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The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.

The Leo Cancer Care (LCC) Patient Positioning Subsystem (EVE) is designed to deliver precise positioning of a patient when combined with an external Beam Therapy device, to provide the intended treatment therapy prescribed for patients requiring radiation treatments.

The Patient Positioning System has 6 degrees of freedom to provide full alignment capability for a patient treatment session, with the patient being located in an upright position. The Eve Patient Positioning Subsystem is held in a static position for the duration of the external Beam Therapy System radiation exposure. After the beam delivery has been completed, the patient positiong subsystem is then aligned to the next patient position required by the treatment system and the process repeated for the required series of different beam placements to achieve the full prescribed treatment delivery for the patient.

The provided text is an FDA 510(k) summary for the "Leo Cancer Care Eve Patient Positioner System." It describes a medical device used for patient positioning in radiation therapy.

However, this document DOES NOT describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML performance.

Instead, the document outlines the substantial equivalence of the Eve Patient Positioner System to a predicate device (LEONI Orion System K160518) based on non-clinical performance testing for device functionality and safety. The document states:

• "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." Therefore, there's no clinical study involving human readers or expert consensus for ground truth as would be relevant for an AI/ML device.
• The performance testing focuses on mechanical and electrical performance (e.g., accuracy of positioning, speed, patient load, motion axes, and compliance with general medical device and software life-cycle standards like ISO 14971, IEC 60601-1, IEC 62304).

Therefore, it is impossible to extract the requested information regarding AI/ML acceptance criteria, study details, human reader performance, or ground truth establishment relevant to an AI/ML algorithm from this document.

If you have a document describing an AI/ML powered medical device, please provide that.

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Smart SPACE Shoulder 3D Positioners and Anatomical Models
The Smart SPACE Shoulder 3D Positioners and Anatomical Models are intended to be used as surgical instruments for adult patients that are candidates for primary elective shoulder replacement surgery and they are intended to to transfer a pre-operative plan into surgery, designed on the basis of patient-specific pre-operative CT scans.
The Smart SPACE Shoulder 3D Positioners are intended, by quiding the surgical instruments in some steps of the orthopedic surgical procedure, to prepare the bone to host the implantable components.
The Smart SPACE Shoulder Anatomical Models are a 3D representation of the patient anatomical condition, as previously evaluated by the surgeon. The model is intended to be used to check that the 3D Positioner(s) is properly placed on the anatomical compartment.
These devices must be exclusively utilized by an orthopedic surgeon who has a good knowledge of the specific operative technique.
Smart SPACE Shoulder 3D Positioners and Anatomical Models are indicated for use on adult patients that are candidates for primary elective reverse and anatomic total shoulder arthroplasty.

Smart SPACE Shoulder Planner
Smart SPACE Shoulder Planner is a medical device for surgeons component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
Smart SPACE Shoulder Planner does not include any system to manufacture the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner is intended to be used by an orthopedic surgeon, with clinical experience in shoulder replacement surgery to make decisions regarding implant position, orientation and sizing.
Smart SPACE Shoulder Planner is intended to be used for adult patients planning only. The Smart SPACE Shoulder Planner is intended for use with patients that are candidates for primary reverse and anatomic total shoulder arthroplasty.
The specific functionalities of the Smart SPACE Shoulder Planner version are described in the User Manual and Quick Start Guide provided by LimaCorporate.

The Smart SPACE Shoulder Planner consists of a software which assists the user in planning anatomic total or reverse shoulder arthroplasty. It provides the user to select surgical execution using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance.
The Smart SPACE Shoulder system was cleared by TechMah Medical via K202151, K202454. K191247, and it includes the Smart SPACE Shoulder Planner, the Cubit Guidance system, the 3D Humeral and Glenoid Positioners and the Anatomical models. TechMah Medical became part of Limacorporate S.p.A in 2021.
With this registration, LimaCorporate aims to:

• introduce an upgrade of the Smart SPACE Shoulder Planner; -
• introduce the Smart SPACE Shoulder 3D Positioners and Anatomical Models manufactured by LimaCorporate, that are provided non-sterile.

The provided document is a 510(k) summary for the Smart SPACE Shoulder Planner and 3D Positioners. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study.

Specifically, the document states: "Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices." This indicates that a study demonstrating the device meets acceptance criteria was not performed as part of this 510(k) submission. The FDA clearance is based on the device being substantially equivalent to a previously cleared device (K202151), not on a new clinical study.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

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

• Cannot be provided: The document does not define specific acceptance criteria for performance, nor does it report performance metrics from a study designed to meet such criteria. It states that "the Smart SPACE Shoulder Planner and 3D Positioners manufactured by LimaCorporate S.p.A. and the Smart SPACE Shoulder System (K202151) manufactured by TechMah Medical LLC have substantially equivalent principles of operation and performance characteristics, with the exception of minor differences that aims to improve the software speed and memory usage, improve the user experience and solve bugs." This is a general statement of equivalence, not a report of measured performance against specific criteria.

