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The ANTHEM® Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur, distal humerus, proximal ulna, and proximal radius plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, extra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions and malunions. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna.

In addition to adult patients, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, distal humerus, proximal ulna, proximal radius, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. Distal femur plates are indicated for use in the diaphyseal and metaphyseal areas of long bones in adolescent pediatric patients. Distal radius, distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.

The ANTHEM® Fracture System is a family of plates, screws, and washers designed to be used for internal bone fixation. The implants are available in various sizes and shapes, and may be contoured or straight, with various lengths to accommodate patient anatomy. The subject ANTHEM® plates are manufactured from titanium alloy per ASTM F136 or stainless steel as specified in ASTM F138 and F139. Plates are also available additively manufactured from titanium alloy powder per ASTM F3001.

I am sorry, but based on the provided FDA clearance letter for the ANTHEM® Fracture System, I cannot extract the information you requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically concerning human-in-the-loop performance, ground truth establishment, or training set details.

This document is a 510(k) clearance letter for a physical medical device (bone fixation system) and focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and mechanical testing of the physical components. It does not appear to involve any AI/software component that would require the kind of performance study details you are asking for (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or different types of ground truth like pathology or outcomes data).

Therefore, I cannot populate the table or answer the specific questions about AI/software performance studies. The "Performance Data" section solely refers to mechanical testing according to ASTM F382 and biocompatibility, which are standard for physical implants.

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The ONVOY Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

The ONVOY™ additional implants consist of acetabular shells, liners, and dual mobility liners and bearings that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. New femoral head sizes are also being introduced. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster-hole design, liners are available in hooded, non-hooded, and lateralized designs used in conjunction with ONVOY shells. Dual mobility polyethylene bearings are used with dual mobility liners.

ONVOY™ acetabular shells are additively manufactured from titanium alloy powder per ASTM F3001. Acetabular liners and dual mobility bearings are manufactured from highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Dual mobility liners are manufactured from Cobalt Chrome (CoCr) alloy and femoral heads are manufactured from alumina matrix composite ceramic.

This document is an FDA 510(k) clearance letter for a medical device called the "ONVOY™ Acetabular System." It details the device's purpose, indications for use, and the basis for its substantial equivalence to other legally marketed devices.

However, it does not contain information about acceptance criteria and a study proving a device meets those criteria for an AI/Software as a Medical Device (SaMD).

This clearance is for an orthopedic implant (hip prosthesis components: acetabular shells, liners, dual mobility implants, and femoral heads), not a software device or an AI application. Therefore, the questions related to MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to the content provided in this FDA 510(k) letter.

The "Performance Data" section solely refers to mechanical and material testing standards relevant to orthopedic implants (fatigue, wear, range of motion, material composition, etc.) and states that "Performance data demonstrate substantial equivalence to the predicate devices." It does not describe any clinical study involving human readers or AI performance metrics.

In summary, based on the provided text, I cannot describe acceptance criteria and a study that proves a device meets those criteria, as the document pertains to an orthopedic implant and not an AI/SaMD.

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The COSINE™ Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

The COSINE™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

This device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

COSINE™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

COSINE™ Spacers are manufactured from titanium alloy per ASTM F136 or ASTM F1295. The endplates are additively manufactured from titanium powder, as specified in ASTM F3001, and an internal component is manufactured from radiolucent PEEK polymer.

This document pertains to the 510(k) premarket notification for the COSINE™ Spacer, an intervertebral body fusion device. Regulatory information for the device is provided in the document. However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document states that:

• Mechanical testing (static and dynamic compression and compression-shear, and subsidence) was conducted in accordance with "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices.
• The subject implants have the same technological characteristics as the predicate devices, including design, intended use, material composition, and range of sizes.
• The subject interbody devices have been found substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use.

To answer your request, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions mechanical testing was performed in accordance with standards, but it does not list specific acceptance criteria (e.g., minimum compression strength, subsidence limits) or the actual performance values achieved by the COSINE™ Spacer.
2. Sample size used for the test set and the data provenance: This information is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as the "ground truth" for mechanical testing is typically defined by engineering standards, not expert interpretation.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This is not applicable as the device is a physical implant, not an AI or imaging system requiring human reader interaction.
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: For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the referenced ASTM standards and FDA guidance. Specific quantitative values are not given.
8. The sample size for the training set: Not applicable as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA communication confirms the clearance of the COSINE™ Spacer based on its substantial equivalence to predicate devices through mechanical testing. However, it does not detail the specific acceptance criteria, test results, or methodology (beyond mentioning adherence to standards) that would allow for a complete answer to your request.

