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The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).

The Apollo TMS Therapy System is comprised of the following principal components:

• User Interface
• Main Unit (with or without housing)
• Stimulation Coil
• Coil Positioning System

The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil. For the treatment of major depressive disorder, the stimulation coil is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system. The observed and documented increase in cortical excitability after high frequency rTMS has been shown to persist beyond the duration of the train of stimulation. For treatment of OCD, the stimulation coil is positioned to the dorsomedial prefrontal cortex (DMPFC).

The provided FDA 510(k) clearance letter and summary for the Apollo TMS Therapy System (K243539) indicate that the device is substantially equivalent to predicate devices. This clearance is based on non-clinical performance data and a comparison to existing cleared devices rather than a de novo clinical comparative effectiveness study.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly for the extended indication of Obsessive-Compulsive Disorder (OCD) treatment. The criteria are therefore focused on matching or being demonstrably similar to the predicate device's performance, especially for the OCD treatment parameters, and adhering to recognized safety and performance standards.

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

The submission does not detail a specific "test set" sample size with patient data for efficacy, as it claims substantial equivalence primarily through non-clinical performance testing and direct comparison of specifications and treatment parameters to already cleared devices.

The "study" relies on:

• Non-clinical performance testing: This would involve engineering and laboratory testing for electrical safety, EMC, usability, temperature, and stimulation intensity, rather than a sample size of patients.
• Leveraged data from prior clearances (K180313 and K232639): This indicates that data from previously cleared versions of the Apollo TMS Therapy System was used as a basis.
• Primary predicate device (HORIZON® 3.0 TMS Therapy System K222171): The effectiveness of the OCD treatment protocol is derived from the established effectiveness of this predicate device, which was itself cleared based on its own clinical or non-clinical data.

Data Provenance: Not specified in terms of country of origin or retrospective/prospective for patient data, as direct clinical effectiveness data for the subject device was not required for this 510(k) clearance due to the substantial equivalence claim. The non-clinical testing would have been conducted by the manufacturer (MAG & More GmbH, Germany).

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

This information is not applicable as the submission does not describe a clinical study where experts established ground truth for a test set of patient data. The clearance is based on comparison to a predicate device and non-clinical engineering tests.

4. Adjudication method for the test set

This information is not applicable as there was no clinical test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The Apollo TMS Therapy System is a therapeutic device that directly applies magnetic stimulation, not an imaging analysis or diagnostic AI device that involves "human readers" or AI assistance in interpretation. No MRMC study was conducted or mentioned.

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

This information is not applicable in the context of an "algorithm only" performance study. The Apollo TMS Therapy System is a hardware device with controlling software. Its performance is always "standalone" in the sense that the device itself (hardware+software) delivers the therapy; there isn't a separate "human-in-the-loop" performance associated with its direct therapeutic action, but rather clinical oversight and operation by a healthcare professional. The software verification and validation are noted, but this is for the control system's reliability, not an "algorithm-only performance" in the diagnostic AI sense.

7. The type of ground truth used

For the effectiveness of the OCD treatment, the "ground truth" is essentially the established clinical efficacy of the primary predicate device (HORIZON® 3.0 TMS Therapy System K222171), whose OCD treatment protocol the Apollo TMS Therapy System replicates. The substantial equivalence claim means that because the subject device's treatment parameters are identical and its output stimulation is adequately similar, it can be expected to achieve the same therapeutic effect.

For the safety and performance of the device itself (e.g., electrical safety, temperature limits, consistent stimulus delivery), the "ground truth" is established through adherence to recognized consensus standards (e.g., IEC 60601-1) and successful non-clinical engineering tests.

8. The sample size for the training set

This information is not applicable. The Apollo TMS Therapy System is not an AI/ML device in the sense of requiring a large "training set" of patient data for its primary function. Its software (Stimware) manages protocols and patient data, but it's not "trained" on patient outcomes to learn or adapt therapeutic delivery in an AI sense.

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

This information is not applicable for the same reasons as point 8.

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ApolloHipX is indicated for use in assisting in Total Hip Replacement in which the use of radiological imaging may be appropriate.