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

• Cannot be provided: No clinical or performance testing on a test set is described.

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)

• Cannot be provided: No test set or ground truth establishment is described.

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

• Cannot be provided: No test set or adjudication 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

• Cannot be provided: No MRMC study was done.

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

• Cannot be provided: No standalone performance study is described. The device is a "pre-surgical planner" and "surgical instruments" intended for use by an orthopedic surgeon.

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

• Cannot be provided: No ground truth is described because no new clinical performance study was conducted.

8. The sample size for the training set

• Cannot be provided: The document does not mention the training of the AI or software, and therefore no training set size is provided. The device is an "upgrade" of an existing system, implying prior development, but details are not given here.

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

• Cannot be provided: As no training set is described, neither is its ground truth establishment.

Based on the provided text, the key information regarding testing is:

• Non-clinical testing: "The Software Testing has been performed on Smart SPACE Shoulder Planner according to the requirements of ANSI AAMI IEC 62304:2006/A1:2015." This refers to software lifecycle processes and safety, not clinical performance.
• Clinical testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices."

Therefore, the document does not contain the information required to populate the fields related to specific acceptance criteria and a study proving those criteria were met, as no such study was performed or deemed necessary for this 510(k) clearance due to the substantial equivalence pathway.

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MyKnee® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient's knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKnee® R Pin Positioners are intended for single use only. Resections are performed through the standard or revision cutting guides. These are positioned on the holes drilled through the MyKnee® R Pin Positioner blocks after removal of the primary total knee implant components and according to the surgeon's preoperative planning. MyKnee® R Pin Positioners are intended for use with GMK® Primary, GMK® SpheriKA, GMK® Revision, GMK® Hinge and their cleared indications for use.

MyKnee R Pin Positioners are a line extension to the currently marketed MyKnee Cutting Blocks (K093806) and MyKnee PPS-Pin Positioners (K170106). The MyKnee R blocks are single use, patient-specific pin positioner blocks designed based on CT images of a patient's knee and the primary TKA implant in situ. They are intended to position the pins for placement of the standard instruments according to the surgeon's preoperative surgical planning. The MyKnee R Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices. They are available in left and right configuration with sizes 1-6 for the both the femurs and the tibia and, as the predicate devices, they can be provided in both non-sterile version.

The provided FDA 510(k) summary for Medacta International S.A.'s MyKnee R Pin Positioners does not describe the specific acceptance criteria and detailed study that proves the device meets those criteria in the way typically expected for an AI/CADe device.

The MyKnee R Pin Positioners are patient-specific surgical guides, not an AI or CADe device in the sense of image analysis or diagnostic assistance. The performance data section explicitly states "No clinical studies were conducted," and the non-clinical studies primarily focus on software validation and cadaver testing validating the intended use, functional characteristics, and features of the physical guides themselves.

Therefore, many of the requested items related to AI/CADe performance (e.g., AUC, sensitivity/specificity, MRMC studies, ground truth establishment for training and test sets, number of experts, adjudication methods) are not applicable to this submission.

However, based on the information provided, we can infer and present what is available, noting the limitations of this document regarding the specific questions.

Here's an attempt to address the request based on the provided document:

Device: MyKnee R Pin Positioners

Device Type: Patient-specific anatomical pin positioners (surgical guides) for revision total knee replacement. This is NOT an AI/CADe device for image analysis or diagnosis.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance values in the context of accuracy metrics (e.g., for an AI algorithm's diagnostic performance). Instead, the "performance data" section focuses on validation activities for the physical device's functionality and intended use.

Note: The document states that "testing activities were conducted to written protocols" and that the "slight differences between the subject and predicate devices do not raise new questions of safety and effectiveness." This implies that the acceptance criteria for these functional aspects were met, but the specific numerical targets or results are not detailed in this public summary.

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

• Test Set Sample Size: Not explicitly stated. The "Cadaver testing" refers to testing the physical device's function. The number of cadavers or specific test cases is not provided.
• Data Provenance: The document does not specify the country of origin for any data related to the cadaver testing. It is implied that the software processes CT images, but the origin of these CT images (e.g., patient demographics, retrospective/prospective collection) is not detailed as this is not an image analysis AI device.

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

• Not Applicable in the AI/CADe sense. This submission is for a physical surgical guide. Ground truth for the geometric accuracy or fit of the guides would likely be established through engineering measurements and potentially surgeon feedback during cadaver trials, rather than expert consensus on image interpretation. The document does not specify the number or qualifications of any experts involved in the cadaver testing or validation of the guide's fit.

