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The AEGIS Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications are:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;
· trauma (i.e., fracture or dislocation);
· deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);

• tumor;
  · pseudarthrosis; and
  · previous failed fusion.

The Anterior Dynamized system is intended for use in anterior decompression instrumentation and fusion for kyphotic deformities, post traumatic kyphotic deformities, degenerative disc discogenic and back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.

The ISOLA Spine System when used as anterior thoracic/lumbar screw fixation system, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The BOWTI Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
The BOWTI Anterior Buttress Staple System is intravertebral body screw fixation/attachment to the T1-S1 spine over one vertebral body extending into the adjacent intervertebral space. Specifically, the device is intended for stabilization and buttressing of bone graft as an aid to spinal fusion. It may be used with other anterolateral or posterior spinal systems.

The DISCOVERY Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods:
Transfacet fixation: The screws are inserted bilaterally through the facet, across the facet joint and into the inferior pedicle.
Translaminar Facet fixation: The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint and into the inferior pedicle.
For both methods this system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;
2. Spondylolisthesis;
3. Spondylolysis:
4. Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity;
5. Degenerative diseases which include:
   (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
   (b) degenerative disease of the facets with instability.

The EXPEDIUM Anterior System is intended for anterolateral screw fixation of the T4 to L4 levels of the spine, with metal at least 1 cm from a major vessel. The EXPEDIUM Anterior System may be used in either thoracoscopic procedures or open procedures.
The EXPEDIUM Anterior Spine System is indicated for:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;

• · trauma (i.e., fracture or dislocation);
  · spinal stenosis:
  · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor;
• · pseudarthrosis; and previous failed fusion.

The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with metal at least 1cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures.
The FRONTIER Anterior Scoliosis System is indicated for:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;

• · trauma (i.e., fracture or dislocation);
  · spinal stenosis:
  · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor;
• · pseudarthrosis; and previous failed fusion.

The KANEDA Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine.
The KANEDA Anterior Scoliosis System is indicated for:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;

• · trauma (i.e., fracture or dislocation);
  · spinal stenosis;
• · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor:
• · pseudarthrosis; and previous failed fusion.

The KANEDA SR Anterior Spinal System is intended for anterolateral screw fixation to the T10 to L3 levels of the spine. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, tumor, fracture and revision of previous surgery.

The intended levels for treatment with the M-2 Anterior Plate System are from T3 to L3. In order to treat levels from T3 to L3, plate attachment is from T2 to L4. The M-2 Anterior Plate System is intended to treat one motion segment per construct.
The M-2 Anterior Plate System is indicated for:
· degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
· spondylolisthesis;

• · trauma (i.e., fracture or dislocation);
  · spinal stenosis:
  · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor;
• · pseudarthrosis; and previous failed fusion.

The MOUNTAINEER Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord.

The intended levels for treatment with the PROFILE Anterior Thoracolumbar Plate System are from T1-L5 spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The UNIVERSITY PLATE Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for the attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

The VIPER F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:
Transfacet fixation: The screws are inserted bilaterally through the facet, across the facet joint and into the inferior pedicle.
This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;
2. Spondylolisthesis;
3. Spondylolysis;
4. Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity;
5. Degenerative diseases which include:
   (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
   (b) degenerative disease of the facets with instability.

