This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for a medical device submitted in 1996. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study data for a new device's performance.

Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. This document is a regulatory submission for pre-market notification, not a clinical study report.

The 510(k) summary outlines:

• Predicate Devices: Lists previously cleared devices that the current device claims substantial equivalence to.
• Device Description: Briefly describes the endosseous implant system, including implants, tools, and particularly pre-machined angulated abutments (15 and 25 degrees) and wide-body abutments (4, 5, and 6 mm platform diameters).
• Intended Use: To facilitate the prosthetic phase and installation of prostheses.
• Technology Characteristic Summary: States that design, material, manufacturing process, sterilization, geometry, and materials are similar to predicate devices. It specifies the use of ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5, and mentions GMP compliance.

Without a clinical study report or a different type of technical document, it's impossible to provide the requested details about acceptance criteria and device performance as these are not part of a standard 510(k) summary.

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