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• Assessment of symptoms that may be related to Rhythm Disturbances of the Heart in patients from pediatric to adult age. Patients with palpitations.
• Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g .: ventricular ectopy, as method of risk assessment.
• Assessment of Efficacy of Antiarrhythmic Therapy. Patients with baseline high frequency, reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
• Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
• Detection of Myocardial Ischemia. Paticnts with chest pain suggestive of Prinzmetal's angina.

The Holter 2000-Software is a device that when installed onto a user's Hardware platform, will convert their system into a Holter scanner analyzes recorded cardiac ECG and creates reports from the recorded data. The patient's ECG is pre-recorded onto one of several data storage mediums, which is fed into user's Holter system whereby the Holter 2000 software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data that is analyzed is individual ECG waveforms and patterns of consecutive waveforms. Cardiac data provided by Zymed's Holter 2000-Software is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns. The Zymed software system presents the user with a number of clinical tools such as ECG report generation. The system also provides tools to review a patient's cardiac performance. Features such as individual ECG printouts, multi-channel automatic ST analysis, multi-channel morphology analysis and Custom Reports further enhance the system's qualities as a valuable and practical clinical tool. The system has the options available: Full Arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Data Acquisition on 2 or 3 Channels Digital Input

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zymed Holter 2000 - Software:

Please note that this document is a 510(k) summary for substantial equivalence, not a detailed clinical study report. Therefore, some information, particularly regarding specific statistical thresholds for acceptance criteria and the full rigor of a standalone study, might not be explicitly stated or as granular as one would find in a peer-reviewed publication.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in the traditional sense (e.g., "sensitivity must be > 90%"). Instead, it states that "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases. Results were typical for the Holter as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each database and measured for QRS. Ventricular. Couplets, Short runs and Long runs. Separate Episode Sensitivities (ESE), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE) and Duration Positive Predictivity (D+P) were examined for the European ST-T (EST) database and measured for ST analysis."

The key "acceptance criterion" implied is substantial equivalence to the predicate device, demonstrated by "nearly identical data" for performance.

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

• Sample Size: Not explicitly stated. The document refers to "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." These are known public databases of ECG recordings, but the exact number of cases or recordings utilized for this specific submission is not provided.
• Data Provenance: The databases mentioned (AHA, MIT, EST) are public, widely recognized, and generally well-documented academic/clinical databases. These are typically retrospective collections of patient ECG data. The specific country of origin for each database's full content is varied, but they are international standards.

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

This information is not provided in the document. For industry-accepted databases like AHA, MIT, and EST, the ground truth (annotations) is meticulously established, often by multiple experienced cardiologists or electrophysiologists, following established guidelines. However, the specific process for this submission's use of those databases is not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given that the ground truth comes from established databases, the adjudication method for their original annotation would have been part of the database creation process. For the purpose of this submission, the device's output was simply compared against the already established ground truth in these databases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done as described in this document. The study focuses solely on the performance of the algorithm (the Zymed Holter 2000-Software) against established ECG databases and a comparison to its predicate device. There is no mention of human readers or AI assistance for human readers.

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

Yes, a standalone study was done. The performance evaluation described is entirely focused on the Zymed Holter 2000-Software's ability to analyze ECG data and generate reports automatically. It measures the algorithm's performance (sensitivities, predictivities, FPR) against the ground truth of the databases. The "Software Trade Name: Holter 2000 - Software" indicates it's an algorithm-driven system for analysis.

7. The Type of Ground Truth Used

The ground truth used was expertly-annotated ECG data from established and industry-accepted databases (AHA, MIT, EST). These databases contain recordings where cardiac events (e.g., QRS complexes, ventricular events, ST changes) have been manually identified and labeled by human experts.

8. The Sample Size for the Training Set

The sample size for the training set is not provided. The document describes a comparison against recognized databases for testing. Information about how the algorithm was trained, including the dataset size, is not included in this 510(k) summary.