The AEGIS Anterior Plate System consists of an assortment of titanium alloy plates and screws. The plates are uniquely shaped to conform to the anatomy of the anterior spine. They feature screw holes for final fixation to the vertebral bodies.
The ALC Dynamized Fixation System is a construct consisting of implant grade titanium alloy dynamized closed screws, closed transverse fixator connector, anterior rods and a closed blocker. The ALC Dynamized Fixation System construct allows continual compression of the bone graft while avoiding hyperextension type forces on the construct.
The Anterior ISOLA Spine System consists of spinal rods, open and closed screws, washers, caps, set screws, and staples.
The BOWTI Anterior Buttress Staple System consists of staples and screws. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two prongs, which engage the vertebral body and prevent rotation, and a screw slot for final fixation.
The DISCOVERY Facet Screw Fixation System consists of titanium alloy bone screws and washers designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. The self-tapping screws are available in two configurations: fully threaded and partially threaded.
The EXPEDIUM Anterior Spine System consists of spinal rods, monoaxial screws, staples, washers, and cross connectors. The components of the EXPEDIUM Anterior Spine System are designed with anatomic limitations in mind, therefore minimizing the profile of the construct.
The FRONTIER Anterior Scoliosis System is a construct that consists of spinal staples, semi-blunt tip open screws, washers, and 3/16 inch (4.75mm) diameter spinal rods.
The KANEDA Anterior Scoliosis System is a construct that consists of Kass spinal staples, Kass blunt tip open and closed screws, standard Isola open and closed screws and Isola 3/16 inch (4.75mm) diameter spinal rods.
The KANEDA SR Anterior Spinal System is an anterolateral spinal implant system which is used in conjunction with some components of the Isola Spine System. KANEDA SR consists of longitudinal members, spinal anchors and transverse rod couplers. The longitudinal members are 1/4 inch (6.35 mm) diameter smooth spinal rods. The Isola rods can be cut to size during the surgical procedure or Kaneda rods are available in precut lengths. The contoured spiked plates are designed to help the construct anchors resist axial forces and serve as a guide for placement of the screws. The plates are available in three sizes (small, medium and large) and are designed as pairs with specific caudal and rostral components. The screws serve to anchor the vertebral bodies to the longitudinal rods and are available in open and closed screw formats. Caps are available to capture the rod onto the open screws. Set screws are used to tighten the screws to the rods. The transverse couplers add stability, contributing to the construct's ability to resist torsional loads.
The M-2 Anterior Plate System is a construct which consists of one plate attached to the lateral aspect of the vertebrae by either four screws or two screws/two bolts. The components of the M-2 Anterior Plate System have been designed with anatomic limitations in mind.
The MOUNTAINEER Laminoplasty System is an implant system that consists of various sizes of plates and screws. The plates are available in the Inline Side-By-Side, and Offset Side-By-Side configurations. The proposed plate devices come in a preformed shape with holes for bone screws. The plates also contain a slot in the middle portion of the plate for allograft or autograft material attachment. The allograft or autograft material is secured to the plate using bone screws that are inserted through the middle slot on the top portion of the plate.
The PROFILE Anterior Thoracolumbar Plate System consists of various lengths of thoracolumbar and high thoracic plates, cancellous screws, cancellous bolts with locking nuts and screws and bone graft screws. The anterior thoracolumbar plates are implanted using two cancellous bolts placed through the plate's bolt slots and fixed with locking nuts and screws, two cancellous screws placed through the plate's threaded screw holes, and an optional graft screw which can be placed through the plate's center slot to provide fixation between the plate and a strut graft if desired. The high thoracic plates are implanted using four to six cancellous screws, placed through the plate's screw holes.
The UNIVERSITY Plate Anterior System plates are fabricated from implant grade titanium alloy. These plates have a contoured low profile to match the curvature of the lateral aspect of the thoracolumbar vertebral bodies. Three pairs of nested slots allow a wide range of screw and bolt placement, while the spherical countersinks allow up to 15 degrees of screw angulation. The UNIVERSITY Plate Anterior System plates are either rectangular or distally tapered, and come in a variety of lengths. Distally tapered plates are used at the L4 level to avoid contact with the common iliac vessels.
The VIPER F2 Facet Fixation System consists of titanium alloy bone screws designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. Washers are available to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories.

This document describes the 510(k) premarket notification for "AEGIS® Anterior Lumbar Plate System" and several other spinal fixation systems. The purpose of this submission is to obtain clearance for magnetic resonance compatibility labeling for these devices.

Here's an analysis of the provided text in relation to acceptance criteria and study 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 specific "sample size" of devices used for each test. It refers to "the subject devices" and "the devices listed" in K192281, which includes fourteen different spinal fixation systems. It can be inferred that representative samples of each system (or components thereof) were tested.

