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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases up to 24 hours. For patients ≥ 12 years old, the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

The EZ-IO Intraosseous Vascular Access System previously cleared with K202492 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

The provided document is an FDA 510(k) clearance letter for the EZ-IO Intraosseous Vascular Access System. It describes a Special 510(k) submission, which means the device being submitted is very similar to a previously cleared predicate device, with only minor changes. In this case, the only change is the sterilization of the EZ-IO Power Driver.

Therefore, the document does not describe a study involving AI performance, human reader improvement with AI assistance, or the establishment of ground truth by expert consensus for an AI-based device. It focuses on demonstrating the substantial equivalence of the modified (now sterile) power driver to the existing non-sterile one through non-clinical performance testing.

Consequently, much of the requested information (related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth for AI) is not applicable to this document.

However, I can extract the information relevant to the provided text:

Acceptance Criteria and Device Performance (for the change in sterility of the driver)

The acceptance criteria for this 510(k submission are not directly stated as clinical performance metrics for the device's indications for use. Instead, they are related to demonstrating that the change (sterilization of the power driver) does not negatively impact the safety and effectiveness compared to the predicate device. The performance is demonstrated through non-clinical testing.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Detailed Information as per Request:

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

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: Not specified in terms of clinical patient numbers. The testing appears to be primarily bench/laboratory testing on physical devices and packaging.
   • Data Provenance: Not specified, but generally, such non-clinical testing for FDA submissions would be conducted in controlled laboratory environments, likely within the US or by certified labs adhering to international standards. The tests are prospective in nature as they evaluate the manufacturing process and design changes.

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. Ground truth in the context of expert consensus for AI models is not relevant here. The ground truth for this submission is established through adherence to recognized international standards for sterilization, packaging, and functional performance testing, which are objectively measurable.

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

   • Not applicable. Adjudication methods are typically for subjective assessments by multiple human readers, often in the context of AI performance evaluation. Here, the "truth" is determined by objective measurements against established engineering and sterilization standards.

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 study was not done as this clearance is not for an AI-enabled device or one that involves human interpretation of medical images.

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

   • Not applicable. This submission is not for an algorithm.

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

   • The "ground truth" for this submission is based on engineering standards, validated sterilization processes, and functional performance specifications of the medical device components (specifically, the power driver). It is objective and measurable, rather than being derived from subjective expert consensus, pathology, or clinical outcomes data in the context of a diagnostic or treatment outcome.

8. The sample size for the training set:

   • Not applicable. This submission does not involve an AI model or a training set.

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

   • Not applicable. This submission does not involve an AI model or a training set.

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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases for up to 24 hours.

Insertion sites:

ADULTS (≥22 years old)

• Proximal humerus
• Proximal tibia
• Distal tibia

PEDIATRICS (≤21 years old)

• Proximal humerus
• Proximal tibia
• Distal tibia
• Distal femur

For patients ≥12 years old, use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

The EZ-IO Intraosseous Vascular Access System previously cleared with K180395 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

The provided text describes a 510(k) submission for the EZ-IO Intraosseous Vascular Access System. This submission is for a device that already has a predicate (K180395) and the only change is to its MR Safety Status labeling, from "MR Unsafe" to "MR Conditional."

The document does not describe a study involving "AI assistance" or "human readers" or "ground truth established by experts" in the context of diagnostic performance, as the device is a medical access system, not an imaging or diagnostic AI. Therefore, many of the requested points regarding AI/MRMC study details are not applicable to this submission.

However, I can extract information related to the non-clinical testing performed to justify the change in MR safety status.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative table for this specific update, as the change is primarily about MR compatibility, not a functional performance metric beyond its existing predicate. The "performance" being evaluated is its behavior in an MRI environment.

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

• Test Article Sample Size: The tests were conducted on the "45 mm needle" as the test article. It's common in such engineering studies to test a representative sample rather than a large clinical cohort. The exact number of 45mm needles tested is not specified, but it's implied to be a sufficient and representative sample for engineering testing.
• Data Provenance: The testing was conducted by "Exponent, 2020," which is a consulting firm specializing in engineering and scientific consulting. The location is not specified, but this is a laboratory/engineering study rather than a clinical data set. It is a prospective test specifically for this regulatory submission.

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

• Not applicable. This is a physical device MR compatibility test, not a diagnostic study requiring human expert interpretation or ground truth establishment in the typical clinical sense. The "ground truth" here is determined by the physical measurements and compliance with engineering standards.

4. Adjudication method for the test set

• Not applicable. This is a physical device test, not a study requiring adjudication of expert opinions.

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. This is not an AI-assisted diagnostic device study. It is a physical medical device.

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

• No. This is not an algorithm.

7. The type of ground truth used

• Engineering/Physical Measurements against established safety standards. The "ground truth" for MR compatibility is determined by the quantitative measurements of parameters like RF-induced heating (as per ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 standards) and ensuring these measurements fall within safe limits for MRI environments.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, no training set was involved.