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

This information is not provided. As with the training set size, the specifics of the algorithm's development and the ground truth used for its training are outside the scope of this 510(k) summary, which focuses on demonstrating substantial equivalence through testing.

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This is to certify that the BodyLoc™™ Whole Body Stereotactic Localizer System For Radiotherapy, as submitted under the above referenced 510(k) number, is indicated for use as a precision patient immobilization and positioning system for the purpose of performing diagnostic localization and fractionated stereotactic radiotherapy/ radiosurgery treatment. It is substantially equivalent to similar devices which are used to position the body during stereotactic radiotherapy of various body lesions. The decision and conditions under which the system is to be used is made by the patient's managing physician(s).

The BodyLoc" is a body stereotactic localizer system which utilizes a coordinate reference system that can be used to reproducibly localize targets during diagnostic and treatment procedures. Stereotactic localization fiducials are positioned in the sides and base of the BodyLoc™ and the localization system is continuous from the head to mid-thigh regions. The BodyLoc" is supplied with a software program for calculation of BodyLoc" stereotactic coordinates from scanner images. Software is functional on IBM or IBM-compatible PC computers with Microsoft® Windows 95. Targets within the system can be aligned by use of the coordinate indicators on the sides of the frame and the moveable arc localizer. Immobilization is achieved by the use of a vacuum mold system or polyurethane foam mold for posterior (the part of the body nearest the frame base) areas and a thermoplastic body mold to cover large body surfaces in the ventral or anterior plane. The BodyLoc™ has quality assurance markers in its base which are used to aid in system set-up and in verifying the accuracy of the coordinate alignment and target calculations.

The provided text describes the "BodyLoc™ Whole Body Stereotactic Localizer System For Radiotherapy" and presents a comparison to predicate devices, including performance data. However, it does not describe acceptance criteria in the traditional sense of pre-defined thresholds that the device must meet, nor does it detail a clinical study with a specified test set and ground truth. Instead, it demonstrates "substantial equivalence" to legally marketed predicate devices through a comparison of technological characteristics and performance metrics.

Here's an attempt to structure the information based on your request, highlighting what is implicitly or explicitly stated and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather presents a comparison table where the performance of the BodyLoc™ is compared to predicate devices. The implicit acceptance criterion is that the BodyLoc™'s performance should be "substantially equivalent" or better than the predicate devices.

Note: The document describes "an overall accuracy range substantially equivalent to that of predicate devices," which is a general statement. The specific numbers provided in the table indicate that the BodyLoc™ actually exceeds the performance of the predicate devices in terms of localization error, rather than just being "equivalent."

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

• Test Set Sample Size: The document mentions "test calculations and measurements of multiple targets throughout the BodyLoc™ using various axial scan slice thicknesses." However, it does not specify a numerical sample size for the test set (e.g., number of targets, number of scan slices, or number of tests).
• Data Provenance: The tests were "developed and performed by MIDCO®" for its BodyLoc System. The context suggests these were retrospective/benchtop tests conducted by the manufacturer, not clinical trials with human subjects. The country of origin of the data is not explicitly stated beyond MIDCO® being a US company.

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

The document does not mention the involvement of any experts (e.g., radiologists) in establishing ground truth for the performance tests. The ground truth for the localization and setup error measurements was likely established through precise physical measurements and pre-defined coordinates within the device itself:

• "Stereotactic localization fiducials are positioned in the sides and base of the BodyLoc™ and the localization system is continuous from the head to mid-thigh regions."
• "The BodyLoc™ has quality assurance markers in its base which are used to aid in system set-up and in verifying the accuracy of the coordinate alignment and target calculations."

This suggests the ground truth was based on the known physical locations of these fiducials and markers.

4. Adjudication Method for the Test Set

No adjudication method is described. The tests were likely objective measurements against known physical standards.

