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The Heartstream XLT Defibrillator/Monitor is to be used for the termination of ventricular tachycardia and ventricular fibrillation.

This device is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-authorized emergency medical response. It must be used by or on the order of a physician.

The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J.

In the manual mode operation, the Heartstream XLT Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials.

AED Therapy:

To be used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.

Pacing:

Noninvasive pacing is one method of treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

SpO2 Monitoring:

SpO2 monitoring is indicated for use when it is beneficial to assess a patient's oxygen saturation level.

The Heartstream XLT Defibrillator/Monitor has two modes of operation: AED and manual. Non-invasive external pacing, as well as SpO2 and 3/5-wire ECG monitoring are also available.

The Heartstream XLT defibrillator uses the Heartstream SMART biphasic waveform for defibrillation, the same waveform utilized in the Heartstream ForeRunner AED.

ECG data and events can be stored on a Data Card by the Heartstream XLT for Jater downloading and reporting with the Heartstream CodeRunner data management system.

The provided text describes a 510(k) summary for the Heartstream XLT Defibrillator/Monitor and its comparison to predicate devices, but it does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and repetition of previous testing. It mentions a "Conclusion from Testing" that the device "does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices," but this is a high-level summary, not a report of specific acceptance criteria and performance data.

Here's an breakdown of what can and cannot be extracted from the provided text according to your request:

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

This information is not present in the provided text. The document states: "For each function on the Heartstream XLT that is leveraged from previous HP products, such as the CodeMaster 100 or the Heartstream ForeRunner, the testing done for the previous product was repeated in order to demonstrate equivalence, although in some cases, more stringent procedures and/or acceptance criteria were required for the XLT." However, neither these "more stringent procedures and/or acceptance criteria" nor the specific performance results are described.

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 explicitly stated for the non-clinical tests.
For the clinical testing of the SMART Biphasic waveform, it states: "The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults." However, it does not provide the sample size, country of origin, or whether it was retrospective or prospective.

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 present in the provided text. The document mentions tests but not the use of experts to establish a ground truth for a test set.

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

This information is not present in the provided 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

This information is not present in the provided text. The device is a defibrillator/monitor, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable in this context.

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

The document mentions "algorithm and software testing" for nonclinical tests, but it does not provide details about standalone performance metrics or if it was conducted without human intervention in the context of defibrillation effectiveness.

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

This information is not explicitly stated. For the "clinical testing in adults" of the SMART Biphasic waveform, it implicitly suggests that the ground truth would be successful termination of ventricular tachyarrhythmias (outcomes data), but this is not definitively stated. For the other non-clinical tests, the ground truth would likely be established in accordance with engineering standards and predicate device performance.

8. The sample size for the training set

This information is not present in the provided text. Since the document primarily describes reuse of existing algorithms and technologies from predicate devices rather than a newly trained AI model, the concept of a "training set" in the context of machine learning might not be directly applicable to the described evaluation.

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

This information is not present in the provided text.

Summary of available information:

The document describes the Heartstream XLT Defibrillator/Monitor and asserts its substantial equivalence to predicate devices (HP CodeMaster 100, HP Heartstream ForeRunner AED, HP CodeMaster XL, HP Viridia Telemetry System).

• Nonclinical Tests: Bench testing (hardware, algorithm, software) and animal testing were performed. The animal testing evaluated the safety and effectiveness of the Heartstream SMART biphasic waveform up to 200J.
• Clinical Testing (for waveform): The SMART Biphasic waveform underwent clinical testing in adults, supporting its effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. No further details on this study (sample size, methodology, acceptance criteria, specific results) are provided.
• Equivalence Approach: The core approach was to repeat tests performed on predicate devices, sometimes with more stringent procedures/acceptance criteria, to demonstrate that the Heartstream XLT does not raise new safety or effectiveness concerns.

To fulfill your request completely, significantly more detailed study reports would be required than what is provided in this 510(k) summary.

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The M2376A Device Link System is indicated for use in data collection and clinical information management either connected directly or through networks with independent bedside devices.

The M2376A is not intended for monitoring purpose, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The Hewlett Packard M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

The provided text describes a 510(k) summary for the Hewlett Packard M2376A Device Link System. However, it does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

The document is a regulatory submission for a device that facilitates electronic data collection and clinical information management by converting data from external devices into the HL7 format. The FDA's response letter confirms substantial equivalence to legally marketed predicate devices.

