The NEO Pedicle Screw System™ is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical firation for the following indications: degenerative disc disease (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, tumor, pseudarthrosis, and/or failed previous fusion.

Device Description

The NEO Pedicle Screw System™ consists of pedicle screws and connecting rods which differ in length and diameter. The system includes the relevant instruments which are single use, disposable and delivered sterile. All components and instruments are sterilized by gamma irradiation.

The screws are offered in diameters of 5.0 - 7.0 mm and lengths of 35 - 55 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100 mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40 mm length. All spinal implant components are made of titanium alloy (Ti6Al4V Eli) in accordance with ASTM F136. The screws are color coded for better identification of the different diameters. The screws are double threaded, cannulated, fenestrated and selftapping.

AI/ML Overview

This document pertains to the 510(k) premarket notification for a medical device called the "NEO Pedicle Screw System™." This submission is for a Class II medical device, and as such, it focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving a totally new level of device performance through extensive clinical trials.

Therefore, the information typically sought regarding acceptance criteria and studies proving the device meets those criteria (especially in the context of device performance metrics like accuracy, sensitivity, specificity, or human-AI reader performance improvements) is not present in this type of regulatory submission.

Here's why and what information IS available:

Nature of the Device: The NEO Pedicle Screw System™ is an orthopedic implant (pedicle screws and rods) used for spinal fixation. Its primary function is mechanical support. Unlike diagnostic AI software, its performance is not measured by diagnostic accuracy or an effect size on human reader improvement.
Regulatory Pathway (510(k)): The 510(k) pathway for Class II devices primarily requires demonstration of "substantial equivalence" to a predicate device already on the market. This is achieved by showing that the new device has:
- The same intended use as the predicate.
- The same technological characteristics as the predicate, OR
- Different technological characteristics, but these do not raise new questions of safety and effectiveness, AND the device is as safe and effective as the predicate.
Focus of Testing: The testing detailed in this document is primarily non-clinical and focuses on:
- Material properties: Biocompatibility (ISO 10993-1), chemical analysis.
- Mechanical performance: Static and dynamic axial compression, static torsion (in accordance with ASTM F1717), showing comparability to other marketed systems.
- Sterilization: Validation (ISO 11137-2), pyrogenicity.
- Packaging: Shelf life (ISO 11607-1), transport studies.
- MRI Compatibility: Magnetic field interactions, heating, artifacts (ASTM F2052-15, F2182-11a, F2119-07).
- Usability: WetLab study with orthopedic surgeons.

Therefore, I cannot provide the requested information about acceptance criteria for AI performance, MRMC studies, or specific effect sizes, as this device is a mechanical implant and not an AI/diagnostic software.

However, I can extract the information relevant to the types of studies conducted for this specific device:

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

For this device, the "acceptance criteria" are not based on diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are based on meeting established standards for mechanical performance, biocompatibility, sterility, and durability, demonstrating "comparability" and "substantial equivalence" to predicate devices. The document implies that the device met these standards, as it received 510(k) clearance.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Testing	Performance comparable to currently marketed pedicle screw systems, in accordance with ASTM F1717 standards (static and dynamic axial compression, static torsion).	"The results revealed that the NEO Pedicle Screw System™ is comparable with regards to mechanical strength to other currently marketed pedicle screw systems."
Sterilization	Validated using VDmax 55 method as described in ISO 11137-2, achieving a Sterility Assurance Level (SAL) of 10⁻⁶.	"Validated using VDmax 55 method as described in ISO 11137-2 and confirmed a Sterility Assurance Level SAL of 10⁻⁶."
Pyrogenicity	Result below the detection limit of the test system (LAL-Test).	"LAL-Test (Limulustest) showed result below the detection limit of the test system."
Packaging Validation	Compliance with ISO 11607-1 for sterile barrier system, demonstrated 5-year shelf life and packaging integrity.	"The sterile barrier system complies with ISO 11607-1. Real time and accelerated ageing studies as well as transport studies were performed to demonstrate 5 year shelf life and packaging integrity."
Biocompatibility	Performance in accordance with ISO 10993-1, including chemical analysis (ISO 10993-18) and cytotoxicity testing.	"Biological evaluation has been performed in accordance with ISO 10993-1. Chemical Analysis according to ISO 10993-18 and Cytotoxicity testing were performed on worst case components of the NEO Pedicle Screw System™." (Implied acceptance - no adverse findings reported, allowing clearance).
MRI Compatibility	Demonstrated MRI conditional status while meeting ASTM F2052-15, F2182-11a, and F2119-07 standards.	"The following tests were performed Magnetic field interactions ASTM F2052-15, MRI-related heating ASTM F2182-11a and Artifacts ASTM F2119-07 (R2013). The NEO Pedicle Screw System™ is MRI conditional and information is provided in the labeling." (Implied acceptance - findings met the criteria for "MRI conditional").
Monoaxial Mode	Locking mechanism of the polyaxial screw with a clip performs as intended.	"Verification of this unique feature showed that lock of the polyaxial screw with a clip performs as intended."
Usability	Suitability of instruments and system use confirmed.	"Suitability of the instruments and use of the NEO Pedicle Screw System™ including its labeling was confirmed in a WetLab study with orthopedic surgeons."
Clinical Equivalence	Demonstrates equivalence to predicate devices based on scientific literature and non-clinical data.	"Clinical Evaluation: Based on review scientific literature, comparison with similar device and non-clinical performance data. Clinical studies were not required. The NEO Pedicle Screw System™ is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function." (This is the overarching conclusion of the 510(k) pathway, not a specific performance metric of the device itself.)

