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The MAGiC Sweep™ EP Mapping Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the heart.

The MAGiC Sweep™ EP Mapping Catheters are biocompatible, flexible, radiopaque fixed catheters that are 130cm in length and available in multiple electrode spacing configurations and multiple magnet spacings. They have magnets encapsulated in the device shaft to allow manipulation through the vasculature and placement by a physician controlled robotic magnetic navigation system. Each device consists of 19 electrodes plus one tip electrode and come in three (3) different electrode spacings. In addition there are twenty (20) different magnet spacings for each electrode spacing configuration. The catheters are 8F diameter tapering to 5F at the distal end of the device shaft. The variety of configurations facilitate the navigation of the device to specific areas of the heart and facilitate recording of intracardiac signals and/or stimulation in the atrial and ventricular regions of the heart during electrophysiology studies.

The MAGiC Sweep™ EP Mapping Catheter is designed to be positioned in various endocardial and intravascular sites utilizing the Stereotaxis magnetic navigation system (MNS) along with the Stereotaxis catheter advancement system (CAS). The MAGiC Sweep™ EP Mapping Catheter is designed for recording intracardiac signals when connected to a recording system and for cardiac stimulation when connected to a stimulation system.

The MAGiC Sweep™ EP Mapping Catheter is comprised of a Pebax catheter shaft, platinum-iridium ring electrodes, platinum-iridium electrode tip, Neodymium Boron Magnets attached to a safety cable, and Redel electrical connectors. The Neodymium Boron Magnets are encapsulated within the catheter shaft.

The provided 510(k) clearance letter and summary describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the Stereotaxis MAGiC Sweep™ EP Mapping Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

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The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.
   The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The Magicore Narrow System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore Narrow implant is treated with RBM (Resorbable Blasted media) or SLA(sand-blasted, large-grit, acid-etched).

This document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. For dental implants, substantial equivalency is typically demonstrated through engineering and material characteristic comparisons to predicate devices, and performance testing, rather than clinical studies with patient outcomes. Therefore, the questions typically associated with clinical studies (like sample size for test sets, number of experts for ground truth, MRMC studies, training set details, etc.) are not directly applicable in the context of this 510(k) summary.

The manufacturer is demonstrating substantial equivalence by comparing the "Magicore Narrow System" to several predicate and reference devices. The acceptance criteria and the "study" proving the device meets these criteria are primarily based on comparative technical characteristics and non-clinical performance testing, rather than a clinical trial with human subjects.

Here's a breakdown based on the provided document, addressing the closest equivalents to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" here refers to demonstrating that the new device's characteristics and performance are substantially equivalent to legally marketed predicate devices, meaning they do not raise new questions of safety or effectiveness. The performance is "reported" by showing that the subject device's features align with or are within acceptable ranges of the predicate devices, and by outlining non-clinical tests performed.

