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The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.

The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.

The Mediana V20, V20a, AVSM3 SNF vital signs monitors are a lightweight and compact device (249 x 211 x 176 (mm) (W×H×D) and 3.1 kg for Standard configuration) powered by AC mains (100-240VAC, 50Hz/60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 8″ TFT-LCD screen.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance for the Mediana V20, V20a, AVSM3 SNF vital signs monitors.

Important Note: The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary. These documents primarily focus on demonstrating substantial equivalence to predicate devices rather than providing detailed, standalone clinical study results for the new device. As such, direct answers to some of your specific questions (like sample sizes for specific new studies, number of experts for ground truth, or MRMC studies) are not explicitly present. The manufacturer is leveraging data from previously cleared devices and relying on the substantial equivalence principle.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for the new devices (V20, V20a, AVSM3 SNF) with corresponding reported performance. Instead, it relies on the concept of substantial equivalence to predicate devices. The implicit acceptance criterion is that the new devices should perform equivalently to the cleared predicate devices according to established standards.

The performance characteristics are stated as:

• Non-Invasive Blood Pressure (NIBP), Pulse Rate (PR), Pulse Oximetry (SpO2), and Temperature (TEMP): The device's specifications and performance for these parameters are stated to be equivalent to the respective predicate devices.

Table of Acceptance Criteria (Inferred from Substantial Equivalence to Predicates):

Study Details:

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

   • The document does not provide specific sample sizes for new clinical test sets for the V20, V20a, AVSM3 SNF devices.
   • It states that for NIBP, "The clinical studies which were carried out by SunTech and AND companies were used to support different NIBP modules of the subject device under their original 510(k) submissions, and that Mediana has licensed the two NIBP modules for use in the subject device." This indicates that clinical data from the original predicate device manufacturers (SunTech and AND) are being leveraged. The provenance of that data would be tied to those original submissions, but it's not detailed here. For other parameters (SpO2, PR, Temp), it simply states equivalence, implying reliance on the predicate device's performance data without necessarily conducting new clinical trials for the Mediana V20 series.
   • The document mentions "system V & V plan #MDR-EG160311-01" for performance testing, which is likely a combination of bench and possibly some limited clinical testing, but specifics are absent.

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

   • This information is not provided in the document. Given the reliance on predicate device data and bench testing, direct ground truth establishment for a new clinical test set (as would be typical for an AI/algorithm-focused submission) doesn't seem to be the primary method for this 510(k).

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

   • This information is not provided as there's no detailed description of a new clinical test where expert adjudication would be relevant for these types of vital signs measurements.

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 was not done. This type of study is typically performed for AI-powered diagnostic imaging devices. The devices in this submission (vital signs monitors) measure physiological parameters directly and do not involve "human readers" interpreting an AI output in this context.

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

   • The devices perform automated measurements (NIBP, SpO2, PR, TEMP). The "performance" described is inherently standalone, as the device calculates and displays these values. However, "standalone performance" in the context of AI usually refers to the algorithm's output before human review. For these vital signs monitors, the measurement algorithm's performance is the device's performance. The document states the "specifications and performance are equivalent" to predicates, implying their algorithms produce comparable results.

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

   • For such vital signs monitors, the "ground truth" for NIBP, SpO2, PR, and TEMP typically involves direct, invasive, or highly accurate reference measurements (e.g., invasive arterial line for NIBP, co-oximetry for SpO2, EKG for PR, highly accurate reference thermometers for TEMP). The document doesn't explicitly detail the ground truth methods used for the predicate studies it references.

7. The sample size for the training set:

   • This information is not provided and is generally not applicable in the same way it would be for AI/ML-based devices. Vital signs monitors often rely on traditional signal processing algorithms rather than machine learning models that require distinct training sets. Even if there were some adaptive algorithms, training set details are not mentioned.

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

   • This information is not provided, as details about a "training set" in the context of this device are absent.

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V2 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "V2 OTC Pain Relief TENS" device (K182767) does not contain the detailed information necessary to answer your request.

The letter is a standard FDA clearance document. It confirms that the device is substantially equivalent to a predicate device and outlines general regulatory provisions. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, or types of studies conducted (e.g., test set, training set).
• Information on expert establishment of ground truth, adjudication methods, or MRMC studies.
• Specifics on standalone algorithm performance or the type of ground truth used.

