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The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue.

The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece.

The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. The change associated with this submission regards a change to materials, labeling artwork, and cable length of the Sonata Dispersive Electrode.

A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. Dispersive Electrodes are placed on the patient's thighs and connected to the RF Generator to complete the electrical circuit. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes.

The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery.

Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.

Two main elements of the SMART Guide are the Ablation Zone and the Thermal Safety Border.

• Ablation Zone (red inner ellipse) – a two-dimensional representation of the outer boundary of the average region of tissue ablation for the selected ablation size
• Thermal Safety Border (green outer ellipse) – the distance at which tissue outside of the Ablation Zone is safe from the potential of thermal damage.

The provided text is an FDA 510(k) clearance letter for the Gynesonics Sonata® Transcervical Fibroid Ablation System 2.2. It details the device's indications for use, technological comparison to a predicate device, and a summary of non-clinical and/or clinical tests performed.

Crucially, this document states that the changes made to the device (materials, labeling artwork, and cable length of the Dispersive Electrode) were minor and did not raise new questions of safety and effectiveness. For such minor modifications, the FDA typically does not require extensive new clinical studies comparing the modified device's performance against detailed acceptance criteria in the manner of an AI/ML algorithm. Instead, the focus is on demonstrating that the modified device still meets existing design requirements and is as safe and effective as its predicate.

Therefore, the information required to answer most of your specific questions regarding acceptance criteria and a study proving the device meets them (especially in the context of an AI/ML algorithm with detailed performance metrics) is not present in this regulatory document. The document describes a modification to an existing, already cleared device, not an initial clearance that would require a new, comprehensive clinical study with detailed performance outcomes.

The "study that proves the device meets the acceptance criteria" in this context refers to the verification and validation testing of the modified components to ensure they still meet the established safety and performance characteristics of the original cleared device. This is primarily non-clinical testing.

Here's how to address your points based on the provided text:

Acceptance Criteria and Device Performance

As this document describes a modification to an already cleared device, not a new device requiring novel clinical performance acceptance criteria, the detailed table you requested is not explicitly provided in the text. The acceptance criteria referenced are for the modified components to ensure they don't negatively impact the established safety and effectiveness of the predicate device.

Note: The document states, "In all cases, the verification and validation testing met acceptance criteria with and without justification." This implies that the tests confirmed the modified components did not degrade the performance or safety of the system, aligning with the predicate device's established levels.

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

• Sample Size: The document does not specify a "test set" sample size in terms of patient data for a clinical study. The testing described (biocompatibility, mechanical performance, etc.) refers to non-clinical, in-vitro, or bench testing of the modified device components.
• Data Provenance: Not applicable as this is primarily non-clinical testing of device components, not a clinical study on patient populations with geographical data provenance.

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

• This is not applicable to the type of testing described in the document. Ground truth establishment by experts (e.g., radiologists for imaging studies) is relevant for clinical studies, particularly those involving AI/ML algorithms, which is not the primary focus of this 510(k) for a device modification. The "ground truth" here is the established safety and performance of the predicate device, against which the modified device's components were evaluated.

4. Adjudication Method for the Test Set

• Not applicable for the non-clinical component testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• Not applicable. This device is a surgical ablation system, not an AI/ML diagnostic or assistive imaging tool that would undergo MRMC studies. The document describes a physical medical device and its modifications.

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

• Not applicable. This is a physical medical device. While it has "Graphical Guidance Software (GGS)" with "SMART Guide," the focus of this 510(k) is a modification to a physical component (Dispersive Electrode), not a new AI algorithm requiring standalone performance evaluation. The software functionality (SMART Guide) is part of the established predicate device.

7. The Type of Ground Truth Used

• For the non-clinical tests conducted on the modified device, the "ground truth" would be engineering specifications, regulatory standards (like FDA recognized standards), and the established performance characteristics of the predicate device. The goal was to demonstrate that modifications did not compromise these established criteria.

8. The Sample Size for the Training Set

• Not applicable. Training sets are relevant for AI/ML model development. This document is about a physical device modification.