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

No MRMC comparative effectiveness study was conducted or reported. The device is a physical immobilization and localization system, not an AI or imaging diagnostic tool that would typically involve human readers interpreting output.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The reported performance metrics (CT localization error, LINAC Set-up Error) are "algorithm only" or "device only" metrics, demonstrating the accuracy of the BodyLoc™ system and its associated software for calculating stereotactic coordinates. The studies evaluated:

• "the accuracy of the fiducial system."
• "the axial imaging localization algorithm used with the fiducial system."
• "the fiducial localization system in relation to quality assurance reference markers embedded in the base of the localizer at known stereotactic frame z-axis levels."
• "The imaging fiducial localization algorithm was then tested against a scanner screen measurement method."

7. Type of Ground Truth Used

The ground truth used was based on known physical coordinates of fiducials and quality assurance markers embedded within the BodyLoc™ frame. This is effectively a physical standard or engineered ground truth, rather than expert consensus, pathology, or outcomes data, which are typically used for diagnostic or predictive AI.

8. Sample Size for the Training Set

No training set is mentioned. This device is a physical system with an associated software for coordinate calculation, not a machine learning or AI model trained on data. Therefore, the concept of a "training set" is not applicable here.

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

As there is no training set, this question is not applicable.

Summary of Missing Information:

• Explicit, pre-defined "acceptance criteria" thresholds.
• Specific numerical sample size for the tests (e.g., how many "multiple targets" were used).
• Details on the methodology of the "Monte Carlo tests and test calculations."
• Involvement of human experts in establishing ground truth for device performance.
• Any form of clinical study or MRMC study.
• Information related to machine learning/AI (training set, validation set, etc.) as the device does not appear to be an AI-driven diagnostic system.

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• Assessment of symptoms that may be related to Rhythm Disturbances of the Heart in patients from pediatric to adult age. Patients with palpitations.
• Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
• Assessment of Efficacy of Antiarrhythmic Therapy. Patients with baseline high frequency, reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
• Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
• Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's angina.

The Holter 2000 is a device that analyzes recorded cardiac ECG and creates reports from the recorded data. The ECG is pre-recorded onto one of several data storage mediums, which is fed into the Holter 2000. The Holter 2000 software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data that is analyzed is individual ECG waveforms and patterns of consecutive waveforms. Cardiac data provided by Holter 2000 is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns. The Zymed system presents the user with a number of clinical tools such as ECG report generation. The system also provides tools to review a patient's cardiac performance. Features such as individual ECG printouts, multi-channel automatic ST analysis, multi-channel morphology analysis and Custom Reports further enhance the system's qualities as a valuable and practical clinical tool. The system has the options available: Full Arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Data Acquisition on 2 or 3 Channels Choice of Cassette Tape or Digital Input Laser Printer

Here's an analysis of the provided text to extract information about the device's acceptance criteria and the study used to demonstrate it, structured as requested:

Device: Zymed Holter 2000

1. Table of Acceptance Criteria and Reported Device Performance

The documentation does not explicitly state numerical acceptance criteria. Instead, it describes performance targets as "typical for the Holter as targeted" and states that "performance data between the two systems shows nearly identical data." The acceptance for the Zymed Holter 2000 is based on demonstrating Substantial Equivalence to the predicate device, the Zymed Holter Scanner Model 2010 Plus.

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

• Sample Size: Not explicitly stated as a numerical sample size of patients or recordings. Instead, the performance was measured against "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases."
• Data Provenance: The databases used (AHA, MIT, EST) are generally recognized as public, retrospective datasets of ECG recordings. The specific country of origin for each database isn't detailed in this document but these are widely known and generally include data from various geographical locations historically. The nature of these established databases means the data is retrospective.

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

The document does not provide information on the number of experts or their qualifications for establishing the ground truth of the AHA, MIT, and EST databases. These databases are standardized and their ground truth (annotations) would have been established independently, often by multiple expert cardiologists/technicians, prior to their general acceptance for benchmarking.

4. Adjudication Method for the Test Set

The document does not detail the adjudication method for the test sets (the AHA, MIT, and EST databases). The annotations within these databases are pre-established and considered the reference standard for performance evaluation.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or reported in this document. The study focuses on comparing the new device's automated analysis performance against a predicate device and established databases.