Therefore, I cannot fulfill your request for the specified information based on the provided input. The input focuses on the device's intended use and regulatory approval, not on performance studies or acceptance criteria.

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Intended Use: The Model 3810A is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a health care professional at the authorized provider.

Indications for Use: The Model 3810A is indicated for patients at home, who are capable and willing self-administrate this device, upon prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction and other post cardiac events. The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information delivered.

The Hewlett-Packard (HP) Model 3810A telemedicine device provides a system for daily collection of weight, blood pressure and ECG used in the management of home care patients.

The main flow of information originates in the home where a patient uses a blood pressure unit, a scale and an ECG rhythm recorder on a daily schedule. Each of the units automatically reports their data wirelessly to a home Hub, which in turn relays the data using a standard modem over the telephone to a secure database. Health care professionals (such as physicians, nurses, and case managers) having approval for access use a secure log-on procedure to gain access to their patient's data. The provider follows up on any unexpected or undesired changes in the patient's data trends with a phone call.

The home Hub incorporates a receiver, an embedded processor with memory, a standard modem and an automatic dial up module. It is designed so that its operation does not interfere with normal use of the phone including an answering machine. Its connections are identical to those of an answering machine, consisting of a standard wall power plug and a daisy chain phone connection. The installation and use of the home Hub poses no significant risk to the patient or other people within the patient's home.

The data forwarded through the home Hub arrives though a standard modem contained in the HP system server. This server is separate from the Telemedicine PC in the clinic and is programmed to decode the data from the home units. The system design provides for data security.

This document, a 510(k) submission for the HP Model 3810A Telemedicine System, primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices and ensuring electrical safety standards are met. It does not contain information regarding detailed acceptance criteria for clinical performance, nor does it describe a study to prove the device meets such criteria.

Therefore, I cannot populate the requested table and sections regarding clinical performance, sample sizes, ground truth, experts, adjudication, or MRMC studies from the provided text.

The "Performance Data" section (E. Performance Data) only mentions electrical safety testing:

E. Performance Data

The M3810A patient units- the M3813A Scale Unit, the M3815A Blood Pressure Unit, and the M3816A Rhythm Strip Recorder Unit- have been tested for electrical safety and has received a certificate of compliance with IEC 60601-1:1988 +A1:1991 +A2:1995 and FCC Part 15.

This indicates that the primary "acceptance criteria" presented in this document relate to electrical safety and regulatory compliance, not clinical performance of the telemedicine system's ability to accurately manage patient data or improve outcomes.

Here's a breakdown of what can be extracted or inferred based on the document's content, and what cannot:

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

   • Acceptance Criteria (Safety/Regulatory): Compliance with IEC 60601-1:1988 +A1:1991 +A2:1995 and FCC Part 15.
   • Reported Device Performance (Safety/Regulatory): "received a certificate of compliance."
   • Clinical Performance Acceptance Criteria: Not specified in the provided text.
   • Clinical Performance Reported Performance: Not specified in the provided text.

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

   • For electrical safety: Not specified (generally not applicable for safety compliance testing in the same way it would be for clinical performance).
   • For clinical performance: Not specified. No clinical test set is mentioned.

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):

   • Not specified, as no clinical performance test set is described.

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

   • Not specified, as no clinical performance test set 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 MRMC study is mentioned. The device is a "telemedicine system" for data collection and transmission, not an AI-based diagnostic tool for interpretation by human readers.

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

   • No standalone performance study for an algorithm is mentioned. The device's function is described as collecting and transmitting data, with "Clinical judgement and experience are required to check and interpret the information delivered." This explicitly states a human-in-the-loop is required for interpretation, implying no standalone diagnostic algorithm.

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

   • Not specified, as no clinical performance study is described.

8. The sample size for the training set:

   • Not applicable/Not specified. The document does not describe an AI/ML algorithm requiring a training set for clinical performance.

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

   • Not applicable/Not specified.

In summary, this 510(k) submission demonstrates the device's safety and regulatory compliance based on testing to electrical standards. It does not provide an analysis of clinical performance or effectiveness studies involving patients or healthcare professionals interpreting data, as these types of studies were likely not required for this particular type of device (a data collection and transmission system, not a diagnostic interpretation tool). The submission focuses on substantial equivalence to predicate devices for its intended use, which is facilitating data transmission.

