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); 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 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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "PASS OCT Spinal System." This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies as one might find for novel drug or high-risk device approvals.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment is largely not present in this type of FDA submission. The provided text primarily addresses material specifications, intended use, and comparison to predicate devices, along with some mechanical testing information.

Here's an attempt to answer your questions based only on the provided text, highlighting what is available and what is not:

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

The document does not explicitly present a table of acceptance criteria for the device itself or reported performance outcomes in terms of clinical efficacy or diagnostic accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if it is equivalent, it meets the same implicit performance standards.

The only "performance" mentioned is in the "Non-clinical Test Summary":

Acceptance Criteria (Implicit)	Reported Device Performance (as tested)
Mechanical integrity under dynamic compression, conforming to ASTM F2706-08	"mechanically evaluated in dynamic compression tests following the ASTM F2706-08."

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

For the non-clinical mechanical testing, the sample size is not specified. The provenance is also not specified, beyond the fact that Medicrea International S.A. is based in France. This was a non-clinical, in-vitro test, not human data.

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)

This is not applicable as the described "study" is a non-clinical mechanical test, not a study involving human subjects or requiring expert interpretation of results for ground truth.

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

This is not applicable as the described "study" is a non-clinical mechanical test that does not involve expert adjudication.

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

The document explicitly states: "No reference devices were used in this submission." and later, under "8. Clinical Test Summary": "Published literature was used to demonstrate substantial equivalence." This indicates that neither a clinical trial nor an MRMC study was conducted by the applicant for this submission. The device is a spinal implant, not an AI-based diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

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

This is not applicable. The device is a spinal implant, not an algorithm or AI product.

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

For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and performance requirements outlined in the ASTM F2706-08 standard. It's a pass/fail against established mechanical properties, not a biological or clinical ground truth.

8. The sample size for the training set

This is not applicable. No training set is mentioned as this is a medical device approval and not a machine learning model.

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

This is not applicable. No training set is mentioned.

Summary of what is available from the document regarding acceptance criteria and studies:

Acceptance Criteria for Device (Implicit): Substantial equivalence to predicate spinal systems (Vertex Reconstruction System, Virage OCT Spinal Fixation System, and a previous version of the PASS OCT Spinal System). This implies meeting the safety and performance characteristics of those already cleared devices.
Specific Performance Criterion (Mechanical): Conformity to ASTM F2706-08 for dynamic compression tests.
Study: A non-clinical, in-vitro mechanical evaluation.
Sample Size (Mechanical Test): Not specified.
Clinical Data: No new clinical studies were conducted by the applicant. Substantial equivalence was demonstrated through comparison to legally marketed predicate devices and reliance on published literature (though the specific literature isn't detailed).

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.

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

October 16, 2015

Medicrea International S.A. Mr. Jean-Denys Marechal Regulatory Affairs Manager 14 Porte du Grand Lyon 01700 Neyron FRANCE

Re: K150918

Trade/Device Name: PASS OCT Spinal System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: October 2, 2015 Received: October 7, 2015

Dear Mr. Marechal:

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

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Page 2 - Mr. Jean-Denys Marechal

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 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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Indications for Use

510(k) Number (if known) K150918

Device Name PASS OCT Spinal 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

MEDICREA INTERNATIONAL's PASS OCT Spinal System

In accordance with 21 CFR 807.92 of the Code of Federal Requlations the following 510(k) summary is submitted to add additional rods to PASS OCT Spinal System and also to get expansion of indications to include posterior cervical screw use.

Date Prepared: 02 October 2015

1. Submitter:

Contact Person:

MEDICREA INTERNATIONAL S.A. 14 Porte du Grand Lyon NEYRON 01700 FR

Jean- Denys MARECHAL MEDICREA INTERNATIONAL 14 Porte du Grand Lyon NEYRON 01700 FR Phone Number: 00 33 4 72 81 87 87

2. Trade name: PASS OCT Spinal System

Regulatory Identification/Classification:

Orthosis, Cervical pedicle screw spinal fixation Product code: NKG Unclassified, Pre-Amendment

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

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

Primary predicate:

Vertex Reconstruction System, (MEDTRONIC SOFAMOR DANEK USA; K143471) . Additional predicates:
Virage OCT Spinal Fixation System; (ZIMMER SPINE, K133556) ●
. PASS OCT Spinal System, (MEDICREA INTERNATIONAL, K121979)

No reference devices were used in this submission.

