(109 days)
The SmartLoc™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., non-pedicle screw), the SmartLoc™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
The SmartLoc™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.
The provided text describes the SmartLoc™ spinal fixation system, a Class II medical device. However, the information available is limited to its regulatory clearance, intended use, and mechanical testing results. It does not present a study with acceptance criteria and reported device performance in the context of an AI/algorithm-based device and its clinical performance metrics.
Therefore, I cannot provide the specific details requested in your prompt regarding:
- A table of acceptance criteria and reported device performance (in the context of AI/algorithm performance)
- Sample sizes and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone (algorithm only) performance
- Type of ground truth used (clinical outcomes, etc.)
- Training set details (sample size, ground truth establishment)
Based on the provided text, the device is a physical spinal implant system, not an AI or algorithm-based diagnostic or assistive device. The "Performance Data" section describes mechanical testing of the physical components.
Here's what I can extract related to acceptance criteria and performance for this physical medical device:
Acceptance Criteria and Device Performance (for a Physical Spinal Fixation System)
The SmartLoc™ spinal fixation system underwent mechanical testing to demonstrate its performance. The acceptance criteria are implicitly tied to demonstrating performance "as well as or better than" predicate devices according to established industry standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Static Compression Bending | Performed as well as or better than predicate devices. |
| Static Torsion | Performed as well as or better than predicate devices. |
| Dynamic Compression Bending | Performed as well as or better than predicate devices. |
| Material Composition | Components manufactured from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 / ASTM F136. |
| Technological Characteristics | Possesses the same basic design (rod-based fixation, mono- and polyaxial pedicle screws, hook shapes/sizes), material (titanium alloy), sizes (rod/screw sizes comparable to predicates), and intended use as predicate devices. The fundamental scientific technology is the same as previously cleared devices. |
Study Information (Mechanical Testing):
- Test Set Sample Size & Data Provenance: Not explicitly stated as a "test set" in the context of clinical data. The study was a mechanical test (laboratory-based) performed on a "worst case SmartLoc™ construct." The data provenance is from the manufacturer's testing in support of their 510(k) submission.
- Number/Qualifications of Experts (Ground Truth): Not applicable for mechanical testing. Performance is evaluated against engineering standards.
- Adjudication Method (Test Set): Not applicable for mechanical testing.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This is a mechanical test of a physical device, not an AI-assisted diagnostic tool.
- Standalone (Algorithm Only) Performance: Not applicable. This is a physical device.
- Type of Ground Truth Used: The "ground truth" for mechanical performance is adherence to the specified ASTM F1717 standard and comparison against the performance of legally marketed predicate devices.
- Training Set Sample Size: Not applicable. This is not a machine learning device.
- How Ground Truth for Training Set Was Established: Not applicable.
Summary regarding your specific questions:
The provided document describes the regulatory clearance of a physical medical device (spinal fixation system), not an AI-based system. Therefore, most of the questions pertaining to AI/algorithm performance, training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "Performance Data" provided is solely about the mechanical integrity of the implant system.
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K111883 Page 1 of 2
OCT 1 8 2011
Image /page/0/Picture/2 description: The image contains the logo for A-Spine. The logo features a stylized letter "A" with the word "spire" written in cursive within the letter. To the right of the "A" is the text "A-SPINE" in a bold, sans-serif font. The logo has a professional and modern look.