• Inner Connection: Internal hex, non-submerged (similar to predicates).
• Endosseous Implant: Tapered, macro threads (similar to predicates).
• Platform Diameters: Ø 4.0.
• Fixture Diameters: Ø 3.0, Ø 3.5 (similar to predicates, with Ø 3.3 for one predicate and Ø 3.0 for another).
• Implantable Lengths: 11.0, 13.0, 15.0 mm (longer lengths supported by reference device K093321).
• Modified Surface: RBM & SLA (Primary predicate K161244 uses SLA; reference device K093321 uses RBM. Differences justified).
• Surgical Technique: 1 and 2 stage, self-tapping (similar to predicates).
  Abutments: Various abutments (Closing Screw, Short Abutment, Magic Abutment, Magicore Solid Abutment, Magicore Solid Abutment Cap, Magicore Healing Cap, Healing Cap Screw, Abutment Screw) are compared to various reference devices (K152520, K192197, K212517, K201981, K173120). Differences in dimensions (diameters, lengths) are noted but justified as not affecting fundamental functions or safety due to similarity in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, and materials. |
  | Sterilization | Device must be sterile or sterilizable, and sterilization methods must be validated and equivalent to predicate devices. | Fixtures are provided sterile via Gamma sterilization (similar to predicates). Closing Screw and Magicore Healing Cap also Gamma sterilized. Other abutments are provided non-sterile for end-user sterilization, with validation tested to ANSVAAMI ST79, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1 (leveraged from predicate K202479 and K140806). |
  | Biocompatibility | Device materials must be biocompatible. | Biocompatibility testing for fixtures (ISO 10993-1, 3, 5, 6, 10, 11) and abutments made of Titanium ELI (ISO 10993-1, 5, 6, 10) was leveraged from predicates (K140806 & K162099), demonstrating equivalence with same materials and manufacturing processes. |
  | Non-Clinical Performance | Mechanical and packaging integrity must be demonstrated as safe and effective. | Shelf Life: Tested for subject fixtures according to ASTM F1980 (results met criteria).
  LAL Testing: Performed for subject fixtures according to USP (referenced in K140806 & K162099, results met criteria).
  Surface Modification Analysis: Surface roughness, surface composition analysis, and SEM imaging compared between subject (RBM and SLA surfaces) and predicate devices (K152520 and K192197) to demonstrate substantial equivalence.
  MR Environment Condition: Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque based on FDA guidance.
  Fixture Packaging Performance: Human Factors testing (usability evaluation for aseptic presentation per ISO 11607-1:2019 and FDA guidance), low and high magnification imaging after removal from packaging to check for damage, and Quality System plan for packaging acceptance activities were provided. Results indicated devices conform to product specifications with packaging design. |

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

This document is a 510(k) summary for a dental implant, which does not typically involve a "test set" or "training set" of patient data in the way an AI/ML device would. Instead, substantial equivalence is demonstrated through comparative engineering data and non-clinical performance testing.

• Sample Size for Testing: The document refers to various standards (e.g., ASTM F1980, ISO 11137-1/2, USP , ANSV/AAMI ST79 series, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1, ISO 10993 series) for non-clinical performance tests. The specific sample sizes for these engineering tests are not detailed in this summary but would be part of the full test reports. For example, biomechanical tests (fatigue, static strength) are typically conducted with small sample sizes (e.g., n=5 or n=10 per group, as per ISO standards for implants).
• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer (InnoBioSurg Co., Ltd.) or leveraged from testing performed for predicate devices from other manufacturers. Data is implicitly prospective in the sense that the manufacturer conducted these tests for this specific submission or leveraged existing valid test data from similar devices. The country of origin for the non-clinical data is not specified but the manufacturer is based in the Republic of Korea.

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

Not applicable. "Ground truth" in the context of clinical expert consensus for image-based diagnostic or prognostic devices is not relevant for this type of medical device (dental implant). Substantial equivalence is based on engineering and material standards, and comparison to already-cleared predicate devices. The "experts" would be the engineers and quality assurance professionals who conducted and reviewed the non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of reconciling differences in expert annotations or diagnoses, as this is not a diagnostic device relying on human interpretation of complex data.

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

No. An MRMC comparative effectiveness study is not performed for dental implants. These studies are typically conducted for AI/ML-driven diagnostic or screening devices to assess how the AI assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm-based diagnostic device.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Engineering Standards: Compliance with recognized international and national standards for medical devices and dental implants (e.g., ASTM, ISO standards for materials, sterilization, biocompatibility, mechanical properties).
• Predicate Device Equivalence: The established safety and effectiveness of legally marketed predicate devices. The "ground truth" is that if the new device is sufficiently similar to a predicate device in termsally relevant characteristics (and any differences do not raise new safety/performance questions), then it is considered safe and effective.
• Non-Clinical Test Results: Data from physical, chemical, mechanical, and biological (biocompatibility) tests proving that the device meets specified performance requirements outlined in the relevant standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device requiring data to learn patterns.

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

Not applicable, as there is no training set.

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MagiCath II is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for general patient with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

MagiCath II, safety IV catheter is inserted into the patient's blood vessel for short-term use to collect blood, monitor blood pressure, or inject drugs. It consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety shielding mechanism that will engage upon needle removal from the patient in order to prevent accidental needlestick injuries. The device is available in 18, 20, 22 and 24-gauge catheter.

