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SYNERGY MARBLE is a hand-held device for over-the counter aesthetic purposes. The device red light and amber light are intended for the use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

The SYNERGY MARBLE is an over-the-counter, battery powered hand-held light emitting diode (LED) device that emits light energy in the red, blue and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The SYNERGY MARBLE components include an applicator, a charging station and an adaptor. The treatment surface is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user repairable components. The device is sold as Over the Counter (OTC).

The provided 510(k) summary for the SYNERGY MARBLE (Model: Opasm) device does NOT include a robust clinical study or performance-based acceptance criteria for its intended uses (treating wrinkles and mild to moderate inflammatory acne).

Instead, the submission relies on non-clinical testing and a demonstration of substantial equivalence to previously cleared predicate devices. Therefore, a table of acceptance criteria and reported device performance with associated study details cannot be fully constructed as requested.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of substantial equivalence and present the non-clinical testing conducted.

Inferred Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Non-Clinical Testing)

Study Details (Based on the provided 510(k) Summary)

The provided document describes non-clinical testing for safety and performance related to electrical safety, EMC, usability, photobiological safety, battery safety, and biocompatibility. It does NOT describe a clinical study to directly prove the device meets acceptance criteria for its intended therapeutic effects (treating wrinkles or acne).

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

   • Test Set Sample Size: Not applicable. The document refers to non-clinical bench testing and conformity to international consensus standards, rather than a test set of patient data.
   • Data Provenance: The data provenance is from laboratory bench testing (non-clinical) and conformity assessments against international standards. No specific country of origin is mentioned for these lab tests, but the manufacturer is YRS Group Inc. (US) and the consultant is from Shanghai, China.

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

   • Not applicable. As this was non-clinical testing against established standards, there was no "ground truth" established by experts in a clinical context. Results were compared against the requirements of the standards themselves.

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

   • Not applicable. There was no clinical test set requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is a light-based therapy device, not an AI-assisted diagnostic or therapeutic device requiring human reader assessment.

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

   • Not applicable. This device is a direct-use therapy device, not an algorithm.

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

   • For the non-clinical testing, the "ground truth" was defined by the specific requirements and limits set forth in the international consensus standards (e.g., maximum current leakage for electrical safety, specific wavelengths and energy densities, cytotoxicity limits). There was no clinical ground truth established for effectiveness.

7. The sample size for the training set:

   • Not applicable. This review concerns non-clinical testing and substantial equivalence, not a machine learning model that requires a training set.

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

   • Not applicable.

Conclusion from document:

The SYNERGY MARBLE device gained clearance by demonstrating substantial equivalence to existing legally marketed predicate devices (K202055 - Looper and K190443 - MMSphere™) through a comparison of technological characteristics and intended uses, alongside conformity to relevant non-clinical safety (electrical, EMC, photobiological, battery, usability, home use) and biocompatibility standards. The submission explicitly states: "The conclusion drawn from the non-clinical tests is that the device is as safe, as effective, and performs as well as the legally marketed predicate device K202055 and reference device K190443." This implies that clinical effectiveness for wrinkle reduction and acne treatment is primarily supported by the established effectiveness of the predicate devices, rather than a new clinical study.

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Synergy Cranial v2.2.9:
The StealthStation System, with Synergy Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures:

• Cranial Biopsies
• Tumor Resections
• Craniotomies/Craniectomies
• Skull Base Procedures
• Transsphenoidal Procedures
• Thalamotomies/Pallidotomies
• Pituitary Tumor Removal
• CSF Leak Repair
• Pediatric Catheter Shunt Placement
• General Catheter Shunt Placement

StealthStation Cranial Software v3.1.4:
The StealthStation System, with StealthStation Cranial software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):

• Cranial biopsies (including stereotactic)
• Deep brain stimulation (DBS) lead placement
• Depth electrode placement
• Tumor resections
• Craniotomies/Craniectomies
• Skull Base Procedures
• Transsphenoidal Procedures
• Thalamotomies/Pallidotomies
• Pituitary Tumor Removal
• CSF leak repair
• Pediatric Ventricular Catheter Placement
• General Ventricular Catheter Placement

The StealthStation System, with StealthStation Cranial software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation Cranial software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. StealthStation Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The Medtronic Navigation, Inc. StealthStation Cranial Software (v3.1.4) and Synergy Cranial Software (v2.2.9) are image-guided surgery (IGS) systems intended to aid in precisely locating anatomical structures during neurosurgical procedures.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for both software versions are related to system accuracy in 3D positional and trajectory angle measurements.