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The Hewlett Packard External Pediatic electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device pediatric patient use, only. The M3503A & M3504A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the pediatic pationt and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum.)

The M3503A & M3504A Pediatric electrodes are designed for, and to be used, with the the Hewlett Packard Codemaster Defibrillator.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Hewlett Packard M3503A and M3504A Multifunction Pediatric Defib Electrodes" and mentions the indications for use, but it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

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The device is intended to provide ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in a professional healthcare facility. It is intended to be used by trained health care personnel. It is not intended for home use.

The indications for use of the Viridia Telemetry System are:

• Condition: The licensed clinician decides that the Viridia Telemetry System should be used to monitor the patient.
• Prescription vs. Over-the-Counter: The HP Viridia Telemetry System is a prescription device.
• Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in contact with the patient's skin. The SpO2 signal is obtained from an accessory sensor in contact with the patient's skin.
• Frequency of use: As prescribed by a licensed physician.
• Physiological purpose: To monitor the ECG or SpO2 of patients on the order of a licensed clinician.
• Patient Population: Adult and pediatric patients.

The HP M2600A Viridia Telemetry System is a radio frequency physiological signal transmitter and receiver. The modification in this submission is the addition of a battery extender to enable the operation of the transmitter from an external power source.

This 510(k) summary describes a modification to an existing medical device, the HP M2600A Viridia Telemetry System. The modification is the addition of a battery extender. The provided text does not contain specific acceptance criteria or a detailed study proving the modified device meets such criteria in terms of performance metrics. Instead, it emphasizes that the modified device has the "same fundamental technology" and "same intended use" as the legally marketed predicate devices, and that verification and validation activities were successfully conducted.

However, based on the information provided, we can infer the approach to demonstrating equivalence and safety, and address the specific points where information is available.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it states that "Pass/fail criteria were based on the specifications cleared for the predicate device and test results demonstrated substantial equivalence." This implies that the acceptance criteria for the modified device (with the battery extender) were alignment with the previously cleared specifications of the predicate device for parameters like ECG and SpO2 monitoring, and overall system functionality and safety.

Given the nature of the modification (a battery extender), the performance criteria would likely focus on:

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

The document does not specify a sample size for the test set. It mentions "system level tests, integration tests, safety testing... interference testing, and hardware testing." These are typically laboratory or bench tests, not clinical studies involving patient data to assess performance metrics like sensitivity or specificity.
Given that this is a modification adding a battery extender, the focus of the testing would be on the electrical, mechanical, and functional integrity of the device and its safety with the new component, rather than performance on patient data datasets. Therefore, there is no mention of country of origin or retrospective/prospective data as these are not relevant to the type of testing described for this modification.

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

Not applicable. This type of device modification (battery extender for a telemetry system) typically involves engineering and safety testing, not clinical performance evaluation against expert-established ground truth. Ground truth as typically defined in diagnostic AI/ML studies is not relevant here.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for comparing the diagnostic performance of human readers with and without AI assistance, which is not applicable to a modification involving a battery extender for a telemetry monitoring system.

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

No, a standalone algorithm performance study was not done. This device is a hardware system for physiological monitoring, not an AI/ML algorithm.

7. The Type of Ground Truth Used

Not applicable in the conventional sense of ground truth for diagnostic devices. The "ground truth" for the testing performed would be engineering specifications, performance standards, and safety regulations for telemetry systems.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training set" for the development of any device would implicitly be the engineering design and development process that leads to the device specifications and prototypes.

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

Not applicable for an AI/ML training set. For the development of the device itself (including the battery extender), the "ground truth" or foundational knowledge would be established through established engineering principles, industry standards (e.g., for electrical safety, EMI/EMC), and medical device regulations. Initial specifications would have been derived from the intended use and performance requirements of the predicate device.

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Indications: For central monitoring of multiple adult, pediatric, and neonatal patients. For monitoring cardiac arrhythmia of adult patients to gain information for addition of treatment, or to exclude causes of symptoms. For monitoring ST Segment of adult patients to gain information for addition of treatment, or to exclude causes of symptoms.

