The NEO Pedicle Screw System™, when used as a posterior 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, curvatures (scolosis, and/or lordosis), turnor, pseudarthrosis, and/ or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intented to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use with 5 mm to 8 mm screw diameters at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Device Description

BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a twocomponent system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a svringe and which then can be iniected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

The NEO Pedicle Screw System™ consists of screws, rods and connectors which are available in different sizes. The system includes the relevant instruments which are mainly single use, disposable and delivered sterile, just few optional instruments are reusable and delivered non-sterile.

All the system components are made of materials compliant with ASTM and/or ISO standards. The screws are made out of a titanium alloy and delivered pre-mounted to a screw extender including a tissue dilator and sterile. The rods are made out of a titanium alloy or cobalt chrome alloy and delivered sterile. Connectors are made out of titanium allov and delivered sterile. Iliac connectors are being added in this special 510(k).

The pedicle screws are offered in diameters of 4.5 – 8.0 mm and lengths of 25 - 55 mm. Illiac screws are offered in diameters of 8.0 mm and lengths of 70 – 100 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 - 500 mm and the special-bent rod in either 30 or 40 mm length.

AI/ML Overview

The provided text is a 510(k) summary for the BonOs® Inject Bone Cement and NEO Pedicle Screw System™. It outlines the administrative information, device description, indications for use, and a comparison to a predicate device. However, it explicitly states, "No clinical studies were conducted," and the provided "SUMMARY OF PERFORMANCE DATA" primarily focuses on non-clinical, mechanical testing (static and dynamic testing, and axial gripping capacity in accordance with ASTM 1798), usability, biocompatibility, MRI safety, and sterilization validation.

Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on clinical outcomes or performance metrics typically seen in AI/ML device studies. It is likely that the "acceptance criteria" here refer to meeting the predicate device's performance through bench testing, rather than performance against a clinical ground truth.

Given this, I cannot fully complete the requested table and answer many of the questions as the information is not present in the provided text. I will indicate where information is missing.

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

Since this is a mechanical device and not an AI/ML diagnostic, the "acceptance criteria" and "reported performance" are typically related to engineering and material standards, not diagnostic metrics like sensitivity or specificity. The document mentions meeting requirements for pedicle screw spinal systems.

Acceptance Criteria (Implied from text)	Reported Device Performance
Requirements for Pedicle Screw Spinal Systems (Spinal System 510(k)s Guidance for Industry and FDA Staff Document, May 3, 2004)	The NEO Pedicle Screw System™ meets these requirements.
Static and dynamic testing in accordance with ASTM 1798	Performed; results demonstrate substantial equivalence to predicate.
Axial gripping capacity in accordance with ASTM 1798	Performed; results demonstrate substantial equivalence to predicate.
Usability, Biocompatibility, MRI safety and compatibility, Sterilization process validation (in context of K212489)	Evaluated; results demonstrate substantial equivalence to predicate.

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

Not applicable. The performance data described is based on non-clinical (bench) testing, not a clinical test set.

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. No clinical ground truth was established as "No clinical studies were conducted."

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

Not applicable. No clinical test set or adjudication was performed.

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. This document does not mention any MRMC study. The device is a physical pedicle screw system and bone cement, not an AI diagnostic tool.

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

Not applicable. The device is a physical pedicle screw system and bone cement, not an algorithm.

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

Not applicable. No clinical ground truth was established as "No clinical studies were conducted." The closest equivalent to "ground truth" here would be the established engineering standards (ASTM and ISO) and the performance of the predicate device.

8. The sample size for the training set

Not applicable. The device is a physical pedicle screw system and bone cement, not an AI/ML model that requires a training set.

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

Not applicable. No training set was used.

Summary

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August 26, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Neo Medical SA % Sandra Soniec Managing Director meditec Consulting GmbH Obermoosstrasse 23 Boll, Berne 3067 Switzerland

Re: K222256

Trade/Device Name: BonOs® Inject Bone Cement; NEO Pedicle Screw System™ Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: PML, NDN, NKB Dated: July 15, 2022 Received: July 27, 2022

Dear Sandra Soniec:

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,

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222256

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K22256

Device Name BonOs® Inject

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

In accordance with 21 CFR 807.92 the following information is provided for the BonOs® Inject Bone Cement, NEO Pedicle Screw System™.

ADMINISTRATIVE INFORMATION

Date prepared	July 22, 2022
Submission type	Special 510(k)
Purpose of 510(k)	Modification to currently marketed NEO Pedicle ScrewSystem™, additional Iliac Connector
Submitter	Neo Medical S.A.Route de Lausanne 157 A1096 Villette (Lavaux), Switzerland
Official Correspondent	Sandra SoniecSenior consultant, meditec Consulting GmbHPhone +41 31 535 3193Email soniec@meditec-consulting.ch
US agent	Vicky Verna, confinis corporationPhone +1 240 252 0891Email vicky.verna@confinis.com

DEVICE NAME AND CLASSIFICATION

Trade name	1) BonOs® Inject Bone Cement,2) NEO Pedicle Screw System™
Common name	1) PMMA bone cement for vertebroplasty2) Pedicle Screw System
Regulation number,Regulation name,Regulatory class, ProductCodes	1) BonOs® Inject Bone Cement21 CFR 888.3027Polymethylmethacrylate (PMMA) bone cementClass IIPML, NDN2) NEO Pedicle Screw System™21 CFR 888.3070Thoracolumbosacral pedicle screw systemClass IINKB

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PREDICATE DEVICES

BonOs® Inject Bone Cement, NEO Pedicle Screw System™ (K212489)

INDICATIONS FOR USE

1) BonOs® Inject

When used in coniunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

2) NEO Pedicle Screw System™

The NEO Pedicle Screw System™, when used as a posterior 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, curvatures (scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are of the spine is not severely compromised. for use with 5 mm to 8 mm screw diameters at spinal levels where the structural integrity of the spine is not severely compromised.

DEVICE DESCRITION

1) BonOs® Inject

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2) NEO Pedicle Screw System™

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE

The modified NEO Pedicle Screw System™ is substantially equivalent to the currently cleared device 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 substantially equivalent to its predicate devices.

SUMMARY OF PERFORMANCE DATA

To demonstrate that the modified NEO Pedicle Screw System™ is substantially equivalent to a cleared predicate, static and dynamic testing and axial gripping capacity in accordance with ASTM 1798.

The new system component has been evaluated in context of K212489 with regards to Usability, Biocompatibility testing, MRI safety and compatibility and is sterilized using the currently validated sterilization process cleared under K212489. No clinical studies were conducted.

CONCLUSION

Based on the indications for use, technological characteristics, and comparison to predicate device, the subject modified BonOs® Inject Bone Cement, NEO Pedicle Screw System™ has been shown to be substantially equivalent to currently cleared device.

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”