(60 days)
JULIET® Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. JULIET® Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage
The JULIET® PO are rectangle-shaped intervertebral body fusion devices with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. The JULIET®PO is made of PEEK Optima LT-1 conforming to ASTM F2026 with Tantalum markers conforming to ASTM F560.
The provided text is a 510(k) premarket notification for a medical device called JULIET® PO, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than an in-depth study proving performance against specific acceptance criteria for an AI/algorithm-driven device.
Therefore, many of the requested categories for AI/algorithm performance studies cannot be extracted or are not applicable. However, I can extract information related to the device's physical performance testing.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Implied by Conclusion) |
|---|---|
| Static axial compression (according to ASTM F2077) | Performed safely and effectively as predicate devices. |
| Static shear compression (according to ASTM F2077) | Performed safely and effectively as predicate devices. |
| Subsidence testing (according to ASTM F2267) | Performed safely and effectively as predicate devices and is substantially equivalent. |
Explanation of the Table: The document states that the tests were conducted "according to ASTM F2077" and "according to ASTM F2267." This implies that the acceptance criteria are defined by these ASTM standards for intervertebral body fusion devices. The conclusion states that "Results demonstrate that JULIET®PO performs as safely and effectively as its predicate devices" and "Non clinical performance testing demonstrates that JULIET®PO is substantially equivalent to predicate devices." This suggests that the device met the performance requirements outlined in those ASTM standards, relative to the predicate devices.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for the mechanical testing of the JULIET® PO device itself (e.g., how many devices were tested for each mechanical test). The data provenance is also not specified; it is assumed to be lab-based mechanical testing, not clinical data from patients or a specific country. This is a non-clinical, mechanical test, not a study involving human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a mechanical device, and the "ground truth" for its performance is established through standardized physical tests (ASTM standards), not human expert consensus.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. There is no human adjudication process described 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
Not applicable. The JULIET® PO is a physical intervertebral body fusion device, not an AI or algorithm-driven diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The JULIET® PO is a physical intervertebral body fusion device, not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on mechanical test results conducted according to established ASTM standards (F2077 and F2267). The performance is then compared to the known performance of predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for a physical medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2014
Spineart Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 route de Pré-Bois - CP 1813 1215 Geneva - SWITZERLAND
Re: K142277
Trade/Device Name: JULIET® PO Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 13, 2014 Received: August 15, 2014
Dear Mr. Pennesi:
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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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" (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.
Ronald#Alean -S for
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 |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name JULIET®PO
Indications for Use (Describe)
JULIET® Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. JULIET® Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Traditional 510k
Juliet® PO
Image /page/3/Picture/2 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with a butterfly above the text. The "a" in "spineart" is a different color than the rest of the text.
510(k) SUMMARY
| SPINEART | |
|---|---|
| Submitted by | International Center Cointrin20 route de pré-boisCP18131215 GENEVA 15SWITZERLAND |
| Contacts | Franck PENNESI Director of Industry & QualityPhone : +41 22 5701246 Fax : +41 22 799 40 26e-mail : fpennesi@spineart.comRegulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)e-mail : idrubaix@nordnet.fr |
| Date Prepared | October 10th, 2014 |
| Common Name | Intervertebral body fusion device |
| Trade Name | JULIET® PO |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | Primary predicate device: Dynamik (Juliet® PO) Lumbar InterbodyFusion Cage (K081888) by Spineart®;Additional predicates include: Juliet®OL Lumbar Interbody FusionCage by (K140474)Spineart®; Lucent® Intervertebral Body FusionDevice (K071724) by Spinal Elements®; Capstone® LumbarInterbody Fusion Cage (K120368) by Medtronic® |
| Indications for use | JULIET® Lumbar Interbody Device is indicated for intervertebral bodyfusion procedures in skeletally mature patients with degenerative discdisease (DDD) at one or two contiguous levels from L2-S1. DDD isdefined as discogenic back pain with degeneration of the discconfirmed by patient history and radiographic studies. These DDDpatients may also have up to Grade 1 spondylolisthesis orretrolisthesis at the involved level(s). This device is to be used withautogenous bone graft. JULIET® Lumbar Interbody Device is to beused with supplemental fixation. Patients should have at least six (6)months of non-operative treatment prior to treatment with anintervertebral cage |
| Purpose of this submission | Line extension to the previously cleared system (Dynamik/Juliet® PO)Lumbar Interbody Fusion Cage (K081888) |
| Description of thedevice | The JULIET® PO are rectangle-shaped intervertebral body fusiondevices with a central cavity that can be filled with bone graft(autograft) to facilitate fusion. The JULIET®PO is made of PEEKOptima LT-1 conforming to ASTM F2026 with Tantalum markersconforming to ASTM F560. |
| TechnologicalCharacteristics | The JULIET® PO are 22mm long devices available in four heights(from 8 to 14 mm) and two lordosis (9° and 12°). The JULIET®PO aredelivered sterile (gamma sterilization) and supplied with dedicatedsurgical instruments (reusable - provided non sterile). |
| Discussion of Testing | The following non-clinical tests were conducted on JULIET®PO: Staticaxial compression, Static shear compression according to ASTMF2077 and subsidence testing according to ASTM F2267. Resultsdemonstrate that JULIET®PO performs as safely and effectively as itspredicate devices. |
| Conclusion | The JULIET® PO is substantially equivalent to its predicate devices interms of intended use, material, design, mechanical properties andfunction. The subject and predicate devices have nearly identicaltechnological characteristics and the minor differences do not raiseany new issues of safety and effectiveness. Non clinical performancetesting demonstrates that JULIET®PO is substantially equivalent topredicate devices. |
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§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.