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

• Not applicable. (See #8)

In summary: The provided FDA 510(k) letter pertains to a minor modification of an already cleared medical device (Sonata® Transcervical Fibroid Ablation System 2.2). The "study" described is a series of non-clinical verification and validation tests (biocompatibility, mechanical, electrical safety, etc.) on the modified components to ensure the device remains as safe and effective as its predicate. It does not involve a new clinical trial with human subjects or the evaluation of an AI/ML algorithm's performance, which would necessitate the detailed information requested in your questions related to ground truth, expert adjudication, or MRMC studies.

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The Sonata® Transcervical Fibroid Ablation System 2.2 is intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue.

The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece.

The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. The change associated with this submission regards a software update to enable smaller ablations and other minor enhancements.

A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes.

The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery.

Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.

Two main elements of the SMART Guide are the Ablation Zone and the Thermal Safety Border.

• . Ablation Zone (red inner ellipse) – a two-dimensional representation of the outer boundary of the average region of tissue ablation for the selected ablation size
• . Thermal Safety Border (green outer ellipse) - the distance at which tissue outside of the Ablation Zone is safe from the potential of thermal damage.

The provided FDA 510(k) summary for the Gynesonics Sonata Transcervical Fibroid Ablation System 2.2 explicitly states that "No additional clinical study data was needed to support substantial equivalence to the predicate." This means that the submission does not include a new clinical study to prove the device meets acceptance criteria.

Instead, the submission relies on:

• Identical Indications for Use: The modified device has the exact same indications as its predicate.
• Identical Technological Characteristics: The design, material, principle of operation, and energy source are the same as the predicate device.
• Software Modification: The only change is a software update to enable smaller ablations and minor enhancements.
• Non-Clinical Testing: Bench testing (ablation dimensions, treatment duration variations, volumetric ablation registration, dispersive electrode thermal performance), Finite Element Method (FEM) Computational Modeling, and software verification and validation were performed.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving the device meets them, as the document states that a new clinical study was not conducted for this specific 510(k) submission. The FDA cleared this device based on its substantial equivalence to a previously cleared predicate device, supported by non-clinical testing of the software changes.

To directly answer your specific points based on the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document states that "In all cases, the verification and validation testing met acceptance criteria," but it does not detail those criteria or the specific reported performance metrics.
2. Sample sized used for the test set and the data provenance: Not applicable, as no new clinical study (test set) was conducted. Non-clinical testing data provenance is not specified beyond "Gynesonics has applied their design control procedures."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 not an AI-assisted diagnostic tool, but an ablation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The software modifications are for controlling the ablation system directly, not for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical testing, ground truth would likely be established through engineering specifications, physical measurements from bench tests, and computational model outputs.
8. The sample size for the training set: Not applicable, as no new clinical study was conducted. Details about software training data (if any for the updates) are not provided in this regulatory summary.
9. How the ground truth for the training set was established: Not applicable.

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The Sonata Transcervical Fibroid Ablation System is intrauterine intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes. The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery. Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation. Two main elements of the SMART Guide are the Ablation Zone and the Thermal Safety Border. Ablation Zone (red inner ellipse) a two-dimensional representation of the outer boundary of the average region of tissue ablation for the selected ablation size. Thermal Safety Border (green outer ellipse) - the distance at which tissue outside of the Ablation Zone is safe from the potential of thermal damage. The change associated with this submission is an update to the Sonata Intrauterine Ultrasound (IUUS) Probe Instructions for Use to include an additional sterilization option.

The provided document is a 510(k) summary for the Sonata Transcervical Fibroid Ablation System 2.2. The purpose of this submission is to introduce an additional sterilization option for the Sonata Intrauterine Ultrasound (IUUS) Probe. As such, the study described focuses on ensuring the device meets acceptance criteria related to this change, primarily sterilization validation and device compatibility.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the test set used in the sterilization validation, biocompatibility, product life, basic safety, essential performance, or usability testing. These studies are typically non-clinical laboratory tests performed on a defined number of device units. The data provenance is not specified, but these tests would be conducted internally or by contract labs following established protocols. Given the nature of a 510(k) for a sterilization change, patient data (retrospective or prospective) is not directly applicable to proving the acceptance criteria for this specific modification.