4. Adjudication Method for the Test Set

• Not Applicable. As there's no clinical imaging data interpretation or diagnostic task, there is no need for an adjudication method for establishing ground truth from image readers.

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

• No MRMC study was done. The document explicitly states "No clinical studies were conducted." The device is a surgical guide, not an AI assistance for human readers in diagnostic tasks.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No standalone algorithm performance study (in the AI sense) was done. The "software validation" performed is likely related to the accuracy of the software in converting CT images into the physical design of the pin positioners and ensuring the correct output for manufacturing, not for diagnostic performance.

7. Type of Ground Truth Used

• For the cadaver testing, the ground truth would inherently be physical measurements and functional assessment of the pin positioners in situ, confirming that they achieve their intended purpose of guiding pin placement accurately according to preoperative plans. No diagnostic "ground truth" (e.g., pathology, outcomes data, or expert consensus on image findings) is mentioned or relevant to the device's function.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML model that requires a training set for learning. The device's design is based on established principles of patient-specific instrumentation derived from CT images, not on training a machine learning model.

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

• Not Applicable. Since there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the device's development lies in anatomical principles, engineering specifications, and the accuracy of the CT data used for individual patient planning.

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The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.

The Breastboard and Overhead Arm Positioner are used to position the patient during external beam radiation therapy. The Breastboard is comprised of a Base, Back Support, and Bottom Stop. The Base serves as the foundation of the assembly and provides a mounting surface for the Back Support, Angle Supports, and the Bottom Stop. The inferior end of the Back Support is mounted to the Base while the superior end of the Back Support is raised/lowered as needed for patient setup using Low Angle Supports. The Bottom Stop is located near the inferior end of the Base and prevents the patient from sliding down the Board. The Low Angle Support is used to position the Back Support at 5°, 7.5°, 10°, 12.5°, and 15° angles. Features on the High Angle Support receive the cutouts on the Low Angle Support and hold the angular position of the Support. The High Angle Support is used to position the Back Support at 17.5°, 20°, 22.5°, and 25° angles. Features on the Base receive the cutouts on the High Angle Support and hold the angular position of the Support. A Lock provides a method of locking the Back Support to the Base at 0° to facilitate easier handling and storage of the Breastboard. The Overhead Arm Positioner provides support for the patient's arms above the head and is attached to the Back Support via a locking assembly. The Overhead Arm Positioner adjusts longitudinally on the Back Support to accommodate a variety of patient sizes. A Hand Grip is mounted on the Overhead Arm Positioner and the location of the Hand Grip is adjustable longitudinally. A Head Support rests on a recessed area of the Overhead Arm Positioner and provides a cushion for positioning of the head of the patient. The Head Support can also be mounted directly on the Breastboard. A Thermoplastic Frame may also be mounted to the Overhead Arm Positioner to enable attachment of a thermoplastic mask for additional patient support. The Breastboard and Overhead Arm Positioner can also be used for supporting and elevating patients undergoing treatment who cannot lay down flat on the table due to their habitus. The Breastboard and Overhead Arm Positioner are reusable devices that are provided nonsterile.

This document is a 510(k) premarket notification for a medical device called the C-Qual M Breastboard and Monarch Overhead Arm Positioner. The notification seeks to add MR (Magnetic Resonance) compatibility to the device's indications for use.

Based on the provided text, there is no study conducted to demonstrate the performance of a device that relies on algorithms or AI assistance, nor is there a study involving human readers or experts to establish ground truth for such a device. The device in question is a physical positioning and immobilization device used in radiation therapy and imaging.

Therefore, many of the typical acceptance criteria and study components requested in your prompt (such as algorithm performance, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for diagnostic/interpretive tasks) are not applicable to this specific device submission.

The "acceptance criteria" for this device relate to its physical safety and compatibility in an MR environment, not to the performance of a diagnostic algorithm.

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

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

The acceptance criteria and performance for this physical device are focused on MR safety and biocompatibility, as no AI/algorithmic performance is being evaluated.

Explanation: The device "passed" criteria for magnetically induced torque and displacement force, indicating it is safe for use in 1.5 T and 3.0 T MR fields under these aspects. Image artifact was observed, but this is reported as a known characteristic, and users are informed. Biocompatibility testing confirmed the materials are safe for patient contact under the specified use conditions.

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

As this is a physical device undergoing safety and compatibility testing (rather than an AI/algorithmic performance study), the concept of a "test set" in the context of data points (like images or patient cases) and "data provenance" (country of origin, retrospective/prospective) is not directly applicable.