The data provenance is from non-clinical testing conducted in alignment with ASTM standards. The country of origin of the data is not specified, but the applicant, Medos International SARL, is located in Switzerland, with the submitter (DePuy Synthes Spine) in Massachusetts, USA. The testing would likely have been conducted in a certified testing facility, potentially in either region or a third-party lab. The studies would be considered prospective in the sense that the testing was designed and conducted specifically to generate data for this regulatory submission.

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

This information is not applicable in this context. The "ground truth" for MR compatibility studies is established by objective measurements based on recognized international standards (ASTM F2213, F2052, F2119, F2182), not by expert consensus on clinical findings or images. These standards define the methodologies and acceptable limits for MR compatibility.

4. Adjudication Method for the Test Set

This information is not applicable. As mentioned above, the data are objective measurements from physical testing, not subjective assessments requiring adjudication by multiple experts.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images with and without AI assistance. The submitted devices are spinal fixation systems, and the submission is for MR compatibility labeling, which involves physical testing, not diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not done. The devices are physical medical implants, not software algorithms or AI systems. The performance studies conducted were physical evaluations of the implants' behavior in an MR environment.

7. Type of Ground Truth Used

The ground truth used for these studies is based on objective physical measurements and adherence to established international standards (ASTM) for magnetic resonance compatibility. These standards define the acceptable physical forces, heating, and artifact levels for a device to be considered safe and compatible in an MR environment.

8. Sample Size for the Training Set

This information is not applicable. The submission concerns traditional medical devices (spinal implants) and their MR compatibility, not an AI or machine learning model that would require a training set.

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

This information is not applicable as there is no training set mentioned in this context.

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The Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair).

The Aegis Transit System is specifically indicated for use in the anterior, superior and middle mediastinum.

The proposed Aegis Transit System introduces modifications to the Instructions for Use to propose the use of the two previously cleared Aegis Illuminated Mediastinal Access Ports as a two-step system to improve access and visualization during surgical procedures. The predicate Illuminated Mediastinal Access Ports were cleared under K141622 and K160171. The modifications discussed in this 510(k) submission are listed below:

• . The Directions for Use in the IFU have been clarified to address the use of the two previously cleared Illuminated Mediastinal Access Ports as a two-step system within a single procedure. Please note, the procedural steps that are included in the revised IFU are consistent with the procedural steps that were submitted in K141622 and K160171;
• The indications for use statement has been enhanced to provide examples of the types of procedures in which the transit system may be used;
• . The small (dissecting) trocar handle has been revised to incorporate the ergonomic handle cleared with the large (delivery) trocar under K160171;
• . The polycarbonate material used in the trocar and cannula of both devices has been changed from industrial grade polycarbonate to medical grade polycarbonate; and
• . The packaging has been changed from a nylon/Tyvek heat sealed pouch to a PETG tray with a Tyvek lid.

Both devices are being used in accordance with their cleared indications for use.

This document is a 510(k) premarket notification for the Aegis Transit System, which is a medical device intended to aid surgeons in visualizing the mediastinum and facilitating surgical instrument introduction and removal. The document does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical accuracy or effectiveness.

Instead, this submission focuses on demonstrating substantial equivalence to already cleared predicate devices (Aegis Surgical, Ltd., Illuminated Mediastinal Access Port, K141622 and K160171) based on technological characteristics and design modifications.

Here's why the requested information cannot be provided from this document:

• Type of Device: The Aegis Transit System is a surgical access system (a mediastinoscope and accessories), not a diagnostic AI/ML device that would typically have performance metrics like sensitivity, specificity, or AUC based on clinical data. Its "performance" is primarily related to its mechanical and material properties, and its ability to provide access and visualization.
• Nature of Submission: A 510(k) submission generally aims to prove that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically involve showing improved clinical outcomes or diagnostic accuracy via large-scale clinical trials in the way an AI/ML diagnostic would.