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

This type of information is not applicable to the non-clinical validation studies described in this 510(k) summary. "Experts" in this context would be laboratory personnel, engineers, and microbiologists trained in sterilization validation and device testing, but their role is to perform tests and interpret results against established standards, not to establish a "ground truth" in the way a clinical expert panel would for disease detection.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is typically used in clinical studies when there are differing interpretations of clinical data or outcomes. For non-clinical validation of sterilization and device compatibility, the results are objectively measured against predefined acceptance criteria.

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. The Sonata Transcervical Fibroid Ablation System is a medical device for treatment, not an AI-assisted diagnostic tool for human readers. The change described in this 510(k) focuses on sterilization validation, not clinical efficacy or diagnostic accuracy.

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

Not applicable. The Sonata System is a physical medical device that combines ultrasound for visualization and radiofrequency energy for therapy; it is not a standalone algorithm.

7. The Type of Ground Truth Used

For the specific acceptance criteria validated in this 510(k) (sterilization, biocompatibility, etc.), the "ground truth" is established by:

• Sterilization: Regulatory standards and established scientific methods (e.g., AAMI standards for sterilization, sterility testing) that define what constitutes a sterile device (e.g., Sterility Assurance Level of 10^-6).
• Biocompatibility: ISO 10993 series of standards and other recognized guidelines for biological evaluation of medical devices.
• Product Life, Safety, Essential Performance, Usability: Device specifications, design requirements, and recognized industry standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/machine learning algorithm for this type of medical device submission. The testing involves physical units of the device.

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

Not applicable, as there is no training set for an AI/machine learning algorithm.

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The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes. The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery. Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.

The provided document is a 510(k) summary for the Sonata® Transcervical Fibroid Ablation System 2.2. It describes modifications made to an already cleared device and demonstrates substantial equivalence to its predicate. The critical point here is that this submission is for modifications to a previously cleared device, and thus, it largely leverages the safety and effectiveness data of the predicate device (K211535). The performance testing done for this specific submission focuses on verifying the impact of the changes.

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

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

For this specific 510(k) submission (K222304), the performance testing was focused on the modifications to the device (new sterilization instructions for the IUUS Probe and the addition of the IUUS Probe Connector Protector). The document states:

"In all cases, the verification and validation testing met the acceptance criteria."

Therefore, the table will reflect the verification of the changes rather than comprehensive performance data of the entire system (as that was covered in the predicate device's clearance).

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

• For the modifications assessed in K222304 (sterilization and connector protector):

  • Sample Size: Not explicitly stated for each specific test (e.g., how many IUUS probes were tested for use life or biocompatibility with the new sterilization methods). However, the document indicates that "verification and validation testing met the acceptance criteria" for these changes.
  • Data Provenance: Not specified as a country of origin. This refers to bench testing and design control activities rather than human subject data. The validation was conducted by Gynesonics, Inc. as part of their design control procedures.
  • Retrospective/Prospective: These are likely prospective bench tests performed specifically for this submission.

• For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535):

  • Sample Size: 147 treated patients (n=147).
  • Data Provenance: The study (IDE G140114, NCT NCT02228174) included 22 centers with treated patients. The specific countries are not mentioned in this summary but are typically part of a full clinical study report.
  • Retrospective/Prospective: This was a single-arm cohort study, effectively prospective, where each subject served as their own control for assessing treatment outcomes.

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

• For the modifications assessed in K222304: This refers to bench testing and design verification/validation. Ground truth would be defined by engineering specifications, recognized standards (e.g., ISO, IEC), and established test protocols. The document does not describe the involvement of external experts for establishing ground truth for these specific non-clinical tests, and it's not typically required for this type of verification.
• For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535): The document does not specify the number or qualifications of experts used to establish ground truth for the clinical outcomes. In clinical trials for this type of device, ground truth for fibroid diagnosis and treatment effect would typically be established by the treating physicians (e.g., gynecologists) and potentially independent assessment committees based on imaging (ultrasound, MRI) and patient-reported outcomes.