Instead, the "test set" would refer to the physical device units that underwent testing. The document does not specify the exact number of units tested for MR safety or biocompatibility. However, it states the "device was tested," implying a sufficient number of samples were used to ensure representativeness for regulatory purposes. The testing was conducted in accordance with ASTM and ISO standards, which define the methodologies and often the minimum number of samples.

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

Not applicable. The ground truth for this device's safety and compatibility is established through standardized physical testing protocols (ASTM F2052-15, F2213-06, F2119-07 for MR safety; ISO 10993 standards for biocompatibility), not through expert consensus or interpretation of medical images. Engineering and materials science experts would conduct and interpret these tests, but their role is not that of clinical "ground truth" adjudicators in the typical sense of a diagnostic AI study.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, where disagreements among human readers or ground truth establishment require a pre-defined resolution process. Since this submission concerns physical device safety and compatibility, such methods are not relevant.

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 passive physical support and positioning system; it does not involve AI, human readers, or diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

Not applicable. This is not an algorithmic device.

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

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

• Scientific and Engineering Standards: Compliance with recognized international standards (ASTM and ISO) for MR safety and biocompatibility.
• Physical Measurements and Observations: Direct measurement of torque, displacement, and visual assessment of image artifact under controlled MR conditions. Laboratory testing for biocompatibility.

8. The sample size for the training set

Not applicable. There is no AI or machine learning component, so no training set is involved.

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

Not applicable. No training set exists for this device.

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The FUJIFILM Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Aspire Cristalle (FDR MS-3500) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast using information extracted from stereotactic pairs of two-dimensional images and/or Digital Breast Tomosynthesis (DBT) images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

The Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Digital Mammography system. It is designed for positioning the needle when performing Stereotactic and/or Tomosynthesis Biopsies, fine needle aspirations, core needle, and vacuum assisted biopsies in an upright position. The Biopsy Positioner uses a Stereo pair of images and/or Tomosynthesis images. The position of the three coordinates (X, Y, and Z) is computed using the position of the object on each of the images, as indicated by the operator, and the known geometry of the system.

FDR-2000BPY is mainly composed of the following elements:

• The Positioner that supports and positions the needle .
• The Positioner Control Cabinet which supplies power to the positioned .
• The Operation panel which displays the distance between the compression plate and . target pathology, the distance between the target pathology and the needle, and also electrically drives the positioner in the X, Y and Z directions.

The subject of this Special 510(k) premarket notification is addinq use of Digital Breast Tomosynthesis (DBT) images for extracting information to determine three dimensional lesion locations in the breast.

This document describes the Biopsy Positioner (FDR-2000BPY) for determining 3D lesion locations in the breast for interventional purposes using stereotactic and/or Digital Breast Tomosynthesis (DBT) images.

There is no information in the provided text regarding a study on "AI" performance or human reader improvement with AI assistance. The device described is a biopsy positioner and not an AI algorithm for image interpretation.

Here's the information that can be extracted based on the provided text, focusing on the device itself and its performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Bench testing was performed... to evaluate the stereotactic and tomosynthesis biopsy needle positioning accuracy." It does not specify a numerical sample size for this bench testing.

• Data Provenance: Bench testing, so it is synthetic/physical testing, not patient data. No country of origin is specified for the bench testing.

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

• This device is a biopsy positioner, not an image interpretation or diagnostic AI device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic performance is not directly applicable.
• The accuracy of the device (e.g., needle positioning) would be verified against physical measurements or established calibration standards during bench testing. No human experts are mentioned for establishing ground truth in this context.

4. Adjudication Method for the Test Set

• Not applicable as the testing involves physical performance metrics (e.g., positioning accuracy) rather than subjective interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The device is a biopsy positioner accessory, not an image reader or an AI diagnostic tool. There is no mention of human readers or AI assistance in the document.

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

• This question is built on the premise that the device is an "algorithm." The FDR-2000BPY is a physical "Biopsy Positioner," an accessory to a mammography system. While it has software and computes 3D coordinates, it is not described as a standalone diagnostic algorithm. Its performance is integrated with the mammography system and involves human operation for marking targets.
• The "performance data" section focuses on hardware-related compliance (EMC, radiation safety) and "needle positioning accuracy" via bench testing, not autonomous algorithmic performance.

7. The Type of Ground Truth Used

• For the needle positioning accuracy, the ground truth would likely be physical measurements against known target coordinates or established calibration standards in a bench test environment. It is not expert consensus, pathology, or outcomes data, as these relate to diagnostic accuracy, not the accuracy of a physical positioning system itself.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical accessory with integrated software for coordinate calculation, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such a system would involve engineering and calibration, not data-driven model training.

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

• Not applicable, as there is no "training set" for an AI model. For the device's development and calibration, ground truth would be established through engineering specifications, precise physical measurements, and system calibration procedures.

