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510(k) Data Aggregation
(112 days)
Mikron Makina Sanayi ve Ticaret Ltd. Sti.
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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(57 days)
Mikron Makina Sanayi ve Ticaret Ltd. Sti.
The MSFX Mikron Cervical Anterior Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. 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
-Spondvlolisthesis
-Spinal stenosis.
The MSFX Cervical Anterior Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The MSFX Mikron cervical anterior plate configurations ranging in lengths from 17 mm to 25 mm for the one-level plates, 27 mm to 40 mm for the two-level plates, 45 mm to 65 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 3.5mm, 4.0mm and 4.5 mm of diameters in lengths of 12 mm - 20 mm. All components made of Ti alloy are subjected to anodizing. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (Ti6Al4V).
The MSFX Cervical Anterior Plate System is supplied non-sterilized by end-user by moistheat, is for single use and is fabricated from titanium alloy (Ti6Al4V-ELD) that conforms to ASTM F136. Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "MSFX Mikron Cervical Anterior Plate System." This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and results as typically seen for AI/ML-based devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set data, and ground truth establishment is not available in this document.
This document describes a spinal implant, which is a physical device, and not an AI/ML-based diagnostic or assistive technology. The "Non-Clinical Testing" section mentions fatigue, static compression, and static torsion tests, but these are mechanical performance tests for the physical device, not related to the accuracy or diagnostic performance of a software or AI component. The document explicitly states that "no new mechanical testing is needed on the subject device" as it is a rebranding of a predicate device.
In summary, the provided text does not contain the information required to answer the questions about acceptance criteria and study details for an AI/ML device.
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(339 days)
MIKRON MAKINA SANAYI VE TICARET LTD STI
The MSFX Pedicle Screw System is 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Mikron Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods, and set screws. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construction to stabilize and promote spinal fusion and it functions to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136-11. Various sizes of these components are available.
Here's a breakdown of the acceptance criteria and study information for the Mikron Spinal Fixation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Standard Applied | Acceptance Criteria (Implied by equivalence) | Reported Device Performance |
|---|---|---|---|
| Determining Torsional Properties of Metallic Bone Screws | ASTM F 543 | Equivalent to or better than predicate devices (4S Spinal System K063708, Optima Spinal System K031585) in torsional properties. The specific quantitative criteria are not provided but are implied to be met through comparison to the predicate's performance. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Flexion-Extension Test of Subassembly | ASTM F 1798-97(2008) | Equivalent to or better than predicate devices in flexion-extension stability and fatigue resistance. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Axial Torque Gripping Capacity Test for Subassembly | ASTM F 1798-97(2008) | Equivalent to or better than predicate devices in axial torque gripping capacity. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Axial Gripping Capacity Test | ASTM F 1798-97(2008) | Equivalent to or better than predicate devices in axial gripping capacity. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Static Compression Test for Subassembly | ASTM F 1717-10 | Equivalent to or better than predicate devices in static compression strength. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Fatigue Test for Subassembly | ASTM F 1717-10 | Equivalent to or better than predicate devices in fatigue life under cyclic loading. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Static Torsion Test | ASTM F 1717-10 | Equivalent to or better than predicate devices in static torsional strength. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
| Single Cycle Bend Testing of Metallic Spinal Rods | ASTM F 2193 | Equivalent to or better than predicate devices in resistance to single-cycle bending. | "The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices." |
Explanation of Acceptance Criteria: The acceptance criteria for this medical device (Mikron Spinal Fixation System) are based on demonstrating substantial equivalence to existing legally marketed predicate devices (4S Spinal System K063708 and Optima Spinal System K031585). This means the device must perform "as well as or better than" the predicate devices in the described non-clinical mechanical tests. The specific quantitative values for acceptance are not explicitly stated but are determined by successful comparison to the predicate devices under the specified ASTM standards.
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical performance testing (mechanical tests), not a clinical study involving human patients or data from patient test sets. Therefore:
- Sample size used for the test set: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of physical device components tested for each test. This specific number is not provided in the document.
- Data provenance: Not applicable. The "data" are results from mechanical tests performed on the physical device components, not from patient populations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device's evaluation is based on non-clinical mechanical testing for substantial equivalence, not on interpretation of patient data by experts. Ground truth in this context would refer to objective mechanical properties rather than expert consensus on medical conditions.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of patient data requiring adjudication. The evaluation is based on direct comparison of mechanical test results against performance of predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study involves human readers interpreting cases (e.g., medical images) with and without AI assistance. This document describes a 510(k) submission for a spinal fixation system, relying on mechanical testing for substantial equivalence, not a study of AI-assisted human reading.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device (spinal fixation system), not an algorithm or AI. Standalone performance testing typically applies to software or AI devices.
7. The Type of Ground Truth Used
The "ground truth" used is the mechanical performance and material characteristics of the legally marketed predicate devices. The Mikron Spinal Fixation System's performance is compared directly against the established performance of the 4S Spinal System (K063708) and Optima Spinal System (K031585) in rigorous laboratory mechanical tests designed to ASTM standards.
8. The Sample Size for the Training Set
Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device submission.
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