Therefore, the following points are not applicable or cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria for clinical accuracy or present data against such criteria. The "performance data" section states "No new bench testing was required" and refers to prior testing for the predicate devices, focusing on the mechanical and material changes.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" for performance metrics like sensitivity/specificity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned as this is not an AI/ML diagnostic or image interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as there is no AI/ML component.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide concerning "performance" and "acceptance":

The document effectively describes the changes from the predicate devices and argues that these changes do not raise new questions of safety or effectiveness. The "acceptance criteria" here are implied to be the demonstration of substantial equivalence by showing that:

• The intended use is the same (with enhanced examples of procedures).
• The principle of operation is the same.
• Material changes (from industrial grade to medical grade polycarbonate) are considered improvements or equivalent, leveraging prior testing of the handle design.
• The shelf life has been extended from 3 months to 3 years, implying successful shelf-life testing, though details are not provided in this summary.
• Packaging changes are noted.

The crucial statement regarding performance is in section 1.7: "No new bench testing was required for an assessment of substantial equivalence; the bench testing submitted and reviewed under K141622 and K160171 is applicable to the proposed Aegis Transit System." This indicates that the previous predicate devices' performance data (presumably related to mechanical integrity, biocompatibility, sterilization, etc.) formed the basis for accepting the current device's performance, as the changes were deemed not to impact safety or effectiveness. The modification to the small trocar handle incorporated a design cleared under K160171, and thus, previous testing of that handle was deemed sufficient.

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Bosworth AEGIS Liner & Restorative Material is used as a light-cured radio-opaque cavity liner and pulp capping material, and, with the addition of tooth shades, as a class V restorative material.

AEGIS Liner & Restorative Material w/ACP

The provided text is a Section 510(k) premarket notification determination letter from the FDA for a dental device, "AEGIS Liner & Restorative Material w/ACP."

This document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria.

The letter's purpose is to inform the manufacturer that the FDA has reviewed their submission and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their original 510(k) submission, which would have included performance data, but that data is not present in this FDA letter.

Therefore, I cannot answer any of the specific questions about acceptance criteria or study details as they are not described in the provided text.

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The AEGIS and AEGIS II Spinal Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, The AEGIS I and AEGIS II Spinal Systems are indicated for patients with deqenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, turnor, pseudoarthrosis, or revision of failed fusion attempts.

The AEGIS® Pedicle Screw System is comprised of pedicle screw with diameters from 4.5mm to 8.5mm with increments of 1mm and length ranging from 20mm to 55 mm with increments of 5mm, a sleeve of standard diameter of 14 mm, and a set screw of M10XP1.0 & rods with standard diameter of 6 mm. All the components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

The mono axial pedicle screw is used as an adjunct to spinal fusion surgery, provides a means of gripping a spinal segment. The screws themselves do not fixate the spinal segment, but act as firm anchor points that can then be connected with a rod. The screws are placed at two or three consecutive spine segments (e.g. lumbar segment 4 and 5) and then a short rod is used to connect the screws. This construct prevents motion at the segments that are being fused.

The Corentec® AEGIS II® Spinal system consists of various Pedicle Screws (mono / poly) with standard and guided type designs, Rod and Rod Link with a set screw, the assembly of which is intended to provide temporary stabilization following surgery to fuse the spine. This system is designed on the basis of long standing spinal technology which is already in the market for more than few decades.

The provided text describes mechanical performance testing for the AEGIS & AEGIS II Spinal Systems. This is not a study involving AI, human readers, or image analysis, but rather physical stress tests on the device itself. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for each mechanical test. The "data provenance" in this context refers to the manufacturing and testing of the physical device components. The tests were performed on the AEGIS and AEGIS II Spinal Systems themselves. The country of origin for the submitter is Korea. The tests are prospective in the sense that they are conducted on newly manufactured devices to ensure they meet standards.

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

Not applicable. This was mechanical testing of a medical device, not a human reader study or clinical evaluation requiring expert interpretation of data. The ground truth refers to the physical properties and performance of the device under stress, as measured by standard engineering tests.

4. Adjudication method for the test set

Not applicable. This was mechanical testing against established ASTM standards, not a diagnostic or interpretive study requiring adjudication of human readings.

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 was a mechanical performance study of a spinal implant system, not a study involving human readers or AI assistance.