4. Adjudication method for the test set

• For the modifications assessed in K222304: Adjudication methods are not described for these bench tests. Compliance is determined against pre-defined engineering specifications and standard requirements.
• For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535): The document does not specify an adjudication method for the clinical trial endpoints. Clinical trials often employ independent data monitoring committees or clinical events committees for adjudication, but this detail is not present in the 510(k) summary.

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. The Sonata System 2.2 is a medical device for fibroid ablation, not an AI-powered diagnostic system that relies on human readers interpreting images. While it uses "Sonata Graphical Guidance Software (GGS)" including a "SMART Guide" with "graphical overlay on the live ultrasound image for targeting and deployment," this is an integrated guidance system for the physician performing the procedure, not a standalone AI diagnostic tool requiring MRMC studies to assess reader improvement. The "SMART Guide" provides real-time visual assistance during the procedure.

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

• Not Applicable. The Sonata System is not a standalone algorithm. It is a physical medical device (ablator) with integrated ultrasound imaging and software guidance, requiring direct human operation (human-in-the-loop) during the transcervical fibroid ablation procedure. The "SMART Guide" is an integral part of the user interface provided to the clinician.

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

• For the modifications assessed in K222304: The ground truth for these specific changes involves adherence to engineering specifications, validated sterilization protocols, biocompatibility standards, and functional performance criteria in bench testing.
• For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535): The clinical trial (IDE G140114) would have relied on a combination of:
  • Clinical outcomes data: Patient symptoms (e.g., heavy menstrual bleeding), quality of life.
  • Imaging: For fibroid identification, sizing, and assessment of treatment effect (e.g., volume reduction of ablated fibroids).
  • Safety data: Adverse event reporting.

8. The sample size for the training set

• Not Applicable. This document describes a medical device with integrated software guidance, not a machine learning or AI model that requires a distinct training set in the typical sense. The software (Sonata System Software v2.1.2) is likely developed through traditional software engineering processes, not by training on a large dataset of patient images or outcomes.

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

• Not Applicable. As this is not an AI/ML system requiring a training set in the typical sense, there is no discussion of how ground truth for a training set was established. The software's functionality and guidance (the "SMART Guide") are based on established medical principles of ultrasound imaging and radiofrequency ablation, not derived from a trained dataset.

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The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery. Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.

The provided document is a 510(k) summary for the Sonata® Transcervical Fibroid Ablation System 2.2. It describes changes made to the device compared to its predicate (Sonata System 2.1) and summarizes the testing conducted to demonstrate substantial equivalence.

However, the document does not contain the detailed information requested regarding acceptance criteria for a study proving the device meets acceptance criteria. Instead, it outlines the company's internal design control procedures, risk analysis, and verification/validation activities for the modifications to the device. It also references prior clinical data from the predicate device and states that no additional clinical data was needed for the 2.2 version.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance from a study proving device meets acceptance criteria. It lists "Performance testing - System level (bench)" and "Performance testing - Ablation" but describes the types of tests, not the specific acceptance criteria or quantitative results.
2. Sample sizes used for a test set in the context of proving performance against acceptance criteria.
3. Number of experts, their qualifications, or adjudication methods for establishing ground truth for a test set. This type of information is usually relevant for AI/ML device evaluations, which this device is not.
4. Details on an MRMC comparative effectiveness study or standalone performance. This device is not an AI/ML device subject to these types of studies.
5. Type of ground truth (e.g., pathology, outcomes data) for a test set.
6. Sample size for a training set.
7. How ground truth for a training set was established.

What the document does provide, relative to your questions:

• Acceptance Criteria & Performance (General):

  • The document states that "The test methods and acceptance criteria used established methods consisting of FDA recognized standards and/or the same methods and criteria as were used in the predicate device submission; thus, meeting the FDA's requirement for a Special 510(k). In all cases, the verification and validation testing met the acceptance criteria."
  • It lists general safety and performance standards met (e.g., Electrical Safety & EMC: ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.).
  • Acoustic Output: Specific values are given for B Mode: ISPTA ≤ 720 mW/cm² (Value: 162 mW/cm²) and MI ≤ 1.9 (Value: 1.7). These are presented as performance measurements.