MagiCath II is designed to allow users handling the device with single-hand, using the MagiGrip. In the MagiGrip, a vent fitting to regulate blood flow is placed. The needle hub is equipped with a vent filter which suppresses blood leakage, so the flashback can be more visible.

The provided document is a 510(k) Summary for the MagiCath II, a safety IV catheter. It discusses the device's substantial equivalence to a predicate device but does not contain specific acceptance criteria, reported device performance metrics in a defined table, or detailed information about a clinical study involving a test set, expert adjudication, or human reader performance with or without AI assistance.

The document primarily focuses on:

• Comparison of technological characteristics with the predicate device (BD Insyte™ Autoguard™ Intravascular Catheter).
• Bench testing against various ISO standards to demonstrate performance and safety, particularly for sharps injury prevention and material compatibility.
• Biocompatibility testing in accordance with ISO 10993 series.
• Sterilization validation per ISO 11135:2014.

Therefore, many of the requested details cannot be extracted from this document as no clinical study with a test set, ground truth experts, or MRMC study is reported.

However, I can provide the acceptance criteria based on the standards cited for performance as these standards implicitly define performance requirements. The "reported device performance" would then be that the device conformed to these standards.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and the Reported Device Performance

Missing Information (Not found in the provided text):

2. Sample size used for the test set and the data provenance: Not applicable as no clinical study or specific test set for AI/human performance is detailed. The performance evaluations are bench tests against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts for a clinical test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process for a test set is described.
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 a physical medical device (catheter), not an AI-powered diagnostic tool, so an MRMC study comparing human readers with/without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/clinical study. For the device's performance, the "ground truth" is defined by adherence to the cited international consensus standards (ISO, ASTM, USP).
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

Summary of the Study Proving Device Meets Criteria:

The "study" proving the device meets the acceptance criteria is a comprehensive set of bench tests, biocompatibility tests, and sterilization validation performed according to recognized international and national standards (ISO, ASTM, USP, FDA guidance). The document asserts that these tests "demonstrate substantial equivalence to the predicate device" and that "no new safety and effectiveness questions are raised." The performance testing per ISO 23908:2011 specifically confirmed the sharps injury prevention feature performs as intended. The biocompatibility assessment was conducted per ISO 10993-1, and sterilization was validated per ISO 11135:2014.

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The MAGIC Flow-Dependent Microcatheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified embolization materials and diagnostic materials such as contrast media.

The MAGIC Flow-Dependent Microcatheter is designed with progressive suppleness and a rigid proximal shaft to allow control and navigability in the vascular system. By their diameter and progressive suppleness features, these catheters are specifically designed for catheterization of small diameter, sinuous distal vessels.

The catheter body and its distal tip (ring) are radiopaque to provide visibility under fluoroscopy. The MAGIC Flow-Dependent Microcatheter has an external hydrophilic coating which provides a lubricious surface during use.

A coated mandrel is included inside the MAGIC Flow-Dependent Microcatheter to provide support during product preparation and insertion through the guide catheter.

The MAGIC Flow-Dependent Microcatheter and accompanying support mandrel are provided sterile, nonpyrogenic, and intended for single use only.

The provided document is a 510(k) Pre-market Notification for the MAGIC Flow-Dependent Microcatheter (K213435). This document does NOT contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. Instead, it details a comparison between the subject device and predicate/reference devices to establish substantial equivalence.

The "acceptance criteria" and "device performance" mentioned in the document relate to bench testing done to demonstrate the subject device's ability to deliver embolic materials. This is not for software performance but for the physical device's function. No AI/ML component is mentioned in the device description or testing.

Therefore, I cannot provide the requested information for an AI/ML device study.

However, based on the provided document, here is the information related to the physical device's performance:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)

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

• Sample Size: Not specified in the document. The description only states "The subject device was evaluated..."
• Data Provenance: The test was non-clinical bench testing, meaning it was conducted in a laboratory setting, not with patient data.