For a medical device like a TENS unit, the primary "study" proving it meets acceptance criteria for substantial equivalence typically involves demonstrating that its technological characteristics (e.g., electrical stimulation parameters, waveform, output intensity) are substantially equivalent to a legally marketed predicate device, and that it performs as intended for its indicated use (temporary pain relief). This is usually supported by:

• Bench testing: To confirm electrical output specifications.
• Performance testing: To ensure it functions as described.
• Biocompatibility testing: If applicable, for patient contact materials.
• Electrical safety and EMC testing: To comply with relevant standards.

The letter itself does not detail these specific tests or their results, nor does it refer to studies involving AI, image analysis, or complex algorithms that would require the kind of detailed information about ground truth, expert consensus, MRMC studies, or training/test sets that you are asking for. Your questions are highly relevant for AI/ML-based medical devices, but this document pertains to a traditional electrical stimulation device for pain relief.

Therefore, I cannot populate the table or answer the specific questions about the study design using the provided text.

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The V2K Rinspiration System is intended to infuse physician specified fluids and remove/aspirate fluid, fresh, soft emboli and thrombi from the peripheral vasculature.

The V2K Rinspiration System is comprised of the V2K Rinspiration Catheter and two accessory components; an Infusion Syringe and a Filter Line. The V2K Rinspiration Catheter is a multi-lumen catheter that has infusion holes located near the distal end of the catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. Simultaneous infusion and aspiration can be performed through these lumens to perform fluid mechanical thrombectomy to remove fluid, fresh, soft emboli and thrombi from peripheral vasculature. The Rinspiration Catheter will be placed in the target vasculature of a patient over an 0.014" guide wire. The V2K Rinspiration Catheter uses a rapid exchange (a.k.a. rail) configuration for the guidewire lumen. The Rinspiration catheter distal tip will be positioned at the intended treatment site. Infusion occurs approximately 1 to 2cm proximal to the distal tip. The catheter includes a smaller radiopaque marker band at the distal tip and two larger radiopaque marker bands designating the infusion portion of the catheter. The catheter has a V-hub on the proximal end that allows access to the infusion and aspiration lumens. Included in the same packaging as the V2K Rinspiration Catheter is a 12cc Infusion Syringe with an attached check valve. The Infusion Syringe is intended to be used for infusing physician specified fluids through the V2K Rinspiration Catheter. The V2K Rinspiration Catheter will also be supplied with an accessory Filter Line which is intended to be used to connect the catheter to a continuous vacuum source such as an aspiration pump or hospital vacuum line. The Filter Line has two connections, one male Luer and one slip-fit connector. The male Luer is connected to the aspiration lumen of the V2K Rinspiration Catheter. The slip-fit connector is connected to the continuous vacuum source. The Filter Line also has an in-line flow control switch and an in-line filter. The in-line flow control switch is used to open/close the connection between the continuous vacuum source and the aspiration lumen of the catheter. This allows the user a simple method to manage the aspiration flow. The in-line filter is used to collect any debris that is aspirated through the catheter and allows the user to clearly visualize what has been aspirated. This also allows for temporary storage, inspection, analysis, transport and / or disposal of the aspirated materials.

The provided document is a 510(k) Summary for the V2K Rinspiration System, outlining its substantial equivalence to a predicate device. It details various performance tests conducted for this medical device, which is an embolectomy/infusion catheter.

However, the questions posed (related to acceptance criteria and study data for an AI/ML powered medical device) are not applicable to the content of this document. This submission does not describe an AI/ML powered device, nor does it contain information about clinical studies with human readers, ground truth establishment by experts, or training/test sets for an algorithm. It focuses on the physical and biological performance characteristics of a catheter system.

Therefore, I cannot extract the requested information from the provided text as it pertains to a different type of medical device and regulatory submission.

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The Viora V20 system is intended for dermatological procedures.

The V-ST Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The V-IPL Handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of: Moderate inflammatory acne vulgaris.

Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). Cutaneous lesions including warts, scars and striae.

Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte and venous malformations. Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The V-Form Handpiece (with BC and FC applicators) is indicated for delivering non thermal RF combined with massage: relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.

The Viora V20 system is a RF and IPL multi application platform with three available treatment Handpieces:

V-ST Handpiece - Bi polar radiofrequency (RF) Handpieces

V-IPL Handpiece - Intense Pulsed Light (IPL) Handpiece

V - Form Handpiece (with BC and FC applicators) - mechanical vacuum massage and Bi-polar radiofrequency (RF) Handpiece.

The Main Unit (console) provides the operational and safety function of the system. The operator can modify the treatment parameters to achieve specific tissue effects depending on individual patient's skin condition and anatomical structure. The Foot Switch is used for system activation.

The provided text does not contain acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) premarket notification for the Viora V20 System, a multi-application RF and IPL device for dermatological procedures. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting performance data from a new study against defined acceptance criteria.

Here's why the requested information cannot be extracted and what is described instead:

• Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or report corresponding performance metrics for a new study. Instead, it argues for substantial equivalence by stating that the current device has "the same technological characteristics and the same performance characteristics" as its predicate devices, or that "no new safety or efficacy issues can be raised."
• Sample Size and Data Provenance: No new study data is presented, so there is no mention of sample size for a test set or data provenance.
• Number and Qualifications of Experts: No experts were used to establish ground truth because no new clinical study data is presented for performance evaluation.
• Adjudication Method: Not applicable, as no new study requiring ground truth establishment is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a 510(k) for a physical medical device, not an AI/ML diagnostic or assistive tool that would typically involve human-in-the-loop studies.
• Standalone Performance: Not applicable. The device is a physical system (RF and IPL handpieces) and not an algorithm/software with standalone performance metrics in the typical AI sense.
• Type of Ground Truth: Not applicable, as no new performance study data is presented.
• Sample Size for Training Set: Not applicable. This refers to an AI/ML training set, which is not relevant to this device's submission type.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does state regarding "proof" and "performance":

• Substantial Equivalence: The core argument is substantial equivalence to predicate devices (Viora V20 system K142093 and Viora V10 system K150035). The manufacturer asserts that the V20 system with the V-Form Handpiece is "exactly the same" or has "the same technological characteristics and the same performance characteristics" as the cleared predicate devices, thus raising "no new safety or efficacy issues."
• Bench Testing: "Bench testing demonstrated that the V20 system (with the V- Form Handpiece) is as safe and effective as the cleared predicate devices." However, specific numerical results or acceptance criteria for this bench testing are not provided in this summary.
• No Clinical Studies Required: "Since the technological parameters of the Viora V20 system with the V- Form Handpiece are well within the parameters of the previously cleared V20 and V10 systems, Viora believes that animal and clinical studies are not required to determine the safety and efficacy of the V20 system with the V- Form Handpiece." This explicitly states that no new clinical study (which would typically generate performance data against acceptance criteria) was conducted or deemed necessary for this submission.
• Compliance with Standards: The V20 system complies with several IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-57), which demonstrate safety and essential performance through adherence to recognized international standards.

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The Viora V20 system is intended for dermatological procedures.

The V-ST Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The V-IPL Handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of:

• Moderate inflammatory acne vulgaris.
• Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
• Cutaneous lesions including warts, scars and striae.
• Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte and venous malformations.
• Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Viora V20 system is a RF and IPL multi application platform with two available treatment Handpieces:
V-ST Handpiece: Bi polar radiofrequency (RF) Handpieces
V-IPL Handpiece: Intense Pulsed Light (IPL) Handpiece
The Main Unit (console) provides the operational and safety function of the system.
The operator can modify the treatment parameters to achieve specific tissue effects depending on individual patient's skin condition and anatomical structure. The Foot Switch is used for system activation.

The provided text describes the Viora V20 System, a medical device, and its substantial equivalence to a predicate device (Viora V-total, K133837). However, the document does not contain the kind of detailed information typically found in a study demonstrating how a device meets specific acceptance criteria based on performance data.

Instead, this document is a 510(k) summary for the FDA, focusing on establishing substantial equivalence to a previously cleared device. It asserts that because the V20 system's technological parameters are "well within" the cleared Viora V-total system and the handpieces are "exactly the same," animal and clinical studies are not required to determine its safety and efficacy.