The modification is primarily a software based change that expands Remote Services Access capability to allow on-line troubleshooting while in the monitoring mode, and enhances both standalone and networking capabilities. Also, improvements were made to upgrade the hardware and operating system environments.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) summary and not a detailed clinical study report:

I. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Hewlett-Packard Viridia Information Software, Release B.01, does not detail specific, quantitative acceptance criteria common in clinical studies (e.g., sensitivity, specificity, accuracy thresholds). Instead, it focuses on demonstrating substantial equivalence to a predicate device (HP CentralVue Software, K964832) through verification, validation, and testing activities.

The acceptance criteria can be inferred as:

• The device performing according to the specifications established for the predicate device.
• Meeting performance, functionality, and reliability requirements.

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

The document does not specify a "test set" in the context of clinical data for performance evaluation (e.g., patient cases with diagnoses). The testing described is primarily software and system-level functional testing.

• Sample Size: Not applicable in the traditional sense of patient samples. The testing involved "system level tests, integration tests, environmental tests, and safety testing." The "Network Test Plan" for Remote Access Services was performed "under a variety of conditions and configurations," but specific numbers are not given.
• Data Provenance: Not applicable, as this was not a clinical study involving patient data. This was technical system testing.

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

• Number of Experts: Not applicable. The "ground truth" for this type of software/system testing would be the predefined functional specifications and expected outputs of the software and hardware system.
• Qualifications of Experts: If any "experts" were involved, they would likely be software engineers, quality assurance testers, and regulatory affairs personnel responsible for verifying compliance with specifications. Their specific qualifications are not listed.

IV. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The testing primarily involved verifying system functionality against predefined technical specifications, rather than adjudicating clinical interpretations. "Pass/Fail criteria were based on the specifications cleared for the predicate device."

V. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document describes technical verification and validation against a predicate device's specifications, not a study comparing human reader performance with and without AI assistance for tasks like arrhythmia detection or ST segment analysis.

VI. If a Standalone (algorithm only without human-in-the-loop performance) was done

• Standalone Performance: The core function of the "Viridia Information Software" is to provide information for monitoring. While the software has "standalone" capabilities (as described in point 4 of the 510(k) summary), the document does not present quantitative performance metrics (e.g., sensitivity, specificity for arrhythmia detection) as a "standalone algorithm" in isolation from a human observer. The validation focuses on the software's functionality within the existing monitoring system.

VII. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's validation was primarily predefined technical specifications (functionality, performance, reliability requirements) derived from the predicate device and internal engineering standards. For the Remote Access Services, the successful operation "under a variety of conditions and configurations" against its specific requirements served as its ground truth.

VIII. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a software update for an existing monitoring system, not the development of a novel machine learning algorithm that would require a "training set" of data.

IX. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as no training set for a machine learning algorithm is mentioned or implied.

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The HP M2331A CareVue 9000 is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by health care providers whenever there is a need for generation of a patient record and computation of drug dosage.

The Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System. The modification is primarily a software based change that expands access to more information data bases. Also, improvements were made to upgrade the hardware and operating system environments.

The provided text is a 510(k) summary for the Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System, seeking clearance from the FDA in 1999. This document is focused on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria in the manner one might expect for a new diagnostic or AI-powered medical device today.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs, expert involvement, and ground truth establishment is not present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The summary refers to "system level tests, integration tests, and safety testing from risk analysis," which typically involve internal testing and possibly simulated data rather than patient data from a specific country or collected retrospectively/prospectively.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Given the nature of a Clinical Information Management System (CIMS), "experts" might have been clinicians or IT professionals evaluating system functionality and data integrity rather than medical diagnosticians establishing ground truth for disease detection, which is not the primary function of this device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The CareVue 9000 is a Clinical Information Management System for data collection, storage, and management, not a diagnostic interpretation tool in itself.

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

• Standalone Performance: Not explicitly stated or in the context of an "algorithm only" performance as understood in AI/ML devices today. The device is a system with software, and its "performance" would be evaluated in terms of its functionality (e.g., data accuracy, accessibility, computational correctness for drug dosages), not standalone diagnostic accuracy.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated as "ground truth" in the modern sense (e.g., pathology, clinical outcomes). For a CIMS, the "ground truth" for its performance would likely relate to:
  • Data Integrity: Whether data is accurately collected, stored, and retrieved.
  • Functional Correctness: Whether computations (e.g., drug dosages) are performed correctly.
  • System Reliability: Whether the system operates as intended without errors or crashes.
  • This would be verified against system specifications and known correct computations/data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not specified. The CareVue 9000 is a rule-based or procedural software system, not an AI/machine learning device that requires a "training set" in the modern sense. Its development would involve software engineering and testing against requirements, not data-driven model training.

