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The retrieval net is intended for use in endoscopic retrieval of foreign objects, food bolus, tissue fragments and excised tissue such as polyps.

The EndoChoice Retrieval Net is a disposable, single-use sterile device comprised of a flexible wire cable and snare loop with net which can be extended and retracted form the flexible outer sheath using a three ring handle. Objects are retrieved by advancing the finger rings of the handle to open the retracted net. The net is then endoscopically manipulated over the foreign object, food bolus, tissue fragment or excised tissue, in which the finger rings of the handle are retracted to close the net once the article has been retrieved.

This document, a 510(k) premarket notification, describes the "EndoChoice Retrieval Net," a retrieval device intended for use in endoscopic procedures. The document aims to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Acceptance Criteria and Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device, the Roth Net® retriever product line (K122462). The core acceptance criterion is that the new device performs at least as safely and effectively as the predicate, based on comparable characteristics.

While a formal table of "acceptance criteria" with specific quantitative targets and reported performance isn't explicitly provided, the substantial equivalence table (Section 7.5) serves this purpose by comparing key characteristics of the new device to the predicate. The "reported device performance" is implicitly that the device meets or matches the predicate in the listed attributes.

Study Information:

1. Sample size used for the test set and the data provenance:
   The document does not describe a clinical performance study with a "test set" in the traditional sense of evaluating diagnostic accuracy or a specific outcome. Instead, it relies on non-clinical testing (sterilization, shelf-life, biocompatibility, and general performance testing) to demonstrate that the device functions as intended and is safe. No specific sample sizes for these tests are provided in the summarized information, nor is data provenance (country of origin, retrospective/prospective) for a clinical test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This submission does not involve a "test set" requiring expert ground truth in the context of diagnostic or interpretive performance. The non-clinical tests rely on established scientific methods and standards.

3. Adjudication method for the test set:
   Not applicable. There is no clinical "test set" or expert review process described for adjudication.

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:
   Not applicable. The device is a physical retrieval tool, not an AI-assisted diagnostic or interpretive product. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical instrument, not an algorithm, and intrinsically requires human operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests:

   • Sterilization and Shelf-Life: Ground truth is established by adherence to recognized international standards (ISO 11135:2014, AAMI ANSI ISO 11737-2:2009, AAMI ANSI ISO 11138-1:2006).
   • Biocompatibility: Ground truth is established by adherence to AAMI ANSI ISO 10993-1:2009.
   • Performance Testing: While details are not given, this would typically involve engineering tests against internal specifications or industry standards to confirm functional performance (e.g., net opening/closing, retrieval capability, material integrity).

7. The sample size for the training set:
   Not applicable. As this is not an AI/machine learning device, there is no "training set."

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set.

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The RescueNet 12-Lead (RN12L) System is a data transmission and reception system that provides the capability to receive 12-Lead ECG reports, other physiological data, patient demographic, and EMS agency information from authorized monitor/defibrillators and other patient care systems and route it to a receiving destination at a remote location for display on an Internet Browser. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

The proposed RescueNet 12-Lead is a software-only product. RescueNet 12-Lead is a web-based management system that uses a web browser to provide quick, easy access to 12-Lead records sent from ZOLL defibrillators, and physiological and patient data from other patient care systems. With RescueNet 12-Lead, users can view, distribute, close, add notes, and print 12-Lead records, and can search for Inbox and/or closed 12-Lead records, and run reports.

The provided text describes a 510(k) premarket notification for the "RescueNet 12-Lead" device, which is a software-only product designed for the transmission and reception of medical data. The application indicates that the device's substantial equivalence is based on its similarity to a predicate device, the Physio-Control LIFENET System (K102757).

Crucially, the provided document does not detail specific acceptance criteria or an explicit study that proves the device meets such criteria in terms of clinical performance. Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device through performance testing.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that "Extensive performance testing ensures that RescueNet 12-Lead performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications." This phrasing implies that the acceptance criteria are linked to achieving equivalence with the predicate device's established performance and functional requirements. However, the specific quantitative or qualitative acceptance criteria themselves are not enumerated in this document.