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. For physical device bench testing, "ground truth" is typically established by engineering specifications and direct physical measurement/observation against those specifications, not by expert consensus in diagnostic interpretation.

4. Adjudication method for the test set:

Not applicable. The testing was a direct performance evaluation against predefined criteria, not an interpretive task requiring adjudication.

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

Not applicable. This is a physical medical device (microcatheter), not an AI/ML algorithm that assists human readers.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used:

For the bench testing, the "ground truth" would be the successful delivery of embolic materials as defined by engineering and performance specifications in the tortuous anatomical model.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

This submission is to add new fixtures and abutments to the previously cleared device, Magicore System (K201981), Magicore II System (K201621), Magicore II System (K192197), and Magic UCLA Abutment System (K202418).
The fixtures and abutments in this system are below:

1. Fixture

• Magicore
• Magicore (Cutting Edge)

2. Abutment

• Magic Multiunit Abutment (Screw type - Hex, Non-Hex & Cemented type - Hex, Non-Hex)
• Magic Multiunit UCLA Cylinder
• Magic Multiunit Cap
• Magic Abutment (Screw type Hex, Non-Hex & Cemented type Hex, Non-Hex)
• Magic UCLA Cement Retained Type (Hex, Non-Hex)
• Magic Cylinder (Hex, Non-Hex, Post)
• Magic Multiunit Cylinder (Hex, Non-Hex, Post)
• Magicore Healing Cap
• Magicore Healing Cap Screw
• Cylinder Screw
  An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The Magicore System consists of dental implants, Abutments, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations.
  The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media).

The provided text describes the regulatory submission for the Magicore System, an endosseous dental implant system, and its determination of substantial equivalence (SE) to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device performance study (e.g., accuracy, sensitivity, specificity, or clinical outcomes).

The document is a 510(k) summary for a dental implant system. The "acceptance criteria" here refers to demonstrating substantial equivalence to a predicate device, as required for FDA 510(k) clearance, rather than performance metrics of an AI model. The studies mentioned are primarily non-clinical (material, mechanical, sterilization, biocompatibility testing) and are leveraged from predicate devices or performed to show equivalence in basic structural and material properties. There is no mention of an AI/ML component in the Magicore System.

Therefore, I cannot provide the requested information about acceptance criteria for AI performance, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided document.

The document discusses physical and material properties of a dental implant system, comparing them to legally marketed predicate devices to establish substantial equivalence.

However, if we were to interpret "acceptance criteria" in the context of this device's type (dental implants), it would refer to regulatory requirements and engineering performance specifications needed to demonstrate safety and effectiveness. Based on the provided text, here's what can be inferred about the "study" for this traditional medical device type regarding its acceptance for market clearance:

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

Since this is a 510(k) submission for a non-AI/ML dental implant device, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices, material safety, mechanical performance, and sterility. The document outlines comparisons to predicate devices for various characteristics, implying these characteristics meeting equivalent or acceptable standards are the acceptance criteria.

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not applicable in the context of an AI/ML test set. The document refers to non-clinical testing (e.g., sterilization, biocompatibility, fatigue, shelf-life). These tests typically involve a defined number of device units or material samples per standard requirements, not "patient data samples." Specific numbers of units tested are not detailed in this summary, but the tests themselves rely on established sample size methodologies for their respective standards.
• Data Provenance: Not applicable for patient data. The "data" provenance in this context refers to the source of non-clinical test reports, which are largely leveraged from previous 510(k) submissions for predicate devices by the same manufacturer (e.g., K201981, K201621, K192197, K202418, K152520, K173120). These are lab-based tests, not human study data.

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

• Not applicable. This pertains to establishing ground truth for AI model training/testing which is not relevant here. For dental implants, the "ground truth" for material, mechanical, and biological properties is established through adherence to recognized international standards (e.g., ASTM, ISO) and laboratory testing protocols.

4. Adjudication method for the test set:

• Not applicable. This refers to consensus methods for AI/ML ground truth, which is not relevant to this device's clearances.

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 type of study is relevant for diagnostic imaging AI. The document describes a physical dental implant.

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

• Not applicable. No AI algorithm is involved.