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

Yes, a standalone performance evaluation was done. The document states, "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." This refers to evaluating the automated analysis software of the Holter 2000 independent of human interaction during the analysis phase (though human review of results is part of clinical workflow).

7. The type of ground truth used

The ground truth used was expert annotated data from industry-accepted databases (AHA, MIT, European ST-T databases). These databases contain ECG recordings with pre-established annotations (e.g., QRS complexes, ventricular events, ST segment changes) considered as the reference standard.

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This type of submission (510(k)) for substantial equivalence, especially in 1999, often focused on validating the performance of the final device against benchmarks, rather than detailing the internal development (training) process. Given the nature of the device as an "analyzer" rather than a deep learning model, it's possible that a "training set" in the modern AI sense wasn't applicable, or it certainly wasn't documented in this submission.

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

Since no training set information is provided, how its ground truth was established is also not detailed.

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• Assessment of symptoms that may be related to rhythm disturbances of the heart: Patients with . palpitations; The evaluation of arrhythmia's in patients from pediatric to adult age.
• Assessment of risk in patients with or without symptoms of arrhythmia.
• Assessment of efficacy of Antiarrhythmic therapy. .
• . Assessment of Pacemaker Function.
• Assessment of real time ST segment analysis .
• . Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing.
• Assessment is for single-hospital environment.
• Assessment of EASI derived 12-lead ST measurements is recommended for patients that meet the . following parameters.
  • 1. Ages: 33 to 82 years
  • 2. Heights: 147 to 185 cm (58 to 73 in)
  • 3. Weights: 53 to 118 kg (117 to 2611b)
  • 4. Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/b.)

A Zymed Telemetry monitoring system consists of a series of interface devices to include ECG transmitters, a central Telemetry monitoring computerized unit with a strip chart recorder, Easi 5 (12 lead derived), and laser printer. The Zymed central monitor supports up to eight patients for real time cardiac monitoring. The system displays each patient's ECG continuously on the screen while performing real time ECG waveform analysis for all eight patients. This analysis permits immediate detection and classification of abnormal beats, cardiac rhythm disturbances and variations.

Each ECG transmitter's frequency can be programmed to operate at any frequency within the entire VHF band. For US domestic sites, the transmitters will comply with FCC band allocations (174-216 Mbz). In addition to ECG data, the transmitters also detect and transmit cardiac pacemaker information. Other information including transmitter status and individual lead impedance is also transmitted to the Zymed system for overall system safety and efficacy.

The Zymed system presents the user with a number of clinical tools such as visual and audible alarms and derived 12 lead display for the diagnosis of patients with various heart conditions. The system also provides tools to review a patient's cardiac performance. On-line review mechanisms as well as detailed analysis screens have been designed into the system to facilitate and to enhance the patient's diagnosis and treatment. Features such as individual ECG printouts, multi-channel automatic ST analysis, trend data analysis, and Full Disclosure data further enhance the system's qualities as a valuable and practical clinical tool.

The system has the following options available:
Choice of 4, 6, or 8 bed central monitor
Full disclosure screen and printout (full resolution programmable from 0 to 168 hours)
Choice of 6 lead sets, based on transmitter capability
Full arrhythmia analysis to include multi-channel automatic ST Analysis
12 lead ECGD
Laser Printer, print server options
Strip Chart
Networking

Here's an analysis of the provided text regarding the Zymed Telemetry System, Model EasiView:

Device: Zymed Telemetry System: Model EasiView Telemetry Central Station Monitor

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail manner. Instead, it states that "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases. Results were typical for the real time monitoring environment for the EasiView as targeted." It then lists the types of metrics examined.

Given this, the table below will present the types of performance metrics used and a general summary of the findings as described in the submission.

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

• Sample Size for Test Set: The document refers to "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." However, it does not explicitly state the specific number of cases or recordings from these databases used for testing this particular device.
• Data Provenance: The document implies the use of pre-existing, standardized databases (AHA, MIT, EST). It does not specify the country of origin of the data within these databases or whether the data was retrospective or prospective. Given they are "industry accepted databases," it's highly likely they contain a mix of retrospective data collected over time from various sources.

