The PASS OCT spinal system is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT spinal system is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the PASS OCT spinal system may be connected to the PASS LP spinal system with the dual diameter rods. Refer to the PASS LP spinal system package insert for a list of the PASS LP spinal system indications of use.

Device Description

The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.

The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.

The purpose of this submission is to add Patient Specific, UNiD OCT rods. The Patient Specific Rod is a rod bent before surgery by MEDICREA, following the design defined by the surgeon only specific to a unique patient.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "PASS OCT Patient Specific Rods." This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing studies to meet specific acceptance criteria in the manner one might find for a novel AI/software product. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, expert qualifications, and specific study designs (like MRMC or standalone performance) is not applicable or not present in this type of submission.

However, I can extract the information that is present and indicate where the requested details are not provided.

Here's a breakdown based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Mechanical Evaluation: - Static Compression - Dynamic Compression - Static Torsion - Dynamic Torsion	Met: - Mechanically evaluated following ASTM F2706-08. - Conducted on a justified worst case. - IMPLICITLY met, as the submission concludes substantial equivalence based on these tests. The document does not provide specific numerical outcomes (e.g., maximum load, cycles to failure) or pass/fail thresholds, but states these tests were performed and support the equivalence claim.

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

Sample size for test set: The document states that "the mechanical test was conducted on a justified worst case." This implies that a limited number of samples (perhaps one or a few representing the worst case) were tested to demonstrate mechanical properties. It does not specify the exact number of samples.
Data provenance: Not specified in the document.

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/Not provided. This submission is for a physical medical device (spinal rods) and relies on mechanical testing standards, not clinical assessments by experts for "ground truth" in the context of image analysis or diagnostic algorithms.

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

Not applicable/Not provided. This is not relevant for mechanical testing of spinal rods.

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 is a submission for a physical medical implant (spinal rods), not an AI or imaging diagnostic device.

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

Not applicable/Not provided. This is not relevant for a physical medical implant.

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

For the non-clinical (mechanical) tests, the "ground truth" is adherence to ASTM F2706-08 standards for static and dynamic compression and torsion. The device's performance is compared against the expected behavior as defined by these engineering standards.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/software product that requires a training set.

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

Not applicable/Not provided. This is not an AI/software product that requires a training set or ground truth in that context. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and predicate device designs.

Summary of Study (Non-Clinical Test Summary):

Study Type: Non-clinical mechanical evaluation.
Purpose: To demonstrate that the PASS OCT Patient Specific Rods are technologically similar and perform comparably to predicate devices in terms of mechanical safety.
Methods: Static and dynamic compression tests and static and dynamic torsion tests were performed. These tests followed the ASTM F2706-08 standard.
Test Cases: The tests were conducted on a "justified worst case" configuration of the device.
Conclusion: Based on these mechanical tests, the components were concluded to be substantially equivalent to legally marketed predicate devices, implying they met the performance expectations outlined in the standard for safety and effectiveness.
Clinical Data: The document explicitly states that "Published literature was used to demonstrate substantial equivalence," meaning no new clinical studies were conducted for this 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and unity.

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

January 29, 2016

Medicrea International Mr. David Ryan VP, Product Development and Marketing 14 Porte du Grand Lyon 01700 Nevron FRANCE

Re: K153169 Trade/Device Name: PASS OCT Patient Specific Rods Regulatory Class: Unclassified Product Code: NKG, KWP Dated: October 30, 2015 Received: November 2, 2015

Dear Mr. Ryan:

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 Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K153169

Device Name PASS OCT Patient Specific Rods

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.

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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:

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"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

MEDICREA INTERNATIONAL's PASS OCT Patient Specific Rods

In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted to add the ranges of Patient Specific Rods to PASS OCT Spinal System.

