The SteriSpine™PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion.

Device Description

SteriSpine™PS system includes pedicle screws (multiaxial and cannulated) and rods (straight and prebent). Implantable components of SteriSpine™PS system are made of Titanium Ti-6Al-4V ELI according to ASTM F136. The SteriSpine™PS range of products is supplied sterile with a sterile single-use set of surgical instruments.

AI/ML Overview

This document is a 510(k) premarket notification for the SteriSpine™ PS, a pedicle screw spinal system. It describes the device, its indications for use, and the data presented to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving device meets them, specifically for an AI/ML device.

Crucially, this document does not describe an AI/ML device. It describes a physical medical device (a spinal implant system). Therefore, the questions related to AI/ML device performance (like multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth, training set details) are not applicable to this submission.

The "Performance data" section refers to mechanical testing and packaging/sterilization validation for the physical implant, not AI algorithm performance.

Let's break down what is present and what is not for this specific device submission:

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

The document states:

Acceptance Criteria (Implicit via "conforms to special control"): The device "conforms to special control established for Pedicle Screw spinal system." This implies meeting design specifications and performance standards for such systems, primarily mechanical integrity and safety.
Reported Device Performance: "Mechanical testing was conducted according to ASTM F1717 and ASTM F1798 Standard. Performed mechanical testing includes the following: Static Compression, static torsion, dynamic torsion, static slipping, static bending and static rotation."
- No specific numerical results are provided in this summary, but the "Discussion of Testing" states: "Mechanical testing demonstrates comparable mechanical properties to the predicate devices." This implies that the 'acceptance criteria' were met by demonstrating equivalence to the predicate's performance under these tests.

Acceptance Criterion (Implicit)	Reported Device Performance/Conclusion
Conformance to "special control established for Pedicle Screw spinal system" (e.g., mechanical integrity, safety)	"Mechanical testing was conducted according to ASTM F1717 and ASTM F1798 Standard. Performed mechanical testing includes the following: Static Compression, static torsion, dynamic torsion, static slipping, static bending and static rotation.""Mechanical testing demonstrates comparable mechanical properties to the predicate devices.""Non clinical performance testing demonstrates that the added devices are substantially equivalent to predicate devices in terms of intended use, materials, design and function."
Packaging Validation	"Packaging validation according to ISO 11607-1 and 11607-2"
Sterilization Revalidation	"sterilization revalidation according to ISO 11137-1, 11137-2 and 11137-3."

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

Test Set Sample Size: For mechanical testing of a physical device, "sample size" typically refers to the number of devices or components tested. This specific numerical sample size is not provided in the document.
Data Provenance: Not explicitly stated, but given the manufacturer is French ("Parc des Bellevues, Eragny sur Oise - FRANCE") and the testing standards are international (ASTM, ISO), the testing would have been conducted in a lab, likely in France or a certified testing facility elsewhere. This is "pre-market" testing, not clinical data from patients.

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

N/A. This applies to AI/ML devices where human expert annotations are used to establish ground truth for diagnostic or prognostic tasks. For this physical device, "ground truth" is established by physical measurement against engineering standards.

4. Adjudication method for the test set:

N/A. This applies to AI/ML devices where inconsistencies in human expert annotations need to be resolved. Not relevant for mechanical testing.

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 applies to AI/ML devices assessing clinical images/data. This device is a physical implant. The document explicitly states: "No clinical data has been presented."

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

N/A. This applies to AI/ML devices. Not relevant for this physical device.

7. The type of ground truth used:

For mechanical properties: Engineering standards and physical measurements (e.g., force applied, deformation, yield strength, fatigue life) as defined by ASTM F1717 and ASTM F1798.
For packaging and sterilization: International standards (ISO 11607-1, 11607-2, 11137-1, 11137-2, 11137-3) for sterility and package integrity.

8. The sample size for the training set:

N/A. This applies to AI/ML devices. This is a physical device; there is no "training set" in the AI sense.