Note: The document refers to "StealthStation Cranial v3.1.3" and also "StealthStation Cranial v3.0 Software" in the testing section for the newer version's accuracy. Assuming v3.1.3 is the subject device and v3.0 is a close predecessor or the system version used for the test. The "v3.1.4" in the 510(k) letter is likely a minor update from v3.1.3, and the reported performance for v3.1.3 is considered representative.

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

The document does not explicitly state the sample size (number of patients or phantom configurations) used for the quantitative accuracy testing (test set). It mentions:

• "Under representative worst-case configuration"
• "utilizing a subset of system components and features that represent the worst-case combinations of all potential system components."
• "Test configurations included CT images with slice spacing and thickness ranging between 0.6 mm to 1.25 mm and T1-weighted MR images with slice spacing and thickness ranging between 1.0 mm to 3.0 mm."

Data Provenance: The data appears to be prospective as it was generated through laboratory and simulated use settings with "anatomically representative phantoms." The country of origin is not explicitly stated, but given Medtronic Navigation, Inc. is located in Louisville, Colorado, USA, it's highly probable the testing was conducted in the USA.

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

The document indicates that the accuracy was determined using "anatomically representative phantoms." This implies that the ground truth for positional and angular accuracy was engineered and precisely measured within a controlled phantom environment, rather than established by human experts interpreting clinical data. Therefore, human experts were likely involved in designing and validating the phantom setup and measurement methodologies, but not in directly establishing ground truth from patient data. The qualifications of these individuals are not specified but would typically be engineers, physicists, or metrology specialists.

4. Adjudication Method for the Test Set

Given that the ground truth was established through a designed phantom and precise measurements, an adjudication method for human interpretation is not applicable here. The measurements are objective and quantitative.

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

No MRMC comparative effectiveness study was mentioned for human readers improving with AI vs. without AI assistance. The device is a surgical navigation system, aiding in real-time guidance, not an AI-assisted diagnostic tool that would typically undergo MRMC studies.

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

Yes, a standalone performance was done for the system's accuracy. The reported positional and trajectory angle errors are measures of the system's inherent accuracy, independent of a specific human-in-the-loop scenario. The study describes "Design verification and validation was performed using the StealthStation Cranial software in laboratory and simulated use settings."

7. The Type of Ground Truth Used

The ground truth used was engineered truth derived from precisely measured anatomical phantoms. This is a highly controlled and quantitative method, suitable for measuring the accuracy of a navigation system.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning model. The device is referred to as "software" for an Image Guided System (IGS), which typically relies on established algorithms for image processing, registration, and tracking, rather than deep learning models that require large training datasets with ground truth labels in the conventional sense. The "training" for such a system would involve rigorous formal verification and validation of these algorithms.

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

As noted above, the concept of a "training set" and its associated ground truth, as typically applied to AI/machine learning, does not appear to be directly applicable to the description of this device's development as presented in the 510(k) summary. The development involved "Software verification and validation testing for each requirement specification" and "System integration performance testing for cranial surgical procedures using anatomical phantoms," suggesting traditional software engineering and testing methodologies rather than machine learning training.

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The Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Synergy Gold (SG) Portable (Models MM011450 and MM011460) breast pump is intended for home use by a single user.

The Synergy Gold (SG) Portable is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to select one or both sides for pumping, to switch from massage mode to expression mode and to control the vacuum levels within those modes. Massage mode consists of 5 suction levels, while expression mode has 12 suction levels. The SG Portable breast pump is capable of providing vacuum levels from 50-270 mmHz with cycling rate or 100 cycles per minute in massage mode and 26 cycles per minute in expression mode. The SG Portable breast pump is powered by a 5V DC adaptor or an internal rechargeable lithium-ion polymer battery.