7. The type of ground truth used:

• For physical and material properties: The ground truth is based on established engineering principles, material science definitions, recognized industry standards (e.g., ASTM, ISO), and performance specifications determined through laboratory testing (e.g., mechanical strength, biocompatibility, sterility assurance levels).
• For substantial equivalence: The "ground truth" for the FDA's decision is the demonstration that the device's characteristics (intended use, design, materials, etc.) are as safe and effective as a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. There is no AI model to train.

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

• Not applicable. There is no AI model to train.

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The Magic 360 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.

The Magic 360 Power Wheelchair is designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons that are restricted or limited to a sitting position.

The Magic 360 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e. concrete, asphalt, indoor flooring, gravel, grass, and bark). The subject device has two seat options: MPS and rehab. The rehab seat option has more built-in adjustments (i.e., width and depth adjustments) and allows for aftermarket cushions. All the wheelchairs include the same power seating options including lift, tilt, recline, and leg elevation to ensure the user to find a position that is comfortable.

The Magic 360 Power Wheelchair includes the following accessories:

• Extra spreader bar
• Slide in table
• Lights
• Luggage rack
• Accessory charger ●
• Posture belt
• Roho cushion
• Jay cushion
• MPS push rail
• MPS peg push handle
• Scooter stopper ●
• Retractable docking pin
• Fold forward kit

Please note, the fold forward kit is an accessory which allows the user to fold the wheelchair and put the wheelchair in a car. To fold the wheelchair the user pulls the red release handle located at the back of the Magic 360 Power Wheelchair. To unfold the wheelchair the user pulls the frame back into place using the armrests.

The provided text is a 510(k) summary for the Magic 360 Power Wheelchair. This document is a regulatory submission to the FDA for medical device clearance, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information regarding acceptance criteria and a study proving device meets acceptance criteria is not directly applicable in the AI/ML context.

However, I can extract the closest analogous information from the document as it pertains to a traditional medical device (power wheelchair).

Here's an interpretation based on the provided text:

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

The document does not present a table of specific acceptance criteria with quantitative performance metrics for the Magic 360 Power Wheelchair in the way one would for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by adherence to recognized ISO standards for wheelchairs and demonstrating substantial equivalence to predicate devices. The "reported device performance" is inferred from the successful completion of these tests.

The comparison table provided in the document (pages 6-7) highlights the characteristics of the Magic 360 Power Wheelchair against predicate devices. The "Statement of Equivalence" column implicitly indicates that the device's performance characteristics are either identical or substantially equivalent to the predicate devices, thus meeting regulatory expectations.

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

This information is not provided because this is a submission for a physical medical device (power wheelchair) and not an AI/ML algorithm. The "test set" in this context refers to physical units of the wheelchair undergoing standardized engineering and performance tests, not a dataset for an algorithm. There is no mention of "data provenance" in the sense of patient data. The manufacturer is based in Australia ("3 International Court, Scoresby, VIC, 3179 Australia").

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)

This is not applicable to this type of device submission. "Ground truth" in this context would implicitly be the established engineering specifications and performance requirements defined by ISO standards and regulatory guidelines, confirmed through physical testing by qualified engineers or technicians.

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

Not applicable. This concept relates to human review of data, which is not described for the performance testing of this physical device. The testing described (e.g., Static stability, Dynamic stability, EMC testing) are objective engineering measurements against defined standards.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this medical device's performance is established by international consensus standards (ISO standards) for wheelchairs regarding functionality, safety, and durability, as well as the performance characteristics of legally marketed predicate devices. The testing verifies that the device performs according to these objective standards and is comparable to equivalent devices already on the market.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set." The device is designed, manufactured, and tested to engineering specifications.

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

Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm.