ApolloHipX is a non-invasive intra-operative, image processing software intended to precisely measure the position of total hip replacement (THR) components. The software operates as a near-real time assistive device for THR, measuring component alignment, to assist in precise placement of THR components. The software is intended to be installed on certified hardware (Apollo Station) located outside the patient field. This is accomplished by:
• Transfer of intra-operative 2D imaging of the patient from a capture source e.g. an X-ray machine
• Registration of the 3D pre-operative patient data to the 2D intra-operative patient imaging
• Calculation and display of the component alignment (for final implants as well as intra-operative instruments e.g., broaches and trials) which can be compared to pre-operative target positions.
ApolloHipX is intended to precisely measure the position of THR components by measuring implant positions relative to bone structures identifiable from radiological images and providing information on component alignment.
Clinical judgment and experience of an orthopaedic surgeon are required to properly interpret the results from the software. The software is not for primary image interpretation.The Apollo Station is the physical structure used to host the power supply and contains two user interfaces (monitor and tablet) from which the user can interact with the software applications. It also houses non-surgical Software that manages the user authentication, system access, data transfer of surgical inputs and communication to Corin's cloudhosted ecosystem. The Apollo Station connects to the imaging device intra-operatively to receive the 2D radiological images.

The provided text describes the ApolloHipX device and its clearance (K241808) by the FDA. However, it does not contain detailed information about the acceptance criteria and the specific study findings in the format requested.

The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (JointPoint K160284). While it mentions "Non-Clinical testing conducted to determine substantial equivalence," and lists several studies like "Algorithm Accuracy Study," it does not provide the acceptance criteria table or the detailed study results that prove the device meets these criteria. It also explicitly states "Not Applicable. No clinical testing performed to support substantial equivalence."

Therefore, based solely on the provided text, I cannot complete most of the requested information.

Here's what can be inferred/extracted from the provided text, and what is missing:

Acceptance Criteria and Device Performance:

A table of acceptance criteria and reported device performance is not provided in this document. The document lists "Algorithm Accuracy Study" as one of the non-clinical tests, implying that accuracy was measured, but no specific criteria or results are detailed.

Study Information (Based on available text):

• Sample size used for the test set and the data provenance: Not specified. The document mentions non-clinical tests including "Algorithm Accuracy Study," "Sawbone study," and "Cadaveric evaluation." The specific number of cases/samples in these studies is not provided, nor is the origin of the data (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. No information is given about the experts involved in establishing ground truth for any of the non-clinical studies.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
• 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 study was done. The document states, "No clinical testing performed to support substantial equivalence." The device is intended to assist a surgeon ("Clinical judgment and experience of an orthopaedic surgeon are required to properly interpret the results from the software. The software is not for primary image interpretation."), but there's no study described on human performance with/without the device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: An "Algorithm Accuracy Study" was performed, which would be a standalone assessment. However, the results and specific metrics for this study are not provided.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "Algorithm Accuracy Study," the type of ground truth is not specified. Given it's a non-clinical study for a measurement device, it likely involved highly precise measurements from physical models (sawbones or cadavers) or highly accurate imaging, but the exact method isn't detailed.
• The sample size for the training set: Not specified. The document describes non-clinical tests but does not provide details on the training data used for the algorithm's development.
• How the ground truth for the training set was established: Not specified.

Summary of what is Lacking (and crucial for a complete answer):

The provided FDA 510(k) clearance letter and summary confirm the device's clearance and its intended use as a measurement assistance tool for Total Hip Replacement. However, it explicitly states that no clinical testing was performed. While non-clinical tests like "Algorithm Accuracy Study" are mentioned, the document lacks the specific acceptance criteria, detailed results, sample sizes, ground truth methodology (for both test and training sets), and expert qualifications/adjudication methods that would describe how the device met its performance goals. This information is typically found in the detailed study reports submitted to the FDA, not necessarily in the public 510(k) summary.

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The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS).

