The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion.

The Dyn-ALIF device is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.

Device Description

The Dyn-ALIF Anterolateral Intervertebral Body Fusion Device is an implantable device manufactured from titanium alloy which is available in the abutting plate interface dimension of 20mm x 30mm and a vertically expandable height ranging from 11mm anterior /9mm posterior to 15mm anterior/13mm posterior to suit the individual anatomic conditions of the patient. The assembled device consists of five components: two abutting plates with hollow threaded shafts, a central turnbuckle sleeve and two locking set screws. The components can be rigidly locked into a variety of heights, with each construct height measured for the individual case

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the Dyn-ALIF Anterolateral Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than proving performance against specific acceptance criteria in a study. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in this document.

Here's a breakdown of the available and unavailable information based on the provided text:

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

Not Applicable / Not Available. This document describes a 510(k) submission, which primarily focuses on demonstrating "substantial equivalence" to predicate devices, not on proving device performance against specific, pre-defined acceptance criteria through a clinical or performance study in the way a PMA (Pre-Market Approval) or a clinical trial for a novel device would.
The document states: "Data was provided which demonstrate the Dyn-ALIF Anterolateral Intervertebral Body Fusion Device to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, function, material, labeling, biocompatibility, performance and standards with the named intervertebral body fusion predicate devices and upon equivalence in design (vertical expansion), material and labeling with the named vertebral body replacement predicate devices." This implies that the 'performance' of the device is considered equivalent to the predicate devices, rather than being measured against explicit numerical acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. The document explicitly states "H. Summary of Clinical Tests (Not Applicable)". This indicates that no clinical studies were performed to generate a "test set" in the context of human data. The testing mentioned is "G. Summary of Non-Clinical Tests Mechanical testing data was presented." This would typically involve bench testing of the device for mechanical properties, not a "test set" of clinical cases or 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 / Not Available. Since no clinical test set was used to evaluate the device's performance against a ground truth, there were no experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Available. As no clinical test set was utilized for performance evaluation requiring expert adjudication, there is no mention of such a method.

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 Available. This document describes an intervertebral body fusion device (an implantable spinal device), not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Available. This refers to an implantable medical device, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Available. For a mechanical implant like this, the "ground truth" for non-clinical testing would relate to engineering specifications and material properties, verified through lab tests (e.g., tensile strength, fatigue life, etc.), which are not detailed in this summary. No clinical ground truth is mentioned. The "Indications for Use" section mentions "degeneration of the disc confirmed by history and radiographic studies" as part of the DDD definition, but this refers to patient diagnosis, not the ground truth for evaluating the device itself.

8. The sample size for the training set

Not Applicable / Not Available. As this is a physical medical device and not a machine learning algorithm, there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not Applicable / Not Available. (See point 8).

Summary of the Study (as described in the document):

The document details a 510(k) premarket notification for the Dyn-ALIF Anterolateral Intervertebral Body Fusion Device. The primary "study" presented is a demonstration of substantial equivalence to previously cleared predicate devices.

Type of Study: Substantial Equivalence Demonstration (not a performance or clinical efficacy study in the traditional sense).
Methodology for Substantial Equivalence: Comparison of the Dyn-ALIF device against predicate devices (NuVasive CoRoent System, Surgical Dynamics Ray TFC, Ionics Levante Intervertebral Pillar, Medtronic Sofamor Danek Verte-Span Spinal System) based on:
- Indications for Use
- Design
- Function
- Material (Titanium alloy)
- Labeling
- Biocompatibility
- Performance (implied to be equivalent to predicates, likely through non-clinical testing)
- Standards adherence
Non-Clinical Tests: "Mechanical testing data was presented." (No further details on the nature or results of these tests are provided in the summary).
Clinical Tests: Explicitly stated as "Not Applicable," meaning no human clinical trials were conducted or submitted as part of this 510(k) according to the summary provided.
Data Provenance: Not applicable for clinical data. For mechanical testing, the provenance would be internal laboratory testing by the manufacturer.

Summary

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Kost 6.13

Ionics Medical Corporation 248 Bird Haven Lane Ether, North Carolina 27247 lmashburn@pinehurst.net

tel. 910-428-9726 fax 910-428-1716

IONICS
MEDICAL CORPORATION

M. Laine Mashbur President and Chief Executive Officer

June 09, 2008

510(K) SUMMARY

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations 21 CFR 807.87(h) and in particular 21 CFR 807.92, the following summary of safety and effectiveness information is provided:

A. Submitted by

M. Laine Mashburn Company President and Director of Regulatory Affairs Ionics Medical Corporation 248 Bird Haven Lane P.O. Box 179 Ether, North Carolina 27247 Telephone: (910) 428-9726 Fax: (910) 428-1716 email: Imashburn@pinehurst.net

B. Device Name

Trade or Proprietary Name: Dyn-ALIF Anterolateral Intervertebral Body Fusion Device Common or Usual Name: Spinal Implant or Intervertebral Body Fusion Device Classification Name: Intervertebral Body Fusion DeviceWith Bone Graft, Lumbar Fixation Orthosis Device Class: Class II Classification: 21 CFR 888.3080 Product Code: MAX

C. Predicate Devices

The subject device is substantially equivalent to the NuVasive CoRoent System intervertebral body fusion device, K071795; the Surgical Dynamics Ray TFC intervertebral body fusion device, P950019/S9; the Ionics Levante Intervertebral Pillar vertebral body replacement device, K983667 and the Medtronic Sofamor Danek Verte-Span Spinal System vertebral body replacement device, K010930 and K024049.

D. Device Description

The Dyn-ALIF Anterolateral Intervertebral Body Fusion Device is an implantable device manufactured from titanium alloy which is available in the abutting plate interface

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NOV 1 4 2008

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dimension of 20mm x 30mm and a vertically expandable height ranging from 11mm anterior /9mm posterior to 15mm anterior/13mm posterior to suit the individual anatomic conditions of the patient. The assembled device consists of five components: two abutting plates with hollow threaded shafts, a central turnbuckle sleeve and two locking set screws. The components can be rigidly locked into a variety of heights, with each construct height measured for the individual case

E. Intended Use

The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.

F. Substantial Equivalence

Data was provided which demonstrate the Dyn-ALIF Anterolateral Intervertebral Body Fusion Device to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, function, material, labeling, biocompatibility, performance and standards with the named intervertebral body fusion predicate devices and upon equivalence in design (vertical expansion), material and labeling with the named vertebral body replacement predicate devices.

G. Summary of Non-Clinical Tests Mechanical testing data was presented.

H. Summary of Clinical Tests (Not Applicable)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2008

NOV 14

Ionic Medical Corporation % M. Laine Mashburn President and Chicf Executive Officer 248 Bird Haven Lane Ether, North Carolina 27247

Rc: K081673

Trade/Device Name: Dyn-ALIF Anterolateral Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: October 29, 2008 Received: November 3, 2008

Dear M. Laine Mashburn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set 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.

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Page 2 - M. Laine Mashburn

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): とokllo73

Device Name: Dyn-ALIF Anterolateral Intervertebral Body Fusion Device

Indications for Use:

The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

NilapReddy. Sir mxm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K081673

Page (_ of _)

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Regulation Number and Section

§ 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.