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

The document does not provide any information about the number or qualifications of experts used to establish the ground truth for the test sets (AHA, MIT, EST databases). For standardized databases like these, the ground truth is typically established by multiple expert cardiologists or arrhythmia technicians through a consensus process, but this submission does not detail that process for these specific databases.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the ground truth of the test set. For pre-existing, standardized databases, the adjudication would have been part of the database creation process, but it's not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses solely on the device's algorithmic performance against established databases and a comparison of its features and performance to a predicate device, not on human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study was done. The entire section describing "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases" focuses on the algorithm's performance in detecting QRS, Ventricular events, Couplets, Short/Long runs, and ST analysis, without human intervention in the interpretation process.

7. The Type of Ground Truth Used:

The type of ground truth used was based on the annotations provided within the industry-accepted AHA, MIT, and European ST-T databases. These databases typically contain expert-adjudicated annotations for cardiac events (e.g., QRS complexes, arrhythmias) and ST segment changes, effectively representing expert consensus.

8. The Sample Size for the Training Set:

The document does not specify the sample size for the training set. It only discusses the performance evaluation against established test databases.

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

The document does not provide information on how the ground truth for the training set (if any distinct training was performed using Zymed's own data) was established. It only refers to using "industry accepted databases" for performance testing. If the device was trained using these same databases, the ground truth would be from those databases, which is typically expert consensus.

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The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.

The AS/3™ NMT Module is a part of the modular anesthesia monitoring system AS/3™. It provides relaxation measurement of patient. The NMT measurement hardware is in the NMT Module stimulates the Mores the patient controlled by the Net Compact Monitor central unit. The News NMT Module measures the respon responses from the NMT module, calculates the NMT values, displays the NMT values, handles NMT trending and NMT monitor features.

This 510(k) summary (K955000) for the Datex AS/3™ M-NMT Device is very brief and unfortunately does not contain the detailed information required to describe the acceptance criteria and the study proving device performance as requested.

The summary describes the device and its intended use but lacks any mention of performance metrics, clinical studies, or validation methods. It's a regulatory submission document primarily focused on demonstrating substantial equivalence to a predicate device, rather than a detailed technical or clinical trial report.

Therefore, I cannot fulfill your request with the provided input. To answer your questions, I would need a different type of document, such as:

• A clinical validation report
• A performance testing report
• A detailed risk analysis document that includes acceptance criteria for safety and efficacy
• A comprehensive summary of the 510(k) submission that includes performance data (which is not typically included in the publicly available 510(k) summary)

Without such detailed information, any attempt to answer the questions would be speculative and inaccurate.

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Not Found

MIDCO has recently developed a quality Couchmount System (Patient Head Support System) for use in radiosurgery. This couchmount system complements the cass collimator set and enables MIDCO to provide its customers with a full set of instrumentation necessary for radiosurgery. The design of this couchmount is such that it will fit most linear accelerators with only slight modifications to the couchmount adapter assembly. The cass Couchmount System has six axes of adjustment which allows for easy setup with the Linac couch/gantry system. An additional feature of the system is a unique laser measurement apparatus for precisely measuring an isocenter of a target volume for Linac-based radiosurgery/stereotactic radiotherapy. These two features also allow for the correction of alignment errors during treatment planning setup, such as errors inherent in the use of room lasers and errors due to couch shifts during patient positioning. It will also give an index of gantry sag or misalignment. Most commercially available stereotactic headrings can be mounted to the cass Couchmount System by the use of a stereotactic frame holder made specifically for the headring. Although most headrings are similar, each has a slightly different adapter plate which rigidly holds the headring. The stereotactic localization features of most frames are similar, differing mainly in the organization of the frame's coordinate system and its mechanical dimensions.