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

• Establishment of Ground Truth for Training Set: Not applicable/not specified, as there is no "training set" in the context of this device.

Summary of Device and Study Context for K992636:

The K992636 submission for the Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System is a premarket notification for a software-based change that expanded access to more information databases and upgraded hardware/operating systems. Its primary function is for data collection, storage, management of patient records, and computation of drug dosages.

The review process for this type of device in 1999 primarily relied on demonstrating substantial equivalence to existing predicate devices. This means the key argument was that the new device had the same intended use, technological characteristics, and performed safely and effectively as its predecessors. The "study" mentioned is general "Verification, validation, and testing activities" that included system-level tests, integration tests, and safety testing aligned with risk analysis. The acceptance criteria were based on the specifications of the predicate devices. This is a very different submission and review context compared to what would be required for a novel AI-powered diagnostic device today, which would necessitate rigorous clinical studies with detailed methodologies for ground truth, expert adjudication, and statistical performance metrics.

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The Hewlett Packard External electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable, single patient use, only. The M3501A & M3502A electrodes provide the conductive interface between and the defibrillator and/or the external pacing instrument. This device is intended for use on adult patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose classified as low power (360 Joule maximum.)

Multifunction Adult Defib. Electrodes Model Numbers M3501A/M3502A

The provided text is a 510(k) premarket notification approval letter for the Hewlett Packard M3501A/M3502A Multifunction Adult Defibrillator Electrodes. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter acknowledges the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory compliance requirements. It details the device's indications for use: "external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable defibrillator and/or external pacing electrode." It specifies that the electrodes are for "single patient use, only" and "intended for use on adult patients," connecting to "defibrillators whose stored energy is classified as low power (360 Joule maximum)."

Therefore, I cannot provide the requested information based on the input text. The document is an FDA approval letter, not a study report.

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The HP M2376A Device Link System is indicated for use in data collection and clinical information management, either connected directly or through networks, with the independent bedside devices that are listed below;

• 1. IMED 1310 (PC-1) channel IV Pump
• 2. In-line Diagnostic HR Crit-Line Monitor
• 3. Newport Wave Ventilator

The Hewlett Packard M2376A DeviceLink System receives digital data frontuced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

When connected to a bedside device, the HP M2376A DeviceLink System is intended for electronic data collection and clinical Information management. DeviceLink is neither patient connected, nor does it remotely control the attached source device.

The provided document is a 510(k) summary for the Hewlett Packard M2376A DeviceLink System. It primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining marketing clearance from the FDA. It does not describe or contain a study proving the device meets acceptance criteria in the way typically expected for a medical device performance study (e.g., clinical trial data, analytical performance data with specific metrics like sensitivity, specificity, accuracy).

Therefore, based on the provided text, a table of acceptance criteria and reported device performance, information about sample sizes, ground truth, expert involvement, MRMC studies, or standalone performance studies cannot be extracted.

The document states:

• Device Function: The Hewlett Packard M2376A DeviceLink System receives digital data from external devices, converts that data into the HL7 format, and transmits that information to any networked Clinical Information System.
• Intended Use: When connected to a bedside device, the HP M2376A DeviceLink System is intended for electronic data collection and clinical information management. DeviceLink is neither patient connected, nor does it remotely control the attached source device.
• Predicate Device: The HP M1032A VueLink Interface Plug-in Module (K923682).
• Technological Characteristics: "The technological characteristics are the same or similar to those found with the predicate device, with the exception that neither waveforms, alarms, nor image data are transmitted in the DeviceLink System."

Conclusion based on the provided text:

This submission is a regulatory clearance document rather than a scientific study report. It focuses on the device's intended use, its functional similarity to a previously cleared device, and its regulatory classification. It does not provide the kind of detailed performance data and study design (acceptance criteria, sample size, ground truth, expert review, standalone performance, etc.) that would typically be associated with proving a device meets specific performance criteria through a dedicated study.