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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Insertion sites: ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur Use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established. Insertion sites: ADULTS (≥22 years): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≥12 years through 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur

The EZ-IO System previously cleared with K14117 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

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

Acceptance Criteria and Device Performance

The core change addressed by this submission is the expansion of the "EZ-IO Intraosseous Vascular Access System" indications for use from up to 24 hours to up to 48 hours. Therefore, the primary acceptance criteria revolve around demonstrating the safety and effectiveness of the device for this extended dwell time.

Study Details

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

   • Sample Size (Test Set): 121 evaluable subjects.
     • 79 healthy volunteers
     • 39 with diabetes only
     • 3 with diabetes and renal insufficiency
   • Data Provenance: US single-site, prospective clinical IDE trial.

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

   • Not explicitly stated. The study involved clinical trial procedures and observations, including physical examinations and x-rays, but the specific number or qualifications of "experts" establish ground truth in the sense of a diagnostic consensus is not detailed. The "ground truth" here is the clinical outcome (complications, pain, patency) observed in the subjects under the study protocol.

3. Adjudication method for the test set:

   • Not explicitly stated in detail for all events. However, adverse events were assessed for relatedness to the device, implying a review process. The primary endpoint was the "absence of serious complications," suggesting a clear definition of what constitutes a serious complication and its determination by the study team.

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. This is not an AI/imaging device. It is a medical device for vascular access.

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

   • N/A. This is not an AI/algorithm device.

6. The type of ground truth used:

   • Clinical outcomes data: The ground truth was based on the presence or absence of serious complications, pain reports, patency, and other observed adverse events during the 48-hour indwelling period and subsequent 30-day follow-up of human subjects. This also included objective measures like IO aspirate cultures and x-rays.

7. The sample size for the training set:

   • N/A. This is a medical device approval, not an AI model requiring a training set. The "development" of the device was based on prior predicate devices and engineering principles, with the clinical study serving as a validation of the extended use.

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

   • N/A. As above, no training set in the AI sense was used.

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The EZ-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-IO Intraosseous Infusion System previously cleared with K132583 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are medical grade. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set catheter serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light.

Clinicians locate anatomical landmarks and clean the insertion site. Using the cordless driver with needle set attached, the needle set is pressed through the soft tissue to the outer cortex of the bone. Depth markers on the catheter must be visible prior to powering driver to ensure adequate needle length for proper placement within the medullary space. Clinicians then squeeze the driver trigger and apply moderate, steady pressure. Trigger is released when a sudden "give" or "pop" is felt, which indicates entry into the medullary space; the needle set will not always be inserted to the hub. After insertion of the needle set, the driver unit is detached from the needle set, leaving the stylet and catheter firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of medications and fluids.

This submission requests the addition of the distal femur as an insertion site for the pediatric population utilizing the same insertion technique and devices previously cleared via 510(k) K132538, which includes the insertion sites of the proximal tibia, distal tibia and proximal humerus.

This document is a 510(k) premarket notification for the Vidacare EZ-IO Intraosseous Infusion System, specifically requesting an expanded indication to include the distal femur as an insertion site for pediatric patients.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative or numerical format, nor does it present device performance in such a table. Instead, the "acceptance criteria" are implied by the applicant demonstrating the safety and efficacy of the EZ-IO system for the new distal femur insertion site, with the key argument being its similarity to currently approved sites and the absence of reported complications from its use in other regions.

The document references:

• Safety: The device has been cleared in the EU since 2011 for pediatric femoral insertion with no reported complications. The target area is "relatively large" making correct insertion "easier."
• Efficacy: Anatomically and physiologically, any bone with a medullary cavity can be used for infusion. The distal femur is closer to the heart, potentially providing "quicker drug and fluid delivery." Multiple publications support the use of the distal femur in pediatric patients for intraosseous access.

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

The document primarily relies on cadaveric studies and preclinical vascular flow studies, and references to existing literature.

• Test Set Description: "cadaveric studies" and "preclinical vascular flow studies" are mentioned. No specific sample sizes for these studies are provided in this summary.
• Data Provenance: Not explicitly stated for the cadaveric and preclinical studies. However, the document mentions that the device is cleared in 39 countries outside the US, suggesting international experience. The EU clearance for pediatric femoral insertion since 2011 implies real-world data from Europe, though details are not provided within this specific submission summary.

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

This information is not provided in the given document. The summary only refers to "cadaveric studies" and "preclinical vascular flow studies."

4. Adjudication Method for the Test Set

This information is not provided in the given document.

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 explicitly mentioned or described in the provided summary. This submission focuses on expanding the indications for an existing device, primarily by demonstrating the safety and efficacy of a new anatomical insertion site, rather than comparing human reader performance.

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

The EZ-IO Intraosseous Infusion System is a physical medical device (a needle set and driver) for intraosseous access, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable to this device. Human interaction is central to its intended use (clinicians performing the insertion).