• Study Proving Device Meets Acceptance Criteria:

  • The document focuses on demonstrating that the changes to the Sonata System 2.2 do not raise new questions of safety and effectiveness, relying heavily on the predicate device's existing data.
  • It mentions "verification and validation testing met the acceptance criteria" for the changes, but doesn't provide a specific study report for this, instead summarizing design control activities in Table 5. These are generally internal engineering tests.
  • For clinical data: "No additional clinical study data was needed to validate the Sonata System 2.2." It explicitly states that "Sonata System 2.2 continues to rely on the clinical trial study as Sonata System 2.1."

• Clinical Trial for Predicate Device (G140114, NCT02228174):

  • Sample Size: n = 147 subjects.
  • Data Provenance: 22 centers with treated patients. (Country of origin not specified, but typically US-based for FDA filings). The trial design was a "Single-arm cohort study with each subject serving as her own control."
  • Ground Truth: For the clinical trial, the "ground truth" would be related to clinical outcomes (safety and effectiveness, e.g., reduction in heavy menstrual bleeding, fibroid volume reduction, adverse events) as assessed by clinicians or objective measurements, not image-based expert consensus. The document does not detail how these clinical outcomes were specifically established, but this is typical for clinical trials where physician assessment and quantitative measurements are used.
  • Retrospective/Prospective: Clinical trials are typically prospective.

• AI/ML Specific Questions (not applicable to this device, as it's not an AI/ML diagnostic tool):

  • Number of experts, qualifications, and adjudication methods for ground truth (Q3, Q4) are not relevant as this is not an AI/ML device.
  • MRMC comparative effectiveness study (Q5) is not relevant.
  • Standalone performance (Q6) is not relevant in the context of AI/ML algorithms. The device's performance is as an integrated system, not a standalone algorithm.
  • Training set information (Q8, Q9) is not relevant as there's no mention of a machine learning algorithm being trained.

Summary Table based on provided text (limited details):

Study Proving Device Meets Acceptance Criteria (Clinical Trial of Predicate):

• Sample size: n = 147 subjects.
• Data Provenance: 22 centers. (Retrospective/Prospective: Typically Prospective for clinical trials). Country not explicitly stated, but for FDA submissions, often includes US sites.
• Number of experts used to establish ground truth & qualifications: Not applicable for a device that is not an AI/ML diagnostic. The clinical trial would establish efficacy and safety through patient outcomes and physician assessments.
• Adjudication method for the test set: Not applicable for device performance against a test set in the AI/ML sense. Data in the clinical trial would be collected and analyzed using standard clinical trial methodologies.
• MRMC comparative effectiveness study: No.
• Standalone performance: Not applicable in the AI/ML context. This is an integrated surgical system.
• Type of ground truth used: Clinical outcomes data (e.g., reduction in heavy menstrual bleeding, fibroid volume, adverse events) from a single-arm cohort study where each subject served as her own control.
• Sample size for training set: Not applicable (not an AI/ML device).
• How ground truth for training set was established: Not applicable.

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The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata® System 2.1 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing, without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata® System 2.1is comprised of medical equipment, software, and various single-use and reusable instruments.

Here's a breakdown of the acceptance criteria and the study information for the Gynesonics Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1, based on the provided FDA 510(k) summary:

The document (K193516) is a 510(k) premarket notification for the Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1. It asserts substantial equivalence to a predicate device (Sonata® System, K173703) rather than presenting a novel device requiring a full clinical trial for de novo acceptance criteria. Therefore, the "acceptance criteria" here largely refer to the successful demonstration of the modified device's performance against its specifications and existing standards, and its equivalence to the predicate device's established safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission asserting substantial equivalence and not a clinical trial establishing new efficacy, the "acceptance criteria" are generally met by demonstrating that the updated device performs equivalently or better than the predicate device and meets relevant performance standards.

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

The document primarily relies on bench testing for the modified components and leverages clinical data from the predicate device.

