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

-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

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

-Pseudoarthrosis; and failed previous fusion

Msfx Mikron System is a top-loading, multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (Straight and curved) , connectors , hooks and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-EL) that conforms to ASTM F136. Various sizes of these components are available.

The provided text is a 510(k) clearance letter from the FDA for a spinal fixation system (MSFX MIKRON SPINAL FIXATION SYSTEM). It does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on the regulatory aspects of a traditional medical device (spinal implants), including:

• Device Name: MSFX Mikron Spinal Fixation System
• Regulation Number/Name: 21 CFR 888.3070, Thoracolumbosacral Pedicle Screw System
• Regulatory Class: Class II
• Product Code: NKB, KWP
• Indications for Use: Provides support during fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Predicate Devices: K171497 (Mikron Spinal Fixation system), K212220 (Artfx Spinal Fixation System), K091445 (CD HORIZON SPINAL SYSTEM), K071373 (XIA 3 Spinal System).
• Device Description: Multi-component, posterior spinal fixation system made of titanium alloy.
• Testing: Biomechanical tests performed according to ASTM F2193 and ASTM F1717, demonstrating substantial equivalence to the predicate device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, its performance, study details (sample size, data provenance, expert ground truth, adjudication), or MRMC/standalone studies, as this document is not about an AI/ML medical device.

To answer your request, I would need a document pertaining to an AI/ML medical device.

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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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