| 510(k) Summary | |
|---|---|
| Date: | 28 June 2011 |
| Sponsor: | A-SPINE ASIA CO., LTD. |
| 11F., No. 1, Aly. 30, Ln. 358, Ruiguang Rd., Neihu District, | |
| Taipei, Taiwan | |
| Phone: +886 (2)2627-2977 | |
| Fax: +886 (2)6606-5955 | |
| Contact Person: | Frank Hsu |
| A-SPINE ASIA CO., LTD. | |
| 11F., No. 1, Aly. 30, Ln. 358, Ruiguang Rd., Neihu District, | |
| Taipei, Taiwan | |
| frank@aspine.com.tw | |
| Phone: +886 (2)2627-2977 | |
| Fax: +886 (2)6606-5955 | |
| Proposed Trade Name: | SmartLoc™ spinal fixation system |
| Device Classification | Class II |
| Classification Name: | Pedicle screw spinal system & Spinal interlaminal fixation |
| orthosis | |
| Regulation: | 888.3070 & 888.3050 |
| Device Product Code: | MNI/MNH & KWP |
| Device Description: | The SmartLoc™ consists of rods, monoaxial and polyaxial |
| pedicle screws, hooks and transverse connectors with locking | |
| set screws. The components are available in various sizes to | |
| accommodate differing patient anatomy. Rods are available in | |
| one diameter and a variety of lengths. Monoaxial and polyaxial | |
| screws are available in a variety of diameter-length | |
| combinations. Hooks are offered in a variety shapes and | |
| sizes. | |
| Intended Use: | The SmartLoc™ is a spinal fixation system intended to provide |
| immobilization and stabilization of thoracic, lumbar, and sacral | |
| spinal segments as an adjunct to fusion. When used as | |
| posterior, pedicle screw fixation, the system is intended for the | |
| treatment of severe spondylolisthesis (grades 3 and 4) of the | |
| L5-S1 vertebra in skeletally mature patients. In addition, when | |
| used as a pedicle screw fixation system in the noncervical | |
| posterior spine (T1 to S2), the system is intended for the | |
| treatment of the following acute and chronic instabilities or |
SmartLoc™
8-2
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. .
| deformities: degenerative spondylolisthesis with objectiveevidence of neurologic impairment, fracture, dislocation,spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor,pseudarthrosis and failed previous fusion in skeletally maturepatients. When used as a posterior, non-cervical, hook and/orsacral/iliac fixation system (i.e., non-pedicle screw), theSmartLoc™ is intended for the treatment of the following acuteand chronic instabilities or deformities: degenerative discdisease (as conformed by patient history and radiographicstudies), spondylolisthesis, fracture, dislocation, scoliosis,kyphosis, lordosis, spinal stenosis, spinal tumor,pseudarthrosis and failed previous fusion. | |
|---|---|
| Materials: | The SmartLoc™ components are manufactured from titaniumalloy (Ti-6Al-4V) as described by ISO 5832-3 / ASTM F136. |
| Predicate Devices: | CD HORIZON® (K031655/K041460)Moss Miami (K992168/K022623)Synergy VLS (K950099/K974749)Optima™ (K024096/K031585/K051971)flamenco (K102853) |
| TechnologicalCharacteristics: | The SmartLoc™ possesses the same technologicalcharacteristics as the predicate devices. These include basic design (rod-based fixation system having monoaxialand polyaxial pedicle screws and various hook shapes andsizes), material (titanium alloy), sizes (rod and screw sizes are encompassed by those offered by the predicate systems) and intended use (as described above). The fundamental scientific technology of the SmartLoc™ isthe same as previously cleared devices. |
| Performance Data: | Static compression bending and torsion, and dynamiccompression bending of the worst case SmartLoc™ constructwas performed according to ASTM F1717. The mechanicaltest results demonstrated that SmartLoc™ performs as well asor better than the predicate devices. |
.
.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol resembling a bird or abstract human figure with outstretched arms.
OCT 1 8 2011
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
A-Spine Asia, Co., LTD. % Mr. Frank Hsu 11F., No. 1, Aly. 30, Ln. 358 Ruiguang Rd., Neihu District, Taipei Taiwan
Re: K111883
Trade/Device Name: SmartLoc" spinal fixation system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal ssytem Regulatory Class: II Product Code: MNI, MNH, KWP Dated: September 14, 2011 Received: September 15, 2011
Dear Mr. Hsu:
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
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Page 2 - Mr. Frank Hsu
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 (OS) 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,
Eunel Keith
ForMark 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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Indications for Use Statement
510(k) Number:_K111883
Device Name: SmartLoc™ spinal fixation system Indications for Use:
The SmartLoc™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the SmartLoc™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, fordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
SmartLoc™
KIII883 510(k) Number___
7-2
N/A