The Jazz Claw System (hooks and rods) is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic. Jumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is intended for posterior 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 (fracture or dislocation);
spinal stenosis; ●
spinal deformities (scoliosis, kyphosis and/or lordlosis) ●
tumor:
. pseudarthrosis; and
revision of a failed fusion attempt. ●

The Jazz Claw System (hooks and rods) is indicated as an adjunct to freat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft.

The JAZZ CLAW connector consists of temporary implants to be used in orthopedic surgery. The JAZZ CLAW connector is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques:
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities 2 such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
1. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ CLAW connector may also be used in conjunction with other medical implants made of titanium alloy or Cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.

Device Description

The JAZZ CLAW System consists of the JAZZ CLAW hook and JAZZ CLAW rod.

The JAZZ CLAW connector and the cleared JAZZ braid are also separate components, as well as manual surgical instruments.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the JAZZ CLAW System, which includes hooks, rods, and a connector. However, this document does not describe the acceptance criteria or a study proving the device meets specific performance criteria.

Instead, this document is a regulatory submission to the FDA for a substantial equivalence determination. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed predicate device, and therefore does not require a full Premarket Approval (PMA) application.

Here's why the requested information about acceptance criteria and study data is largely absent:

Substantial Equivalence (510(k)) vs. Clinical Trials/Performance Studies: A 510(k) often relies on bench testing, comparison to predicates, and engineering rationale rather than extensive, de novo clinical trials or detailed performance studies with human subjects. The goal is to show similarity, not necessarily to independently prove a specific performance metric against a defined acceptance criterion through rigorous clinical data.
Focus on Safety and Effectiveness: The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... 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." This emphasizes regulatory compliance and similarity to existing devices, not a detailed breakdown of a device's specific acceptance criteria from a performance study.

Based on the provided text, I can extract the following, but many of your requested points are not present:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria or a table of specific performance metrics are provided in this document. The document states:

"The strength of the overall construct (JAZZ CLAW connector used with hooks and rods) was assessed per ASTM F1717 dynamic axial compression testing and found to be equivalent to the predicate JAZZ system (K151740) and Implanet Spinal System (K143731)."
"In addition, engineering rationales were performed to support device performance of the JAZZ CLAW connector and the JAZZ CLAW System (hooks and rods)."

This indicates that performance was evaluated against a standard (ASTM F1717) and compared for equivalence to predicate devices, rather than meeting predefined acceptance criteria for a new performance 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: Not specified for the ASTM F1717 testing.
Data Provenance: Not specified. This would typically be bench testing, 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)

Not applicable. Ground truth as typically understood in AI/imaging studies is not relevant here. The "ground truth" for this type of device (spinal implant) is its mechanical integrity and biocompatibility, typically assessed through engineering tests and material science, not expert consensus on medical images.

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

Not applicable. This concept is typically used in clinical studies or expert review processes, not mechanical bench 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

Not applicable. This is a spinal implant, not an AI diagnostic device.

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

Not applicable. This is a spinal implant, not an algorithm.

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

Not explicitly stated. For mechanical devices like this, the "ground truth" for performance would be objective measurements obtained through standard mechanical tests (e.g., force, displacement, fatigue cycles) that demonstrate structural integrity and durability. The document mentions "ASTM F1717 dynamic axial compression testing," which is a standardized test for spinal implant constructs.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable.

Summary of what is available:

Device: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
Purpose of Evaluation: To demonstrate substantial equivalence to predicate devices for a 510(k) premarket notification.
Testing Mentioned: ASTM F1717 dynamic axial compression testing.
Outcome: Found to be "equivalent" to predicate devices (JAZZ system (K151740) and Implanet Spinal System (K143731)).
Other Evidence: Engineering rationales to support device performance.
Conclusion: Minor technological differences between the new device and predicate devices raise no new issues of safety or effectiveness.

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, stacked on top of each other.

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

May 18, 2016

Implanet, S.A. % Ms. Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K160226

Trade/Device Name: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP, OWI Dated: April 11, 2016 Received: April 11, 2016

Dear Ms. Hogan:

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 (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 (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/ResourcesforYou/Industry/default.htm. 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/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)

K160226

Device Name

JAZZ CLAW System (hooks and rods)

Indications for Use (Describe)

degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed ● by history and radiographic studies);
spondylolisthesis;
trauma (fracture or dislocation);
spinal stenosis; ●
spinal deformities (scoliosis, kyphosis and/or lordlosis) ●
tumor:
. pseudarthrosis; and
revision of a failed fusion attempt. ●

The Jazz Claw System (hooks and rods) is indicated as an adjunct to freat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft.

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.qov

"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.

FORM FDA 3881 (8/14)

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

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

510(k) Number (if known)

K160226

Device Name

JAZZ CLAW connector

Indications for Use (Describe)

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques:
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities 2 such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
1. Spinal degenerative surgery, as an adjunct to spinal fusions.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

区 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.