• Bench Testing: Sample sizes are not explicitly stated for most individual bench tests (e.g., "ex vivo testing," "type testing"). However, for the Human Factors (HF) Evaluation for Treatment, 15 gynecologists participated.
• Data Provenance:
  • Bench testing: Primarily ex vivo (bovine tissue models) and in vitro (phantoms, component testing) conducted by the manufacturer, Gynesonics, Inc.
  • Human Factors Evaluation: Conducted with representative users (gynecologists).
  • Clinical Data (Leveraged): The document explicitly states "No additional clinical study data was needed to validate the Sonata® System 2.1." It leverages clinical data from the predicate device, K173703, which was based on an IDE study (G140114, NCT02228174) with n = 147 subjects across 22 centers. This predicate clinical data would be considered prospective from the original study. The country of origin for the predicate clinical study is not specified in the provided text.

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

• Bench Testing: "Ground truth" for bench tests is generally based on metrology, physical measurements, and adherence to engineering specifications and international standards. This does not involve human experts establishing ground truth in the diagnostic sense.
• Human Factors Evaluation: 15 gynecologists participated in the HF study. Their qualifications are described as "representative of typical users involved with performing RFA for fibroids and impacted by device changes." Specific years of experience or board certifications are not provided in this summary.
• Clinical Data (Leveraged from Predicate): For the predicate clinical study (n=147), ground truth would have been established through standard clinical diagnostic methods for uterine fibroids (imaging, pathology, physician assessment of symptoms and outcomes). The number and qualifications of experts involved in establishing this clinical ground truth are not detailed in this 510(k) summary, as it's leveraging previously cleared data.

4. Adjudication Method for the Test Set

• Bench Testing: Adjudication is typically against pre-defined specifications and standards; it does not involve expert consensus in the way a diagnostic study would.
• Human Factors Evaluation: The HF study assesses the device's usability and user-related risks. The "ground truth" here is whether the device can be used safely and effectively by typical users without critical errors. This is usually determined by observing user performance against a task list and assessing identified use errors by a Human Factors team. An explicit "adjudication method" like 2+1 or 3+1 is not applicable for this type of study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done.
• The Sonata® System 2.1 is an interventional medical device for fibroid ablation, not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable in this context. The integrated ultrasound is for real-time visualization and guidance during the procedure, not primarily for diagnostic interpretation by multiple readers.

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

• The Sonata® System 2.1 is an interventional device with integrated imaging and ablation capabilities, inherently designed for human-in-the-loop operation. It's not a standalone diagnostic algorithm. The "SMART Guide" is a graphical overlay that assists the clinician, not an autonomous algorithm. Therefore, a standalone performance study without human-in-the-loop is not relevant or applicable for this device.

7. The Type of Ground Truth Used

• Benchmark Ground Truth: For the "SMART Guide" development and confirmation, ex vivo ablation dimensions in bovine tissue models served as a physical, measured "ground truth" to ensure the graphical representation (Ablation Zone, Thermal Safety Border) accurately reflects the physical effect of ablation.
• Conformance Ground Truth: For most other bench tests (electrical safety, biocompatibility, sterilization, mechanical testing), the "ground truth" is conformance to established international standards (e.g., ISO, IEC) and internal product specifications.
• Usability Ground Truth: For Human Factors studies, the ground truth is the demonstration that the device design, labeling, and training allow intended users to perform critical tasks safely and effectively, avoiding critical use errors.
• Clinical Ground Truth (Leveraged): For the predicate device's clinical trial (K173703), the ground truth for fibroid treatment effectiveness would have been based on clinical outcomes data (e.g., reduction in heavy menstrual bleeding, fibroid volume reduction, patient symptom scores) and potentially pathology for confirmed fibroid presence.

8. The Sample Size for the Training Set

• Training Set for SMART Guide (Algorithm/Graphical Overlay):

  • Ex vivo testing with non-perfused bovine tissue models was used for preliminary development of the Ablation Zone (AZ) and Thermal Safety Border (TSB) dimensions. This would represent the "training" data for these graphical representations.
  • In vivo peri- and pre-hysterectomy studies data were also used to "set final SMART Guide dimensions." The exact sample size for these in vivo studies specifically for SMART Guide development is not given, but they refer to the predicate's clinical experience. (Note: These would be considered part of the training/development of the SMART Guide, not necessarily the training of a machine learning algorithm).

• No explicit "training set" in the machine learning sense is described for an AI algorithm for diagnostic purposes, as this is primarily a procedural device with graphical guidance, not an AI diagnostic tool.

