K Number

Device Name

Manufacturer

SOFAMOR DANEK USA,INC.

Date Cleared

1999-08-27

(141 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNA-LOK PLUS™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is also 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 (1.3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used for posterior, non-pedicle screw fixation, the DYNA-LOK PLUS™ Spinal system is intended for thoracic, lumbar, and sacral (T1 - Sacrum) fixation only.

When used as an anterolateral thoracic/lumbar system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

Device Description

The DYNA-LOK PLUS™ Spinal System consists of a variety of shapes and sizes of rods, bolts, plates, screws, clamps, connectors, cross-connectors, washers and nuts. The DYNA-LOK PLUS™ Spinal System may be used with TSRH® Hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates and/or MULTI-AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates. The DYNA-LOK PLUS™ Spinal System bolts and rod/bolt connectors may be used in conjunction with GDLH™ Spinal System rods, TSRH® Spinal System rods, TENOR™ Spinal System rods and CD® HORIZON Spinal System rods and their respective system indications. These components are assembled to fit the patient's anatomic specific needs. Instrumentation is also available to facilitate implantation of the device components.

DYNA-LOK PLUS™ Spinal System implant components are fabricated from stainless steel conforming to ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the implant components may be manufactured from titanium alloy conforming to ASTM F-136 titanium alloy, or ISO 5832-3. These implants may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implants in a spinal construct.

AI/ML Overview

The provided text is a "Summary of Safety and Effectiveness" for the DYNA-LOK PLUS™ Spinal System, a medical device. This type of document is a regulatory submission to the FDA (specifically a 510(k) premarket notification) to demonstrate that a new device is "substantially equivalent" to an already legally marketed device.

This document describes the device, its indications for use, and a statement of substantial equivalence. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as one would typically find for performance-based acceptance for AI/ML devices or novel technologies.

Instead, for devices like spinal systems, the "acceptance criteria" for regulatory clearance through a 510(k) pathway are generally met by demonstrating substantial equivalence to a predicate device. This often involves:

Same intended use.
Same technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness.
Performance data (e.g., mechanical testing, biocompatibility) demonstrating that newly introduced differences do not compromise safety or effectiveness.

The document states: "The DYNA-LOK PLUS™ Spinal System is substantially equivalent to other legally marketed devices. Mechanical testing data were provided or referenced to demonstrate substantial equivalence."

Given this context, I cannot provide a table of acceptance criteria and reported device performance in the manner you've requested for AI/ML devices, nor can I detail specific studies for a performance-based criteria as that's not how this device's regulatory pathway (510(k) substantial equivalence) is typically fulfilled.

Here's a breakdown of what can be extracted or inferred from the provided text regarding the device's regulatory acceptance, recognizing that it's not a direct answer to the AI/ML-focused questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for 510(k) Substantial Equivalence Pathway)	Reported Device Performance (as stated in document)
Intended Use Equivalence: The new device has the same intended use as a predicate device.	The DYNA-LOK PLUS™ Spinal System has indications for use as a pedicle screw fixation system, posterior non-cervical non-pedicle screw fixation, and anterolateral thoracic/lumbar system (detailed in "IV. Indications" and "Indications for Use" sections). These uses are deemed equivalent to legally marketed predicate devices.
Technological Characteristics Equivalence: The new device has the same technological characteristics as a predicate device, or different characteristics that do not raise different questions of safety and effectiveness.	The system consists of rods, bolts, plates, screws, clamps, connectors, etc., fabricated from stainless steel (ASTM F138 or ISO 5832-1/5832-9) or titanium alloy (ASTM F-136 or ISO 5832-3). These materials and components are consistent with predicate spinal systems.
Performance Data (e.g., Mechanical Testing): Where technological differences exist, performance data demonstrate that the device is as safe and effective as the predicate device.	"Mechanical testing data were provided or referenced to demonstrate substantial equivalence." (Specific results or criteria for this testing are not detailed in this summary.)
Biocompatibility: (Inferred for implantable devices)	Implied to be sufficient given the use of medical-grade stainless steel and titanium alloy, commonly used in predicate devices.
Labeling Requirements: Compliance with labeling regulations.	Implied by the FDA's clearance letter.
Quality System Regulation (GMP): Adherence to Good Manufacturing Practices.	The FDA letter ("A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement...") confirms this is a prerequisite.

Regarding the specific questions about AI/ML studies:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This device is a mechanical implant, not an AI/ML diagnostic or therapeutic device.
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/Not provided. Ground truth in this context would relate to the mechanical and biological performance of the implant, typically evaluated through engineering tests and clinical follow-up, not expert image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) 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/Not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For substantial equivalence of a spinal implant, "ground truth" would be established through:
  - Mechanical testing standards: Adherence to ASTM/ISO standards for strength, fatigue, etc.
  - Biocompatibility testing: According to ISO 10993.
  - Clinical outcomes data: Often referenced from predicate devices or previous clinical studies (though this document doesn't detail new clinical studies performed for this specific 510(k) submission beyond mechanical data).
8. The sample size for the training set
- Not applicable/Not provided.
9. How the ground truth for the training set was established
- Not applicable/Not provided.

In summary, the provided document serves as a regulatory clearance summary for a spinal implant device based on substantial equivalence, not a performance study report for an AI/ML product. Therefore, most of the requested information regarding AI/ML study specifics is not present or applicable.

Summary

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AUG 2 / પિકને

DYNA-LOK PLUSTM Spinal System -Summary of Safety and Effectivenes May 26, 1999

Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proposed Proprietary Trade Name: DYNA-LOK PLUSTM Spinal System 【】.

Product Description III.

IV. Indications

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When used for posterior, non-pedicle screw fixation, the DYNA-LOK PLUS™ Spinal system is intended for thoracic, lumbar, and sacral (T1 - Sacrum) fixation only.

V. Substantial Equivalence

The DYNA-LOK PLUS™ Spinal System is substantially equivalent to other legally marketed devices. Mechanical testing data were provided or referenced to demonstrate substantial equivalence.

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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

AUG 27 19999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Richard W. Treharne Vice President, Research and Regulatory Affairs Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K991198

Trade Name: DYNA-LOK PLUS Spinal System Regulatory Class: II Product Code: KWP, KWQ, MNH and MNI Dated: July 8, 1999 Received: July 9, 1999

Dear Dr. Treharne:

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.

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.

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Page 2 - Dr. Richard W. Treharne

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,

Thurell J. Hager

ダン〜 Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K991198

DYNA-LOK PLUS™ Spinal System Device Name: Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNA-LOK PLUS™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbarfirst sacral (LS-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.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used for posterior, non-pedicle screw fixation, the DYNA-LOK PLUS™ Spinal system is intended for thoracic, lumbar, and sacral (T1 - Sacrum) fixation only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

OR Over-the-counter Use __

Junell P. Payne Sartin

(Division Sign-Off) Division of General Restorative Device 510(k) Number

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.