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

Not applicable. This was mechanical testing of a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used was the performance of the device under specific mechanical stress tests, compared against the performance of "legally marketed predicate devices" as defined by established ASTM (American Society for Testing and Materials) standards (F1717-04, 543-07, F1798-97).

8. The sample size for the training set

Not applicable. This was not a machine learning study with a training set.

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

Not applicable. There was no training set.

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This device provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. Supported imaging modalities include Magnetic Resonance (MR), Ultrasound (US), Single Photon Emission Computed Tomography (SPECT), Computed Tomography (CT), Positron Emission Tomography (PET), Fluoroscopy and Endoscopy. Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices.

This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to biopsy needles, guidance wires, imaging probes or other tracked devices.

This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications (including pelvis).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by the FDA.

Aegis Navigation and Aegis Pelvic Application products are line-extensions to Sentinelle's medical image software product Aegis. These are also referred to below as (Aegis) plug-ins.

The products are designed to assist with multi-modality (including MRI, US, SPECT, CT, PET, Fluoroscopy, Endoscopy and others) imaging and guidance of screening and interventional procedures for anatomical structures such as head and neck, thoracic, breast, abdominal and pelvis(including prostate).

Aegis Pelvic Application is a software tool intended for analyzing multi-modality images. This plug-in also identifies where and how deeply, a biopsy or localization needle should be inserted into a region of interest (including prostate and surrounding structures) to strike a target or region of interest. Registration of target anatomy with an interventional device can be performed manually or automatically based on fiducial markers. This in turn provides a calculation of the location and depth of the targeted region of interest.

Similarly, Aegis Navigation is a software tool intended for analyzing multi-modality images. This plug-in also identifies where an imaging device (e.g. an ultrasound transducer), interventional tool (e.g. a biopsy or localization needle) or other tracked instrument should be placed in order to visualize or strike a target or region of interest. In addition, Aegis Navigation provides the user with the option to view previously acquired DICOM data (e.g. MRI data) alongside of a separate imaging modality such as Ultrasound (US) or a fluoroscopic device. In the context of US, a 3-D tracking system provides positional data regarding the transducer, which is used to guide the real-time reformatting of DICOM data to match the current US image. Interventional and imaging device operation and manipulation remains under the manual control of the trained medical professional at all times.

Additional applications of Aegis Navigation include:

• The ability to display the position of a tracked probe or instrument, overlaid on DICOM . (e.g.MR or CT) data
• The ability to track the position of an US transducer as it collects data, then retrospectively display reformatted DICOM (e.g. MR/CT) data slices oriented to match the previously acquired ultrasound images.

Here's a breakdown of the acceptance criteria and the study information for the Sentinelle Aegis Navigation and Pelvic Application, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to fulfilling functional requirements and meeting or exceeding specified accuracy criteria. The performance is gauged by comparison to the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "targeting locations within a phantom" and "volunteers," but does not quantify the number of phantoms, volunteers, or the specific cases used in the accuracy and verification tests.
• Data Provenance: The tests were conducted "in-house by trained personnel in a simulated work-environment using phantoms or volunteers." This implies prospective data collection specifically for these tests. The country of origin of the data is Canada (where Sentinelle Medical Inc. is located).

3. Number of Experts and Their Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states "trained personnel" conducted the testing but does not elaborate on their clinical or expert qualifications for establishing ground truth for the device's accuracy.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Ground truth establishment appears to be based on the direct observation and measurement of the device's output against the known properties of the phantoms or volunteer setups, rather than an expert consensus process requiring adjudication.

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

• Was an MRMC study done? No. The document does not mention any MRMC study comparing human readers with and without AI assistance. The testing focuses on the device's standalone accuracy and functionality.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The entire testing described in the document (registration accuracy, needle verification, and functional tests) describes the performance of the Aegis Navigation and Aegis Pelvic Application software itself, independent of a human operator, to verify its accuracy and functionality.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the accuracy tests was established using phantoms or volunteers with known anatomical structures and target locations. This provides a measurable, objective ground truth against which the device's calculations and guidance were compared. Specifically, "targeting locations within a phantom and confirming that the selected target location/needle location based on the registration calculation is within the same tolerance range or better than the Aegis predicate device."