Therefore, many of the requested categories of information cannot be extracted from this document, as a standalone performance study with detailed acceptance criteria and results is not presented here.

Here's a breakdown based on the available information:

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

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

• Not provided. The document states that "animal and clinical studies are not required" to determine safety and efficacy due to technological equivalence. The mention of "performance testing" and "bench testing" does not specify sample sizes or data provenance.

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

• Not applicable / Not provided. Since clinical studies or specific performance evaluations with a "test set" and "ground truth" (in the typical sense of expert review of patient data) were deemed unnecessary for this 510(k) submission, this information is absent.

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

• Not applicable / Not provided. See point 3.

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:

• Not applicable. This device is an aesthetic and dermatological treatment system (IPL/RF), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

• Not applicable. This device is a physical system with handpieces for treatment, not an algorithm.

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

• Not applicable / Not provided. The basis for clearance relies on substantial equivalence to a predicate device, which implies that the prior device's established safety and efficacy serve as the "ground truth" for the current device's performance claims. No new, specific ground truth creation for the V20 system itself is detailed.

8. The sample size for the training set:

• Not applicable / Not provided. This document does not describe the development of a machine learning algorithm or an AI model that would require a training set.

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

• Not applicable / Not provided. See point 8.

In summary: The provided text is a regulatory submission focused on substantial equivalence. It asserts that the V20 system is substantially equivalent to a previously cleared device (Viora V-total K133837) due to identical intended use, indications for use, and handpiece technology, along with compliance with performance standards and positive bench testing. It explicitly states that clinical studies were not required for this determination, which means the detailed performance study information requested is not present in this document.

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The LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data. When integrated with the Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. I Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.

The V2.7 software for the LabSystem™ PRO EP Recording System is substantially similar to the currently commercialized software (V2.6a) with the difference that the V2.7 software runs on a Microsoft Windows 7 platform as compared to V2.6a which runs on a Windows XP platform. Other than the platform update, there are no changes to the LabSystem PRO EP Recording System software functionality. There are no changes to the fundamental scientific technology of the device nor are there any changes to the intended use. The LabSystem™ PRO EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient via ECG leadwires and catheters. It does not transmit alarms and does not have arrhythmia detection capabilities.

The Boston Scientific Corporation's K141185 submission for the LabSystem™ PRO EP Recording System V2.7 did not include a study with specific acceptance criteria and reported device performance in the form of a table for clinical metrics. Instead, the submission focused on software validation and substantial equivalence to previously cleared devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain a table of acceptance criteria with reported quantitative device performance for clinical outcomes or metrics. The submission states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System." However, these acceptance criteria and the specific results are not provided.

The device is a data acquisition and analysis tool, not one that generates a diagnostic output based on an algorithm or AI. Therefore, the concept of sensitivity, specificity, or similar performance metrics typically associated with AI/CAD devices is not applicable in this context. The "acceptance criteria" referred to are related to software functionality and safety standards compliance.

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

Not applicable. The submission describes internal software qualification and testing without mention of a distinct "test set" in the context of clinical data or patient samples. The testing would have been against software requirements and design specifications.

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

Not applicable. Ground truth, in the context of expert consensus or pathological diagnosis, is not relevant for this type of software validation, which focuses on the proper functioning of a data acquisition and display system.

4. Adjudication Method for the Test Set:

Not applicable for the reasons mentioned above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human readers interpret medical images or data. The LabSystem™ PRO EP Recording System is a data acquisition and display system, not a diagnostic interpretation tool in itself, though it facilitates physician analysis.

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

The device is a standalone algorithm/software in the sense that its operation doesn't inherently involve a human in real-time within its core function to generate data (it acquires and processes). However, standalone performance in the context of an AI/CAD system (e.g., sensitivity/specificity of an algorithm making a diagnosis) is not applicable here as the device's function is data acquisition and display, not automated diagnosis or interpretation. The system's performance revolves around its ability to accurately acquire, process, and display physiological data according to its specifications.

