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The NEUROVENT is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-PX is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P-TEMP is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP-IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-PTO is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The NEUROVENT-PTO-2L is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The BOLT(-DRILL) KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The DRILL KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The Tunneling KITs are indicated to provide a cranial access for catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The RAUMEDIC® NEUROMONITORING-SYSTEM consists of several different models of probes and probe catheters capable of performing one or several different functions:

• Models with a dedicated lumen can be used for drainage of cerebrospinal fluid (CSF).
• Models equipped with ICP sensors can determine the level and change in intracranial pressure (ICP).
• Models equipped with temperature thermistors can monitor intracranial temperature.
• Models equipped with fiber optic sensors can monitor partial tissue oxygen pressure (ptiO2).

The RAUMEDIC® NEUROMONITORING-SYSTEM is intended to be used in conjunction with previously cleared RAUMEDIC® EASY logO Monitor (K130529), RAUMEDIC® MPR2 logO DATALOGGER (K171666), RAUMEDIC® NPS3 (K103206) or RAUMEDIC® NPS2 X (Brand name for NPS2 cleared in K103206).

The RAUMEDIC® NEUROMONITORING-SYSTEM includes components needed to facilitate the surgical implantation of NEUROVENT® catheters.

The RAUMEDIC® NEUROMONITORING-SYSTEM can be used in MR environment under specific constraints (MR conditional). Those constraints vary by device type, implantation method (bolting or tunneling), and magnetic field strength (1.5 or 3.0 Tesla).

The provided FDA 510(k) clearance letter for NEUROVENT Devices does not contain the specific details required to describe the acceptance criteria and the study that proves the device meets those criteria, particularly for performance metrics.

The document primarily focuses on:

• Device Identification: Listing all device names, regulation numbers, classification, and product codes.
• Regulatory Equivalence: Stating that the device is substantially equivalent to previously cleared predicate devices based on intended use, indications for use, and technological characteristics.
• Intended Use/Indications for Use: Detailed descriptions of what each NEUROVENT component is used for (e.g., ICP monitoring, CSF drainage, brain temperature, tissue oxygen partial pressure).
• MR Safety Testing: A list of ASTM and ISO/TS standards used to confirm the device's MR conditional status, along with the specific tests performed (magnetically induced displacement force, torque, image artifacts, heating, malfunction for various fields).

Crucially, the document explicitly states: "Based on performance testing and the available information concerning the referenced comparison devices, the RAUMEDIC® NEUROMONITORING-SYSTEM is equivalent in that: - The devices have the same intended use and indication for use. - Performance characteristics are suitable for designated indications for use."

However, it does NOT provide:

• A table of specific numerical acceptance criteria (e.g., ICP accuracy within X mmHg, temperature accuracy within Y °C, ptiO2 accuracy within Z mmHg).
• The reported device performance metrics against those criteria.
• Details about the "performance testing" beyond the MR safety tests. This implies that the performance characteristics (accuracy, precision, etc., for measuring ICP, temperature, ptiO2) were either derived from the predicate devices, established using bench testing, or considered suitable without presenting detailed clinical performance data in this 510(k) summary. Given the device type, it's highly likely a combination of bench and possibly animal/cadaveric testing, as well as reliance on the long-established performance of similar predicate devices, was used.
• Information about clinical study design. There is no mention of human subject data, test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies. The phrases "anticipated clinical performance" and "does not raise new issues of safety or effectiveness" suggest reliance on the substantial equivalence principle rather than novel clinical trial data.

Therefore, based solely on the provided text, I cannot complete the requested information for acceptance criteria and the study proving the device meets them, beyond the MR safety aspects.

I will indicate "Not provided in the document" for sections where the information is missing.

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)

• Sample Size for test set: Not provided in the document. The document primarily refers to "performance testing" and "MR safety requirements" being "tested and confirmed" to meet standards, rather than a clinical test set from human subjects.
• Data provenance: Not provided. The MR safety tests are likely laboratory-based.

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 applicable/Not provided. The document does not describe a study involving expert-established ground truth for performance evaluation of vital sign monitoring. The evaluation methodology focuses on substantial equivalence and laboratory testing for MR compatibility.

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

• Not applicable/Not provided.

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 a monitoring system and a kit for surgical access, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. The performance evaluation discussed pertains to the physical and functional aspects of the hardware (catheters, sensors, and their compatibility with MR environments), not a standalone algorithm.

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

• For the MR safety testing, the "ground truth" would be established by the specifications and measurement techniques defined in the referenced ASTM and ISO/TS standards.
• For the core physiological measurements (ICP, temp, ptiO2), the "ground truth" would typically refer to the accuracy of the sensors against calibrated reference standards in laboratory or animal models. This specific detail is not provided, but it's implied compliance with recognized industry standards or internal validation that is deemed "suitable for designated indications for use" and "equivalent."