The Apollo TMS Therapy System is comprised of the following principal components:

• User Interface
• Main Unit (with or without housing)
• Stimulation Coil
• Coil Positioning System

The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil which is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of a coil positioning system. The observed and documented increase in cortical excitability after high frequency (10Hz) rTMS has been shown to persist beyond the duration of the train of stimulation.

This document does not contain information about a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for the Apollo TMS Therapy System, demonstrating its substantial equivalence to previously cleared predicate devices for the treatment of Major Depressive Disorder.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on:

• Intended Use and Device Description: The Apollo TMS Therapy System is an electromagnetic device for non-invasive stimulation of the cerebral cortex to treat Major Depressive Disorder.
• Compliance with Standards: Conforms to various ISO and IEC standards for medical devices, electrical safety, usability, software life cycle processes, and risk management.
• Non-Clinical and Clinical Performance Data: States that non-clinical testing was performed according to standards, and comparative testing for additional coils demonstrated substantial equivalence to predicate devices. It specifically mentions that clinical data on the treatment efficacy of the iTBS protocol was already demonstrated in a previous summary (K173620) and that verification testing confirmed constant intensity of individual stimuli.
• Software Verification and Validation: Conducted in accordance with IEC 62304, considered "basic documentation" as software failures are not likely to present high-risk situations.
• Risk Management: Applied throughout the product development life cycle, concluding no new hazards compared to predicate devices.
• Substantial Equivalence: The core of the submission, asserting that the Apollo TMS Therapy System is substantially equivalent to the HORIZON® TMS Therapy System (K182853) and an earlier version of the Apollo TMS Therapy System (K180313). This equivalence is based on identical intended use, indications for use, system components, operational procedures, and treatment protocols (especially iTBS).
• Comparative Table: Provides a detailed comparison of characteristics between the subject device and its predicates, highlighting similarities in indications for use, product code, classification, standard treatment stimulation parameters (e.g., area of brain stimulated, stimulation intensity, frequency, pulse train duration), output stimulation parameters, and coil parameters. It explicitly notes that the performance and clinical effectiveness are substantially equivalent.

In summary, this document is a regulatory submission demonstrating substantial equivalence rather than a clinical study report with specific acceptance criteria and performance data from a clinical trial.

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The Apollo ESG NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI between 30-50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures.

The Apollo REVISE NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with between 30-50 kg/m2 by enabling transoral outlet reduction as a revision to a previous bariatric procedure.

These devices are used to perform gastric remodelling through the placement of anchor-sutures and locking cinch device. The Apollo ESG NXT system is for intended for endoscopic sleeve gastroplasty (ESG) while the Apollo REVISE NXT device is intended for transoral outlet reduction, as a revision to a previous bariatric procedure. The two device systems differ in terms of the number of anchor-sutures and cinches needed to perform ESG and TORe procedures. Both systems are comprised of a Needle Driver Assembly and Anchor Exchange Device, and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The Apollo ESG NXT and Apollo REVISE NXT needle driver assembies are designed to be compatible with single channel endoscopes. The endcap assembly of the needle driver is mounted onto the endoscope using polyester medical tape. The external catheter sheath has two working channels through which the Anchor Exchange and other accessories can operate, independent of the endoscope channel. The needle driver assembly also incorporates a pull string feature that, when pulled, allows the physician to further control the retroflexion capabilities of the endoscope.

The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations. A previously cleared Tissue Helix is provided with Apollo ESG NXT while the NXT Tissue Helix Pro is provided with Apollo REVISE NXT. Both instruments are used for manipulating tissue into the suturing window of the needle driver assembly. These devices also include a matching number of anchor-sutures and cinches to perform the gastroplasty or revision procedure.

The NXT Tissue Helix Pro is used to acquire tissue by rotating the device's handle to to gather tissue onto the exposed exposed helix coil. The acquired tissue is then pulled into proximity of the needle body to complete the stitching operation. Tissue is released by rotating the handle in the opposite direction.

The provided document describes a 510(k) premarket notification for the Apollo ESG NXT System and Apollo REVISE NXT System. The study presented here focuses on demonstrating substantial equivalence to a predicate device (DEN210045-Apollo ESG Sx System, Apollo Revise Sx System) rather than proving the device meets acceptance criteria for a new, independent performance claim for an AI/ML-based device.