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MyKnee® PPS-Pin Positioners are intended to be used as anatomical pin positioners specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding of bone before cutting. MyKnee® PPS-Pin Positioners are intended for use with the GMK Total Knee System and its cleared indications for use. MyKnee® PPS-Pin Positioners are intended for single use only.

The MyKnee® PPS-Pin Positioners are single use femoral and tibial pin positioning patientspecific blocks. The MyKnee® PPS-Pin Positioners are designed and manufactured from patient MRI imaging data so the positioners match the patient's anatomy. The MyKnee® PPS-Pin Positioners are used with Medacta International SA's existing GMK Total Knee System. GMK Primary, GMK Sphere and GMK-Primary Narrow. The pin positioners are developed only for placement of the standard metal instruments (distal/tibial cut guide and 4-in-1 femoral cut guide) following the positions planned by the surgeon.

The MRI images are provided by the hospitals to Medacta International SA prepared according to a specific protocol for an individual patient. Medacta International SA uses these images in combination with Mimics (Materialise) and Solidworks (Dassault Systemes) to import DICOM images from a patient's MRI scans and these scans are then processed into accurate 3D models.

The MyKnee® PPS-Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices. MyKnee® PPS-Pin Positioners blocks are available in sizes 1-7 for the femur and sizes 1-6 for the tibia. The pin positioners will be provided in both non-sterile and sterile versions.

Here's a breakdown of the acceptance criteria and the study information for the MyKnee® PPS-Pin Positioners, based on the provided document:

This device is not an AI/ML device, therefore, please note that some of the requested information, such as sample size for the test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details, are not applicable or not explicitly detailed in the context of a traditional medical device submission for a physical pin positioner. The provided document focuses on demonstrating substantial equivalence to a predicate device through non-clinical studies.

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 explicitly stated in the document as this is not an AI/ML device that would typically have a separate "test set" in that context. The "test" here refers to non-clinical evaluations of physical device properties.
• Data Provenance: The studies were non-clinical, involving design comparisons, breakage evaluations, manufacturing process evaluations, functional/fitting evaluations, and sterilization impact studies of the physical device. This data would be generated in a lab or workshop setting by Medacta International SA.

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

This information is not applicable and not provided. The "ground truth" for a physical device like a pin positioner is its physical properties and functionality, which are assessed through engineering and performance testing, not by expert interpretation of data in the same way as an AI/ML diagnostic device.

4. Adjudication Method for the Test Set

Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in interpreting medical images or clinical data, which is not relevant for the testing of this physical device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "no clinical studies were conducted." MRMC studies are generally used to evaluate the diagnostic performance of AI/ML systems with or without human-in-the-loop.

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

Not applicable. The MyKnee® PPS-Pin Positioners are physical, patient-specific surgical guides, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on engineering and performance specifications, design requirements, and established material properties. This is verified through:

• Measurement against design specifications (dimensional/geometrical comparison).
• Physical testing for durability (breakage evaluation).
• Assessment of manufacturing consistency (manufacturing process evaluation).
• Evaluation of intended function (functional and fitting evaluation), likely in cadaver workshops.
• Compliance with biocompatibility standards (by demonstrating equivalence to predicate materials).
• Compliance with sterilization requirements.

8. The Sample Size for the Training Set

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

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established for training.

Summary of the Study Proving Acceptance Criteria:

The document describes a series of non-clinical studies to demonstrate substantial equivalence of the MyKnee® PPS-Pin Positioners to the predicate device (MyKnee® Cutting Blocks, K093806). These studies focused on:

• Design Comparison (Dimensional/Geometrical): This compared the subject device to the predicate, noting the key difference as the removal of integrated cut slots. The evaluation concluded this difference did not raise new safety or effectiveness concerns.
• Breakage Evaluation: Assessed the structural integrity and durability of the device.
• Manufacturing Process Evaluation: Verified the consistency and control of the manufacturing process.
• Functional and Fitting Evaluation: Conducted according to written protocols, likely in cadaver workshops, to ensure the pin positioners function as intended in guiding surgical instruments.
• Biocompatibility: Noted that the material (medical grade nylon for sintering) and manufacturing process are identical to the predicate device, for which biocompatibility testing (to ISO 10993-1, -5, -10 for short-term contact) had already been conducted and deemed sufficient.
• Sterilization Studies: Included a "sterilization dimensional and functional impact study" and a "gamma sterilization criticality assessment" to ensure the sterilization process does not compromise the device's integrity or function, and that both non-sterile and gamma-sterilized versions are acceptable.

The conclusion is that these non-clinical studies and comparisons support that the MyKnee® PPS-Pin Positioners are as safe and effective as the predicate devices, and the minor design differences do not raise any new questions of safety or effectiveness, thus proving substantial equivalence for device acceptance. No clinical studies were performed.