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4. Description of the device:

Never use stainless steel and titanium implant components in the same construct.

To achieve best results, do not use any of the PASS OCT Spinal System implant components with components from any other systems or manufacturer unless specifically labeled to do so in this or another MEDICREA® INTERNATIONAL document.

MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F136-11 & ISO 5832-30; CP Titanium according to the ASTM F67 and ISO 5832-2; PEEK OPTIMA LT1® according to the ASTM F2026-10 and cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO5832-12 and ASTM F1537.

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

· To provide immobilization and stabilization of posterior spinal segments
· to auqment 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 seqments 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); 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.

6. Substantial equivalence claimed to predicate devices

The PASS OCT Spinal system components are technologically similar to the already cleared PASS OCT Spinal System Components, Vertex Reconstruction System Components and Synapse

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Occipital Cervical Thoracic Components in terms of intended use, materials used, mechanical safety and performances

PASS OCT Spinal System, (MEDICREA INTERNATIONAL, K121979) .
. Vertex Reconstruction System, (MEDTRONIC SOFAMOR DANEK USA; K143471)
Virage OCT Spinal Fixation System; (ZIMMER SPINE, K133556) .

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

Device	MEDICREAINTERNATIONALPASS OCTSpinal SystemNEWCOMPONENT	MEDTRONICSOFAMOR DANEKVertexReconstructionSystem	ZIMMERSPINEVirage OCT SpinalFixation System	MEDICREAINTERNATIONALPASS OCT SpinalSystem
510(k)number	Unknown	K143471	K133556	K121979
Intendeduse
Occipital	Yes	Yes	Yes	Yes
Cervical	Yes	Yes	Yes	Yes
Thoracic	Yes	Yes	Yes	Yes
Components
Anchoragemeans	- Polyaxialscrews- Polyaxialhooks- Occipital bonescrews	- Multi-axialscrews- Hooks- Occipital bonescrews	- Polyaxial Screws- Hooks- Occipital bonescrews	- Polyaxial screws- Polyaxial hooks- Occipital bonescrews
Rodsdiameter	Ø3.5 mm	Ø3.5mm andØ3.2mm	Ø3.5mm	Ø3.5 mm
Straight rods	Yes	Yes	Yes	Yes
Pre-bentrods	Yes	Yes	Yes	No
Materials

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MEDICREAINTERNATIONALPASS OCTSpinal SystemNEWCOMPONENT	MEDTRONICSOFAMOR DANEKVertexReconstructionSystem	ZIMMERSPINEVirage OCT SpinalFixation System	MEDICREAINTERNATIONALPASS OCT SpinalSystem
Titanium Alloy(Ti-6Al-4V)accordingtoASTM F136 &ISO 5832-3	Titanium Alloy (Ti-6Al-4V) accordingto ASTM F136 &ISO 5832-3	Ti-6Al-4V (ASTMF136)Or Co-Cr 28Mo6alloy 1 (followingthe ASTMF1537)	Titanium Alloy (Ti-6Al-4V) accordingto ASTM F136 &ISO 5832-3
-Grade TitaniumaccordingtoASTM F67-13 &ISO 5832-2PEEK OPTIMALT1 conformingto ASTM F2026	- Grade TitaniumaccordingtoASTM F67 & ISO5832-2- Shape MemoryAlloy (Nitinol-NiTi)according toASTM F2063		PEEK OPTIMALT1 conforming toASTM F2026
Co-Cr 28Mo6alloy 1 (followingthe ASTMF1537)

7. Non-clinical Test Summary:

The components of the PASS OCT spinal were mechanically evaluated in dynamic compression tests following the ASTM F2706-08.

8. Clinical Test Summary

Published literature was used to demonstrate substantial equivalence.

9. Conclusions Non clinical and Clinical

The PASS OCT Spinal System 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.