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The ARTFX Trauma Bone Plate and Screw System is indicated for fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The ARTFX Trauma Bone Plate and Screw System is not intended for use in the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine, nor for fixation of the sacroiliac joint. The system is intended for single use and for adult patients only.

The ARTFX 3.5 System is indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpal, phalangeal), fibula, foot (tarsal, metatarsal, phalangeal), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The ARTFX 4.5 System is indicated for fixation of lower extremity (femur, tibia, fibula) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions and reconstructions.

The ARTFX Mini-Plate System is indicated for fixation of hand (metacarpal, phalangeal) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, malunions and reconstructions.

The subject ARTFX Trauma Bone Plate and Screw System is submitted as a bundled submission and consists of four sub-systems: the ARTFX 3.5 System, the ARTFX 4.5 System, the ARTFX Mini-Plate System, and the ARTFX Bone Screw System. The subject system consists of bone plates and screw that are used in the treatment of fractures, fusions, osteotomies, non-unions, malunions, and reconstructive surgeries of the upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), pelvis, and clavicle. After fracture reduction, these devices provide stability and maintain the alignment of bone fragments throughout the healing process. Compression is used whenever possible to increase the contact area and stability between the fragments and reduce stress on the implant. Compression is achieved by using non-locking screws that are placed in compression slots or holes of the plate, allowing for compression of the bone fragments as the screws are tightened. The locking screws do not provide compression, as they are designed to lock into the plate and stabilize the bone fragments through fixed-angle constructs. The special feature of the subject devices is the free choice of screw placement. The user is able to set any desired screw in any hole (either using a locking or non-locking screw). The free choice of screw angulation provides an advantage in fracture treatment, especially in the case of complex fractures.

Generally, the subject plates are designed to the contour of their intended anatomical location and used with cortical, cancellous, non-locking, and cancellous subject screws. The subject bone plates and bone screws are manufactured from Titanium (Ti6Al4V-ELI) per ASTM F136. The subject devices are supplied non-sterile and must be steam-sterilized prior to use.

The subject plates of the ARTFX 3.5 System consist of the clavicle shaft locking plate combi hole, clavicle distal locking plate combi hole, clavicle hook locking plate combi hole, tubular locking plate, olecranon locking plate, olecranon hook locking plate, humerus distal medial locking plate, humerus distal posterolateral locking plate, humerus distal lateral locking plate, distal ulna locking hook plate, radius distal styloid plate, radius distal dorsal L locking plate, radius distal dorsal T locking plate, proximal radius locking plate, radius distal volar locking plate, radius distal volar locking plate small, radius distal volar locking plate TP2, distal ulna locking plate, small 3.5 compression plate combi hole, small 3.5 TP2 compression plate combi hole, humerus proximal locking plate combi hole, reconstruction shaft locking plate, pelvic reconstruction curving locking plate, pelvic reconstruction straight locking plate, pelvic symphyseal plate. The plates of this system range in thickness from 1.4mm to 4.0mm and in width from 6.0mm to 13.0mm.

The subject plates of the ARTFX 4.5 System consist of the tibia distal medial locking plate, tibia distal lateral locking plate, tibia distal lateral locking plate TP2, large broad T locking plate, large broad L support locking plate, small proximal femur plate, tibia proximal medial plate, large broad T support locking plate, tibia high osteotomy plate, large narrow locking plate, tibia proximal lateral locking plate, femur distal locking plate, femur proximal locking plate, large broad locking plate, fibula locking plate, fibula distal locking plate, calcaneus locking plate. The plates of this system range in thickness from 2.0mm to 5.5mm and in width from 9.5mm to 18.0mm.