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The TruGuard Custom Tongue and Jaw Positioner from Bionix Development Corporation is intended to be used for repeat positioning and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.
It is intended to be used by or under the direction of a licensed physician.

The TruGuard Custom Tongue and Jaw Positioner consists of two dental bite trays composed of rigid plastic and connected at the base of their arcs in a bivalve fashion so as to allow the upper and lower bite trays to open and close in similar fashion as the upper and lower jaws of the patient. The two bite trays are each lined with an insert of low-temperature EVA (ethylene vinyl acetate) thermoplastic material similar to that used in commercial mouth guards. Projections on the lower and upper bite trays mate securely to a plastic indexing tab component that has holes at pre-set locations. When the plastic indexing tab is joined to the upper and lower bite trays the jaw is held open at pre-set angles, depending on the hole selected. This allows the mouth to be positioned and repositioned as needed, and ensures unrestricted air flow to the patient. An optional tongue depressor interlocks with the lower bite tray to restrict the tongue position to the lower portion of the oral cavity.

The provided document describes the TruGuard Custom Tongue and Jaw Positioner from Bionix Development Corporation and its substantial equivalence to a predicate device. It primarily focuses on comparing the new device against an existing one, the Dental Tray for use with the Gill-Thomas-Cosman Relocatable Head Holder, manufactured by Integra.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for the TruGuard device in terms of performance metrics like accuracy, specificity, or recall. Instead, it demonstrates "substantial equivalence" to a predicate device, focusing on similar design, features, composition, and function, particularly concerning reproducible patient positioning and shielding efficacy.

The key performance described is related to shielding efficacy against backscatter radiation.

Study Information

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

   • Sample Size: The bench testing involved a "phantom (teeth with amalgam fillings)". The number of phantoms or trials is not specified beyond this.
   • Data Provenance: The study was a bench test, so no human patient data was used. The provenance is internal Bionix Development Corporation testing.

2. 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 information is not provided. Given it was a bench test, expert consensus for ground truth might not be directly applicable in the same way as clinical studies. The ground truth for backscatter radiation was measured using Gafchromic EBT3 film.

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

   • This information is not applicable as the test was a bench test measuring physical properties (radiation dose), not a clinical study requiring human adjudication of results.

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:

   • An MRMC study was not done. This device is a physical medical device (positioner/immobilizer) for radiation therapy, not an AI software device.

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

   • A standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.

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

   • For the shielding efficacy test, the ground truth was quantitative measurement of radiation dose using "industry standard Gafchromic EBT3 film." This is a physical and objective measurement.

7. The sample size for the training set:

   • This information is not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

   • This information is not applicable as there is no training set for a physical device.

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The Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg. The Pediatric Positioner Pad Set is indicated for use in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.0T GE MRI Systems for positioning of the pediatric patient.

The Pediatric Positioner Pad Set is a positioning device for pediatric patients used with brain, spine, and neurovascular surface coils in Magnetic Resonance Imaging. It is comprised of foam coated in Polyscan. The Pediatric Positioner Pad Set is comprised of seven components: the Base Pad, the Main Pad, the Child Head Pad, the Infant Head Pad, the two Pad Side Supports, and the Head Strap. The Base Pad rests on the MR System table. The Main Pad is then placed on top of the Base Pad. The patient is positioned on top of the Main Pad. The two Pad Side Supports are secured on either side of the patient via Velcro. Lastly, either the Child Head Pad or Infant Head Pad is used with the Head Strap to hold the patient's head in place. There are two sizes for the head pad to accommodate different patient sizes.

The provided text describes a 510(k) premarket notification for a medical device called the "Pediatric Positioner Pad Set." This device is a passive positioning aid for pediatric patients during Magnetic Resonance Imaging (MRI).

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in terms of performance metrics (e.g., specific accuracy, sensitivity, or specificity values) for the Pediatric Positioner Pad Set. This is because the device is a passive positioning aid and not an active diagnostic or therapeutic device that produces measurable outputs requiring such criteria.

Instead, the document states the device's compliance with qualitative requirements related to its intended use and safety.

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

• Sample Size for Test Set: The document states that a "clinical study on pediatric subjects" was conducted. However, it does not specify the sample size (number of subjects) used in this clinical study (which serves as the "test set" for performance evaluation).
• Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a GE Healthcare submission to the FDA, it is highly probable the data was collected in the United States. The study was prospective, as it was a "clinical study on pediatric subjects" specifically conducted to support this submission.

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

The document does not mention "experts" being used to establish a formal "ground truth" in the traditional sense (e.g., for diagnostic accuracy). Since this is a positioning device, the "ground truth" would likely be the successful positioning of the patient and the acquisition of diagnostic quality MRI images.