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The MAGIC Infusion Catheter is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The MAGIC Infusion Catheter may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

The MAGIC Infusion Catheters are microcatheters designed with progressive suppleness and a rigid proximal shaft to allow control and navigability in the vascular system. By their diameter and progressive suppleness features, these catheters are specifically designed for catheterization of small diameter, sinuous distal vessels. The catheter body and its distal tip (ring) are radiopaque to provide visibility under fluoroscopy. The MAGIC Infusion Catheter has an external hydrophilic coating which provides a lubricious surface during use. A PTFE coated mandrel is included inside the MAGIC Infusion Catheter to provide support during product preparation and insertion through the guide catheter. The MAGIC Infusion Catheters and accompanying support mandrels are provided sterile, non-pyrogenic, and intended for single use only.

The provided document describes the MAGIC Infusion Catheter and its 510(k) summary. The study is a bench and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

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 numerical sample sizes for each specific bench test. It generally refers to "the 1.2F MAGIC Infusion Catheter (subject device)" as being tested. For biocompatibility, it states "The 1.2F MAGIC Infusion Catheter was assessed for biocompatibility."

The provenance of the data is retrospective, as it refers to testing conducted on the subject device to demonstrate substantial equivalence to a previously cleared predicate device. The document does not specify the country of origin of the data beyond the applicant "Balt USA, LLC" being located in Irvine, CA, USA.

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

This information is not applicable to this type of device submission. The study describes physical and biological bench testing of a medical device, not a diagnostic or AI-powered device that requires expert-established ground truth from a test set of clinical images or data. The "ground truth" for these tests is defined by established engineering standards and biological testing protocols (e.g., ISO standards, ASTM standards, USP criteria).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving expert readers for diagnostic accuracy. This submission relies on objective physical and biological measurements against predefined acceptance criteria.

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

This information is not applicable. This submission is for a physical medical device (infusion catheter) and does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable. This is not an AI-powered device.

7. The Type of Ground Truth Used

The ground truth for the bench tests is based on established engineering specifications, international standards (ISO 105551-1, ASTM F640-12, USP ), and biological testing protocols (ISO 10993-series, ASTM F756, ASTM F2382-18, ASTM F2888-19). These standards define the acceptable performance characteristics and biological response for such medical devices.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device, so there is no "training set."

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

This information is not applicable as there is no training set for this type of device.

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The Magic UCLA Abutment System is intended to replace missing teeth to restore chewing function. The Magic UCLA Abutment System can be placed in support of single or multiple-unit restorations including: cement retained, screw retained, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

The Magic UCLA Abutment System is used with a dental implant to provide support to prosthetic restorations such as crowns, bridges, and overdentures in partially or fully edentulous patients. The system includes Magic UCLA Screw Retained Type (Hex, Non-Hex) and Magic UCLA Cement Retained Type (Hex, Non-Hex) abutments. The abutments are fabricated from Co-Cr-Mo Alloy with Poly Diacetate, provided non-sterile, and packaged separately. They must be sterilized before use. The abutments are not intended to be cast at angulation or placed to provide angular correction.

The provided document is a 510(k) premarket notification for a dental device, the "Magic UCLA Abutment System." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a new AI/medical image analysis device.

Therefore, this document does not contain the information required to answer your request about acceptance criteria and a study proving device performance for an AI/medical image analysis device.

The relevant sections of your request (acceptance criteria, test set details, expert ground truth, MRMC study, standalone performance, training set details) are specific to the validation of AI/image analysis algorithms, which is not the subject of this 510(k) submission. This submission is for a physical dental implant component and leverages non-clinical testing performed on predicate devices to demonstrate equivalence.

Here's a breakdown of why this document cannot fulfill your request:

• No AI/Image Analysis: The "Magic UCLA Abutment System" is a physical dental implant component (abutment). There is no mention of it being an AI device or involving image analysis.
• No Performance Study Against Acceptance Criteria (as you defined them): The document confirms "Non-clinical testing was not performed for the subject device" (page 9) because it's considered substantially equivalent to predicate devices based on material, manufacturing, and design similarities. The "tests" mentioned are biocompatibility, galvanic reaction, and sterilization tests, which are standard for physical medical devices and not related to AI performance metrics like sensitivity, specificity, F1-score, etc., nor do they involve human expert review for ground truth in the context of image analysis.
• No Test/Training Sets: Since there's no AI component, there are no test or training sets of data/images to evaluate an algorithm's performance.
• No Experts for Ground Truth (in the context of AI): The document doesn't discuss establishing ground truth by experts for image analysis.
• No MRMC Study: An MRMC study is relevant for evaluating human reader performance with and without AI assistance. This is not applicable here.
• No Standalone Performance: Standalone performance refers to an algorithm's performance without human intervention. This is not reported.