The subject plates of the ARTFX Mini-Plate System consist of the 1.5mm system, 2.5mm system, and 2.7mm system. The 1.5mm system consists of the 1.5mm hand/foot mini locking strut plate, hand/foot mini H plate, hand/foot mini locking T plate head 3 holes, hand/foot mini locking straight plate, hand/foot mini straight plate non-locking, hand/foot mini locking Y plate, hand/foot mini locking condylar plate, hand/foot mini non-locking T plate, mini non-locking mallet finger plate, and mini locking T plate head 4 holes. The 2.0mm system consists of the 2.0mm hand/foot mini locking straight plate, hand/foot mini locking T plate, hand/foot mini locking condylar plate, hand/foot mini adaptation locking straight plate, and hand/foot mini adaptation locking T plate. The 2.5mm system consists of the 2.5mm hand/foot locking H plate, hand/foot mini locking straight plate, hand/foot mini locking condylar plate, foot locking X plate, hand/foot mini locking L plate oblique, hand/foot mini locking L plate, hand/foot mini adaptation locked straight plate, and hand/foot mini locking T plate 3 holes. The 2.7mm system consists of the 2.7mm hand/foot locking H plate, hand/foot mini locked straight plate, hand/foot mini locked T plate, hand/foot mini locking condylar plate, foot locking X plate, hand/foot mini locked L plate oblique, hand/foot mini locking L plate. The plates of the ARTFX Mini-Plate System range in thickness from 0.8mm to 2.5mm.

The subject screws of the ARTFX Bone Screw System consist of the locking self tapping cortical screw, non-locking self-tapping cortical screw, non-locking self tapping cancellous screw full thread, nonlocking self tapping cancellous screw half thread, non-locking self tapping spongiose screw half thread, cannulated compression screw, locking cannulated full thread screw, locking self tapping cancellous screw, headless cannulated full thread screw, cannulated cancellous Herbert screw stamps. The screws in this system ranges in major diameter from 1.5mm. The screw stamps have a thickness of 1.5mm and range in outer diameter from 6.0mm and inner diameter from 3.0mm to 7.8mm.

This is a 510(k) premarket notification for a medical device called the ARTFX Trauma Bone Plate and Screw System. This document does not contain information on acceptance criteria for an AI/ML device or a study proving that the device meets those criteria. The ARTFX Trauma Bone Plate and Screw System is a hardware device used for orthopedic trauma fixation and is not an AI/ML powered medical device. Therefore, the requested information points, such as sample size for test set, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance, training set sample size, and ground truth establishment are not applicable.

The document describes the device, its indications for use, and establishes substantial equivalence to predicate devices based on similarities in design, dimensions, performance criteria, materials, and sterilization methods. Non-clinical performance testing was conducted according to ASTM F382-17 and ASTM F543-23, and the device met the performance criteria outlined in FDA guidance for bone screws and plates. Biocompatibility was established by demonstrating the device's identity in formulation, processing, sterilization, and geometry to a previously cleared device (K212220 – ARTFX Spinal Fixation System).

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The ARTFX Lumbar PEEK Cages are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment.

The devices are designed to be used with supplemental fixation and autograft/autologous bone grafts to facilitate fusion for each spinal region.

The ARTFX Lumbar PEEK Cages consist of 3 different models: TLIF, PLIF and Expandable PLIF. The System implants are supplied sterile, for single use and are fabricated from PEEK Optima that conforms to ASTM F2026. Various sizes of these components are available.

The Lumbar Cages are lumbar intervertebral devices to be implanted into the appropriate lumbar vertebral section to help provide stability for spinal fusion after a diseased lumbar disc producing back pain is removed during spinal decompression.

ARTFX Lumbar PEEK Cages feature an open cavity to accommodate autogenous bone graft and provide stability for fusion. The height of the Expandable PLIF device, can be increased by up to 2 mm due to the expandable structure. Also, sharp teeth on the implant's surface engage the vertebral endplates to prevent cage migration.

The provided document is a 510(k) premarket notification letter from the FDA regarding ARTFX Lumbar PEEK Cages. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on material, design, and function.

However, the document does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria related to AI/algorithm performance, clinical effectiveness, or human reader improvement with AI assistance.

The information provided pertains to the substantial equivalence determination for a physical medical device (intervertebral body fusion cages), not an AI/software as a medical device (SaMD). The review process for such a device primarily involves demonstrating:

• Same intended use as a predicate device.
• Same technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This is typically assessed through non-clinical (bench) testing and material compliance.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/algorithm performance, clinical study design (sample size, ground truth, experts, MRMC studies, etc.). The document explicitly states:

• Non-clinical testing (bench testing) was conducted: "Non-clinical testing including static and dynamic axial compression and compression-shear testing in accordance with ASTM F2077 and subsidence per ASTM F2267 were conducted."
• Result of the non-clinical testing: "The results showed that the performance of the proposed devices is substantially equivalent."

