(88 days)
The Universal MultiAXis (UNIMAX™) Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior 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: (1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (6) Spinal tumor, and (7) Failed previous fusion (pseudoarthrosis). " When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
The UNIMAX Pedicle Screw System consists of plates, bolts, screws and is used to build a spinal construct. The purpose of the UNIMAX System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes. The components and instruments needed for this system are described in the Surgical Technique Manual. The UNIMAX Pedicle Screw System components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM standard F-136. The UNIMAX components will be provided non-sterile.
The provided text describes a 510(k) pre-market notification for the UNIMAX Pedicle Screw System. It does not contain information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications) typically associated with AI/ML-based medical devices or diagnostic tools.
The document is for a traditional medical device (spinal implant) and focuses on demonstrating substantial equivalence to a predicate device based primarily on:
- Intended Use/Indications: Comparing the conditions the device is designed to treat.
- System Components and Materials: Verifying that the materials (titanium alloy, Ti-6Al-4V) conform to established ASTM standards.
- Biomechanical Test Results: These verify design specifications and support substantial equivalence in terms of safety and performance. However, specific acceptance criteria or detailed results of these biomechanical tests are not enumerated in the provided summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the specific questions about the study design, as that information is not present in the provided text. The questions posed ("What was the effect size of how much human readers improve with AI vs without AI assistance," "If a standalone (i.e. algorithm only without human-in-the-loop performance) was done," etc.) are relevant for AI/ML devices, not for a pedicle screw system, which is a physical implant.
Based on the provided text, the following information can be extracted/inferred:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the summary. For a device like a pedicle screw system, acceptance criteria would typically relate to mechanical strength, fatigue life, torsional rigidity, pull-out strength, and material biocompatibility, often benchmarked against the predicate device. The summary generally states "Biomechanical test results verify the design specifications and support substantial equivalence."
- Reported Device Performance: The summary states: "Test results support the safety and performance of the UNIMAX System for its intended use." No specific performance metrics (e.g., specific load capacities, cycles to failure) are provided.
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. The "test set" here would refer to the samples used in biomechanical testing, not a dataset for an AI model. Details about the number of components or constructs tested are not in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This question is for AI/ML diagnostic devices, where "ground truth" often involves expert annotation of medical images or data. For a mechanical device, performance is typically measured through physical tests with objective outcomes, not expert consensus on diagnostic interpretations.
4. Adjudication method for the test set:
- Not applicable/Not provided.
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 not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- For the biomechanical studies, the "ground truth" would be objective physical measurements of strength, durability, and material properties, compared against pre-defined engineering specifications and/or performance of the predicate device.
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This is not an AI/ML device.
In summary, the provided document is a 510(k) summary for a traditional medical device (spinal implant) and therefore does not contain the type of information requested regarding AI/ML device evaluation criteria, study design, or performance metrics. It focuses on demonstrating substantial equivalence through comparison of intended use, materials, and generic mention of biomechanical test results.
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510(k) Summary
[As required by 21 CFR 807.92(c)]
Submitter's Name / Contact Person
Pisharodi Surgicals, Inc. 942 Wildrose Lane Brownsville, TX 78520
Contact Person: Madhavan Pisharodi, M.D. Tel: 956-541-6725
General Information
| Trade Name | UNIMAX Pedicle Screw System |
|---|---|
| Common Name | Pedicle Screw Spinal System |
| Classification | Class II (Orthopedic Devices Panel -Code 87, Product Code MNI)21 CFR 888.3070 - Pedicle Screw Spinal System |
| Predicate | DYNA-LOK CLASSIC Spinal System, Medtronic Sofamor Danek USA(K001532) |
Device Description
The UNIMAX Pedicle Screw System consists of plates, bolts, screws and is used to build a spinal construct. The purpose of the UNIMAX System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes. The components and instruments needed for this system are described in the Surgical Technique Manual. The UNIMAX Pedicle Screw System components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM standard F-136. The UNIMAX components will be provided non-sterile.
Intended Use / Indications
The Universal MultiAXis (UNIMAX™) Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior 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:
(1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (8) Spinal tumor, and (7) Failed previous fusion (pseudoarthrosis). "
MAR 2 9 2002
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Confidential
Pisharodi Surgicals, Inc. 510(k) Pre-Market Notification UNIMAX Pedicle Screw System
When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and indicated for JREFELLify maxare plats (L5-S1) vertebral joint; (b) who are receiving fusions using 4) of the his humber first ly; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
Substantial Equivalence Comparison
The UNIMAX System is substantially equivalent to the following device with respect to intended use/indications, system components and materials:
DYNA-LOK CLASSIC Spinal System, Medtronic Sofamor Danek USA (K001532)
Summary of Studies
Biomechanical test results verify the design specifications and support substantial equivalence for the UNIMAX System. Test results support the safety and performance of the UNIMAX System for its intended use.
Conclusion
The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the Pisharodi Surgicals UNIMAX Pedicle Screw System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Madhavan Pisharodi, MD Pisharodi Surgical, Inc. 942 Wildrose Lane Brownsville, Texas 78520
MAR 2 9 2002
Re: K014302
Trade Name: Universal MultiAXis (UNIMAX) Pedicle Screw System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation, Orthosis Regulatory Class: II Product Code: MNH, MNI Dated: December 28, 2001 Received: December 31, 2001
Dear Dr. Pisharodi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Madhavan Pisharodi, MD
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Pisharodi Surgicals, Inc 510(k) Pre-Market Notificati UNIMAX Podicle Screw System
INDICATIONS / INTENDED USE STATEMENT
Page 1 of 1
510(k) Number:
Device Name: UNiversal MultiAXis (UNIMAX) Pedicle Screw System
Indications / Intended Use:
The Universal MultiAXis (UNIMAX™) Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior 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:
(1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (6) Spinal tumor, and (7) Failed previous fusion (psaudoarthrosis). "
When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Restorative
510(k) Number K014302
INDICATIONS / INT
§ 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.