Therefore, many of the requested elements pertaining to an AI/ML device's acceptance criteria, performance study design (e.g., ground truth establishment, MRMC studies, standalone performance), and expert input are not applicable to this submission, as the fundamental claim is one of equivalence based on similar design, materials, and intended use as a physical medical device.

However, I can extract the information relevant to what types of testing were performed to show this equivalence and where "acceptance criteria were met."

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

Acceptance Criteria and Device Performance (as demonstrated for Substantial Equivalence)

Here's an analysis of the requested elements:

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

   • See table above. The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to the predicate device and adherence to relevant standards for biocompatibility, sterility, etc. The "reported device performance" is a summary of the non-clinical testing performed.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • The document does not specify sample sizes for the bench or functional testing (e.g., number of devices tested for tensile strength, torque, etc.). It states: "Appropriate product testing was performed... All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility."
   • The document primarily relies on non-clinical (bench and ex vivo) testing for the current device and leverages existing clinical data from the predicate device (DEN210045).
   • Data Provenance: The new testing is likely proprietary, conducted at Boston Scientific facilities or their chosen testing labs. No information is given about the country of origin for the data itself. The clinical data is leveraged from the predicate's De Novo clearance, which would have had its own clinical study details (not provided in this 510(k) summary).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not Applicable. This is a physical medical device submission, not an AI/ML diagnostic or image analysis device. There is no concept of "ground truth" established by experts in the context of image interpretation or diagnosis for this device's performance claims. The "ground truth" for the device's function (e.g., successful suturing, material integrity) is established through engineering and performance testing against specifications.

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

   • Not Applicable. As per point 3, this is not an AI/ML or diagnostic study requiring human expert adjudication of output.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable. This is not an AI-assisted diagnostic or image analysis device, so no MRMC studies were performed. The device is a surgical/endoscopic suturing system.

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

   • Not Applicable. This device does not have an "algorithm only" or a "human-in-the-loop" component in the context of AI/ML performance. Its standalone performance refers to its mechanical and functional reliability as a physical instrument.

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

   • For the non-clinical testing: The "ground truth" refers to the established engineering specifications and validated test methods (e.g., a specific tensile strength must be met, a specific number of stitches must be capable of being performed successfully).
   • For the clinical performance: The document states "These devices, which use the De Novo clearance devices as predicates, leverage the clinical data presented in that De Novo." This implies that the 'ground truth' for clinical efficacy (weight loss) and safety (adverse events) for the predicate device would have been established through its own clinical trials, likely using patient outcomes data. The current submission argues that because the new device performs the "same procedures" with "same implant placements and the same implants," the clinical data from the predicate is applicable.

8. The sample size for the training set

   • Not Applicable. This device is not an AI/ML algorithm that requires a "training set."

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

   • Not Applicable. As per point 8, there is no AI/ML training set for this device.

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ApolloKnee is indicated to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee arthroplasty.

Apollo Robot and BalanceBot are optional accessories and are specifically indicated for use in total knee arthroplasty with the ApolloKnee system.

ApolloKnee is compatible with the following implant systems:

• · Apex Knee™ System.
• · Unity Knee™ System.

ApolloKnee is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate.

ApolloKnee™ (formerly OMNBotics) is a robotic-assisted stereotaxic surgery system that aids the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee replacement (TKR). ApolloKnee is composed of eight sub-systems that integrate to form the ApolloKnee system. Four of these sub-components (Station, Tracking System, Communication Module and Nonsurgical Application) form the main structure of Corin's core platform for robotic or computer assisted surgeries. This core platform is referred to as "Apollo". Future Corin technologies are intended to be developed on the basis of the Apollo core platform. ApolloKnee is one such technology built upon the Apollo common platform. ApolloKnee includes four system specific sub-components (Apollo Robot, BalanceBot, TKR Instruments and ApolloKnee Software),

ApolloKnee is an evolution of the former OMNIBotics Knee System. ApolloKnee is the first launched under Corin Ltd following acquisition of the OMNIBotics' prior manufacturer OMNIlife Science. ApolloKnee differs from OMNIBotics Knee System (as previously marketed under K200888) in branding (for commercial reasons), as well as redesigns of the station and software, and introduction of additional surgical instrumentation, namely the BalanceBot Pre-Resection Paddles, Tibial Cutting Guide and V-Array.