The context of your questions (acceptance criteria for device performance, ground truth, expert consensus, MRMC studies, training/test sets, etc.) is highly relevant for Artificial Intelligence/Machine Learning (AI/ML) based medical devices or those requiring clinical effectiveness studies, which is not the subject of this FDA clearance letter.

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ARTFX MEDICAL Cervical PEEK Cages are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of nonoperative treatment.

Cervical PEEK Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autogenous bone. ARTFX MEDICAL Cervical PEEK Cages are to be used with supplemental fixation.

"Cervical Peek Cage" refers to a type of intervertebral cage used in spine surgery in the cervical (neck) region. ARTFX Cervical Cages cervical intervertebral devices made from PEEK Optima (per ASTM F2026) are created to be implanted into appropriate vertebral sections to help provide stability for spinal fusion after a diseased cervical disc-producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical peek cages are often used in spinal fusion surqeries.

Fusion surgeries are designed to fuse two vertebrae.

The single-use implant devices feature an open cavity in the interior geometry to accommodate autogenous bone graft and maximize bone growth, with anti-migration teeth to engage the vertebral end plates and prevent expulsion.

The ARTFX Cervical Cages are supplied sterile, single-use, and are fabricated from PEEK that conforms to ASTM F2026 for cages, and with markers and pins that are titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

ARTFX En Vivo Spinal Cervical Peek Cage has a peek cage body.

Components of the ARTFX En Vivo Spinal cage have two pins, which assist in the positive anchorage of the implant between the superior and inferior vertebral bodies, and three radiographic markers.

ARTFX Simplex Spinal XI Cervical Locking Peek Cage has a peek cage body. Components of ARTFX Simplex Spinal XI Cervical Locking Peek Cage has two titanium screws which the system is attached to the cervical spine and a titanium locking screw.

Cervical cages consist of 3 models: En Vivo Anatomical Surface, En Vivo Straight Structure, and Simplex.

This document (K240893) is a 510(k) premarket notification for a medical device called ARTFX MEDICAL Cervical PEEK Cages. It focuses on demonstrating that the new device is substantially equivalent to existing, legally marketed predicate devices.

Crucially, this document describes a physical medical implant (intervertebral cage) and its mechanical properties, not a software-based medical device that relies on algorithms for diagnostic or prognostic purposes. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of algorithms (e.g., sensitivity, specificity, human reader performance with/without AI assistance, ground truth establishment) are not applicable to this submission.

The "study" mentioned in the document refers to non-clinical mechanical testing to ensure the physical properties of the implant are comparable to the predicates, not a clinical study involving data analysis from patients or images.

Here's how the provided information relates to your questions, highlighting why most are not applicable for this type of device:

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

• Not Applicable in the traditional sense for an AI/algorithm-driven device.
• The "acceptance criteria" here relate to mechanical performance standards (e.g., load-bearing capacity, fatigue resistance) as defined by ASTM standards. The document states:
  • "Non-clinical testing including subsidence per ASTM F2267 and static and dynamic axial compression, compression-shear, and torsion per ASTM F2077 was conducted."
  • "The results showed that the performance of the proposed devices is substantially equivalent."
• A table would typically show specific force values or deformation limits from these ASTM standards, and the corresponding measured values for the ARTFX MEDICAL Cervical PEEK Cages, demonstrating they fall within the acceptable range or perform comparably to the predicate. This specific data table is not included in the provided FDA letter/summary, but the statement confirms the testing was done and met the criteria for substantial equivalence.

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 refers to mechanical testing of physical implants, not data samples for an algorithm. The "sample size" would refer to the number of physical cages tested in the lab. Data provenance is irrelevant for mechanical testing.

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 AI/algorithms, refers to the definitive correct answer for a diagnosis or measurement derived from expert consensus, pathology, or clinical outcome. For a physical implant, "ground truth" relates to the physical properties meeting engineering specifications, which is verified through standardized mechanical tests, not expert interpretation of data.

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

• Not Applicable. Adjudication is used for conflicting expert interpretations in clinical data for algorithms. Mechanical testing results are objective measurements from instruments.

