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510(k) Data Aggregation
(63 days)
The nextaro® va. 15mm, 5um is indicated for the transfer and mixing of drugs contained in vials.
The nextaro® va, 15mm, 5μm is a sterile packaged vial adapter for single withdrawal of drug solutions with a single-use syringe via Luer adapter from drug vials or for one-time injection of a low-particle and sterile solution with immediate withdrawal of the prepared drug solution with a single-use syringe via Luer adapter from drug vials.
The provided text describes a 510(k) premarket notification for a medical device called nextaro® va, 15mm, 5µm. This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to a legally marketed predicate device (nextaro® va, K183187).
This type of submission focuses on demonstrating substantial equivalence rather than proving device performance against specific clinical acceptance criteria in the way an AI-powered diagnostic device would. Therefore, the information typically requested in your prompt regarding AI/machine learning device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document. This document describes a physical medical device (an intravascular administration set) and changes to its physical characteristics, not an AI or software device.
However, I can extract the information that is relevant to the "acceptance criteria" and "proof" provided within this regulatory context.
Acceptance Criteria and Study for nextaro® va, 15mm, 5µm
The "acceptance criteria" in this context refer to the performance standards and regulatory requirements that the modified device must meet to demonstrate its substantial equivalence to the predicate device and ensure its safety and effectiveness for its intended use. The "study that proves" the device meets these criteria is the performance testing conducted.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of a typical AI performance table (e.g., sensitivity, specificity), the "acceptance criteria" here are defined by various testing standards and the "reported device performance" is a general statement of compliance with those standards.
| Test Name | Testing Standard | Acceptance Criteria Implicitly Met | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Asssessment (e.g., Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Hemocompatibility, EO Residues) | ISO 10993 Series, ASTM F756, USP <151> | Device materials must be safe for patient contact and not cause adverse biological reactions (e.g., toxicity, irritation, sensitization, fever, hemolysis). EO residues must be within acceptable limits. Implicitly, the proposed device must show biocompatibility equivalent or superior to the predicate and meet the specific criteria outlined in the referenced standards for each test (e.g., no significant cytotoxicity, no sensitization, etc.). | "Pass," "Pass," "Pass," "Pass," "Pass," "Pass," "Pass" (from table, indicating compliance with the respective standards). Also, "The biocompatibility tests show that the subject device is biocompatible and can be regarded as substantially equivalent regarding biocompatibility." |
| Chemical Characterization (Leachables/Extractables) | ISO 10993-18 | Leachables and extractables from the device materials must be within safe limits and not pose a toxicological risk. | Not explicitly stated as "Pass" but implied by passing biocompatibility and risk assessment. |
| Reducing (oxidizable) ingredients | ISO 8536-4 | The device must not release substances that would act as reducing agents in the drug solution beyond acceptable limits. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Titration acidity or alkalinity | ISO 8536-4 | The device must not significantly alter the pH of the drug solution. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Residue on Evaporation | ISO 8536-4 | The device must not release an unacceptable amount of non-volatile residue into the drug solution. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| UV absorption of the extract | ISO 8536-4 | Extracts from the device should not show unacceptable UV absorption, indicating the presence of harmful or undesirable substances. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Detection of metal ions | ISO 8536-4 | The device must not release an unacceptable amount of metal ions into the drug solution. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Particulate contamination | ISO 8536-4 and USP <788> | The device must not shed an unacceptable number of particulate contaminants into the drug solution during use. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Filter Retention Rate | ISO 8536-4 | The filter must retain a specified percentage of particles of a given size. Specifically, "A retention rate of ≥80 % of particles with a size of ≥ 20 µm was confirmed for the subject device." This is compared to the predicate device, also meeting this criterion. | "Confirmed" to meet the ≥80% retention rate for ≥20µm particles. "The performance of the filters (retention) of the subject and predicate devices has been shown to be substantially equivalent." |
| Leakage / Tightness of the system | ISO 8536-4 / ISO 22413 | The device must maintain its integrity and not leak during use. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Tensile strength | ISO 8536-4 / ISO 22413 | The device components must withstand specified tensile forces without breaking. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Penetration Force | ISO 22413 (using a test procedure outlined in Annex B of ISO 8536-2) | The force required to penetrate the vial stopper must be within acceptable limits for user ease and safety. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Fragmentation Test | ISO 22413 | The device must not cause excessive fragmentation of the vial stopper during penetration. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Verification of the design specification for Transfer devices with housing | ISO 22413 | The physical design and dimensions must conform to specified requirements for safe and effective use. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Luer connector testing | ISO 80369-7 (test methods according to ISO 80369-20) | The Luer connector must meet international standards for secure and leak-free connection to syringes. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Retention Force | Internal performance standard | The device must securely attach to the vial and retain the syringe, preventing accidental detachment. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Transfer performance (practical transfer and residual volume) | Internal performance standard | The device must allow for efficient transfer of liquid with minimal residual volume. | Not explicitly stated as "Pass" but implied by overall "Testing verified that all acceptance criteria were met." |
| Conformity of the packaging / packaging process validation (e.g., seal width, peel feature, seal strength, dye penetration, transport test, bubble test, visual inspection, burst testing) | ISO 11607-1 / ISO 11607-2, DIN EN 868-5, ASTM F1929, ASTM D4169, ASTM F2096, ASTM F1886/1886M, ASTM F2054/F2054M | The sterile barrier system must maintain sterility and product integrity until the point of use. Packaging must withstand handling (transport test) and maintain seals (seal strength, dye penetration, bubble test, burst testing), and be easily opened (peel feature). | "Packaging testing has been shown that the packaging of the subject and the predicate device are substantially equivalent." Implied passage of all listed tests. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (N) for each of the performance tests. Regulatory submissions often report that tests were conducted according to the relevant standards, which themselves may define minimum sample sizes for specific tests.