8. The sample size for the training set

• Not applicable. The document does not describe the use of machine learning or AI, and therefore, no "training set."

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

• Not applicable.

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The RAUMEDIC® MPR2 is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure, temperature as well as to determine the partial oxygen pressure ptiO2 of the interstitial fluid.

The MPR2 is a small bedside monitor for measuring, displaying and monitoring of physiological parameters in the human brain which is used only in conjunction with RAUMEDIC ® -catheters. Analog signals can be relayed to a series-connected bedside monitor via its 2 analog outputs. Optionally, the device can be operated in stand-alone mode. The power is supplied by either the internal rechargeable battery or by an external, medically approved wide range wall plug transformer.

The MPR2 is a diagnostic device with physiological limit value monitor for measuring, displaying and monitoring the following physiological parameters: oxygen partial pressure (pO2), intracranial pressure (ICP) and brain temperature (T). These parameters are determined exclusively by connecting RAUMEDIC® catheters for single channel ICP measurement or with RAUMEDIC® multi-parameter catheters for combined measurement of ICP, pO2 and temperature (thermistor-based with YSI400 characteristic) or combinations derived from them such as pO2 and temperature. Optionally the pO2 and ICP signals can be relayed via the 2 analog outputs to a bedside monitor with limit value monitoring.

The provided document is a 510(k) Premarket Notification from the FDA regarding the RAUMEDIC® MPR2 logO DATALOGGER. This document is focused on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a performance study against a defined set of acceptance criteria for a new AI/Machine Learning device.

Therefore, many of the typical acceptance criteria and study design elements requested for an AI/ML device (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.) are not present in this type of regulatory submission.

Instead, the document focuses on:

• Intended Use/Indications for Use: Comparing the intended use of the new device to predicates.
• Technological Characteristics: Comparing features, materials, and form/function.
• Performance Testing: Stating that "extensive performance testing" was conducted and results showed the device is "safe for its intended use," but without providing specific test data, methodologies, or acceptance criteria in the format typically used for AI/ML device validation. The performance parameters listed in Table 1 (Accuracy of ICP Measurement, Temperature Measurement, etc.) are characteristics of the device itself and are compared to the predicate devices, serving as a form of "acceptance criteria" for substantial equivalence.

Given this context, I will extract the information that is available and clearly state what information is not present.

Acceptance Criteria and Device Performance (Derived from Substantial Equivalence Comparison)

The acceptance criteria are not explicitly stated as pass/fail thresholds in the traditional sense for a de novo device. Instead, they are implied through the comparison to predicate devices, where the new device's performance characteristics must be "substantially equivalent" or better. The reported device performance is listed alongside the predicate devices.

Table 1: Device Performance Comparison (Acting as Acceptance Criteria Check)

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The RAUMEDIC® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concem.

Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.

The RAUMEDIC® -PTO-Monitoring-System determines the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors, in temperature using thermistors, and in partial oxygen pressure ptiO2 using a luminescence optical sensor fibre.

The PTO-Monitoring-System consists of intracranial catheters, a cranial bolt kit, the user interface unit (EASY logO), cables to connect the catheters to the EASY logO and cables for the EASY logO to send the measurements to specific patient monitoring units.

Three intracranial catheters are provided: NEUROVENT®-PTO, NEUROVENT® TO and NEUROVENT® PTO 2L. The NEUROVENT®-PTO measures three physiological parameters - ICP, temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO). The NEUROVENT -PTO 2L also measures these three parameters, but has to be placed with a multi lumen Bolt (BOLT KIT PTO 2L) or via tunneling process. The NEUROVENT® TO measures two physiological parameters – temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO).

The NEUROVENT®-PTO or the NEUROVENT®-TO is implanted in the parenchyma using a BOLT KIT PTO. The NEUROVENT®-PTO 2L is implanted in the parenchyma using a BOLT KIT PTO 2L or using a RAUMEDIC® spliceable tunnelling sleeve CH8 (already cleared for market under 510(k) K112017).

For connecting the catheters to the EASY logO two cables – cable PTO and cable LWL - are needed. The cable PTO transfers the electrical signal for ICP and temperature. The cable LWL transfers the optical signal for oxygen pressure.

The EASY logO is the user interface that displays the measurements and alerts the user to the status of the intracranial catheters. The EASY logO displays: oxygen partial pressure pO2, intracranial pressure ICP, pulse amplitude ICPA and temperature T. ICP is a pulsatile signal that consists of the ICP average value and a pulsatile ICPA component, which is superimposed over the ICP average value.

DATALOGGER cables allows the EASY logO to send the measurements to specific patient monitoring units.