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

The document does not specify a test set sample size or its data provenance (e.g., country of origin, retrospective or prospective). The "performance testing" mentioned appears to refer to validation of the software's functionality and equivalence rather than a clinical study with a patient data test set.

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

Not applicable. The document does not describe a clinical study involving a test set that required expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a test set requiring adjudication.

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

No. The document does not describe an MRMC comparative effectiveness study or any effect size related to AI assistance for human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

The device is described as a "data transmission and reception system" for 12-Lead ECG reports and other data, intended for "diagnosis, disposition, and therapy decisions by qualified medical personnel." This indicates it's a tool for human review, not a standalone diagnostic algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not directly applicable in the context of a diagnostic algorithm here. The performance testing focuses on the software's ability to transmit and receive data accurately and reliably, rather than its ability to interpret medical data independently.

7. Type of Ground Truth Used:

Not applicable. The "performance testing" described in the document pertains to the software's ability to transmit and receive data, not to its diagnostic accuracy against a medical ground truth (like pathology or outcomes data).

8. Sample Size for the Training Set:

Not applicable. The device is a data transmission and reception system, not an AI/ML algorithm that requires a training set in the typical sense for image interpretation or diagnostic prediction.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through "extensive performance testing" of the software's functionality and its ability to act as a data transmission and reception system, similar to its predicate device. It does not contain information about clinical studies with specific acceptance criteria, test sets, ground truth establishment methods, or AI performance metrics as typically expected for diagnostic AI/ML devices.

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RescueNet Link is intended for use in the collection and display of data that is entered by a user (caregiver), or captured from specified medical devices or from a vehicle navigation system. RescueNet Link is indicated for use by health care providers whenever there is a need for collection and display of patient, care reporting and transport data.

The proposed RescueNet Link is a software-only product. The ZOLL RescueNet Link system is an Emergency Medical Services (EMS) data system that electronically captures and displays patient monitoring, charting and ambulance location and navigation system data within the ambulance and communicates it for display to other locations throughout the pre-hospital and inhospital system of care. The system is comprised of two computer hardware/software based components, MobileLink and FieldLink. Both components use general purpose, commercially available computers, networking and communications hardware combined with software supplied by ZOLL. The MobileLink component resides within each EMS ambulance where it collects, integrates and displays patient monitoring, care reporting and ambulance location and navigation data on a large, easy to read touch screen display. Patient, care and transport data collected by MobileLink are transmitted to a central FieldLink server via cellular/internet connections. This server provides a distribution point from which internet accessible web pages displaying the information collected within each ambulance can be viewed. The FieldLink server also provides each receiving hospital with web pages showing information about the MobileLink-equipped ambulances currently on route to the medical facility and monitoring and charting information about the patients they are transporting. RescueNet Link is non-alarming software.

The provided text is a 510(k) summary for the ZOLL RescueNet Link device, which is a software-only product for collecting and displaying patient, care reporting, and transport data in emergency medical services (EMS) settings.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific, quantified performance results. Instead, it makes a general statement about performance testing:

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

The document does not specify the sample size used for performance testing (e.g., number of cases, records, or patients). It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.

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 about the number of experts used to establish ground truth or their qualifications. Given that this is a data collection and display system, and not an AI-driven diagnostic tool, the concept of "ground truth" derived from expert consensus may not directly apply in the same way. The performance testing likely focused on the accuracy and reliability of data capture, transmission, and display compared to expected system behavior.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none). This information is typically relevant for studies where subjective interpretation or complex diagnostic decisions are involved.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic AI tools where human reader performance is being evaluated with and without AI assistance. The ZOLL RescueNet Link is described as a data collection and display system, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance Study

The document describes "Performance Testing" which indicates a standalone evaluation of the algorithm's functionality and specifications. However, it does not explicitly label it as a "standalone (i.e. algorithm only without human-in-the-loop performance) study." The device is a "software-only product" and the testing would assess its software features and functions.

7. Type of Ground Truth Used

The document implies that the ground truth for performance testing would be based on the expected functional requirements and performance specifications of the device, likely assessed against reference data or simulated scenarios to ensure accurate data collection, transmission, and display. It does not mention pathology, outcomes data, or expert consensus in the context of establishing ground truth for this device's performance.