- Data Provenance: The tests were conducted by the manufacturer, SFM Medical Devices GmbH, located in Waechtersbach, Hessen, Germany. The data is prospective, as it was generated specifically for this 510(k) submission to demonstrate the performance of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This is not applicable. For a physical medical device like an intravascular administration set, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM, DIN, USP) and by direct physical and chemical testing, not by expert human interpretation of data in the way a diagnostic AI device would require (e.g., radiologists reviewing images). The acceptance criteria are objective measurements against these standards.
4. Adjudication Method for the Test Set:
- This is not applicable as the tests are objective physical and chemical analyses based on established standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- This is not applicable. MRMC studies are relevant for diagnostic devices where human readers interpret data, often with or without AI assistance, to assess diagnostic performance. This device is an intravenous fluid transfer set, not a diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is not an AI/software algorithm. Its "performance" is determined by its physical and chemical properties and functionality, not by an algorithm's output.
7. The Type of Ground Truth Used:
- For this device, the "ground truth" is established through objective measurements and analyses against pre-defined engineering, chemical, and biological performance specifications derived from international and national standards (e.g., ISO 10993 for biocompatibility, ISO 8536-4 for infusions sets, ISO 22413 for vial adapters, ISO 80369-7 for Luer connectors, ISO 11607 for packaging). These standards represent the accepted scientific and engineering consensus for safe and effective device performance.
8. The Sample Size for the Training Set:
- This is not applicable. This is a physical device, not an AI/machine learning model that undergoes "training" on a dataset. The device design and manufacturing processes are developed through engineering and quality management systems, not through machine learning.
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable for the reasons stated above.
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(28 days)
The nextaro® v, 20/20 is indicated for the transfer and mixing of drugs contained in vials.
The nextaro® v, 20/20 is a sterile-packaged transfer device with ventilation on solvent side with built-in particle filter (15µm nominal) installed on solvent and drug side and a female Luer-Lock adapter for the connection of a single-use syringe for a low-particle withdrawal of the prepared drug solution.
The nextaro® v, 20/20 consists of two components already assembled (screwed together) in the delivery condition. Each of the components has a plastic spike which is used to perforate the seals of a solvent vial, or lyophilizated pharmaceutical vial, respectively. The components have a male and female Luer adapter to create an air-tight inner media-carrying system with open ends at the spikes.
Both components are equipped with a filter element to prevent particles (fragments of vial seals, undissolved pharmaceutical) from being administered into the patient's circulatory system.
To be used as intended, the spike of the blue ("upper") part of the nextaro® v, 20/20 is used to perforate the seal of the solvent vial. The assembly is flipped vertically and the spike of the white ("bottom") part of the device is used to perforate the seal of the pharmaceutical vial. The solvent transfer process starts immediately due to the vacuum in the pharmaceutical vial.
The spike of the upper part has two lumen allows air to enter the solvent vial so that ventilation takes place during the transfer. The other lumen ensures that the solvent is transferred to the pharmaceutical vial.
After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, the blue component of the device is removed from the white part by unscrewing, a standard syringe with a male Luer is attached to the exposed female Luer of the device to aspirate the prepared solution.
