NEO Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.

The indication for use is Degenerative Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis at the involved levels. 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 six months of non-operative treatment.

Device Description

The NEO Cage System™ is an intervertebral fusion device with bone graft intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The cages are intended to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage implants may be implanted via an open posterior approach.

The Neo Cage System™ consists of cages of different lengths, sizes and lordotic angles to adapt to a variety of patient anatomies. The size and form of the devices is adjusted to the morphology of the body and the surgical technique. The cages of the Neo Cage system are made of titanium alloy (Ti6Al4V) according to ISO 5832-3 or ASTM F3001 and are supplied sterile. The system includes the relevant instruments which are either single use only and delivered sterile or reusable. The Instruments are to be used for the implantation of the above mentioned medical devices.

AI/ML Overview

This document is a 510(k) Premarket Notification from Neo Medical S.A. to the FDA for their NEO Cage System™. It outlines the device's indications for use, description, and a summary of the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices.

Let's break down the requested information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the typical sense of a clinical study for a new AI/software medical device where performance metrics (e.g., sensitivity, specificity) are directly tied to specific thresholds.

Instead, this 510(k) submission focuses on non-clinical testing to demonstrate substantial equivalence for a physical medical device (an intervertebral body fusion device). The "acceptance criteria" are implied by the standards and successful completion of the tests, and the "reported device performance" is that the device met these standards.

Here's an interpretation based on the provided "Summary of testing":

Test Category	Implied Acceptance Criteria	Reported Device Performance
Sterilization	Sterility Assurance Level (SAL) of $10^{-6}$ (as per ISO 11137-2, VDmax25 method)	"The minimal dose of 25kGy is validated... and confirmed a Sterility Assurance Level SAL of $10^{-6}$."
Pyrogenicity	Absence of pyrogens (as determined by LAL-Test)	"The pyrogenicity is tested with the LAL-Test (Limulustest)." (Implies successful completion as no failure is reported, and the conclusion states it meets requirements.)
Packaging	Compliance with ISO 11607-1, demonstration of 5-year shelf life and packaging integrity through real-time, accelerated aging, and transport studies.	"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	Compliance with ISO 10993-1, ISO 10993-18 (Chemical Analysis), and ISO 10993-5 (Cytotoxicity); no adverse biological reactions.	"Biological evaluation has been performed in accordance with ISO 10993-1. Chemical Analysis according to ISO 10993-18 and Cytotoxicity testing according to ISO 10993-5 were performed... Cytotoxicity testing and testing of inorganic and organic residues was repeated to confirm biocompatibility of the line extension." (Implies successful as it's concluded it meets requirements).
Mechanical Testing	Compliance with ASTM F2077 for static (compression, shear, torsion) and dynamic (compression, shear, torsion) tests; compliance with ASTM F2267 (Subsidence); compliance with ISO 17853 (Wear); successful Expulsion test. Device must withstand forces comparable to its intended use.	"Mechanical testing has therefore been repeated and completed successfully. The following tests were performed in accordance with ASTM F2077... Additional testing included... Subsidence test according to ASTM F2267, Wear testing (debris) according to ISO 17853, Expulsion test."
MRI Compatibility	Compliance with ASTM F2052-15 (Magnetic field interactions), ASTM F2182-11a (MRI-related heating), and ASTM F2119-07 (R2013) (Artifacts). Device must be safe for MRI environment and labeled as "MRI conditional."	"The following tests were performed with the new worst-case regarding MRI related issues... Magnetic field interactions ASTM F2052-15, MRI-related heating ASTM F2182-11a and Artifacts ASTM F2119-07 (R2013). The NEO Cage System™ is MRI conditional and information is provided in the labeling."
Usability	Demonstration of suitability of instruments and use of the system, including labeling.	"Suitability of the instruments and use of the NEO Cage System™ including its labeling was confirmed in a WetLab study with orthopedic surgeons."

Regarding the study that proves the device meets acceptance criteria:

The "study" in this context is the comprehensive set of non-clinical performance testing summarized, not a traditional clinical trial or AI model validation study. The document explicitly states: "Clinical Evaluation: Clinical studies were not required, based upon review an evaluation of scientific literature, comparison with similar devices and non-clinical performance data."

