(161 days)
The Leva® Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva® Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
The Leva® Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva® Inserter Instrument. Both the fixed and expandable implants are provided in different heights and shapes (convex or lordotic) to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.
This document describes a 510(k) premarket notification for the Leva® Spacer System, specifically a line addition including new 10° lordotic implant sizes. It is a medical device, not an AI/ML product, and therefore the standard AI/ML acceptance criteria and study aspects you've asked for (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set sample size) are not applicable or described in this document.
The document discusses mechanical testing to demonstrate substantial equivalence to predicate devices, which is the relevant "performance data" for this type of medical device.
Here's an attempt to answer your questions based on the provided text, primarily focusing on what is present. Much of your requested information is for AI/ML devices and is not found in this document for a physical medical implant.
1. Table of acceptance criteria and the reported device performance
Since this is not an AI/ML device, the "acceptance criteria" discussed are primarily about mechanical performance and substantial equivalence to legally marketed predicate devices, rather than statistical performance metrics like sensitivity, specificity, or AUC.
| Acceptance Criteria (Mechanical Performance) | Reported Device Performance (Summary) |
|---|---|
| Static Axial Compression (ASTM F2077) | Demonstrated substantial equivalence to predicate device. |
| Dynamic Axial Compression (ASTM F2077) | Demonstrated substantial equivalence to predicate device. |
| Static Compression Shear (ASTM F2077) | Demonstrated substantial equivalence to predicate device. |
| Dynamic Compression Shear (ASTM F2077) | Demonstrated substantial equivalence to predicate device. |
| Subsidence (ASTM F2267) | Compared to constructs previously tested. Demonstrated substantial equivalence to predicate device. |
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 for Test Set: This information is not provided in the document. The testing involved mechanical measurements on the device itself, not clinical data or data from a "test set" in the AI/ML sense.
- Data Provenance: Not applicable. The "data" refers to mechanical test results from the fabricated implants, not patient 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" in the context of this device refers to established mechanical engineering standards and the performance of predicate devices, not expert human assessment of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no "adjudication" in the AI/ML sense 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 is a physical medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating the safety and effectiveness of this device (a physical implant) is based on established mechanical engineering standards (ASTM F2077, ASTM F2267) and comparison to the performance of legally marketed predicate devices. These standards dictate acceptable performance parameters for intervertebral body fusion devices.
8. The sample size for the training set
Not applicable. There is no "training set" for physical implant device testing in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned or implied in the context of this device's evaluation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
4/15/2016
Spine Wave, Incorporated Mr. Amnon Talmor Senior Regulatory Affairs Manager 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K153222
Trade/Device Name: Leva® Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 23, 2016 Received: March 24, 2016
Dear Mr. Talmor:
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 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/Resourcesfor You/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,
Vincent J. Devlin -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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Indications for Use
510(k) Number (if known)
K153222
Device Name Leva® Spacer System
Indications for Use (Describe)
The Leva® Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva® Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
| 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 Leva® Spacer System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise DriveSuite 210Shelton, CT 06484 |
| Telephone: | 203-712-1837 |
| Telefax: | 203-944-9493 |
| Contact: | Amnon Talmor |
| Date Prepared: | April 12, 2016 |
2. Device Information
| Trade Name: | Leva® Spacer System |
|---|---|
| Classification Name: | Intervertebral Body Fusion Device |
| Classification: | Class II (special controls) per 21 CFR 888.3080 |
| Common Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Product Code: | MAX |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a line addition to the Leva® Spacer System, which adds 10° lordotic implant sizes.
4. Predicate Device Information
The Leva® Spacer System described in this submission is substantially equivalent to the following predicates:
| Primary Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Leva® Spacer System | Spine Wave, Inc. | K151581 |
| Reference Predicate Devices | Manufacturer | 510(k) No. |
| Patriot Spacer | Globus | K122097 |
5. Device Description
The Leva® Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available
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in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva® Inserter Instrument. Both the fixed and expandable implants are provided in different heights and shapes (convex or lordotic) to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.
6. Indications for Use
The Leva® Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Leva® Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral body fusion device.
7. Comparison of Technological Characteristics
The substantial equivalence of the Leva® Spacer System to the predicates is shown by similarity in intended use, indications for use, materials and performance.
8. Performance Data
The modified implants were compared to constructs previously tested in static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077) and subsidence (ASTM F2267). Engineering analysis and mechanical testing, which included dynamic compression shear (ASTM F2077), static compression shear (ASTM F2077) and static axial compression (ASTM F2077), demonstrated substantial equivalence to the predicate device.
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Leva® Spacer System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness.
§ 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.