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

• For the SMART Guide:
  • Ex vivo tissue models: Physical measurements of ablation zones created in bovine tissue.
  • In vivo peri- and pre-hysterectomy studies: Clinical observation and potentially pathological examination of ablated tissue in human subjects. This would have been established through a combination of imaging (ultrasound, MRI), physician assessment, and potentially macroscopic/microscopic examination of excised tissue if a hysterectomy followed ablation. The specific methodology for establishing this "ground truth" for SMART Guide dimensions is not fully detailed in this 510(k) summary for the updated device, as it leverages prior work.

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The Acessa Pro Vu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.

The Acessa ProVu System provides radiofrequency (RF) ablation, ultrasound visualization and guidance within a single console and includes additional accessories. The Acessa ProVu System consists of a console with push buttons to control menu functionality. The console contains the following hardware and electronic components:

• RF Ablation System
• Ultrasound Visualization System
• Guidance System

The following accessories connect to the console:

• Dual Foot pedal (one for RF ablation and one for coagulation)
• Video Cable
• Power Cord
• Acessa Pads and Acessa Pad Cable
• Acessa ProVu Handpiece and Acessa ProVu Handpiece Cable
• Acessa Transducer, either:
  • Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (embedded with sensor), or
  • Acessa ProVu Transducer with (embedded) sensor
• Acessa Table Top Field Generator or Acessa ProVu Planar Field Generator
• Monitor (hospital-owned accessory monitor, not provided by Acessa)

The Acessa ProVu System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Power Control and Coagulation Mode. The graphical user interface (GUI) is displayed on a hospital-owned monitor. The system enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Acessa ProVu Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the monitor. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal.

The Acessa ProVu System uses electromagnetic tracking technology to track the positions of the Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (or the Acessa ProVu Transducer with embedded sensor) and the Acessa ProVu Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Acessa ProVu Handpiece shaft's future path in relation to the features in the ultrasound slice. The use of the guidance functionality is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The provided text describes the Acessa ProVu System and its premarket notification to the FDA. However, it does not contain a study to prove the device meets acceptance criteria, nor does it define specific acceptance criteria with quantitative performance metrics for the device. The document primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and a summary of non-clinical bench testing.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, sample size used for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, and how training ground truth was established. This information is not present in the provided text.

The closest relevant information is a general statement that "The performance data demonstrate that the subject device is substantially equivalent to the predicate devices" and a list of non-clinical bench tests performed:

• Biocompatibility Testing
• Use Life Testing of Transducers
• Electrical Safety and Electromagnetic Compatibility testing per various IEC/ANSI standards
• Software Validation and Verification Testing per FDA guidance (software considered "major" level of concern)
• Acessa ProVu Console and Guidance System Level Testing
• Benchtop Ablation Testing to validate substantial equivalence to the predicate
• Acessa ProVu Handpiece Performance Testing
• Acessa Pads Performance Testing
• Acessa ProVu Transducer Performance Testing (Acoustical and Thermal Measurement, in conformance with IEC 60601-2-37)
• Acessa ProVu Transducer Sleeve Testing

The document states that the Acessa ProVu System includes optional electromagnetic guidance with an accuracy of ±10 mm. This is the only quantitative performance metric mentioned in relation to the device's functionality. It does not, however, present this as an "acceptance criterion" that was tested in a "study" with specific results.

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The Sonata® Sonography-Guided Transcervical Fibroid Ablation System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing, without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments.

The provided text describes the acceptance criteria and the clinical study results for the Gynesonics Sonata® Sonography-Guided Transcervical Fibroid Ablation System.

1. Table of Acceptance Criteria and Reported Device Performance

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The Acessa Guidance System is indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended as an optional accessory for use during the Acessa System procedure.

The Acessa Guidance System consists of the following components: Guidance Controller (Model Number 5100), Guidance Ultrasound Transducer Sleeve (Model Number 5500), Guidance Field Generator (Model Number 5200), Guidance Handpiece Cable (Model Number 5400), and Power Cord (Model Number 4110). The Acessa Guidance System uses electromagnetic tracking technology to track the positions of the Guidance Ultrasound Transducer Sleeve and the Guidance Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Guidance Handpiece shaft's future path in relation to the features in the ultrasound slice. The Acessa Guidance System is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The Acessa Guidance System includes the following performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify sample sizes for any of the listed performance tests.
• The provenance of the data (e.g., country of origin, retrospective or prospective) is not provided for any of the tests.