The provided text describes the RAUMEDIC® -PTO-Monitoring-System and its performance testing to demonstrate substantial equivalence to previously cleared devices. It does not contain information about a study proving the device meets explicit acceptance criteria in the format requested. However, it does provide performance specifications and comparison to predicate devices, which serve as a de facto set of acceptance criteria for regulatory clearance.

Here’s a summary of the available information, fitted to the request structure where possible.

Device Name: RAUMEDIC® -PTO-Monitoring-System

Intended Use: Measures intracranial pressure (ICP), temperature, and oxygen (ptiO2) as an adjunct monitor of trends, indicating perfusion status of cerebral tissue local to sensor placement. Not for use as the sole basis for diagnosis or therapy. For use in children at least one year old.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance specifications of the predicate devices and relevant standards (ANSI/AAMI NS 28:1988/(R) 2006 for ICP, ASTM E1112-00 (2006) for Temperature, and comparison to K980380 for ptiO2). The tables provided (Table 5, Table 6, and Table 7) list the performance testing and results, demonstrating that the device meets these established comparables.

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The RAUMEDIC®-ICP-TEMP-Monitoring-System is indicated for use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the parenchyma and in the ventricle and cerebrospinal fluid drainage applications.

Use of the parenchymal and ventricular intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old.

The RAUMEDIC® catheters are MR Unsafe.

The RAUMEDIC® -ICP-TEMP-Monitoring-System determines the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors and temperature monitoring using thermistors.

The NEUROVENT®-TEMP IFD-S and NEUROVENT®-TEMP IFD-R are indicated for use in ventricular pressure and temperature monitoring and cerebrospinal fluid drainage applications. The NEUROVENT®-P-TEMP is indicated for use in parenchymal pressure and temperature monitoring.

The RAUMEDIC® -ICP-TEMP-Monitoring-System is composed of the following elements:

• NEUROVENT®-TEMP IFD-S
• NEUROVENT®-TEMP IFD-R
• NEUROVENT®-P-TEMP
• ICP-TEMP-Adapter
• ICP-TEMP-Adapter HP / Philips

The company Raumedic AG submitted a 510(k) premarket notification for their RAUMEDIC® -ICP-TEMP-Monitoring-System (K120252), an intracranial pressure and temperature monitoring device.

Here's an analysis of the provided information regarding acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device's technical specifications and compares them to predicate devices, rather than explicit "acceptance criteria" and "reported performance" of a clinical trial. However, we can infer some performance characteristics from the comparison tables. It's important to note that these are design specifications and bench test results, not clinical performance data in terms of diagnostic accuracy or patient outcomes.

2. Sample Size and Data Provenance for the Test Set

The submission does not describe a clinical study or a "test set" in the context of evaluation of diagnostic or predictive performance. Instead, it details "extensive performance testing" of the catheters and biocompatibility studies.

• Sample Size: Not specified in terms of number of devices or number of patient cases typically associated with a test set for clinical performance. The testing mentioned appears to be bench testing on the device itself.
• Data Provenance: The biocompatibility studies were conducted "per ISO 10993 standard." The performance testing of catheters also appears to be laboratory/bench-based. No mention of human patient data or country of origin for such data.
• Retrospective/Prospective: Not applicable as no clinical study or patient data test set is described.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. As no clinical study or test set involving human data is described, there's no mention of experts establishing ground truth for diagnostic or prognostic performance. The 'ground truth' for the device's technical specifications would be established against engineering standards and validated measurement techniques during the performance testing.

4. Adjudication Method for the Test Set

Not applicable. No test set involving human interpretation requiring adjudication is mentioned.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (intracranial pressure and temperature monitoring system), not a diagnostic algorithm that enhances human reader performance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical monitoring system, not a software algorithm that performs diagnostic analysis. It measures physiological parameters (ICP and temperature) directly, and its performance is assessed by comparing its measurements to established standards or other validated monitoring systems through bench testing or direct physical validation, not through an "algorithm only" study.

7. Type of Ground Truth Used

For the performance testing mentioned:

• Biocompatibility: Established by adherence to ISO 10993 standard, which involves a series of tests to evaluate the biological response to medical devices.
• Catheter Performance Testing: Ground truth would be established through engineering and metrological standards, using calibrated reference instruments to verify accuracy, stability, and range of pressure and temperature measurements. This is intrinsic to device design and validation.

8. Sample Size for the Training Set

Not applicable. The device is hardware-based, not an AI/ML algorithm that requires a "training set."

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

Not applicable. No training set is involved.

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The RAUMEDIC® -ICP-Monitoring-System ventricular is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. Use of the ventricular intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® catheters are MR Unsafe.

The RAUMEDIC® -ICP-Monitoring-System ventricular is composed of NEUROVENT® components, spliceable tunneling sleeves, and bolt and drill kits. The device is used for intracranial pressure monitoring and cerebrospinal fluid drainage applications, and is implanted in the ventricle using various methods.