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ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in skeletally mature individuals undergoing reconstruction of severely disabled and/or very painful joints.

ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

ACTIFY™ Total Knee System is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use.

ACTIFY™ 3D Total Knee System is indicated for cemented and uncemented use.

The ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System implants consist of modular femoral, tibial, and patellar implants that are used as part of a complete knee system in total knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Femoral components and tibial inserts are available in posterior-stabilized (PS) and cruciate-retaining (CR) designs.

Femurs are manufactured from cobalt chromium alloy (CoCr) with a CoCr coating. Tibial inserts and patella implants are manufactured from ultrahigh molecular weight polyethylene (UHMWPE) with and without Vitamin E. ACTIFY™ 3D Total Knee tibia trays and the patella metal base are additively manufactured from titanium alloy powder per ASTM F3001. ACTIFY™ Total Knee tibia trays are manufactured from titanium alloy per ASTM F136.

The provided document describes the K240669 submission for the ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System. This submission focuses on orthopedic implants, specifically knee joint prostheses, not AI/ML-driven medical devices. Therefore, the questions related to AI/ML acceptance criteria, study design for AI models, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC studies are not applicable to this 510(k) summary.

The performance data section mentions mechanical testing conducted in accordance with several ASTM standards and a guidance document. These tests are standard for evaluating the mechanical integrity and performance of orthopedic implants and ensure their substantial equivalence to predicate devices, particularly regarding issues such as fatigue, shear, and tensile strength. However, specific acceptance criteria values and reported device performance from these mechanical tests are not explicitly detailed in the provided text.

The document states:

• Performance Data: Mechanical testing (tray fatigue, A-P shear, shear, and tensile) was conducted in accordance with the "Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses - Class II Special Controls Guidance Document for Industry and FDA Staff," January 16, 2003, ASTM F2083, ASTM F1800, ASTM F1044, ASTM F1147, and ASTM F1672. Performance data demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

This indicates that the device's performance was evaluated against the requirements outlined in these standards and guidance documents, and the results supported a finding of substantial equivalence. Without access to the full submission, the specific numerical acceptance criteria and the device's performance against those criteria cannot be provided.

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The DuraPro™ Oscillating System is indicated for drilling, burring, removing, and otherwise manipulating hard and soft tissue, bone, and other bone related tissue during spinal and orthopedic procedures.

ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

DuraPro™ Oscillating System consists of electrical The drill handpieces/attachments powered by an oscillating motor with a foot switch, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided non-sterile and are reusable. Attachments are provided sterile and are single-use.

The provided text does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device. The document is a 510(k) clearance letter for a device called "DuraPro™ Oscillating System," which is a surgical tool.

The document discusses:

• Device Name: DuraPro™ Oscillating System
• Regulation Number: 21 CFR 882.4560 (Stereotaxic Instrument)
• Indications for Use: Drilling, burring, manipulating hard and soft tissue, bone during spinal and orthopedic procedures. It also mentions its use with ExcelsiusGPS® and ExcelsiusHub™ for navigation and guiding surgical instruments for screw and interbody fusion device placement.
• Technological Characteristics: States it has similar characteristics to predicate instruments in design, intended use, material composition, function, and range of sizes.
• Performance Testing: "The navigation and guidance accuracy of the DuraPro™ Oscillating System was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification."
• Electrical Safety/EMC: Confirmed to meet all standards.

However, none of this information outlines specific acceptance criteria for performance metrics usually associated with AI/ML devices (e.g., sensitivity, specificity, AUC), nor does it describe a study using human readers, ground truth establishment by experts, or training/test set details that would be relevant to an AI/ML performance evaluation. The "Performance Testing" section is very high-level and does not provide the granular details requested in your prompt regarding AI/ML device evaluation.

Therefore, I cannot provide the requested table and details because the source document does not pertain to the evaluation of an AI/ML medical device's performance in the way your prompt describes.

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