Date Prepared: 30 October 2015

1. Submitter:

Submitter:	Contact Person:
MEDICREA INTERNATIONAL	David RYAN
14 Porte du Grand Lyon	MEDICREA INTERNATIONAL
NEYRON 01700	14 Porte du Grand Lyon
	NEYRON 01700 FR
	Ph +33 4 72 01 87 87

1. Trade name: PASS OCT Patient Specific Rods

Regulatory Identification/Classification:

Orthosis, Cervical Pedicle Screw Spinal Fixation Product Code: NKG Unclassified, Pre-Amendment

Spinal Interlaminal Fixation Orthosis Requlation Number: 21CFR 888.3050 Product Code: KWP Class II

3. Predicate or leqally marketed devices which are substantially equivalent:

Primary predicate:

PASS OCT Spinal System, (MEDICREA INTERNATIONAL, K150918) . No recall recorded for this product.

Reference Device:

PASS LP Spinal System - Patient Specific Rods, (MEDICREA INTERNATIONAL, K140738)

4. Description of the device:

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Function: The PASS OCT spinal system was developed as an implant:

· To provide immobilization and stabilization of posterior spinal segments
to augment the development of a solid spinal fusion
· to provide stability to ease fusion
to be mechanically resistant to allow the fusion of the operated level

5. Indication for Use

The PASS OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); turnors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT Spinal System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the PASS OCT® Spinal System may be connected to the PASS LP ® Spinal System rods with the dual diameter rods. Refer to the PASS LP ® Spinal System package insert for a list of the PASS LP ® Spinal System indications of use.

Substantial equivalence claimed to predicate devices 6.

The PASS OCT Patient Specific Rods are technologically similar to the already cleared PASS OCT Spinal System Rods in terms of intended use, materials used, mechanical safety and performances

The table below compares the features and characteristics of PASS OCT components to their predicate devices.

Device	MEDICREA INTERNATIONAL(subject device)	MEDICREA INTERNATIONALPASS OCT Spinal System
510(k) number	Unknown	K150918
Intended use
Occipital	Yes	Yes
Cervical	Yes	Yes
Thoracic	Yes	Yes
Components
Anchorage means	-Polyaxial screws- Polyaxial hooks- Occipital bone screws	-Polyaxial screws- Polyaxial hooks- Occipital bone screws
Rods diameter	Ø3.5 mm	Ø3.5 mm
Dual Diameter Rods	Ø3.5mm/ Ø5.5mmØ3.5mm/ Ø6.0 mm	Ø3.5mm/ Ø5.5mmØ3.5mm/ Ø6.0 mm
Straight rods	No	Yes
Pre-bent rods	No	Yes

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Patient Specific Rods,pre-bent before surgery	Yes	No
---------------------------------------------------	-----	----

Device	MEDICREA INTERNATIONAL(subject device)	MEDICREA INTERNATIONALPASS OCT Spinal System
Materials
	Titanium Alloy (Ti-6Al-4V)according to ASTM F136 & ISO5832-3	Titanium Alloy (Ti-6Al-4V)according to ASTM F136 & ISO5832-3
	-Grade Titanium according toASTM F67-13 & ISO 5832-2	-Grade Titanium according toASTM F67-13 & ISO 5832-2
	PEEK OPTIMA LT1conforming to ASTM F2026	PEEK OPTIMA LT1 conforming toASTM F2026
	Co-Cr 28Mo6 alloy 1 (followingthe ASTMF1537	Co-Cr 28Mo6 alloy 1 (followingthe ASTMF1537

7. Non-clinical Test Summary:

The components of the PASS OCT Patient Specific Rods were mechanically evaluated in static and dynamic compression and static and dynamic torsion tests following the ASTM F2706-08. Each time, the mechanical test was conducted on a justified worst case.

8. Clinical Test Summary

Published literature was used to demonstrate substantial equivalence

9. Conclusions Non clinical and Clinical

The PASS OCT Patient Specific Rods components are substantially equivalent to legally marketed predicate device.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.