7. The type of ground truth used:

The "ground truth" for this device's validation would be its functional specifications (e.g., correct acquisition of ECG, intracardiac, and pressure data; accurate display; proper integration with CARTO™ 3). This is established through internal verification and validation against design documents and industry standards (IEEE, EN, IEC). It is not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:

Not applicable. The device is not a machine learning or AI algorithm that requires a "training set" of data to learn patterns. Its software is programmed based on defined rules and functionalities.

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

Not applicable, as there is no training set for this device.

Summary of Acceptance Criteria and Study from the Document:

The acceptance criteria for the LabSystem™ PRO EP Recording System V2.7 are primarily derived from compliance with regulatory standards and software development processes. The study that proves the device meets these criteria is the in-house software qualification and testing.

The key aspects of this validation include adherence to:

• Software Quality Assurance Plans (IEEE Standard 730-2002)
• Software Test Documentation (IEEE Standard 829-2008)
• Software Verification and Validation Plans (IEEE Standard 1012-2012)
• Software Requirement Specifications (IEEE Standard 830-1998)
• Software Unit Testing (IEEE Standard 1008-1987)
• EMC, Radiated emissions and Conducted emissions requirements (EN 60601-1-2:2007)
• Patient Leakage current (EN 60601-1:2005 - Section 19, Table IV, Type CF, 50uA)
• Medical Device Software - Software Life Cycle Processes (IEC 62304:2006)

The document explicitly states: "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System."

The primary goal of this 510(k) submission was to establish substantial equivalence to existing predicate devices (Bard LabSystem PRO EP Recording System K031000 and V2.6 Software K113811) for the V2.7 software update, which primarily concerned running on a new operating system (Windows 7 vs. Windows XP) without changes to core functionality or intended use. This implies that the safety and effectiveness were largely demonstrated by the predicate devices, and the updated software passed rigorous software lifecycle testing to ensure the new platform did not compromise those aspects.

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The V2F™ Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis or a failed previous spine surgery.

The V2F™ Anterior Fixation System is a temporary supplemental fixation device consisting of: thoracolumbar plates, cap screws, bone screws and instrumentation necessary for implantation of the system.

The V2FTM Anterior Fixation System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anteriorlateral approach. All implant components are manufactured from titanium alloy as specified in ASTM F136.

Here's an analysis of the provided text regarding the V2F™ Anterior Fixation System, focusing on acceptance criteria and supporting studies:

This submission is for a medical device (spinal fixation system), and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally related to mechanical performance and substantial equivalence to predicate devices, rather than diagnostic performance or algorithm efficacy which would involve the concepts of sensitivity, specificity, human readers, ground truth consensus, etc.

Therefore, many of the questions related to AI/algorithm performance (e.g., sample size for test set, experts, MRMC studies, standalone performance, training set) are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study referenced is based on mechanical testing according to ASTM F1717 standards. The specific tests performed were:

• Static compression bending
• Static torsion
• Dynamic compression bending

The conclusion drawn from these tests is that the V2F™ Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s). The predicate devices used for comparison are:

• InCompass Spinal Fixation System (K021564)
• Synthes Thoracolumbar Spine Locking Plate (TSLP) System (K020244)

Additional Information (Where Applicable)

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

   • Not Applicable (N/A): This is a mechanical device. The "test set" would refer to the number of physical samples of the device components subjected to the ASTM F1717 tests. This information (specific number of samples tested) is not detailed in the summary but would be part of the full test report. Data provenance (country, retrospective/prospective) is not relevant for mechanical testing of this nature.

2. 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):

   • N/A: Ground truth in the context of diagnostic or AI performance is not relevant for the mechanical testing of a spinal fixation system. The "ground truth" for mechanical testing is defined by the ASTM standards themselves and the physical laws governing material properties and structural integrity.

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

   • N/A: Adjudication methods are used to resolve discrepancies in human interpretations or classifications, typically in the context of diagnostic performance studies. This is not applicable to standardized mechanical engineering tests.

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:

   • N/A: MRMC studies are used for evaluating diagnostic imaging systems or AI algorithms with human readers. This device is a surgical implant.

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

   • N/A: This submission is for a physical medical device, not an algorithm or AI system.

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

   • N/A: As mentioned, ground truth in this context refers to the adherence to established mechanical testing standards (ASTM F1717) and the physical properties of the materials and design compared to predicates.

