Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above TS.

Device Description

The proposed devices of Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis.

It is made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility.

The proposed device includes three models, which are TL5.5, TL6.0 and TL6.35. All models use the same material, and same design principle. The only difference is the parts size which does not affect the design. There is no surface modified or coated.

The proposed device consists of the following components: FAS, Reduction FAS, Spine Hook, Rod and Crosslink Plate

The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 100 by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per 150 17665-1: 2006 Sterilization of health care products -- Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization. process for medical devices.

AI/ML Overview

The provided text describes a medical device, the "Devine Spinal System," and its submission for 510(k) clearance. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria based on performance metrics like sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be fully provided from the given document.

The document details a non-clinical bench test study to demonstrate that the device meets design specifications and is substantially equivalent to a predicate device, not a study to prove acceptance criteria based on clinical performance metrics.

Here is what can be extracted and inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test Standard)	Reported Device Performance
ASTM F1717-09 Static Axial Compression	Met all design specifications and was Substantially Equivalent (SE) to the predicate device.
ASTM F1717-09 Dynamic Axial Compression	Met all design specifications and was Substantially Equivalent (SE) to the predicate device.
ASTM F1717-09 Static Torsion	Met all design specifications and was Substantially Equivalent (SE) to the predicate device.

Note: The acceptance criteria here are based on meeting the requirements of the ASTM F1717-09 standard for spinal implant constructs in a vertebrectomy model, not clinical performance metrics. The reported performance is a statement of compliance and substantial equivalence to a predicate device, not specific quantitative results for each test.

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

The document describes bench tests conducted to verify mechanical performance, not a test set for assessing clinical performance using patient data. Therefore, the concept of "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) is not applicable here.
The sample sizes for the mechanical tests (e.g., number of implant constructs tested) are not specified in the provided text.

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

This question is not applicable as the study described is a non-clinical bench test of mechanical properties, not an evaluation of a diagnostic or assistive device requiring expert consensus for ground truth on patient data.

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

This question is not applicable as the study described is a non-clinical bench test of mechanical properties. Adjudication methods are typically used for establishing ground truth from expert interpretations of clinical data.

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, an MRMC comparative effectiveness study was not done. The device is an orthopedic implant (spinal system), not an AI-assisted diagnostic or imaging device.

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

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical spinal system.

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

For the bench tests, the "ground truth" would be the physical properties and performance characteristics defined by the ASTM F1717-09 standard. The device's components were also made from Titanium Alloy (Ti-6AL-4V) meeting ASTM F136-02a, which serves as a material "ground truth" for biocompatibility and material properties.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical bench testing, not an AI or machine learning model.

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

This question is not applicable for the same reasons as point 8.

Summary

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Additional Information II K111690 - Attachment III 510(k) Summary

Attachment III 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

1. Date of Submission: April 7, 2011
1. Sponsor Changzhou Orthmed Medical Instrument Co., Ltd No.177, Qinling Road, New Zone, Changzhou, Jiangsu, China, 213022

Establishment Registration Number: 3005596372

Contact Person: Dongxia Zhou Position: Quality Manager Tel: +86-519-85123770-8055 Fax: +86-519-85123776 Email: zhoudongxia@orthmed.com

1. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
1. Proposed Device Identification
- Proposed Device Name: Devine Spinal System Proposed Device Model: TL5.5, TL6.0, TL6.35 Classification: II Product Code: MNH, MNI Regulation Number: 21 CFR 888.3070 Review Panel: Orthopedic Intended Use Statement:

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Additional Information II KI11690 - Attachment III 510(k) Summary

Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior. spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above 18.

1. Predicate Device Identification
  510(k) Number: K082617 Product Name: Trauson General Spinal System (GSS) Manufacturer: TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
Device Description ্ত
The proposed devices of Devine Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis.

The proposed device consists of the following components: FAS, Reduction FAS, Spine Hook, Rod and Crosslink Plate

7. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed

III-2

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device complies with the following standards:

ASTM F1717-09 , Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

The specific tests performed according to ASTM F1717 to evaluate the mechanical performance of the proposed device includes: static axial compression, dynamic axial compression, and static torsion.

1. Substantially Equivalent Conclusion
  The proposed device, Devine Spinal System, is determined to be Substantially Equivalent (SE) to the predicate device, Trauson General Spinal System (GSS) (K082617), in respect of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

NO.V. 2 2 2011

Changzhou Orthmed Medical Instrument Co., Ltd. % Mid-Link Consulting Co., Ltd. Ms. Diana Hong P. O. Box 237-023 Shanghai, 200237, China

Re: K111690

Trade/Device Name: Devine Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: November 21, 2011 Received: November 21, 2011

Dear Ms. Hong:

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

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Page 2 - Ms. Diana Hong

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Fintan O'Toole

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

Enclosure

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Attachment II Indications for Use

510(k) Number: K111690 Device Name: Devine Spinal System

Indications for Use:

�PRESCRIPTION USE (Part 21 CFR 801 Subpari D)

□OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K 1111690

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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.