The SG Portable breast pump is sold in two configurations (with and without breast shield and bottle sets). Model MM011450 includes the SG Portable breast pump, double collection kit (MM12302-C; breast shield set - medium 24 mm), power adapter, and two collection bottles. Model MM011460 includes the SG Portable breast pump and power adaptor: this model is to be used with separately purchased compatible breast shields and bottle sets.

The SG Portable breast pump and associated breast pump kits are intended for a single user.

The provided document is a 510(k) Premarket Notification from the FDA for a powered breast pump (Synergy Gold (SG) Portable). This type of document focuses on establishing substantial equivalence to a predicate device based on non-clinical testing, rather than extensive clinical studies or acceptance criteria for an AI/ML device.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI/ML device, a study proving it meets those criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment methods for an AI/ML context.

The document primarily details:

• Device Name: Synergy Gold (SG) Portable (Models MM011450 and MM011460)
• Regulation Number: 21 CFR 884.5160
• Regulation Name: Powered Breast Pump
• Product Code: HGX
• Regulatory Class: II
• Predicate Device: K191208 Spectra Cashmere Breast Pump
• Intended Use: For lactating women to express and collect milk from their breast, intended for home use by a single user.
• Non-Clinical Testing Summarized: Electrical Safety (ANSI/AAMI ES60601-1:2005+A1:2012, IEC 60601-1-11:2015, IEC 62133:2012), Risk Analysis (ISO 14971:2007), Electromagnetic Compatibility (IEC 60601-1-2:2014), Biocompatibility (by reference to predicate), Software Validation ("Moderate" level of concern per FDA Guidance 2005), Bench Testing (vacuum, cycles, AC/battery power, various breast shield sizes, backflow protection), Battery and pump use-life testing.

The "acceptance criteria" discussed in this document refer to the device meeting its performance specifications through bench testing and compliance with electrical safety and EMC standards, a standard process for a physical medical device. It does not relate to the performance metrics of an AI/ML algorithm.

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The SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.

The SYNERGY is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and infrared spectrum for the treatment of wrinkles on the face. The SYNERGY components include an applicator, a charging station and an adaptor. The treatment surface is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user repairable components. The device is sold for Over the Counter (OTC) use.

The provided text is a 510(k) summary for the "SYNERGY" device, a red/IR light therapy device intended for treating facial wrinkles. It establishes substantial equivalence to a predicate device, "Elevare Plus" (K172909).

However, the provided document does not contain any information about acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction) or any study that proves the device meets such criteria (e.g., a clinical study with human subjects). It focuses primarily on the safety and technological equivalence to a predicate device.

The document details non-clinical testing for electrical safety, EMC, photobiological safety, battery safety, and biocompatibility, as well as software validation and skin temperature testing. These tests ensure the device is safe to use and performs within its design specifications, but they do not address the clinical effectiveness of wrinkle reduction or any acceptance criteria for that purpose.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance

   • The document does not provide acceptance criteria for clinical efficacy (e.g., quantitative wrinkle reduction) or corresponding performance data. The "performance testing" mentioned refers to software validation and skin temperature, not clinical outcomes.

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

   • No human test set for clinical performance is described. The "test set" for non-clinical testing (e.g., electrical safety, temperature) would refer to the device units tested, not human subjects.

3. Number of experts used to establish the ground truth

   • Not applicable, as no clinical efficacy study or ground truth establishment for clinical outcomes is described.

4. Adjudication method

   • Not applicable.

5. MRMC comparative effectiveness study

   • Not applicable.

6. Standalone performance

   • Not explicitly described in terms of clinical efficacy. The standalone performance testing mentioned is for device safety and functional specifications (e.g., skin temperature).

7. Type of ground truth used

   • Not applicable for clinical ground truth. For the safety tests, the "ground truth" would be established by the standards themselves (e.g., IEC 60601-1, IEC 62471).

8. Sample size for the training set

   • Not applicable, as this is a physical device, not an AI/ML algorithm that requires a training set of data for clinical performance.

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

   • Not applicable.

Summary of Information Available Related to Safety and Technical Performance:

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and safety standards.