2. Sample sized used for the test set and the data provenance:

Sample Size for Test Set: Not applicable in the context of diagnostic AI. For mechanical and biological testing, sample sizes are dictated by the specific ASTM/ISO standards referenced (e.g., number of test specimens for mechanical strength, number of samples for sterility validation), but these specifics are not provided in this summary. Data provenance is implied to be from the manufacturer's own internal testing and external certified labs commissioned by the manufacturer. It is not clinical data (retrospective or prospective) in the sense of patient data.

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

Not applicable for this type of device. "Ground truth" in the context of AI diagnostic performance relies on expert consensus or biopsy/pathology. Here, the "truth" for mechanical performance is defined by adherence to engineering standards (ASTM, ISO), and human experts (orthopedic surgeons) were involved in a "WetLab study" for usability, but not to establish "ground truth" for a diagnostic test.

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

Not applicable. This refers to methods for consolidating expert opinions in diagnostic studies, which is not relevant here.

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:

No. An MRMC study is for evaluating human performance with and without AI assistance for diagnostic tasks. This device is a surgical implant, not a diagnostic AI.

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

Not applicable. This refers to the performance of an AI algorithm alone.

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

For this device, "ground truth" is established by:
- Engineering standards and specifications: For mechanical strength (ASTM F1717), sterility (ISO 11137-2), biocompatibility (ISO 10993-1), MRI compatibility (ASTM F2052-15, F2182-11a, F2119-07), and packaging (ISO 11607-1).
- Functional verification: For the monoaxial mode and overall usability (WetLab confirmation by surgeons).
- Published scientific literature: Used for clinical evaluation to demonstrate equivalence to predicate devices, as "Clinical studies were not required."

8. The sample size for the training set:

Not applicable. This term is relevant for machine learning models.

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

Not applicable. This term is relevant for machine learning models.

In summary, the provided document describes a regulatory submission for a physical medical device (spinal implant) through the 510(k) pathway. The evidence presented focuses on ensuring the device is safe and effective as a mechanical and biological component, rather than as a diagnostic tool or AI algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2017

Neo Medical S.A. % Mr. Samuel Lainez Owner, Senior Consultant, U.S. Agent confinis USA 2511 Saint Ignatius Court Orlando, Florida 32835

Re: K171582

Trade/Device Name: NEO Pedicle Screw System™ Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: August 16, 2017 Received: August 18, 2017

Dear Mr. Lainez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171582

Device Name NEO Pedicle Screw System™

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Purpose of submission

510(k) type	Traditional 510(k)
Purpose of submission	Introduction of a new spinal system

Submitter information

Submitter	Neo Medical S.A.Route de Lausanne 157 A1096 Villette (Lavaux), Switzerland
ContactUS agent confinis USA	Mr. Samuel LainezMailto: samuel.lainez@confinis.comPhone: +1 (386) 299 5218Fax: +1 (407) 296 7139

Device name and classification

Trade name	NEO Pedicle Screw System™™
Common name	Pedicle screw spinal system
Device panel	Orthopedic
Classification name	Thoracolumbosacral Pedicle Screw System
Class	II
Product code	NKB
CFR section	888.3070

Predicate devices

The Neo Pedicle Screw System™ is substantially equivalent to the primary predicate 'Safe Orthopedics SteriSpine PS System' (K112453) and additional predicates DePuy Synthes 'Expedium, VIPER/VIPER2 System' (K11136, K131802) as well as the 'Joimax Percusys System' (K143200).

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Indications for use

The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (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, tumor, pseudarthrosis, and/or failed previous fusion,

Device description

Summary of testing

Sterilization validation: Validated using VDmax 55 method as described in ISO 11137-2 and confirmed a Sterility Assurance Level SAL of 10°.

Pyrogenicity: LAL-Test (Limulustest) showed result below the detection limit of the test system.

Packaging validation: The sterile barrier system complies with ISO 11607-1. Real time and accelerated ageing studies as well as transport studies were performed to demonstrate 5 year shelf life and packaging integrity.

Biocompatibility: Biological evaluation has been performed in accordance with ISO 10993-1. Chemical Analysis according to ISO 10993-18 and Cytotoxicity testing were performed on worst case components of the NEO Pedicle Screw System™.

Mechanical testing: The following mechanical tests were performed in accordance with ASTM F1717: static and dynamic axial compression and static torsion. The results revealed that the NEO Pedicle Screw System™ is comparable with regards to mechanical strength to other currently marketed pedicle screw systems. MRI Compatibility: The following tests were performed Magnetic field interactions ASTM F2052-15, MRI-related heating ASTM F2182-11a and Artifacts ASTM F2119-07 (R2013). The NEO Pedicle Screw System™ is MRI conditional an information is provided in the labeling.

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Monoaxial mode: Verification of this unique feature showed that lock of the polyaxial screw with a clip performs as intended.

Usability: Suitability of the instruments and use of the NEO Pedicle Screw System™ including its labeling was confirmed in a WetLab study with orthopedic surgeons.

Clinical Evaluation: Based on review scientific literature, comparison with similar device and non-clinical performance data. Clinical studies were not required.

Conclusion

The NEO Pedicle Screw System™ is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function. Non-clinical performance testing demonstrate that the NEO Pedicle Screw System™ meets the requirements for Pedicle screw spinal systems according to Spinal System 510(k)s Guidance for Industry and FDA Staff Document issued on: May 3, 2004 and is as safe, as effective, as its predicate devices.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to 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). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.