In summary, the provided text describes a regulatory submission for a physical dental device, not an AI or image analysis device, and thus does not contain the information requested about acceptance criteria and performance studies typical for AI/medical imaging products.

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The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

This submission is to add new implants and abutments to the previously cleared device, Magicore System (K152520). The newly added implants and abutments are below: Fixture - Magicore (4mm of Neck length Implants) . - . Magicore (Cutting Edge) Abutment - Magicore Solid Abutment - Healing Cap For Magicore Solid Abutment Cap, no other changes are being made to the previous clearance except for product name change. An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The Magicore System consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media).

This document describes the Magicore System, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics. The information provided is for regulatory clearance (510(k)) and focuses on comparing the new components of the Magicore System to previously cleared devices.

Therefore, many of the requested categories related to clinical study design, performance metrics, and ground truth establishment are not applicable.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for the Magicore System or clinical performance results. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on design, materials, indications for use, and non-clinical testing.

The acceptance criteria for this 510(k) submission are based on meeting the requirements for substantial equivalence to legally marketed predicate devices. This means showing that the new components of the Magicore System are as safe and effective as the predicate devices and do not raise new questions of safety or effectiveness.

The document states: "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." However, it does not specify what those "criteria" were in terms of quantifiable device performance. It refers to compliance with ISO and ASTM standards for non-clinical aspects.

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

Not applicable. This document is a 510(k) submission for new dental implant components, not a clinical study assessing performance with a test set of data. The testing mentioned is non-clinical (material properties, sterilization, biocompatibility, etc.).

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

Not applicable. Ground truth establishment by experts for a test set is not relevant to this type of regulatory submission, which relies on engineering and biological testing against established standards and comparison to predicate devices.

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

Not applicable. No test set requiring expert adjudication for ground truth was used in this submission.

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 a study assessing AI performance or human reader improvement.

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

Not applicable. This product is a physical dental implant system, not an algorithm.

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

Not applicable. The concept of "ground truth" as it applies to diagnostic or treatment efficacy studies is not relevant here. The "truth" in this context is adherence to recognized standards and demonstrated equivalence to already approved devices through non-clinical testing.

8. The sample size for the training set

Not applicable. This product is a physical dental implant system, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

This submission is to add new abutments to the previously cleared device. Magicore II System (K192197). The newly added abutments are Magic Multiunit Abutments (Screw type – Hex. Non-Hex. Cemented type - Hex, Non-Hex) with the new angulations of 5, 10, 20°. For Magic Multiunit Cylinder, Magic Multiunit Abutment ST, and Mazic Multi Abutment Cap, no other changes are being made to the previous clearances except for model names. The Abutments are fabricated from Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The Abutments are provided non-sterile and packaged separately. The abutment should be sterilized before use.

This document is a 510(k) summary for the Magicore II System, an endosseous dental implant abutment. It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML device.

The provided text pertains to a physical dental implant abutment and its substantial equivalence to a previously cleared device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to a demonstration that the new abutments are sufficiently similar to an existing predicate device, primarily through dimensional comparison analysis and shared materials/manufacturing processes.

Therefore, I cannot provide the requested table or answer the specific questions related to AI/ML device performance, such as:

• Acceptance criteria and reported device performance (in an AI/ML context).
• Sample size for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study, and effect size with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states: "No need to perform any non-clinical testing for the subject device since and predicate device are substantially equivalent in indications, fundamental technology, material and design. Although the dimensions and angulations are different, by performing product's dimensional comparison analysis, it concluded that the predicate device is the mechanical worst case and demonstrated the substantial equivalence."

This indicates that the "study" was a non-clinical dimensional comparison analysis focusing on mechanical worst-case scenarios, rather than a performance study involving patient data or expert interpretation.

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