• Acceptance Criteria (Safety/Technical Performance): The device conforms to several international consensus standards for electrical safety (ANSI AAMI ES60601-1, ANSI AAMI IEC 60601-1-2, ANSI AAMI IEC60601-1-11), photobiological safety (IEC 62471), battery safety (IEC 62133-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Additionally, skin temperature testing ensured the device stayed within 41 ± 2℃ and did not elevate skin temperature above 43°C. Software validation was conducted per FDA guidance.
• Study Proving Acceptance Criteria (Safety/Technical Performance):
  • The document states that "The SYNERGY has been tested and conforms to international consensus standards" and lists the specific standards.
  • For skin temperature, it states "The test results concluded that the SYNERGY was within specification of 41± 2℃ and did not elevate skin temperature above 43°C."
• Sample size and data provenance for these technical tests: Not specified beyond the implication that device units were tested in a non-clinical setting. The data provenance would be from laboratory testing.
• Experts/Ground truth for technical tests: Ground truth is established by the specified international consensus standards for device safety and performance. No "experts" in the sense of clinical reviewers are mentioned for these technical tests; rather, certified testing laboratories and their protocols would be involved.
• MRMC/Standalone (clinical efficacy): Not relevant or discussed in this document.

In conclusion, the provided FDA 510(k) summary addresses the safety and technical specifications of the SYNERGY device, demonstrating its substantial equivalence to a predicate device. It does not include information on clinical efficacy studies or acceptance criteria related to the device's intended effect on wrinkles.

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Entry-level EMLA (Synergy Platform/Synergy)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
• It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard dose fractionation, and hypofractionation in all areas of the body where such treatment is indicated.
• The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

Mid-level EMLA (Infinity)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
• It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard dose fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT: stereotactic ablative radiotherapy – SABR) in all areas of the body where such treatment is indicated.
• The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

High-level EMLA (Versa HD)
• The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner.
• It is intended to assist a licenced practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT: stereotactic ablative radiotherapy - SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated.
• The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body and for the treatment of functional disorders, such as trigeminal neuralgia.

The Elekta Medical Linear Accelerator system is an image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume.
The system consists of components of the accelerator, such as, beam shaping, with imaging and accessories for patient positioning and set-up to deliver therapeutic treatments.
The Elekta Medical Linear Accelerator System is currently available in the following model variants - Precise Treatment System, Elekta Synergy Platform, Elekta Synergy, Elekta Infinity and Versa HD.

This document, K192242, is an FDA 510(k) premarket notification for an Elekta Medical Linear Accelerator system. It outlines the device's indications for use and asserts its substantial equivalence to a predicate device (EMLA K182138).

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria based on performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/ML component. Instead, the notification primarily concerns restructuring and clarifying the Indications for Use statements for different models of the linear accelerator.

The "Summary of performance testing (non-clinical)" section explicitly states: "Since no changes to the hardware or software was made in this submission, no additional non-clinical testing has been conducted." Similarly, for "Summary of performance testing (clinical)", it mentions, "The only change in this submission concern Indications for Use. An extensive literature search was conducted to collect and analyze available clinical evidence in order to support new Indications for Use."

Therefore, based on the provided text, it is not possible to complete the requested information about acceptance criteria and a study demonstrating device performance for an AI/ML component. The document does not contain such a study or performance metrics.

However, if we were to infer the types of information that would be present in such a study, and filling in with "N/A" or "Not provided" for elements not found in the text, here's how the table and subsequent points would be structured:

Acceptance Criteria and Device Performance Study Information (Based on the supplied document, which does not contain this data):

As the provided FDA 510(k) notification (K192242) for the Elekta Medical Linear Accelerator focuses on clarifying Indications for Use and asserts substantial equivalence without new performance testing, the specific details regarding acceptance criteria and a study proving an AI/ML device meets these criteria are not available in the document. The document explicitly states no changes were made to hardware or software and no additional non-clinical testing was conducted for this submission.

Therefore, the following table and subsequent points will indicate "Not Provided" or "N/A" for the requested information, as it is not present in the given text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not provided. The submission states that no new non-clinical testing was conducted, and for clinical "performance," an extensive literature search was performed, not a new clinical study with a defined test set.
• Data Provenance: The document refers to "extensive literature search" for clinical evidence, but does not detail the origin (e.g., country of origin, retrospective/prospective nature) of data within that literature.