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 specific to AI-assisted diagnostic devices. This submission concerns a physical implant.

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

• Not Applicable. This is specific to AI/algorithms. No algorithm is being submitted here.

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

• Not Applicable. As explained in point 3, ground truth for this device is established by adherence to engineering standards and mechanical test results (e.g., ASTM F2267, ASTM F2077), not by clinical expert consensus or pathology data.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. No training set exists for this type of device.

In summary, the provided document is a 510(k) clearance letter for a physical medical implant, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. Therefore, the questions posed, which are tailored for AI/algorithm-based medical devices, are largely not relevant to the information contained in this specific FDA submission. The "proof" of meeting acceptance criteria for this device rests on successful non-clinical mechanical testing that demonstrated substantial equivalence to predicate devices in terms of material properties, design, and function.

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ARTFX SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as an anterior anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

-Degenerative dise disease (DDD) (defined as back pain of discogenic origin with degeneration of the dise confirmed by history and radiographic studies): .

-Spondylolisthesis;

• Trauma (i.e. fi acture or dislocation);
  -Spinal stenosis:

• -Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)

• Tumor:

• -Pseudoarthrosis; and Failed previous fusion

The Proposed system is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated screws , rods (Straight and pre-bent) , connectors , hooks and setscrews. The Artfx Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

ARTFX SPINAL FIXATION SYSTEM is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

The provided text describes the 510(k) premarket notification for the ArtFX Spinal Fixation System. It details the device's design, materials, indications for use, and performance testing relative to predicate devices. However, this document does not contain any information about an AI/ML-driven device, nor does it present any studies that involve acceptance criteria, performance metrics, ground truth establishment, or human reader studies typically associated with AI/ML medical devices.

The document primarily focuses on demonstrating substantial equivalence for a physical medical device (spinal fixation system) based on material properties, mechanical testing (ASTM F1717, F1798), and similarity in design and intended use to existing predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them for an AI/ML context using the provided text. The information required for your request (AI/ML performance, ground truth, sample sizes for AI training/testing, expert review, human-in-the-loop studies) is not present in this FDA clearance letter for a spinal implant.

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The Venus Cervical Plate System is intervertebral screw fixation of the cervical spine at levels C2-T 1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

-Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

-Trauma (including fractures)

-Tumors

-Deformities or curvatures (including kyphosis, lordosis, or scoliosis)

-Pseudarthrosis

-Failed previous fusion

-Decompression of the spinal cord following total or partial cervical vertebrectomy

-Spondylolisthesis

-Spinal stenosis.

The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available. The Venus Cervical Plate System configurations ranging in lengths from 17 mm to the one-level plates, 27 mm to 40 mm for the two-level plates, 45 mm for the three-level plates, , and 70 mm to 90 mm for the four -level plates. All of the plate levels incorporate blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with fixed angles available in self- tapping design. The fixed bone screws are inserted at a defined angle. The bone screws are offered in 3.5 mm, 4.0 mm and 4.50 mm diameters in lengths of 12 mm – 22 mm. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (TI6Al4V-ELI).

The Venus Cervical Plate System is intended for use as an aid in cervical spinal fusion .

The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available.

The provided text is a 510(k) summary for the Venus Cervical Plate System, a medical device for spinal fixation. It details the device's indications for use, description, non-clinical testing, and comparison to predicate devices.

However, the document does not describe:

• Acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy.
• A study proving the device meets such acceptance criteria.
• Any information regarding a test set, data provenance, expert panels, adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for diagnostic or clinical evaluation.
• Sample sizes for training sets or how ground truth for training sets was established.

The document focuses on the mechanical and material performance of the device, not its AI/software performance or diagnostic accuracy. The "Non-Clinical Testing" section describes engineering tests (e.g., Pull-out Test, Fatigue Test) to ensure the device's physical integrity and equivalence to predicate devices, which is typical for implantable orthopedic devices.

Therefore, I cannot fulfill your request for information related to AI/software performance, diagnostic accuracy, or clinical study methodologies (like MRMC studies, expert adjudication, etc.) based on the provided text. The information you're asking for would be relevant to software as a medical device (SaMD) or AI-enabled medical devices that involve image analysis, diagnosis, or prognostication, which is not what this document addresses.

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