This document, a 510(k) Summary for the ApolloKnee device, details the premarket notification to the FDA. However, it does not contain the specific information required to answer your prompt about acceptance criteria and a study proving the device meets them.

The sections you've highlighted (Non-Clinical Testing, Conclusion) mention "Accuracy testing per custom protocols and ASTM F2554-22" and "surgeon user validation studies (cadaver evaluations)." While these indicate testing was performed, the document does not provide the acceptance criteria or detailed results of these studies.

Therefore, I cannot provide the requested information from this document. It lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on MRMC studies or effect sizes.
• Standalone performance data.
• Specific type of ground truth used.
• Sample size for training sets.
• How ground truth for training was established.

This document primarily focuses on establishing substantial equivalence to a predicate device based on design, intended use, and general non-clinical testing categories, rather than presenting a detailed clinical or performance study report with specific acceptance criteria and detailed outcomes.

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APOLLO ADVANTAGE Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

APOLLO ADVANTAGE Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151 and ASTM D6319. The proposed device is non-sterile and powder free.

This document is primarily concerned with the 510(k) premarket notification for APOLLO ADVANTAGE Nitrile Examination Gloves, asserting its substantial equivalence to a predicate device. It details acceptance criteria and performance data for various physical and biocompatibility characteristics of the gloves.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Apollo Knotless Suture Anchors are intended for use in soft tissue to bone fixation in areas such as the shoulder, elbow, knee, hip, wrist, hand, foot, and ankle.

The Apollo Knotless Suture Anchors are made from PEEK (Zeniva ZA-500 and Zeniva ZA-600) per ASTM F2026. The Anchors are provided loaded on individual inserters with and without integrated sutures made of ultra-high molecular weight polyethylene (UHMWPE), sterile, for single use only.

This document is a 510(k) Summary for the Maruho Medical Apollo Knotless Suture Anchor. It details the device, its intended use, and a comparison to predicate devices, but it does not contain details about acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic or AI/machine learning device.

Instead, this document describes a medical device (a suture anchor) and its substantial equivalence to previously cleared predicate devices. The "performance testing" mentioned is related to the physical characteristics of the suture anchor (e.g., pullout strength, fatigue) and material biocompatibility, not diagnostic performance metrics like sensitivity, specificity, or AUC as would be expected for an AI/ML-driven device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because this document is not about an AI/ML-enabled medical device or a diagnostic tool with performance metrics typically associated with such criteria.

The information provided is about a physical implantable medical device and its mechanical/physical performance.

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STAR Apollo™ Mapping System assists users in manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The STAR Apollo 100 Mapping System is a software driven system designed to assist operators in identifying Early Site of Activations (ESA) and Repetitive Patterns of Activation (RPA) in patients undergoing a cardiac mapping procedure for Atrial Fibrillation (AF). The software is designed for use in association with a commercially approved electroanatomic mapping system, specifically, Ensite Precision Cardiac Mapping System Model EE 3000 (V2.6) or Ensite X EP System (V 1.1.1) (Abbott Medical), and the commercially approved catheter, Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (Abbott Medical). The system consists of proprietary Star Apollo Mapping System software and a hardware component. Star Apollo Mapping System software consists of 3 main components: Electroanatomic data import, the STAR Apollo Mapping System engine (C++ code) and Graphics User Interface (GUI). The STAR Apollo Mapping System is designed to run on a laptop computer running Windows 10 or later operating system. Star Apollo Mapping System software is pre-installed onto the laptop. The STAR Apollo Mapping System uses export data from the Ensite Precision or Ensite X EP system that has been collected with the HD Grid catheter during the mapping procedure. The HD Grid is used to collect anatomy, localization and electrogram data in the atria. Recordings are made for 30 seconds with the HD Grid in a stable position and in contact with the atrial wall. These 30 seconds acquisitions are made in multiple, non-overlapping locations, so as to generate recordings over the entire atrial chamber. Once the data has been acquired, the data is anonymized and exported, via a portable external data storage device, to the laptop computer running the STAR Apollo Mapping System. The export data from the Ensite Precision or Ensite X EP systems consists of electrograms, electrode coordinates, ECG recordings and the geometry model. The data are imported, utilizing the portable external data storage device, into the STAR Apollo Mapping System and then processed by the STAR Apollo engine to generate a STAR Apollo map visualized by the GUI.