Despite the user's request, the provided document does not contain the detailed information necessary to describe acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or multi-reader multi-case studies for a diagnostic AI device.

The document is a 510(k) summary for a medical device called the "RAUMEDIC® -ICP-Monitoring-System ventricular." This device is an intracranial pressure monitoring system, not an AI-powered diagnostic tool. The information provided is typical for a traditional medical device submission, focusing on:

• Device Identification: Name, applicant, contact, date.
• Device Description: Components (NEUROVENT® components, tunneling sleeves, bolt and drill kits).
• Intended Use/Indications for Use: Ventricular pressure monitoring and cerebrospinal fluid drainage, contraindications (children under one year old for the bolt kit), and MR safety status (MR unsafe).
• Substantial Equivalence: Comparison to predicate devices (K103206 and K062584).
• Testing: Mentions biocompatibility studies and performance testing to demonstrate safety and compliance with standards, but does not provide details on specific performance metrics, acceptance criteria, or study methodologies that would be relevant for an AI diagnostic device.
• Regulatory Classification: Class II, product code GWM.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details as they pertain to an AI diagnostic device, because the provided text describes a physical medical device for monitoring and fluid drainage, not an AI software.

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The RAUMEDIC® -ICP-Monitoring-System is indicated for use in parenchymal pressure monitoring. Use of the parenchymal intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® precision pressure catheters are MR Unsafe.

The RAUMEDIC® -ICP-Monitoring-System determines safely, quickly and accurately the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors. The Neurovent® - P and Neurovent® - P - C are indicated for use in parenchymal pressure monitoring. Both types of catheters are implanted in parenchyma via a RAUMEDIC® - Bolt Kit CH5. In addition to the catheter a zero point module NPS2 x is needed. "x" depends on the type of patient monitor available in the hospital - there are 20 different references. To the equipment also belongs an ICP-Temp-Cable and a NPS3 pressure display unit. The difference between the Neurovent® - P and the Neurovent® - P - C is that the housing material in the C-version is ceramic instead of titanium. The RAUMEDIC® -ICP-Monitoring-System is composed of the following elements: Neurovent® - P, Neurovent® P C, RAUMEDIC® - Bolt Kit (CH 5), RAUMEDIC® Drill Kit 4,5 mm (CH 5), ICP-TEMP-Cable, NPS2, NPS3.

The provided document is a 510(k) summary for the RAUMEDIC® -ICP-Monitoring-System, which describes the device, its intended use, and its substantial equivalence to a predicate device. While it mentions device testing, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or multi-reader studies.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported performance, nor can I detail the specifics of a study that is not present in the document.

However, I can extract what is mentioned about device testing and regulatory acceptance:

Key Takeaways from the Document Regarding Testing and Acceptance:

• Substantial Equivalence: The primary basis for acceptance is substantial equivalence to a legally marketed predicate device (Pressio® ICP MONITORING SYSTEM, K062584). This means the FDA determined the RAUMEDIC® system is as safe and effective as the predicate device.
• Biocompatibility: Studies were conducted per ISO 10993 standard, demonstrating the materials are safe for intended use.
• Performance Testing (Catheters): The two implantable catheters (Neurovent® P and Neurovent® P C) "were subjected to extensive performance testing." The results "showed that the catheter designs are safe for their intended uses." No specific performance metrics, acceptance criteria, or study details are provided.
• Safety Tests (NPS3): The NPS3 unit "underwent numerous safety tests, including testing to IEC 60601-1." No specific safety metrics or acceptance criteria are provided.
• Manufacturing Compliance: The manufacturing process complies with FDA and European Standards for medical devices.

Missing Information:

The document explicitly states that performance characteristics are "suitable for designated indications for use," but does not define these characteristics quantitatively (e.g., accuracy +/- X mmHg, drift rate, etc.) or provide a study demonstrating achievement of these criteria. Therefore, most of the requested points cannot be answered based on the provided text.

Specifically, the document does not include:

1. A table of specific acceptance criteria and detailed reported device performance for clinical accuracy or efficacy.
2. Sample sizes used for a "test set" (clinical data) or data provenance.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Any multi-reader multi-case (MRMC) comparative effectiveness study.
6. Detailed standalone (algorithm-only) performance results.
7. The type of ground truth used (beyond implying the predicate device's established performance).
8. Sample size for a training set (as this is a hardware device, not an AI/ML algorithm in the context of the questions).
9. How ground truth for a training set was established.

This is a typical scope for a 510(k) summary, which often relies on demonstrating equivalence through design, materials, and general performance testing rather than a de novo clinical trial with defined acceptance criteria and statistical power to show performance against those criteria.

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