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

• Not applicable as no specific test set requiring expert-established ground truth for an AI/ML component's performance is described in this submission. The "ground truth" for the current submission is based on existing clinical literature supporting the general use of linear accelerators for radiation therapy.

4. Adjudication Method for the Test Set

• Not applicable as no specific test set requiring adjudication is described.

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

• Was an MRMC study done? No. The document does not describe any MRMC study.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No. The document refers to the Elekta Medical Linear Accelerator system as a whole, not a specific standalone AI algorithm, and states no new non-clinical testing was performed.

7. Type of Ground Truth Used for the Test Set

• Not applicable for a performance study of an AI/ML component. The current submission's "ground truth" for its claims relates to the well-established clinical indications for external beam radiation therapy, supported by existing literature.

8. Sample Size for the Training Set

• Not applicable as no AI/ML training set is described in this submission, which focuses on device indications and substantial equivalence rather than a new AI component's development or validation.

9. How Ground Truth for the Training Set Was Established

• Not applicable.

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Synergy ODM is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, clinical information, reports from ophthalmic diagnostic instruments through either a direct comection with the instruments or through computerized networks.

Synergy ODM is a modification to Synergy ODM cleared in K132667. The key differences between the cleared product and the one that is the subject of this 510(k) are minor modifications to the GUI. addition of a mobile GUI. minor workflow enhancements, additional measurements based on existing line and area measurement tools, minor enhancements to the data acquisition and export functionality, addition of two new reports, minor enhancements to external access to Synergy ODM, performance enhancements to decrease start up time, enhancement to external interfaces, changes to configuration options and tools which are not accessible to the end user, modifications required to maintain compatibility with external products, modification to tools which are not accessible to the user, and bug fixes.

Synergy ODM is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy ODM is used together with a number of computerized digital imaging devices. In addition. Synergy ODM software collects and manages patient demographics, image data, and clinical reports from a range of medical devices. Synergy ODM enables a real-time review of diagnostic patient information at a PC workstation. Synergy ODM also includes an internetbrowser-based user interface to allow authorized users to access, view, create reports, and analyze patient and examination data saved in a centralized database. The system utilizes dual level authentication and 128-bit encryption to ensure secure networking environment.

The provided text describes a 510(k) premarket notification for the "Synergy ODM" device. It is a software platform for managing ophthalmic images and patient data. However, the document explicitly states that "No performance data was required or provided." Therefore, I cannot provide the detailed information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

Here's why I cannot fulfill your request based on the provided text:

• No performance data: The critical sentence "No performance data was required or provided. Software validation and verification demonstrate that the Synergy ODM performs as intended and meets its' specifications" indicates that the regulatory submission did not include a study with performance metrics against acceptance criteria.
• Substantial Equivalence: The submission focuses on demonstrating "Substantial Equivalence" to a predicate device (Topcon Corporation Synergy ODM, K132667) rather than proving performance against novel acceptance criteria. This means the device is considered safe and effective because it is very similar to an already approved device, not because a new clinical performance study was conducted.

Since the document explicitly states no performance data was provided, I cannot generate the requested table or answer the other questions about acceptance criteria and study details. The device's approval was based on demonstrating substantial equivalence to a predicate device, not on a new performance study.

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The StealthStation System, with Synergy® Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy.

This can include, but is not limited to, the following cranial procedures:

• Cranial Biopsies
• Tumor Resections
• Craniotomies/Craniectomies
• Skull Base Procedures
• Transsphenoidal Procedures
• Thalamotomies/Pallidotomies
• Pituitary Tumor Removal
• CSF Leak Repair
• Pediatric Catheter Shunt Placement
• General Catheter Shunt Placement

The StealthStation System, with Synergy Cranial v2.2.7 software helps guide surqeons during cranial surgical procedures such as biopsies, tumor resections, and shunt placements. The Synergy Cranial v2.2.7 software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surqical instruments, a referencing system and platform/computer hardware. Image quidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. Synergy Cranial v2.2.7 software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

Here's a breakdown of the acceptance criteria and study information for the StealthStation System with Synergy Cranial Software, based on the provided document:

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 a numerical "sample size" for the test set in terms of cases or patients. Instead, it describes:

• Test Setup: "an anatomically representative phantom." This suggests a single or very limited number of phantoms were used to test accuracy.
• Data Provenance: The testing was conducted "in laboratory and simulated use settings." This indicates a retrospective and simulated provenance, not based on real patient data from a specific country.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for accuracy testing on a phantom would typically be established by the precise design and known dimensions of the phantom itself, and the accurate measurement tools used during the test.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Since the performance testing was based on an anatomically representative phantom and direct measurements of positional and angular error, adjudication by human experts (as would be typical for image interpretation tasks) was not applicable or performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies or a comparison of human reader performance with and without AI assistance. The testing focuses solely on the device's inherent accuracy in a simulated environment.