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

N/A. Applies to AI/ML devices.

In summary: This document is typical for a 510(k) for a physical implant device, focusing on substantial equivalence through material properties, mechanical performance, and manufacturing processes (sterilization, packaging) compared to predicate devices. It explicitly states "No clinical data has been presented," confirming that no human-in-the-loop or clinical efficacy studies were part of this specific submission for clearance. The questions posed in your prompt are primarily geared towards AI/ML medical devices, which this product is not.

Summary

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

October 8, 2015

Safe Orthopaedics % Mr. Pierre Dumouchel Industrialization Director / QARA Director Parc des Bellevues, Allée R. Luxembourg - Le Californie 95610 Eragny sur Oise FRANCE

Re: K151921 Trade/Device Name: SteriSpine™ PS Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP Dated: July 23, 2015 Received: July 27, 2015

Dear Mr. Dumouchel:

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

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Page 2 - Mr. Pierre Dumouchel

device-related 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 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) K151921

Device Name SteriSpineTMPS

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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Traditional 510k

SteriSpine ™ PS

510(k) SUMMARY

510k	Traditional
Submitted by	Safe OrthopaedicsParc des BellevuesAllée R. Luxembourg - Le Californie95610 Eragny sur Oise - FRANCE
Contacts	Pierre DUMOUCHEL Industrialization Director / QARA Directorp.dumouchel@safeorthopaedics.com+33 (0) 1 34 21 50 00Isabelle DRUBAIX Regulatory contactidee-consulting@nordnet.fr+33 (0)3 21 05 64 23
Date Prepared	October 6th 2015
Common Name	Pedicle screw spinal system
Trade Name	SteriSpine™PS
Classification Name	Pedicle screw spinal system
Class	III
Product Code	NKB, MNI, MNH, KWP
CFR section	888.3070
Device panel	Orthopedic
Legally marketedpredicate devices	Primary predicate device: Synergy VLS (K011437) manufactured byInterpore Cross International.Other predicate device: STERISPINE™ PS manufactured by SAFEORTHOPAEDICS (K112453)
Indications for use	The SteriSpine™PS system is intended to provide immobilizationand stabilization of spinal segments in skeletally mature patients asan adjunct to fusion. SteriSpine™PS System is intended forposterior, non-cervical pedicle and non-pedicle fixation for thefollowing indications: degenerative disc disease (DDD) (defined asback pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies); spondylolisthesis;trauma (i.e., fracture or dislocation); spinal stenosis; tumor;pseudoarthrosis; and failed previous fusion.
Description of thedevice	SteriSpine™PS system includes pedicle screws (multiaxial andcannulated) and rods (straight and prebent). Implantablecomponents of SteriSpine™PS system are made of Titanium Ti-6Al-4V ELI according to ASTM F136. The SteriSpine™PS range ofproducts is supplied sterile with a sterile single-use set of surgicalinstruments.
TechnologicalCharacteristics	The purpose of this 510(k) submission is to obtain clearance for anew extended head max cannulated screw and the associatedextended head screwdriver as well as the addition of a «window» tothe external packaging of SteriSpine ™ PS devices supplied sterile.
Performance data	SteriSpine™ PS conforms to special control established for PedicleScrew spinal system. Mechanical testing was conducted accordingto ASTM F1717 and ASTM F1798 Standard. Performed mechanicaltesting includes the following: Static Compression, static torsion,dynamic torsion, static slipping, static bending and static rotation.The following non-clinical tests were conducted: Packagingvalidation according to ISO 11607-1 and 11607-2 and sterilizationrevalidation according to ISO 11137-1, 11137-2 and 11137-3.No clinical data has been presented.
Discussion ofTesting	Mechanical testing demonstrates comparable mechanical propertiesto the predicate devices.
Conclusion	Non clinical performance testing demonstrates that the addeddevices are substantially equivalent to predicate devices in terms ofintended use, materials, design and function.

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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.