7. The sample size for the training set:

   • N/A: There is no "training set" as this is not an AI/machine learning device.

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

   • N/A: No training set exists.

Summary of Device Performance Determination:

The V2F™ Anterior Fixation System's acceptance criteria are centered on its mechanical properties and performance. The device is deemed to meet these criteria by demonstrating substantial equivalence to predicate devices through conformity to the ASTM F1717 standard for static compression bending, static torsion, and dynamic compression bending. The "study" is the mechanical testing conducted according to this recognized standard.

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The Bard LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data.

When integrated with the Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.

The V2.6 software for the LabSystem™ PRO EP Recording System is a bidirectional software interface that links the Bard LabSystem PRO EP Recording System with the Biosense-Webster CARTO 3 mapping/navigation system. The V2.6 software also incorporates the core recording system functionality of the released V2.4b software for the LabSystem PRO EP Recording System. The joint integrated solution provides a single repository for the resulting CARTO 3D electro-anatomical map and procedure information collected by LabSystem PRO EP Recording System. This interface will enhance the usability of the two systems when used in tandem. This will result in a workflow improvement, more streamlined data management, and simpler review of case details. The information will be shared via a network link using a BWI communication protocol.

The V2.6 software is intended for use with the LabSystem PRO EP Recording System (K031000). The LabSystem™ PRO EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient via ECG leadwires and catheters. It does not transmit alarms nor does it have arrhythmia detection capabilities.

This document is a 510(k) summary for the V2.6 software for the Bard LabSystem PRO EP Recording System, which is a programmable diagnostic computer used in electrophysiology procedures. The submission focuses on demonstrating substantial equivalence to predicate devices and does not contain details about specific acceptance criteria or a clinical study in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer the questions based on the provided text, highlighting what is not available:

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

   • Acceptance Criteria: The document states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System." However, the specific acceptance criteria (e.g., performance metrics, thresholds) are not detailed in this summary.
   • Reported Device Performance: No specific performance metrics or quantitative results are provided in this summary. The document focuses on demonstrating functional equivalence and adherence to standards.

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 available in the provided 510(k) summary. It describes "Software qualification" being performed "in-house," but does not specify sample sizes for testing or data provenance.

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 available. The document does not describe the establishment of ground truth by experts for a test set.

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

   • This information is not available. No adjudication method is mentioned.

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 is not applicable/not available. The device (LabSystem™ PRO EP Recording System software) is not an AI-assisted diagnostic tool that would typically undergo an MRMC study comparing human readers with and without AI. It's a data acquisition, display, and integration system.

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

   • Not explicitly applicable in the context of an "algorithm-only" performance as one might see for an AI diagnostic tool. The "software qualification" mentioned is an in-house verification and validation process for the software's functionality and integration capabilities. The device itself is a system for acquiring and displaying data for physician analysis.

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

   • This information is not available. The concept of "ground truth" as used in clinical performance studies is not detailed for this type of software verification. The testing would likely focus on functional accuracy (e.g., data transfer integrity, correct display of information, proper integration).

8. The sample size for the training set

   • This information is not available. This device's software (V2.6) for data acquisition and integration does not appear to involve a "training set" in the sense of machine learning algorithms. Its development and testing would involve traditional software engineering verification and validation.

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

   • This information is not available, as no training set (in the machine learning sense) is mentioned or implies.

Summary of what is available regarding "acceptance criteria" and "study":

• Acceptance Criteria Mentioned: The document states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System."
• Study Described: The core study mentioned is "Software qualification performed in-house." This is not a clinical study but rather a non-clinical verification and validation process.
• Standards Referenced for Software Development/Testing:
  • IEEE Standard 730-1995 Software Quality Assurance Plans
  • IEEE Standard 829-1983 Software Test Documentation
  • IEEE Standard 1012-1986 Software Verification and Validation Plans
  • IEEE Standard 830-1993 Software Requirement Specifications
  • IEEE Standard 1008-1987 Software Unit Testing
  • EN 60601-1-2:2007 EMC, Radiated emissions and Conducted emissions requirements
  • EN 60601-1:2005 Patient Leakage current (Section 19, Table IV, Type CF, 50uA)
• Conclusion of Study: The non-clinical testing confirmed the safety and effectiveness of each functional aspect of the system, supporting the claim of substantial equivalence to predicate devices based on "same Indications for Use, principles of operation, and the technological characteristics."