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

Yes, a standalone performance evaluation was conducted. The document states that the testing demonstrated the system's "performance in 3D positional accuracy" and "trajectory angle accuracy." These are measurements of the algorithm/system's precision in guiding instruments, independent of a human's interpretation or decision-making. The device, an Image Guided System (IGS), inherently functions as a standalone guidance system, providing objective measurements to the surgeon.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for the performance testing was based on the known physical properties and precise measurements of an anatomically representative phantom. This is a form of engineered or objective ground truth, not derived from subjective expert consensus, pathology, or patient outcomes.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for a training set. This is typical for a medical device cleared via 510(k) where the focus is on substantial equivalence to a predicate device and performance validation, rather than the development and training of a novel AI algorithm from a large dataset. The Synergy Cranial software is likely a refined version or update to existing navigation software, rather than a de-novo AI model requiring extensive training data.

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

As no training set is described, there is no information on how its ground truth would have been established.

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SYNERGY is intended for use in: Augmentation or reconstructive treatment of alveolar ridge Filling periodontal defects Filling defects after root resection, apicoectomy, and cystectomy Filling extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). Filling peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Synergy is a Xenograft of bovine origin. It contains macro and micro porous structures similar to Bio-Oss. Synergy is a purified osteoconductive mineral structure produced from bone in a multi-stage purification process. Synergy is chemically as well as structurally comparable to mineralized Bio Oss and Equimatrix. Synergy is used as an adjunctive therapy in restoring bony defects in the mouth. Synergy is produced from selected bovine bone. Physical and chemical analysis has demonstrated that the composition of Synergy is similar to the predicate devices which have been shown to be anorganic, osteoconductive hydroxyapatite bone mineral. The product is milled to generate granules of two sizes (0.30 - 0. 84 mm or 0.84 - 2.0 mm) which are put into glass vials and sterilized by gamma irradiation. Synergy has porous structure and composition, encouraging the formation and ingrowth of new bone at the implantation. In the course of time Synergy is partially remodelled by osteoclasts and osteoblasts (physiological remodelling).

The provided text describes a 510(k) premarket notification for a dental bone grafting material called "Synergy" (K123876). The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a study designed to meet specific performance targets.

Therefore, the document does not contain the requested information regarding specific acceptance criteria for device performance or a study proving the device meets said criteria in the way a clinical trial or performance study report would.

The document primarily provides:

• Device description and intended use for Synergy, the predicate devices (Bio-Oss and Equimatrix™), and a comparison table.
• A statement of substantial equivalence to the predicate devices based on intended use, biocompatibility, sterility, physical and chemical testing, performance evaluation in an anatomically relevant animal model, and results of clinical cases (though the details of these cases or the animal study are not provided).
• Compliance with recognized standards (ISO 10993, ASTM F1088 - 04a, USP 31, ASTM F1185 - 03, ASTM F1581 - 08, Argentine Pharmacopeia) and FDA Special Controls Guidance Document for Dental Bone Grafting Material Devices.

Since the document does not present specific acceptance criteria or a detailed study to meet them, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, etc. Those details are typically found in a dedicated performance study report, which is not part of this 510(k) summary.

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Synergy ODM is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Synergy ODM is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy ODM is used together with a number of computerized digital imaging devices. In addition, Synergy ODM software collects and manages patient demographics, image data, and clinical reports from a range of medical devices. Synergy ODM enables a real-time review of diagnostic patient information at a PC workstation. Synergy ODM also includes an internetbrowser-based user interface to allow authorized users to access, view, create reports, and analyze patient and examination data saved in a centralized database. The system utilizes dual level authentication and 128-bit encryption to ensure secure networking environment.