The provided text describes a 510(k) premarket notification for a medical device called nextaro® v, 20/20. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device (nextaro® Transfer System).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the "Testing verified that all acceptance criteria were met." However, it does not provide the specific numerical acceptance criteria for each test or the exact performance values observed for the proposed device (nextaro® v, 20/20). It only lists the tests performed and the standards used.
| Test Name | Testing Standard | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document, but affirmed as "met acceptance criteria") |
|---|---|---|---|
| Penetration force | ISO 22413 (using a test procedure outlined in Annex B of ISO 8536-2) | Not provided in document | Met acceptance criteria |
| Fragmentation | ISO 22413 | Not provided in document | Met acceptance criteria |
| Transfer performance (practical transfer and residual volume) | Internal performance standard | Not provided in document | Met acceptance criteria |
| Verification of the design specification for Transfer devices with housing | ISO 22413 | Not provided in document | Met acceptance criteria |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample sizes used for any of the performance tests.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the document describes performance testing of a physical medical device (intravascular administration set), not software or an AI algorithm requiring expert ground truth for interpretation. The tests mentioned are physical and functional assessments.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging AI devices to assess the impact on human reader performance. The device in question is a physical transfer system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone study was not done. This concept is relevant for AI algorithms. The nextaro® v, 20/20 is a physical medical device, not an AI algorithm. Its performance is inherent to its design and function.
7. The Type of Ground Truth Used:
For the performance tests mentioned (Penetration force, Fragmentation, Transfer performance, Design verification), the "ground truth" would be established by the defined specifications and requirements of the relevant ISO standards (ISO 22413, ISO 8536-2) and the internal performance standard. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic tools, but rather objective measurements against pre-defined engineering and safety limits.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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(116 days)
The nextaro® Transfer System and nextaro® va is indicated for the transfer and mixing of drugs contained in vials.
The nextaro® Transfer System and nextaro® va is practically one system with two variants which are to be used independently.
The nextaro® Transfer System consists of two components already assembled (screwed together) in the delivery condition. Each of the components has a plastic spike which is used to perforate the seals of a solvent vial, or lyophilizated pharmaceutical vial, respectively. The components have a male and female Luer adapter to create an air-tight inner media-carrying system with open ends for fluid transfer. Both components are equipped with a filter element to prevent particles (fragments of vial seals, undissolved pharmaceutical) from being administered into the patient's circulatory system.
To be used as intended, the spike of the blue ("upper") part of the nextaro® Transfer System is used to perforate the seal of the solvent vial. The assembly is flipped vertically and the spike of the white ("lower") part of the device is used to perforate the seal of the pharmaceutical vial. The solvent transfer process starts immediately due to the vacuum in the pharmaceutical vial.
After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, the blue component of the device is removed from the white part by unscrewing, a standard syringe with a male Luer is attached to the exposed female Luer of the device to aspirate the ready-to-use solution.
The nextaro® va is a standalone device. Basically, it is the lower part of the nextaro® Transfer System, but without the thread which the latter has to connect the upper part. After connecting the nextaro® va to a pharmaceutical vial by pushing it downwards, a solvent can be transferred by a syringe via the female Luer. After solvent transfer and reconstitution of the pharmaceutical by gentle swirling, a standard syringe with a male Luer is attached to the female Luer of the device to aspirate the ready-to-use solution.
The provided document is a 510(k) summary for the nextaro® Transfer System and nextaro® va, which are drug transfer devices. It does not describe a study involving human readers or AI. Therefore, I cannot provide details on sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies.
Here's the information regarding acceptance criteria and device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by meeting various international and ASTM standards. The reported device performance is indicated by "Pass" or "Equivalent" to the predicate device, or by specific measured values where stated.