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

• This information is not provided in the document. The tests described are primarily engineering, biocompatibility, and simulated environment tests, rather than clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set:

• This information is not applicable as the provided testing is not a clinical study involving human reader interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not conducted or described in this document. The device is a guidance system, and the testing focuses on its engineering and functional performance rather than its impact on human reader performance in a diagnostic context.

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

• The document describes performance testing that largely functions as "standalone" performance for the device's components (electrical, safety, biocompatibility, mechanical). The "system worse-case accuracy comparison testing in a simulated clinical environment" evaluates the algorithm's accuracy in a controlled setting without explicit mention of human-in-the-loop performance influencing the measurement. However, the device is an "optional accessory" for use during a procedure and is meant to enhance ultrasonic images and predict tool paths, implying human interaction during its intended use. Therefore, while some tests are algorithmic/system performance, it's not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used:

• Electrical and Safety Testing: Ground truth is established by the specified international standards (e.g., ANSI/AAMI ES 60601-1).
• Biocompatibility Testing: Ground truth is established by the specified international standards (e.g., ISO 10993 series).
• Mechanical (Guidance Sleeve end cap tensile testing): Ground truth would be engineered specifications or established industry standards for material strength.
• Accuracy (System worse-case accuracy comparison): Ground truth would be defined reference points or known positional values within the simulated clinical environment.
• Software Validation: Ground truth would be the software requirements specifications and expected functional behavior.

8. The Sample Size for the Training Set:

• The document does not mention a "training set" in the context of machine learning or AI models. The software is noted to be from the manufacturer of the predicate device and based on their cleared device, implying reuse or adaptation of existing software rather than a de novo development requiring a distinct training phase.

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

• This information is not applicable as no training set for an AI model is described.

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The Acessa Guidance Handpiece is indicated for use in percutaneous laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

Acessa Guidance Handpiece (Model Number 5300):

The Acessa Guidance Handpiece, when used with the tracking system, is meant to guide the tip of the Handpiece up to the uterine serosa. Once the device is advanced into the uterus, standard ultrasound views are used to guide the tip to the fibroid. Ultrasound visualization for fibroid penetration and treatment remain unchanged.

The Acessa Guidance Handpiece is a single-use only, sterile, radiofrequency (RF) applicator that connects to the Acessa Generator by a custom Cable. The Handpiece consists of a handle with a trocar shaft, active needle tip, and seven deployable needle electrodes each with embedded thermocouple sensors for real-time temperature feedback. The Acessa Guidance Handpiece also has control buttons that allow the user to access the User Interface.

This Acessa Guidance Handpiece also contains the magnetic guidance sensor used to determine spatial location. The embedded sensor and SROM can be used with the electromagnetic tracking technologies to track the positions of an Ultrasound Transducer and the Handpiece shaft, and draws virtual representations of them in their spatial relationship, so that a physician can predict the Handpiece shaft's future path in relation to the features in the ultrasound slice. These electromagnetic tracking technologies are considered optional accessories to Acessa System procedure.

Here's a summary of the acceptance criteria and study information for the Acessa Guidance Handpiece based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes performance testing of the device itself (electrical, safety, biocompatibility, mechanical, and compatibility with a tracking system), not a clinical study on patient data. Therefore, there isn't a "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective nature for such a clinical study. The testing was technical in nature, conducted on the device hardware and materials.

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

Not applicable. As noted above, this was not a study evaluating performance against a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. This was not a study involving expert adjudication of clinical cases.

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 document describes the 510(k) submission for a medical device (Acessa Guidance Handpiece) which is a physical instrument, not an AI or software algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant here.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing was based on:

• Established national and international standards for electrical safety (EN/IEC 60601 series).
• Established national and international standards for biocompatibility (ISO 10993 series).
• Internal criteria for flexural strength and compatibility with the electromagnetic tracking system.

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.

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