7. The Type of Ground Truth Used

The ground truth implicitly used for the studies mentioned appears to be a combination of:

• Anatomical/Physiological Feasibility: The statement, "Anatomically and physiologically any bone that has a medullary cavity can be used to safely infuse drugs and fluids...", establishes a fundamental biological ground truth.
• Direct Observation/Measurement: Implied by "cadaveric studies" (demonstrating physical insertion and placement) and "preclinical vascular flow studies" (demonstrating fluid delivery).
• Clinical Outcomes/Absence of Complications: The lack of reported complications from EU use since 2011 serves as a form of clinical ground truth for safety.
• Expert Consensus/Literature Review: The document cites multiple publications and notes that the distal femur IO insertion site is "noted to be an option and has been used with success in pediatric patients." This relies on established medical knowledge and expert consensus in the field.

8. The Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. Since the EZ-IO Intraosseous Infusion System is a physical medical device, there is no training set in the context of an algorithm.

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

As there is no training set (see point 8), this question is not applicable.

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The EZ-10 Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-IO Intraosseous Infusion System including previously cleared K091140 EZ-MIO Distal Tibia, EZ-10 Distal Tibia; EZ-10 (formerly Vidaport) Intraosseous Infusion System ; EZ-IO Humeral Head and K101026 Powered PD IO Infusion System; EZ-IO Humeral Head; Powered PD-IO is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids for vascular access. All system materials are medical grade. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (3-39 kg); 25 mm (40 kg or over) and 45 mm (40 kg or over). Black lines on the needle set catheter serve as depth markers. The needle sets connect to the driver/drill/ manual handle shaft with a magnetic disc. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. The EZ-MIO consists of a manual handle device which is primarily used by the armed forces.

Clinicians locate anatomical landmarks and clean the insertion site. Using the cordless driver or manual handle with needle set attached the needle set is pressed through the soft tissue to the outer cortex of the bone. Depth markers on the catheter must be visible prior to powering driver or manually inserting the needle set to ensure placement within the medullary space. If using the powered driver clinicians then squeeze the driver trigger and apply moderate, steady pressure. Trigger is released when a sudden "give" or "pop" is felt, which indicates entry into medullary space; the catheter will not always be inserted to the hub. If using the manual handle, clinicians apply downward pressure and rotation through the bone until a change in pressure is felt as a "give" or "pop" or desired depth is reached. For both methods after insertion of the needle set, the driver unit is detached from the needle set, leaving the stylet and cannula firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of medications and fluids.

This submission requests a label change only to the 25 mm needle set from "40 kg or over" to" 3 kg or over" utilizing the same technique and devices previously cleared via 510(k)s K091140 and K101026.

The provided text describes the EZ-IO Intraosseous Infusion System and a 510(k) submission for a label change. However, it does not contain information about acceptance criteria, specific studies proving the device meets those criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The submission is for a label change for a physical medical device (intraosseous needle) to expand its approved weight range, not for a software-as-a-medical-device (SaMD) or an AI/ML component. The "study" mentioned refers to cadaveric pediatric studies demonstrating safety for the expanded needle length, rather than performance metrics of an AI model.

Therefore, I cannot fulfill your request for the specific AI/ML related information (such as reported device performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details) because this information is not present in the provided document.

The document states:

• "This submission requests a label change only to the 25 mm needle set from '40 kg or over' to '3 kg or over' utilizing the same technique and devices previously cleared via 510(k)s K091140 and K101026."
• "The labeling change requires no new technology to facilitate the safe application of the product."
• "There have been no changes to the design or components of the Vidacare devices..."

This indicates that no new performance studies (especially not for an AI/ML component) were conducted or are being presented here. The "performance data" mentioned in the summary refers to existing data and clinical observations supporting the expanded weight range of the physical needle.

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The EZ-IO is for emergency vascular access when standard venous access is not possible. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible.

The EZ-IO (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired depth within the bone marrow. The driver then separates from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar/stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringes and IV lines for administration of drugs and fluids via the humeral head.

The provided text describes the EZ-IO Humeral Head device and its substantial equivalence to a predicate device, the VidaPort Intraosseous Infusion System. It does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test/training sets, expert qualifications, or detailed ground truth methodologies. The document is primarily a 510(k) premarket notification summary and an FDA clearance letter based on substantial equivalence.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I can only extract what is available.

Here's what I can provide based on the given text:

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

The document does not explicitly state acceptance criteria or a study with reported numerical device performance against such criteria. Instead, it relies on substantial equivalence. The "performance" assessment is qualitative, comparing characteristics to the predicate device.

2. Sample size used for the test set and the data provenance
Not explicitly mentioned in the provided text. The submission is a 510(k) for substantial equivalence, which often relies on comparative analysis rather than new clinical trial data for direct performance measurements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly mentioned in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not explicitly mentioned in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (intraosseous infusion system), not an AI diagnostic tool involving human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly mentioned in the provided text for establishing performance. The "ground truth" for the submission is the legally marketed predicate device (VidaPort Intraosseous Infusion System), against which the new device (EZ-IO Humeral Head) is compared for "similar technological characteristics and to be equivalent."

8. The sample size for the training set
Not applicable/not mentioned. This is a medical device clearance based on substantial equivalence, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established
Not applicable/not mentioned. (See #8)

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