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The document describes a software plug-in whose functionality is inherited from an approved device (Sentinelle Aegis) and combines features of several predicate devices. There is no mention of a machine learning or AI model being trained, thus no explicit training set. The performance evaluation is based on verifying its compliance with specifications and equivalence to predicate devices, not on a new learning algorithm.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning model.

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Aegis is a software application that is intended for use in analyzing magnetic resonance imaging (MRI) medical images as well as other multi-modality images. Its primary goal is to identify where and how deep a biopsy or localization needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional. Aeris receives images and data from various sources (including but not linited to CT, MR, US, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Aegis can be used to communicate, process, and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. These user-defined post-processing functions include image subtractions, multiplanar reformats, maximum intensity projections, and segmenting of regions based on enhancement characteristics.

The digitized mammographic images and/or ultrasound images displayed by Aegis on the laptop display (or on any display not approved by the FDA for such purposes) must not be used for primary diagnostic interpretation.

Typical users of Aegis are trained medical professionals, including but not limited, to radiologists, technologists and clinicians. When interpreted by a skilled user, this device provides information that may be useful in screening and diagnosis. Patient management decisions shoulding be made solely on the results of Aegis analysis.

Aegis is one of the components of a PACS (Picture Archiving and Communications System), Aegis is visualization software designed for breast imaging and intervention procedures. Aegis receives DICOM 3.0 images over a medical imaging network where its primary goal is to identify where and how deep a biopsy needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional.

This 510(k) submission (K070244) for Aegis does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the provided document. The submission focuses on device description, indications for use, and comparison to a predicate device to demonstrate substantial equivalence, which is typical for 510(k) submissions.

Therefore, I cannot populate the table or provide details for the requested points based solely on the provided text.

The document states: "The potential hazards have been studied and controlled as part of the product development validation houring risk analysis, test and design considerations, and planned verification and validation testing processes. Aegis provides images and functionality comparable to the breadicate device." This indicates that some validation and verification testing was performed, but the specifics of these tests, acceptance criteria, and results are not included in this summary.

Information not available in the provided document:

• A specific table of acceptance criteria and reported device performance.
• Sample sizes used for any test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for test sets.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (pathology, expert consensus, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

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The AEGIS Anterior Lumbar Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels.

The device is intended as a temporary fixation device until fusion is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1 - S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The AEGIS Anterior Lumbar Plate System consists of an assortment of plates and screws.

The AEGIS Anterior Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document describes the regulatory submission for the AEGIS Anterior Lumbar Plate System, a medical device. It does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance.

The provided text is a 510(k) summary for a spinal implant system, which focuses on device description, intended use, materials, and substantial equivalence to predicate devices, rather than performance as would be measured for AI/ML systems. Therefore, most of the requested information regarding AI/ML study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this document.

However, I can extract the information provided about the performance data and the type of evaluation conducted for this medical device:

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

The document states: "Performance data were submitted to characterize the AEGIS Anterior Lumbar Plate System components."

Without the actual performance data or explicit acceptance criteria from the 510(k) submission, a detailed table cannot be created. For a mechanical implant like this, "acceptance criteria" generally refer to specific mechanical testing standards (e.g., fatigue strength, torsional rigidity) that the device must meet, and "reported device performance" would be the results of those tests. The 510(k) process primarily relies on demonstrating substantial equivalence to predicate devices, often through mechanical testing to show similar performance characteristics.

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

Not applicable. This is a medical device (spinal implant) approval, not an AI/ML diagnostic or predictive device. The "test set" in this context would refer to mechanical test specimens, and not a dataset of patient information. The document does not specify the number of test specimens or the provenance of the material testing data, but it is implied to be laboratory-based testing of the device components.

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" in the context of this device's approval would relate to established engineering principles, material science standards, and the performance of predicate devices, not expert consensus on diagnostic interpretations.

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

Not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or AI/ML ground truth establishment, neither of which are detailed in this 510(k) summary for a mechanical device.