The primary "evaluation" would have been performed by the medical staff (MR technologists, radiologists) involved in the clinical study, who would have assessed the device's ability to facilitate effective patient positioning for image acquisition. Their qualifications are not specified but would implicitly be relevant medical professionals.

4. Adjudication Method for the Test Set

No specific adjudication method (like 2+1, 3+1 consensus) is described, as the evaluation likely revolved around the usability and effectiveness of patient positioning rather than a diagnostic decision requiring such 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

An MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human readers are assisted by AI. The Pediatric Positioner Pad Set is a passive physical device, not an AI or software-based diagnostic tool.

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

A standalone performance evaluation was not done. Again, this concept applies to algorithms or software. The Pediatric Positioner Pad Set is a physical device that functions with human interaction (positioning the patient) to achieve its intended purpose.

7. The Type of Ground Truth Used

The "ground truth" for this device would be the successful, safe, and stable positioning of pediatric patients for MRI scans, leading to the acquisition of diagnostic quality images. It is not a pathology diagnosis or an outcome measure in the typical sense. The "ground truth" is inherently tied to the practical utility in a clinical setting.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is not an AI or machine learning algorithm. Its design and development followed standard engineering and quality system processes, as indicated by the "Quality Assurance Measures" (Risk Analysis, Requirements Reviews, Design Reviews, etc.).

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

Since there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the device's design and development comes from user needs, regulatory requirements, risk analysis, and engineering specifications.

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Overnight use of a temporary oral appliance to determine in which patients with obstructive sleep apnea mandibular advancement by an oral appliance will reduce obstruction of airflow and thereby to identify patients suitable for oral appliance therapy. The device is also used to recommend a target mandibular position that will reduce obstruction of airflow in patients determined to be suitable for oral appliance therapy.

The RCMP appliance is a device used in the clinical setting to identify patients with obstructive sleep apnea that will be successfully treated with an oral appliance. A temporary appliance fits to the patient's teeth and incrementally and reversibly advances the patient's mandible anteriorly with respect to the maxilla while the patient is under full polysomnographic monitoring. The repositioning of the mandible pulls the tongue forward and increases the patient's airway space. Such obstruction can be a causative factor in obstructive sleep apnea and snoring. The RCMP is used in the clinical setting by a technician to advance the mandible until the polysomnographic data indicates removal of the obstruction of airflow in the airway. The device is used to recommend a target mandibular position that will reduce obstruction of airflow in patients determined to be suitable for oral appliance therapy.

The RCMP appliance consists of upper and lower disposable dental titration trays that are used to hold onto the teeth by means of a quick-set retention material. The trays attach to a mandibular positioner that retracts and extends a rod to adjust the tray positioning by means of a small force linear actuator. By extending the linear actuator rod attached to the upper tray, the RCMP pushes on the upper teeth and pulls on the lower teeth, thus displacing the jaw. RCMP software interacts with the polysomnography to allow the technician to control fine adjustments of the relative position of the mandible.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria for the device beyond demonstrating that it is "at least as safe and effective as the predicate device at selecting candidates for oral appliance therapy." It highlights performance characteristics and differences from the predicate without setting specific numerical targets.

However, based on the qualitative descriptions and the overall goal of the study, we can infer some implied performance objectives:

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

• Sample Size for Test Set: 66 patients.
• Data Provenance: The study was a prospective clinical study. Patients were recruited from a sleep center and dentist.

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

The document mentions that:

• The RCMP is used "by a trained sleep technician".
• "The final assessment and recommendation for treatment by an appliance is completed by a physician who reviews the positioning data and associated cardio-respiratory reaction."
• The procedure was "user friendly to both the technician and the sleep expert."

While it confirms the involvement of a trained sleep technician for device operation and a physician (sleep expert) for final assessment and recommendation, it does not specify the exact number of physicians/sleep experts used to establish the ground truth (i.e., assess the suitability for oral appliance therapy and optimal mandibular position for each patient in the test set). It implies at least one physician. The qualifications are broadly described as "physician" and "sleep expert."

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for establishing ground truth from multiple experts. It states that "the final assessment and recommendation for treatment by an appliance is completed by a physician who reviews the positioning data and associated cardio-respiratory reaction." This suggests a single physician's review is part of the process for determining the "therapeutically effective target protrusive distance" and identifying suitable patients, rather than a multi-expert adjudication of the ground truth itself based on labels provided by independent readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The study focused on demonstrating the safety and effectiveness of the RCMP device itself, particularly its ability to identify suitable candidates and recommend an effective mandibular position, not on improving human reader performance.