Here's a breakdown of the acceptance criteria and study information for the cass Linac Radiosurgery Hardware Couchmount Stereotactic Frame Support System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size:
     • For the Lutz method test: "random phantom targets throughout the extremes of the coordinate system of the Leksell frame and BRW frame" were set up. No specific number is given, but it implies a range of targets.
     • For the overall system accuracy (humanoid phantom and dosimetry film): A single "humanoid phantom" was used, with a target point radiated.
     • For port film tests: "various predetermined target sites" were used. No specific number is given.
   • Data Provenance: The tests were conducted using a Varian 2100 C Linac, which is a common radiation therapy machine. The data is prospective, generated specifically for these tests by MIDCO and its consultants/instructors. There's no mention of specific countries of origin beyond the machine type.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not explicitly state the number or specific qualifications of experts used to establish the ground truth for the test set. However, it indicates involvement of:

   • "appropriate consultants and instructors" from MIDCO for on-site instructions.
   • "radiation oncologists and radiation physicists" at each institution being "ultimately responsible for accurate measurements and gathering of data for the use of this system."
   • The studies cited (Lutz, Serago, et al.) are foundational in the field, implying that the ground truth methodology is based on established scientific and medical consensus within the radiosurgery community, as recognized by qualified physicists and clinicians.

3. Adjudication method for the test set:
   The document does not describe a formal "adjudication method" in the sense of multiple independent reviewers resolving discrepancies for the test set results. The results (e.g., error ranges for Dx, Dy, Dz displacements) appear to be direct measurements from the phantom studies. The methodology relies on established protocols from cited literature (Lutz method, Serago et al. method), which inherently incorporate methods for accurate measurement and calculation of discrepancies.

4. 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:
   No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is a hardware system (couchmount and collimators) for radiosurgery, not an AI or imaging diagnostic tool that would typically involve human readers interpreting output.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This question is not entirely applicable as the device is a hardware system. However, the performance reported (e.g., accuracy measurements like 0.48 mm ± 0.262 mm) represents the "standalone" mechanical accuracy of the system (Linac + collimators + couchmount) as configured and operated according to established protocols, without additional human interpretive input influencing the measurement of accuracy itself. The laser measurement system is an automated component for precise targeting. While humans operate the system, the reported accuracies are objective measurements of the system's physical performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth for the mechanical accuracy tests was established through phantom studies and dosimetry film analysis.

   • Lutz method: Uses a phantom pointer to simulate test targets at known stereotactic coordinates. Radiographic images are then taken, and x, y, z displacements are measured against the known phantom target positions.
   • Overall accuracy test: A humanoid phantom with a known target point is radiated, and the isocenter of the multiple intersecting beams is compared to the known position of the phantom target point indicator.
   • Port film tests: Predetermined target sites are set (aided by the Laser Measurement System), and then A-P and lateral port films are used to verify the actual versus intended target locations.
   • This is a form of empirical ground truth based on physical measurements against precisely known phantom positions.

7. The sample size for the training set:
   The document does not describe a "training set" in the context of machine learning. This device is a mechanical system, not an AI or software algorithm that requires a training set of data. The development process involved engineering design, prototyping, and testing, not machine learning model training.

8. How the ground truth for the training set was established:
   As there is no training set mentioned for this hardware device, this question is not applicable.

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The AS/3TM COPSv module is intended to be used in the Datex AS/3TM Anaesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, in intensive care department etc.

The AS/3TM COPSv Module is a parts of the modular anesthesia monitoring system AS/3™. It provides cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2) and invasive measurement of patient.

The provided text is a 510(k) summary for a medical device (Datex AS/3™ Cardiac Output and SvO2 Module). It describes the device, its intended use, and its measurement techniques. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics that would allow for the completion of the requested table and study description.

Therefore, I cannot provide the requested information based on the input text. The 510(k) summary primarily focuses on the description and equivalence to previously cleared devices, not on the detailed clinical validation studies and their results.

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The AS/31M Compact Airway Module M-CAiOV is intended to be used in the Datex AS/3TM Anesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.