| Standard / Test Performed | Acceptance Criteria (Implied by Standard) | Reported Device Performance |
|---|---|---|
| ISO 22413 | ||
| Fragmentation | Meets standard requirements for limiting fragmentation. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." (Implies meeting the standard's criteria) |
| Penetration Force | Meets standard requirements for penetration force. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Piercing | Meets standard requirements for piercing. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Verification of Design Specifications for Transfer Devices with Housing | Meets specified design requirements. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ISO 594-2 | ||
| Male Conical Fitting / Luer Connector | Meets standard requirements for Luer fittings (e.g., leakage, security). | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ISO 8536-4 | ||
| Flow Rate of Infusion Fluid | Meets standard requirements for flow rate. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Fluid Filter (Retention Rate) | Retains particles as specified by the standard. | "A retention rate of > 95 % of particles sized ≥ 15 um has been confirmed by testing." "The performance of the filters (retention) of the subject and predicate devices has been shown to be substantially equivalent." (Note: The filter mesh traps particles ≥ 11 µm, but retention rate is reported for ≥ 15 µm). |
| Leakage (Aging/ Submersion Test) | No leakage after aging and submersion. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Metal Ions | Below specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Particulate Contamination | Below specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Penetration Force (also under ISO 22413) | Meets standard requirements. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Reduction of Oxidizable Matter | Within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Residue on Evaporation | Within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Tensile Strength | Meets standard requirements. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Titration Acidity or Alkalinity | Within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| UV Absorption of Extract Solution | Within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ISO 11607 | ||
| Sterile Barrier and Packaging Systems | Meets standard requirements for maintaining sterility of the product until point of use. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ASTM D3078 | ||
| Bubble Emissions | No unacceptable bubble emissions, indicating seal integrity. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ASTM F 1886 | ||
| Integrity of Seals | Seals maintain integrity. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ASTM F 1929-12 | ||
| Seal Leakage | No unacceptable seal leakage. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ASTM F 1980-07 | ||
| Accelerated Aging | Performance maintained after accelerated aging, correlating to shelf-life. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." Also implies devices meet 5-year shelf-life claim. |
| ASTM F 2054-07, EN 868-5 | ||
| Seal Strength | Seals meet required strength for packaging. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| ISTA 2A | ||
| Transport Testing | Device integrity and functionality maintained after transport simulation. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| USP <85> , USP <161> | ||
| Bacterial Endotoxin | Endotoxin levels below specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." |
| Biocompatibility (ISO 10993-1) | All biocompatibility tests (e.g., cytotoxicity, sensitization, irritation, material mediated pyrogenicity, LAL Testing) pass for patient contact type. | "Tests were conducted to show that the nextaro® Transfer System and the nextaro® va were evaluated for biocompatibility in accordance with ISO 10993-1." "The biocompatibility tests show that the subject devices are biocompatible and can therefore be regarded as substantially equivalent in regard to biocompatibility." (Pass) |
| Material Mediated Pyrogenicity, LAL Testing | Materials are non-pyrogenic. | "Material Mediated Pyrogenicity LAL Testing" (Implies pass, as part of biocompatibility.) |
| Sterility (ISO 11135:2014) | Sterility Assurance Level (SAL) of 10-6 achieved. Residual EtO and ECH within ISO 10993-7 guidelines. | "The sterility... were validated in accordance with ISO 11135:2014... SAL 10-6." "The maximum levels of ethylene oxide (EtO) and ethylene chlorohydrin (ECH) residuals remaining on the products were within the guidelines for... ISO 10993-7:2008." |
| N/A - Roll Inhibition (to design specification) | Meets specific design requirements for roll inhibition. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." (Implies meeting the design specification) |
| N/A - Transfer performance for residual volume (to design specification) | Residual volume after transfer is within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." (Implies meeting the design specification) |
| N/A - Opening torque (to design specification) | Opening torque is within specified limits. | "Testing conducted [to demonstrate] that the nextaro® Transfer System and nextaro® va perform as intended." (Implies meeting the design specification) |
| Shelf Life | At least 3 years (predicate) / 5 years (proposed device). | Predicate: > 3 years. Proposed Device: 5 years. "The subject devices are substantially equivalent with regard to their shelf-life." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the various tests performed. The testing was conducted by sfm medical devices GmbH, which is located in Waechtersbach Hessen, Germany, suggesting the data provenance is likely Germany. The tests appear to be prospective, laboratory-based engineering and performance tests on the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical medical device (fluid transfer set), not an AI/imaging diagnostic device that would require expert-established ground truth for a test set. Its performance relies on objective measurements against engineering and biocompatibility standards.
4. Adjudication method for the test set
This information is not applicable for this type of device and testing. The tests are based on objective pass/fail criteria from recognized standards, not on subjective expert evaluations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a physical drug transfer system, not an AI or imaging system designed to be used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this question is not applicable to the device described. This is a physical, manually operated medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for evaluating the nextaro® Transfer System and nextaro® va is based on:
- Compliance with established international and national standards (ISO, ASTM, USP).
- Meeting pre-defined engineering design specifications (e.g., residual volume, roll inhibition, opening torque).
- Laboratory testing results (e.g., retention rate, biocompatibility, sterility) against specified acceptance limits derived from these standards.
8. The sample size for the training set
This information is not applicable. The nextaro® Transfer System and nextaro® va are physical devices, not AI/machine learning models that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a physical medical device.
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