The provided FDA 510(k) summary for the STAR Apollo™ Mapping System outlines the device's acceptance criteria and the studies conducted to demonstrate its performance.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from "Software design verification testing" and "Verification of algorithm calculations and graphic output." The performance is reported by stating that the software met these criteria.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided document. The descriptions refer to "test cases" and "electrophysiologists performing manual annotation of ECGs" and "electrophysiologists and rated the overall use." No specific number of cases or patient data points is given.
• Data Provenance: Not explicitly stated. The studies are described as "simulated testing." It is not clear if these simulations used real patient data (retrospective/prospective) or synthetically generated data. There is no mention of country of origin for the data.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated. The document mentions "electrophysiologists" (plural), but not a specific count.
• Qualifications of Experts: They are identified as "electrophysiologists," which implies medical doctors specializing in cardiac electrophysiology. No further details regarding their experience level (e.g., years of experience, board certification) are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. For the "Blinded Physician Validation," it says "electrophysiologists performing manual annotation of ECGs and comparing the results with the STAR Apollo Mapping System." This suggests a comparison to individual expert annotation rather than a formal consensus or adjudication process among multiple experts to establish a single ground truth.

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

• MRMC Study: No, a formal MRMC comparative effectiveness study demonstrating how human readers improve with AI vs. without AI assistance was not reported. The studies described are:
  • Blinded Physician Validation: This compares the device's output to manual human annotation, suggesting a standalone performance aspect relative to human interpretation, but not the human-in-the-loop improvement.
  • STAR Apollo Physician Use: This assessed the usability and appropriateness of the device, which is a qualitative assessment of user experience, not an effectiveness study.
• Effect Size: Not applicable, as no MRMC study was performed or reported.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, aspects of standalone performance were evaluated.
  • "Algorithm description and testing" and "Verification of algorithm calculations and graphic output" describe testing the core algorithms' accuracy against predetermined outputs, which is a standalone assessment.
  • The "Blinded Physician Validation (Manual Annotation versus STAR Apollo Mapping System)" also assesses the device's output independently, comparing it to human annotation, rather than measuring human improvement when using the device.

7. Type of Ground Truth Used

• Ground Truth Type:
  • For algorithm and software verification, the ground truth was "correct, predetermined output" and "acceptance criteria for each of the test cases" set during development. This implies a ground truth defined by the developers based on internal specifications.
  • For the "Blinded Physician Validation," the ground truth was "manual annotation" performed by electrophysiologists, essentially using expert interpretation as a reference. There is no mention of pathology or outcomes data as ground truth.

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated. The document describes the device as using "fixed algorithms and equations" rather than deep learning or machine learning that would typically require a training set. The comparison to the predicate (VX1) explicitly states: "VX1 is a software that utilizes deep learning based algorithms to analyze data sets, whereas the STAR Apollo Mapping System software uses fixed algorithms and equations to analyze the data sets." Therefore, a traditional "training set" as understood in machine learning may not apply in the same way, or its size is not relevant for a fixed-algorithm system.

9. How Ground Truth for Training Set was Established

• Training Set Ground Truth Establishment: Not applicable given that the device uses "fixed algorithms and equations" and not deep learning, negating the need for a labeled training dataset in the conventional sense. The "ground truth" for its development would be the fundamental principles of electrophysiology and the expected mapping outcomes that the algorithms are designed to mimic.

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