The AS/3TM Compact Airway Module M-CAiOV is a part of the modular anesthesia monitoring system AS/3TM. It measures carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2) and anesthetic agent concentration (AA) of respiratory gases. The Airway Module also identifies anesthetic agent (ID) and measures airway pressure and volume (pV).

The sampled gases are analyzed by an infrared photometer and a paramagnetic oxygen sensor. Respiratory rate is derived from the CO2 signal. The anesthetic agents (halothane, enflurane, isoflurane, desflurane and sevoflurane) are identified from the sampled gases with infrared technique. Airway gas flow is measured with the aid of a pneumotachometer type transducer and airway pressure is measured from the same adapter by means of a pressure transducer.

This document appears to be a 510(k) summary for a medical device, specifically an AS/3™ Compact Airway Module M-CAiOV. It describes the device, its intended use, and argues for its substantial equivalence to a previously approved device (Datex AS/3™ Airway Module G-AiOV).

However, the provided text does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

Missing Information:

1. A table of acceptance criteria and the reported device performance: The document states that "Both gas measurement and spirometry measurement accuracy's were verified with both Compact Airway Module M-CAiOV and Airway Module G-AiOV at the same time. The results showed that both performed within specifications and the results were substantially equivalent." However, it does not list what those "specifications" (acceptance criteria) are, nor does it provide specific reported performance values for parameters like accuracy, precision, bias, etc., for the M-CAiOV.
2. Sample size used for the test set and the data provenance: The document mentions "results showed that both performed," implying a test was conducted, but provides no details about the sample size (e.g., number of measurements, number of patients, duration of testing), nor the origin or nature of the data (e.g., in-vitro, in-vivo, clinical trial, retrospective/prospective).
3. Number of experts used to establish the ground truth... and their qualifications: This device measures physiological parameters (gas concentrations, pressure, volume). The "ground truth" for these measurements would typically be established by highly accurate reference instruments or calibrated gas mixtures, not by human experts adjudicating images or clinical outcomes. The document does not describe how the reference standards were established.
4. Adjudication method for the test set: Not applicable, as it's a measurement device, not an interpretative one relying on expert review.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. MRMC studies are typically for image analysis or diagnostic interpretation devices where human readers are involved in diagnosis. This device provides quantitative measurements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of its measurement function. The "study" likely involved testing the device against known standards or another reference device.
7. The type of ground truth used: As mentioned above, for this type of device, ground truth would be established by highly accurate, calibrated reference instrumentation or certified gas mixtures. The document does not specify this.
8. The sample size for the training set: This device is not described as using machine learning or AI that would require a "training set" in the typical sense for diagnostic algorithms. It's an infrared photometer and paramagnetic oxygen sensor system.
9. How the ground truth for the training set was established: Not applicable, as there's no mention of a training set for an AI/ML algorithm.

Conclusion:

The provided text serves as a regulatory summary focusing on substantial equivalence, rather than a detailed technical report or study publication. While it asserts that "accuracy's were verified" and "results were substantially equivalent," it lacks the specific quantitative data, methodology details, and specific acceptance criteria needed to complete your request.

To answer your questions fully, you would need access to the actual verification and validation reports or the detailed specifications documents referenced in the 510(k) submission.

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The Model 2010 Plus was designed for the busy Holter environment that places a premium on throughput analysis. This powerful computer provides the "muscle" to analyze even the most difficult recordings quickly and accurately.

Three channels of recorded patient ECG are utilized by the sophisticated arrhythmia analysis program to detect abnormalities. The system provides a number of clinical tools such as individual ECG printouts. trend data analysis, HRV time domain, and full disclosure to enable the clinician to review a patients cardiac performance.

The 2010-Plus gives the flexibility to process Holter recordings prospectively or retrospectively. Prospective interaction lets the technician supervise the analysis by viewing the ECG chronologically and fine-tuning the arrhythmia processor on-line for error-free results. Superimposition, paging, or a combination of both techniques can be used for prospective scanning. Or, the system can automatically analyze the data in approximately 12 minutes. Once the preliminary analysis is complete, the technician can use powerful retrospective tools to validate and edit the report.