Therefore, many of the specific questions about an AI/software device's validation are not applicable here.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not applicable in the sense of patient data for an AI/software test set. The "samples" would be the physical devices or materials used for the various non-clinical tests (e.g., a certain number of cages for mechanical testing, sterile samples for SAL validation, material extracts for biocompatibility). The document doesn't specify these quantities but successful completion implies sufficient sampling per the referenced standards.
Data Provenance: Not applicable for patient data. The testing was conducted by Neo Medical S.A. (Switzerland) and its affiliated labs (likely contract labs based on the testing types). The tests followed international standards (ISO, ASTM).

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)

Experts: Not applicable in the context of establishing ground truth for medical image interpretation or similar.
The "Usability" study involved "orthopedic surgeons," who are experts in their field, to confirm the suitability of the instruments and system. This is an expert-based review of the physical device and its surgical use, not ground truth for a diagnostic algorithm.

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

Not applicable. There is no "test set" in the context of human interpretation that would require adjudication. The non-clinical tests are objective measurements against defined standards.

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 for a physical intervertebral fusion device, not an AI or imaging diagnostic device. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for this device is the adherence to internationally recognized standards (ISO, ASTM) and successful performance in rigorous non-clinical laboratory tests (e.g., materials characterization, mechanical strength, sterility, biocompatibility).
For the "Usability" study, the "ground truth" was the expert opinion/confirmation of orthopedic surgeons regarding the suitability of the system.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

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December 13, 2019

Neo Medical S.A. % Mr. Charles Cathlin President Confinis Corporation 15807 Glacier Ct North Potomac, Maryland 20878

Re: K191796

Trade/Device Name: NEO Cage System™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 4, 2019 Received: November 12, 2019

Dear Mr. Cathlin:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191796

Device Name NEO Cage System™

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date prepared	October 28, 2019, according to 21 CFR 807.92
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Purpose of submission

510(k) type	Traditional 510(k)
Purpose of submission	Line extension to currently cleared NEO CageSystemTM K181048

Submitter information

Submitter	Neo Medical S.A.Route de Lausanne 157 A1096 Villette (Lavaux), Switzerland
Contact US agentconfinis corporation	Mr. Charles CathlinMailto: charles.cathlin@confinis.comPhone: +1 240 252 0891

Device name and classification

Trade name	NEO Cage System™
Common name	Intervertebral body fusion device
Device panel	Orthopedic
Classification name	Intervertebral body fusion device
Class	II
Product code	MAX
CFR section	888.3080

Predicate devices

The NEO Cage System™ is substantially equivalent to the primary predicate device NEO Cage System™ (K181048) as well as the following additional predicate devices: Stryker Tritanium Cage (K152304), Spineart Juliet Ti (K153621), Medtronic Capstone (K073291 (initial), K082342 (PEEK introduced)) and SpineVision SpaceVision System (K153783).

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Indications for use

Neo Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach.

The indication for use is Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis at the involved levels. 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 six months of non-operative treatment.

Device description

Summary of testing

Sterilization validation: The minimal dose of 25kGy is validated using VDmax25 method as described in ISO 11137-2 and confirmed a Sterility Assurance Level SAL of 10-6.

Pyrogenicity: The pyrogenicity is tested with the LAL-Test (Limulustest).

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 according to ISO 10993-5 were performed on worst case components of the NEO Cage System™ for K181048. Cytotoxicity testing and testing of inorganic and organic residues was repeated to confirm biocompatibility of the line extension.

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Mechanical testing: A new worst case cage is introduced with the line extension. Mechanical testing has therefore been repeated and completed successfully. The following tests were performed in accordance with ASTM F2077

Static compression test ●
Static shear compression test ●
Static torsion test ●
Dynamic compression test ●
. Dynamic shear compression test
. Dynamic torsion test

Additional testing included

Subsidence test according to ASTM F2267
Wear testing (debris) according to ISO 17853 ●
Expulsion test ●

Trabecular structure: The trabecular structure has been characterized by tomography examination for the currently cleared cage NEO Cage System™ K181048 and is not affected by the line extension.

MRI Compatibility: The following tests were performed with the new worst-case regarding MRI related issues

. Magnetic field interactions ASTM F2052-15
MRI-related heating ASTM F2182-11a and .
Artifacts ASTM F2119-07 (R2013) .

The NEO Cage System™ is MRI conditional and information is provided in the labeling.

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

Clinical Evaluation: Clinical studies were not required, based upon review an evaluation of scientific literature, comparison with similar devices and non-clinical performance data.

Conclusion

The NEO Cage System™ is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function.

Non-clinical performance testing demonstrates that the NEO Cage System™ meets the requirements according to FDA Guidance for Intervertebral Body Fusion Device, issued on June 12, 2007, and is as safe and effective as its predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.