The provided text for K132667 states: "No performance data was required or provided. Software validation and verification demonstrate that the Synergy ODM performs as intended and meets its' specifications."

Therefore, it is not possible to describe acceptance criteria or a study proving device performance based on the provided document. The device, Synergy ODM, is a software platform for image management in ophthalmology, and its 510(k) clearance was based on substantial equivalence to predicate devices, without requiring clinical performance data.

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The Synergy Focus is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Synergy Focus may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Synergy Focus is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Synergy Focus is intended to be used by a qualified healthcare provider.

The Natus Synergy Focus (Synergy Focus) is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). Synergy Focus provides a variety of tests spanning the various modalities.

The Synergy Focus consists of the following major components:

• Console base unit with integrated control panel;
• Amplifier (with three non-switched amplifier channels);
• Desktop or laptop computer with a keyboard and mouse;
• Display monitor; and
• Synergy Software.

The Synergy Focus optional accessories/components consists of the following:

• Stimulator probes (RS 10 probe, Stimulus Probe with controls)
• Footswitches (triple)
• LED goggles
• Headphones or other auditory transducers
• Patient response button
• Cart
• Isolation transformer
• Printer.

The Natus Synergy Focus is an electromyograph (EMG) device intended for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance relies heavily on demonstrating substantial equivalence to predicate devices (K112052 CareFusion Nicolet EDX with Viking Software and K120979 CareFusion Nicolet EDX with Synergy Software). Therefore, the "acceptance criteria" are primarily defined by the performance characteristics of these predicate devices, and the "reported device performance" demonstrates that the Synergy Focus either matches or improves upon these characteristics, or where there are differences, they do not raise new questions of safety or effectiveness.

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

The provided 510(k) summary does not explicitly state a sample size for a test set or data provenance in the context of clinical performance or AI/algorithm performance.

Instead, the submission relies on demonstrating substantial equivalence to its predicate devices (K112052 and K120979) through:

• Comparison of technical characteristics.
• Non-clinical performance testing (biocompatibility, software validation, electrical safety, EMC, and bench testing to applicable standards like IEC 60601-2-40).
• The explicitly stated conclusion that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness."

This indicates that there was no separate "test set" of patient data used for evaluating the performance of the Synergy Focus in a clinical or AI context, as its performance is considered equivalent due to identical or functionally equivalent hardware and software to already cleared devices.

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

Since no clinical or AI-specific test set was used requiring ground truth establishment by experts, this information is not applicable to this 510(k) submission.

4. Adjudication Method for the Test Set

As no test set involving human interpretation requiring adjudication was used, this information is not applicable.

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

An MRMC comparative effectiveness study was not done. The submission explicitly states that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness," and the device is a diagnostic electromyograph, not an AI-assisted diagnostic tool in the sense of image interpretation. Therefore, there is no AI assistance improvement effect size to report.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on an algorithm's performance without human-in-the-loop was not done. The Synergy Focus is a hardware and software system for acquiring and displaying physiological signals, not a standalone algorithm providing diagnostic outputs. The software component, categorized as "MODERATE level of concern," underwent rigorous verification and validation during development, as noted in the "Software testing" section, but this is distinct from an AI algorithm's standalone performance study.

7. Type of Ground Truth Used

Given the nature of the device and the submission's focus on substantial equivalence through technical characteristics and non-clinical testing, there was no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of evaluating the diagnostic accuracy of a new algorithm or clinical performance. The ground truth (or reference standard) in this submission relates to:

• Engineering specifications and standards: The device's performance was compared against the technical specifications of the predicate devices and national/international standards (e.g., IEC 60601-2-40 for safety and performance of electromyographs).
• Predicate device characteristics: The primary "ground truth" for demonstrating substantial equivalence was the established safety and effectiveness of the Nicolet EDX with Viking and Synergy software systems.

8. Sample Size for the Training Set

Since there is no mention of an AI algorithm or machine learning component in this submission that would require training data, information regarding the sample size for a training set is not applicable. The software validation focused on standard software development lifecycle testing (verification and validation of pre-determined specifications), not on training a model.

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

As there was no training set for an AI algorithm, the question of how its ground truth was established is not applicable.

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