A Zymed Holter Scanner system consists of a series of interface devices to include a central monitoring computerized unit, a high Resolution Super VGA raster graphics display monitor, a minimum 500 megabites hard disk drive for two 36-hour digital tape readings, Intel Pentium System Board CPU, 8 megabites of RAM, built in math co-processor, cassette tape drive, mouse and keyboard , 3.5 " floppy disk drive, and a laser printer.

Over 1000 final reports can be stored on line, the operating system is DOS compatible, and Holter reports can be transmitted via facsimile systems.

The analysis software package includes standard, pediatric, and AFib to name a few, and the user can program individual custom styles. Other programmable software features include ECG display; scanning speed up to 240 X real time; scanning styles to include retrospective, prospective, superimposition, and paging; auto stops; highlighting; noise algorithm; color schemes, and report formats. The system 3-channel QRS detection/arrhythmia analysis, 3-channel ST segment analysis, full provides disclosure, automatic 2 of 3 channel morphology analysis, customized report software, HRV-Time Domain, and Pacemaker evaluation display.

The provided text is a 510(k) summary for a medical device (Zymed Holter Scanner; Model 2010 Plus) from 1998. It primarily focuses on demonstrating substantial equivalence to a predicate device (Zymed Holter Scanner Model 2010) based on technological characteristics.

Therefore, much of the requested information regarding acceptance criteria and detailed study designs for device performance against specific acceptance criteria is not explicitly present in this 510(k) summary. These summaries, especially from that era, often focused on direct comparison to predicate devices rather than presenting standalone performance studies with pre-defined acceptance criteria in the way a modern regulatory submission might.

However, I can extract and infer some information based on the provided text, while also clearly stating what is not available.

Acceptance Criteria and Study for Zymed Holter Scanner; Model 2010 Plus

The 510(k) summary does not outline specific, quantified acceptance criteria for the new Zymed Holter Scanner Model 2010 Plus in terms of diagnostic performance metrics (e.g., sensitivity, specificity for arrhythmia detection) or a formal clinical study to prove these criteria. Instead, the "acceptance criteria" appear to be implicit in demonstrating substantial equivalence to the predicate device (Zymed Holter Scanner Model 2010) through a comparison of technological characteristics and a general statement about performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" are inferred based on the intention to demonstrate substantial equivalence, as explicit performance thresholds are not provided in the summary.

Study Used to Prove Device Meets Acceptance Criteria:

The key "study" described is a comparison of technological characteristics between the predicate device (Zymed Holter Scanner Model 2010) and the new device (Zymed Holter Scanner Model 2010 Plus). The conclusion drawn from this comparison is that "Performance between the two systems is almost identical and clearly supports a claim of substantial equivalence."

Specific Information based on the text:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The summary does not describe a clinical test set or patient data used for a performance validation study. The comparison is based on hardware and software features.
• Data Provenance: Not applicable, as no external data set is described for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set:

• Not applicable. No test set requiring adjudication is described.

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:

• No, an MRMC study was not described. The device is a Holter scanner, which assists clinicians in analyzing ECG data, but the submission focuses on its equivalence to an existing scanner, not a comparative effectiveness study involving human readers with/without the new scanner. The term "AI" as understood today is also not applicable to this 1998 submission.

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

• A standalone algorithm performance study with quantitative metrics (like sensitivity/specificity for arrhythmia detection) is not explicitly described in the summary. The statement "Performance between the two systems is almost identical" suggests an internal assessment or reliance on the predicate's established performance, but no details are given.

7. The type of ground truth used:

• Not applicable, as no specific ground truth for an independent performance study is described. For a Holter scanner, ground truth for arrhythmias would typically be established by expert cardiologist review.

8. The sample size for the training set:

• Not applicable. This document does not describe a machine learning model requiring a training set in the modern sense. It refers to a "sophisticated arrhythmia analysis program," but details about its development or training data are not provided.

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

• Not applicable. (See #8)

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