FORM FDA 3881 (8/14)

Page 1 of 4

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510(k) SUMMARY

Implanet, S.A.'s JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Implanet S.A. Technopole Bordeaux Montesquieu Allée Francois Magendie 33650 Martillac France

Phone: +33 557 995 555 Facsimile: +33 557 995 700

Contact Person: Regis Le Couedic, Director of Quality and Regulatory Affairs; Chief Technology Officer

Date Prepared: May 17, 2016

Name of Device

1. JAZZ CLAW connector
1. JAZZ CLAW System (hooks and rods)

Common or Usual Name

1. Bone fixation cerclage
1. Pedicle screw system

Classification Name

1. 21 CFR § 888.3010, Bone fixation cerclage; Product Code: OWI
1. 21 CFR § 888.3070, Pedicle screw spinal system; Product Codes: NKB, OSH, MNI, MNH; 21 CFR § 888.3050, Spinal interlaminal fixation orthosis ; Product Code: KWP

Predicate and Reference Devices

1. Implanet S.A. JAZZ System (K151740) (primary predicate for JAZZ CLAW connector)
1. Implanet S.A. Spinal System (K143731) (primary predicate for JAZZ CLAW System (hooks and rods)); Synthes Cervifix System (K030377) (reference for JAZZ CLAW System (hooks and rods))

Intended Use / Indications for Use

1. The JAZZ CLAW connector consists of temporary implants to be used in orthopedic surgery. The JAZZ CLAW connector is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

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The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
1. Spinal reconstructive surqery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
1. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ CLAW connector may also be used in coniunction with other medical implants made of titanium allov or Cobalt-chromium-molybdenum alloy whenever "wiring" mav help secure the attachment of other implants.

1. The Jazz Claw System (hooks and rods) is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Jazz Claw System (hooks and rods) is intended for posterior 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 (fracture or dislocation); ●
- spinal stenosis: ●
- spinal deformities (scoliosis, kyphosis and/or lordlosis) ●
- tumor; ●
- pseudarthrosis; and ●
- o revision of a failed fusion attempt.

The Jazz Claw System (hooks and rods) is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft.

Device Description / Technological Characteristics

The JAZZ CLAW System consists of the JAZZ CLAW hook and JAZZ CLAW rod.

The JAZZ CLAW connector and the cleared JAZZ braid are also separate components, as well as manual surgical instruments.

Technological Comparison

The technological differences with the JAZZ CLAW connector and the JAZZ CLAW System (hooks and rods) in comparison to the predicates for each device are minor. Both the JAZZ CLAW connector and the JAZZ System consist of a connector that attaches to the rods of a pedicle screw system (i.e., the JAZZ CLAW System (hooks and rods) and contains a braid to "wire" the surrounding bony structure.

The JAZZ CLAW System (hooks and rods) also contains an additional component, a laminar hook. This hook is similar to other hooks cleared in pedicle screw systems, such as the Implanet Spine System (K143731), and provides an additional attachment point to the spine. The addition of the hook does not raise different safety or effectiveness questions as it is a component typically included in pedicle screw systems to which the JAZZ CLAW connector

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attaches. Thus, the modification to include a hook simply supplies the surgeon with an alternate method to add a laminar hook to the previously cleared Implanet Spine System.

Both the JAZZ CLAW connector and the cleared JAZZ System use established connection mechanisms. Specifically, both the JAZZ System and the JAZZ CLAW connector contain an internal screw used to tighten the device onto a rod. For the cleared JAZZ system, the rod is part of a separately cleared pedicle screw system while the JAZZ CLAW is connected to the JAZZ CLAW System (hooks and rods) via a rod dedicated for the hook. The JAZZ CLAW System also contains a set screw locking mechanism, identical to the locking mechanism cleared with the ISS pedicle screw system (K143731). The hook also attaches to its dedicated rod via the same set screw mechanism.

Performance Data

The strength of the overall construct (JAZZ CLAW connector used with hooks and rods) was assessed per ASTM F1717 dynamic axial compression testing and found to be equivalent to the predicate JAZZ system (K151740) and Implanet Spinal System (K143731). In addition. enqineering rationales were performed to support device performance of the JAZZ CLAW connector and the JAZZ CLAW System (hooks and rods).

Substantial Equivalence

The JAZZ CLAW connector is substantially equivalent to the cleared JAZZ System. The JAZZ CLAW System (hooks and rods) are substantially equivalent to the cleared Implanet Spinal System and Synthes Cervifix System. The subject devices have the same intended uses and indications, and similar technological characteristics, and principles of operation as their associated predicate devices. The minor technological differences between the subject devices and the predicate devices raise no new issues of safety or effectiveness.

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.