This 510(k) submission is for a software update to an existing electrophysiology recording system, primarily focusing on integration capabilities. The "study" referenced is standard software verification and validation, not a clinical performance study with "ground truth" and "readers" in the context of diagnostic AI.

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The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. They are intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The Esprit and V200 Ventilators are intended for use in either invasive or non-invasive applications.

The Esprit and V200 Ventilators with APRV Mode are intended for use for invasively ventilated adult and pediatric patients as prescribed by a physician

The intended use is the same as that of the predicate devices, except that the APRV Mode is for use on a subset of the patient population the original devices are cleared for (e.g. neonatal patients and non-invasive applications are excluded).

The Esprit and V200 Ventilators are microprocessor controlled, electrically powered, mechanical ventilators. This modification to the currently marketed Esprit Ventilator and V200 Ventilators is the addition of the APRV Mode.

The APRV Mode is an optional software upgrade. It is both a breath type and ventilation mode intended for invasively ventilated adult and pediatric patient populations. APRV enables the ventilator to deliver gas via an endotracheal tube or tracheostomy tube at two levels of pressure (Press High and Press Low), and allows for spontaneous or supported breathing at both levels.

The APRV Mode is activated via a software download through an I-button and is integrated into the Esprit and V200 Ventilators in the same way as other currently released software options. It can either be installed in the factory or in the field as an upgrade to existing Esprit and V200 ventilators. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn APRV on and off.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Esprit Ventilator and V200 Ventilator with APRV Option.

It's important to note that the provided text is a 510(k) summary and FDA clearance letter, which typically summarizes the validation rather than detailing the full study protocols and results. As such, some specific details like exact acceptance criteria or raw performance data might not be explicitly stated in quantitative terms.

Acceptance Criteria and Reported Device Performance

The document states that "performance testing and a clinical simulation were conducted and support the assertion that the APRV Mode does not raise any new questions regarding safety and effectiveness."

Since this is a 510(k) for an addition of a mode (APRV) to existing cleared ventilators, the acceptance criteria are generally focused on demonstrating that this new mode performs as intended and does not negatively impact the overall safety and effectiveness of the existing device. The performance is assessed against the established specifications and safety profile of the predicate devices.

Study Details

Due to the nature of the provided document (510(k) summary), many of the specific details for a full study report are not present. Information below is extracted or inferred from the text.

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

   • Test Set Size: Not explicitly stated. The document mentions "performance testing and a clinical simulation." For a ventilator, performance testing typically involves bench testing on a ventilator, and a clinical simulation usually involves scenarios or mock patients rather than a large cohort of real patients.
   • Data Provenance: Not specified. Given the context of performance testing and clinical simulation, it would likely be laboratory or in-house data rather than patient data from specific countries. It's prospective in the sense that the testing was conducted on the modified device.

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

   • Not specified. For performance and clinical simulations of a ventilator, the "ground truth" would be the expected performance according to engineering specifications, physiological models, and clinical guidelines. This would typically be established by internal engineering, clinical, and regulatory experts within Respironics.

3. Adjudication Method for the Test Set:

   • Not specified. Given the nature of performance testing and clinical simulation for a medical device's functional mode, adjudication methods (like 2+1 reads) typical for diagnostic image analysis are not directly applicable. Performance is usually assessed against predefined technical and clinical thresholds.

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

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or conducted as described. This type of study is more common for diagnostic imaging AI devices where human reader performance (with and without AI assistance) is being evaluated against ground truth. The current device is a ventilator with an added mode, not a diagnostic tool requiring reader interpretation in the same way. The evaluation focused on the device's functional performance and safety.

5. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

   • Yes, in essence. The "performance testing" and "clinical simulation" mentioned for the APRV Mode would constitute a standalone evaluation of the algorithm's (software's) performance within the ventilator system, independent of human interpretation or assistance during operation. The software's outputs (e.g., pressure, flow, volume delivery as per the APRV settings) are directly measured and compared against specifications.