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

This device (RCMP) is not an AI algorithm but a physical, remotely controlled mechanical device. Its operation is explicitly stated to involve a "trained technician" and "physician" in a clinical setting. Therefore, a standalone (algorithm only) performance assessment is not applicable and was not performed. The device requires human interaction for its use and interpretation of its outputs.

7. The Type of Ground Truth Used

The ground truth used was based on polysomnographic data reviewed by a physician/sleep expert. Specifically, the device is used "in the clinical setting under full polysomnographic cardio-respiratory monitoring" to identify patients and then a "physician... reviews the positioning data and associated cardio-respiratory reaction" to make the final assessment and recommendation for treatment. This combines objective physiological measurements (polysomnography) with expert clinical judgment.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. The clinical study described is a 66-patient validation study. Given that the RCMP is a device with mechanical and software components rather than a machine learning model, a distinct "training set" in the context of AI/ML is not relevant here. The device's design, software, and operational parameters would have been developed and tested through bench and engineering processes, not via a machine learning training dataset.

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

As no training set (in the ML sense) is mentioned, this question is not applicable. The device's functionality and efficacy were validated through the clinical study and bench testing, as opposed to being "trained" on a dataset.

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The FUJIFILM Biopsy Positioner (FDR-1000BPY) is an optional accessory for the Aspire HD (FDR MS-1000) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, presurgical localization or treatment devices).

The FUJIFILM Biopsy Positioner is an optional accessory for the Aspire HD (FDR MS-1000) full field digital mammography system and future Fujifilm digital mammography exposure stands. It is designed for positioning the needle when performing stereotactic biopsies, fine needle aspirations, core needle, and vacuum assisted biopsies in an upright position. The Biopsy Positioner uses a stereo pair of images, taken with the tube arm angled to +1 5° from vertical (orthogonal to the plane of the image receptor). The position of the three coordinates (X, Y, and Z) is computed using the position of the object on each of the two images, as indicated by the operator, and the known geometry of the system.

The Biopsy Positioner is composed of the following elements:

• The Positioner that supports and positions the needle .
• The Operation panel which displays the distance between the compression plate and target ● pathology, the distance between the target pathology and the needle, and also electrically drives the positioner in the X, Y and Z directions.
• The Positioner Control Unit which supplies power to the positioner

The provided text describes a 510(k) premarket notification for the FUJIFILM Biopsy Positioner (FDR-1000BPY) but does not contain a specific study proving the device meets quantitative acceptance criteria for performance. The document focuses on demonstrating substantial equivalence to a predicate device and compliance with various safety and electrical standards.

However, based on the information provided regarding the device's function, we can infer a key performance metric and a potential acceptance criterion for its primary function.

Primary Function of the Device:
The device's core purpose is to calculate the three-dimensional coordinates of a target pathology with position accuracy. The document states: "The software calculates the three-dimensional coordinates of the target pathology with position accuracy of -/+1.0mm or less." This statement itself implies an acceptance criterion.

Here's a breakdown of the requested information based on the provided text, with an acknowledgment of missing details:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not explicitly state other quantitative acceptance criteria, nor does it provide a detailed report of a study directly demonstrating the device's performance against this (or any other) criterion. The statement "The software calculates... with position accuracy of -/+1.0mm or less" is a claim about the device's capability rather than a report of a verification study result with a measured mean or standard deviation.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document outlines the device's design and intended use but does not describe a clinical or technical test set used to verify its accuracy.

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

• Number of Experts: Not applicable, as no described test set or ground truth establishment process is detailed for performance verification.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no described test set or adjudication process is detailed.

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

• Was an MRMC study done? No. The document does not describe an MRMC study. The device is a "Biopsy Positioner," which is an accessory for guidance, not a diagnostic AI system directly interpreting images alongside human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Was a standalone study done? The document states: "The software calculates the three-dimensional coordinates of the target pathology with position accuracy of -/+1.0mm or less." While this implies an internal validation of the software's accuracy, the text does not describe the methodology or results of a standalone study to prove this claim. It's a statement of capability rather than a report of a study's findings.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated for performance verification. For a device that measures physical dimensions and positions, the ground truth would typically be established through precise metrological measurements using phantom objects or calibrated systems, not clinical pathology or outcomes data. However, the document does not detail how the stated accuracy was verified.

8. Sample Size for the Training Set

• Sample Size: Not applicable. The "Biopsy Positioner" is described as a system that calculates coordinates based on known geometry and operator input from stereo images. It is not presented as an AI/ML device that requires a training set in the typical sense (e.g., for image interpretation). Its function is more akin to precise geometric calculation rather than pattern recognition learning.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable. As noted above, the device's functionality does not appear to involve a "training set" in the context of machine learning. Its accuracy would be verified based on its computational precision relative to physical measurements rather than learned patterns.

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