Therefore, the requested information cannot be filled out from the provided text.

If this were a different type of medical device (e.g., an AI-powered diagnostic tool), the 510(k) summary would typically include a section detailing analytical and/or clinical performance studies with the requested metrics. However, for a data communication system like the DeviceLink, the primary focus for regulatory clearance is often on functional equivalence and safety (e.g., no adverse control of connected devices, proper data transmission format).

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Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Musculo-skeletal Conventional, Musculo-skeletal Superficial, Small Parts (small organ), Peripheral Vascular. Diagnostic Ultrasound System: Fetal, Abdominal, Pediatric, Small Parts I (small organ), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

This premarket notification describes modifications to the ImagePoint M2410A system. It adds two new intended uses to the operating platform covering Musculo-Skeletal and Adult Cephalic (Transcranial Doppler) imaging. It adds harmonic imaging mode for the following applications: fetal, abdominal, pediatric, adult cephalic and cardiac. Hewlett-Packard considers Harmonic imaging to be a subset of 2D / B-mode imaging. This premarket notification also adds a transducer with new patient contact materials indicated for musculo-skeletal, vascular and small parts imaging. The classification names for these devices are: Diagnostic Oltrasound Transducer, Ultrasonic Pulsed Echo Imaging System and Ultrasonic Pulsed Doppler Imaging System. The modification involves expanded intended uses to the M2410A system, as well as, the addition of a new transducer with new patient contact materials, to be known as the HP 21376A Transducer. The ImagePoint system, with new platform modes, new indications for use, and new transcucer, functions in the same way as its predicate devices, the M2410A K954028), M2424A (K964309 and K980687) and the Acuson Aspen System, with L7 probe, (K973079) by allowing ultrasound imaging of the humar anatomy. The subject platform and transqucer have the same functionality and intended uses as their bredicates. The M2410A platform and HP 21376A transducer on the M2410A are similar to the predicate devices in all respects except the transducer has new patient contact materials. This 510(k) Notification includes biocompatibility test results that demonstrate biocompatibility of the new materia s.

This document describes the 510(k) summary for modifications to the ImagePoint M2410A ultrasound system and a new transducer, the HP 21376A. The modifications include expanded intended uses for the platform and the addition of a new transducer with new patient contact materials.

1. Acceptance Criteria and Reported Device Performance

The provided text does not contain any specific acceptance criteria or reported device performance metrics for the ImagePoint M2410A system or the HP 21376A transducer. The document focuses on demonstrating substantial equivalence to predicate devices and expanding the indications for use.

The tables in the document (Diagnostic Ultrasound Indications for Use Form) primarily listed the "Mode of Operation" for various "Clinical Application" categories. The 'N' in the tables indicates a "new indication" and 'P' indicates "previously cleared by FDA". There are no numerical performance values or targets.

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

The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective or prospective data). The submission focuses on substantial equivalence based on the device's functionality and intended uses being similar to predicate devices. For biocompatibility, it states "biocompatibility test results that demonstrate biocompatibility of the new materials" were included, but details are absent here.

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

The document does not mention any ground truth establishment by experts for a test set. This type of study detail is not typically found in a substantial equivalence claim for an ultrasound device based on expanded indications and new transducer materials.

4. Adjudication Method for the Test Set

As there is no mention of a test set or ground truth establishment, there is no adjudication method described.

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

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information on how human readers' performance might improve with or without AI assistance, as this submission predates widespread AI integration in medical imaging and focuses on fundamental device capabilities and safety/equivalence.

6. Standalone (Algorithm Only) Performance Study

The provided text does not include information about a standalone (algorithm only) performance study. The device described is a whole ultrasound imaging system and transducer.

7. Type of Ground Truth Used

Given the nature of the 510(k) submission (primarily focusing on expanded indications, new transducer materials, and substantial equivalence to predicate devices), there is no explicit mention of ground truth types (e.g., expert consensus, pathology, outcomes data) in the context of device performance evaluation. The "ground truth" in this context would likely be implicitly tied to the established safety and effectiveness of the predicate devices for similar applications.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This type of information is relevant for AI/ML-based devices, which are not the focus of this 1999 ultrasound device submission.

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

As there is no mention of a training set, there is no information on how its ground truth was established.

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