6. Type of Ground Truth Used:

   • For performance testing: Engineering specifications, physiological models, and established clinical parameters for ventilation. These would define the expected output and behavior of the APRV mode under various simulated patient conditions.
   • For clinical simulation: Clinically acceptable ranges and responses as determined by medical professionals or established medical guidelines for ventilation.

7. Sample Size for the Training Set:

   • Not applicable / Not specified. This device is a software-controlled mechanical ventilator, not a machine learning or AI algorithm that 'learns' from a training dataset in the typical sense (e.g., image recognition). The "training" for such a system involves software development, coding, and internal validation against design specifications, not a dataset of examples.

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

   • Not applicable. As above, there isn't a "training set" in the sense of data used to train a machine learning model. The software's logic and behavior are designed based on established medical science, engineering principles for mechanical ventilation, regulatory requirements, and internal development methodologies. The "ground truth" during development and testing refers to what the device is designed to do and what it should achieve safely and effectively.

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The V200 Ventilator is a microprocessor-controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients as prescribed by a physician. The V200 Ventilator is intended for use in either invasive or non-invasive applications.

The IntelliTrak option provides new triggering and cycling functionality that is intended for use only with adult and pediatric patients in invasive applications.

The V200 Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The IntelliTrak Software Option will add a new triggering and cycling mechanism based on the equation of motion for the purpose of improving patient-ventilator synchrony. The IntelliTrak software option is activated and is integrated into the V200 in the same way as other currently marketed V200 software options. It can either be installed in the factory or in the field as an upgrade to existing V200 ventilators. The IntelliTrak option is added to the currently commercially released software version and instrument. Downloading this option will add a "button" to the Graphical User Interface (GUI), which is used to turn IntelliTrak on and off.

The provided text describes a 510(k) premarket notification for a modification to a ventilator device, the V200 Ventilator with IntelliTrak Option. The submission focuses on demonstrating substantial equivalence to a predicate device (the unmodified V200 Ventilator) based on bench performance testing and software verification/validation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The document doesn't explicitly list a table of acceptance criteria with specific numerical targets. Instead, it states that "bench performance testing was performed for the new option and performance was compared between the Respironics V200 with flow triggering set at 3 LPM and cycling set at 25% of peak flow and the Respironics V200 IntelliTrak option." This implies the acceptance criterion was that the IntelliTrak option performs comparably or acceptably in a bench setting to the predicate device's specified settings.

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

The document mentions "bench performance testing" but does not specify the sample size of these tests (e.g., number of test scenarios, duration of tests, number of physical devices tested). The provenance is implied to be internal testing ("Respironics California, Inc, policies and procedures") and is retrospective as it's part of a 510(k) submission showing the device meets certain standards before market approval. There is no information on the country of origin of the data beyond the company's location (Carlsbad, CA).

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

The document does not mention the use of experts to establish ground truth for the bench performance testing. The "ground truth" for this type of device modification would likely be the expected mechanical and physiological responses simulated during the bench tests, as defined by engineering specifications and potentially clinical guidelines.

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

There is no mention of an adjudication method, as the testing described is bench performance testing, not human-in-the-loop evaluation requiring expert consensus.

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 comparative effectiveness study was done or mentioned. This is a ventilator modification, not an imaging or diagnostic AI tool that would typically involve human "readers." The focus is on the device's operational performance.

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

The performance testing described is inherently "standalone" in the sense that it's testing the device's (or its software's) mechanical triggering and cycling functionality on a bench. There is no human intervention mentioned as part of the primary performance evaluation. The IntelliTrak option is an algorithm that modifies how the ventilator triggers and cycles breaths.

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

The "ground truth" implicitly used for the bench performance testing would be the expected and established mechanical and physiological responses of a ventilator under controlled conditions, based on engineering specifications and potentially industry standards for ventilator performance. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

The document does not mention a "training set." The IntelliTrak option is described as a software feature that provides new triggering and cycling functionality based on the "equation of motion." This suggests it's likely a model-based control algorithm rather than a machine learning algorithm that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established:
As no training set is mentioned or implied, this question is not applicable based on the provided text. The "ground truth" for the development of such an algorithm would be the principles of respiratory mechanics and the "equation of motion," which are established scientific and engineering principles.

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