8. Sample Size for the Training Set

As this device is a software system for data collection and display and not a machine learning or AI model in the sense of predictive analytics or image analysis, there is no mention of a "training set" in the document.

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

Since there is no mention of a training set, the method for establishing its ground truth is also not applicable or described.

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RescueNet ePCR is intended for the collection, storage and printing of patient data that is entered by a user (caregiver), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). RescueNet ePCR is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. RescueNet ePCR is indicated for use by health care providers whenever there is a need for generation of a patient record.

The proposed RescueNet ePCR is a software-only product. RescueNet ePCR is a medical data collection system used to collect, store and print patient data that is entered by a user (caregiver), or captured from specified medical devices, and is integrated into a patient care report (patient electronic medical record). RescueNet ePCR is non-alarming software that runs on a variety of commercial off-the-shelf hardware.

Here's an analysis of the provided text regarding the acceptance criteria and study for the RescueNet ePCR device:

Based on the provided FDA 510(k) summary for RescueNet ePCR (K103473), the information regarding acceptance criteria and a detailed study proving performance is very limited. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical performance study with specific acceptance criteria.

However, I can extract the relevant (and often limited) information and structure it according to your requested format.

Acceptance Criteria and Device Performance Study for RescueNet ePCR (K103473)

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. The document states "Extensive performance testing," but does not provide details on the number of cases, data points, or scenarios used in the testing.
• Data Provenance: Not specified. It's highly likely that this involved internal testing and validation by ZOLL Medical Corporation, but the country of origin of any test data or whether it was retrospective or prospective is not mentioned. Given the nature of a software-only device for data management, the "data" would likely refer to simulated scenarios, test cases, and possibly real-world data processed through the software.

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

• Not specified. The document does not describe the establishment of a "ground truth" in the traditional sense of a clinical diagnostic study. The testing likely focused on functional verification and validation (e.g., data input accuracy, report generation accuracy, integration with other devices), rather than diagnostic accuracy against a clinical gold standard.

4. Adjudication Method for the Test Set

• Not specified. This information is not relevant or not provided for the type of performance testing described in the summary.

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

• No. An MRMC study was not conducted or mentioned. The device is a data collection and management software, not a diagnostic imaging or interpretive device that would typically involve human readers evaluating cases.

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

• Yes, effectively. The device itself is a "software-only product." The performance testing described focuses on the software's ability to collect, store, and print data, and integrate with other medical devices. The evaluation is implicitly standalone in that it assesses the software's functionality and accuracy in its designed tasks. However, its intended use always involves a "user (caregiver)" for data entry and interaction.

7. The type of ground truth used

• Not explicitly defined as "ground truth" in the diagnostic sense. For functional validation of a data management system, the "ground truth" would likely be:
  • Defined specifications and requirements: The software must correctly perform actions as per its design.
  • Source data accuracy: Data received from medical devices or entered by users must be stored and presented accurately.
  • Output accuracy: Printed reports must accurately reflect the stored data.
  • Predicate device's known performance: The primary comparison is to a legally marketed predicate device, implying its performance serves as a de facto "ground truth" for what is acceptable.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device is a data collection and management system, not a machine learning or AI algorithm that typically has a "training set." Its development would involve traditional software engineering and testing methodologies.

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

• Not applicable. As there is no "training set" for this type of software, no ground truth was established for it.

Summary of the Study:

The document describes a performance testing study conducted by ZOLL Medical Corporation to demonstrate that RescueNet ePCR's "features and functions are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device (Philips Medical Systems IntelliVue Clinical Information Portfolio K100272)."

The study primarily focused on functional equivalence, safety, and effectiveness through internal performance testing. It aimed to prove that the proposed device performs the same intended uses and does not raise new questions of safety or effectiveness compared to the predicate. The details of this "extensive performance testing" such as specific methodologies, sample sizes (e.g., number of test cases, simulated data inputs), or detailed quantitative results are not provided in this 510(k) summary. The conclusion is a qualitative assertion that the testing demonstrates substantial equivalence.

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