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

Not applicable. This is not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is a physical medical implant, not an algorithm.

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

For a mechanical device like this, the "ground truth" for demonstrating performance usually comes from:

• Mechanical testing standards: Compliance with established ASTM or ISO standards for spinal implants (e.g., fatigue, static strength).
• Material properties: Verification that the materials used (ASTM F-136 implant grade titanium alloy) meet published specifications.
• Predicate device comparison: Performance is often compared against legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set:

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

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

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

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The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, light-cure (light-activated) resin-adhesive is indicated. This type of cure is used when sufficient light exposure is possible due to the low opacity of the bracket or through excessive use of adhesive the adhesive can be directly exposed to light.

The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled light-cure resin-adhesive is indicated (sufficient light exposure is possible to cure/harden/polymerize the adhesive).

The adhesive can also be used to bond or cement a non-opaque dental restoration (crown, bridge, vencer, inlay,only, etc.) to the tooth when the material of the restoration permits sufficient light through it to cure/harden/polymerize the adhesive. It is not indicated when radiopacity is needed in the adlesive.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "Aegis® ORTHO Light-Cured Orthodontic Adhesive." This type of document declares "substantial equivalence" to a predicate device, which means the new device is as safe and effective as a legally marketed device that does not require premarket approval.

It is important to understand that this document does NOT contain a detailed description of acceptance criteria or a study proving the device meets those criteria in the way you've outlined for a typical AI/software medical device submission.

This document is for a physical dental adhesive, not an AI or software device. Therefore, the specific questions you've asked regarding AI device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth definitions are not applicable to the content of this 510(k) letter.

The FDA's review for this type of device primarily relies on:

• Comparison to a predicate device: Showing that the new device has the same intended use, technological characteristics, and performs as well as a device already on the market.
• Performance testing: This would involve bench testing (e.g., bond strength, wear, solubility, biocompatibility) to demonstrate that the device meets an accepted standard or performs comparably to the predicate. Details of these tests are not included in this summary letter.

Therefore, I cannot populate your requested table and information points based on the provided text. The document does not contain the information requested.

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The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, two component, dual-cure (light-activated with a post-cure chemical-cure) resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic brackets to teeth. This latter type of cure is used when sufficient light exposure is not possible due to the opacity of the bracket.

The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled, two component, dual-cure resin-adhesive is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond orthodontic bands.

The adhesive can also be used to cement dental restorations (crowns, bridges, veneers, inlays, onlys, etc.) where a filled, two component, dual-cure resin is indicated. The adhesive is also indicated when a self-cure or chemical-cure only adhesive is needed to bond or cement a dental restoration.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental adhesive device, Aegis® ORTHO Dual-Cured Orthodontic Adhesive. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.

The document primarily addresses the substantial equivalence of the device to existing predicate devices under the FDA's 510(k) pathway. This pathway is for medical devices that are substantially equivalent to a legally marketed predicate device and does not typically involve the detailed performance studies, acceptance criteria, or ground truth establishment that would be associated with AI/ML devices.

Therefore, for your request, I cannot provide the information as it relates to an AI/ML device study because:

• No acceptance criteria are mentioned for an AI/ML device. The document discusses regulatory compliance for a physical dental adhesive.
• No study proving device performance in the context of AI/ML is detailed. The letter acknowledges the device's substantial equivalence to predicate devices, but this is a regulatory determination, not a performance study for an AI/ML algorithm.
• None of the requested specific categories (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) are present in the document. These are relevant to AI/ML device evaluation, not a physical dental adhesive.

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Aegis Pit & Fissure Sealant with ACP is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth.

The Aegis Pit & Fissure Sealant with ACP is available in opaque and tinted shades, when different shades are indicated for use.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Aegis® Pit & Fissure Sealant." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML or diagnostic devices.

The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory compliance and general controls but does not include technical study details.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. The requested information types (e.g., test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are characteristic of performance evaluations for diagnostic or AI/ML-driven devices, which are not described in this regulatory clearance letter for a dental sealant.

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