The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.

The intended use of the 4.5mm LS Facet Compression Device with Polymer Washer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.

Device Description

The 4.5mm LS Facet Compression Device is a double-helix screw with a compressionlocking collar. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for single use only.

Devices are provided "STERILE" and are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "4.5mm LS Facet Compression Device with Polymer Washer." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested elements for an AI/algorithm-focused study are not directly applicable or present in this document. I will extract the information that is available and indicate where the information is not provided.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

This document does not present quantitative acceptance criteria or detailed device performance metrics in the format of a clinical study or algorithm validation. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, as determined by mechanical testing and biocompatibility.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (materials meet specified standards)	Titanium meets ASTM F-136, Stainless steel meets ASTM F-138. Polymer washer meets USP Class VI and ISO 10993-1.
Functional Performance (mechanical similarity to predicate)	"Performance test results indicate that the device is safe and satisfies functional performance requirements when used as indicated."
Substantial Equivalence to Predicate Device (BONE-LOK® 4.5mm Facet Screw, K043351)	"The test results demonstrate that the modified 4.5mm LS Facet Compression Device with Polymer Washer is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use."

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

Not applicable. This document is for a mechanical medical device, not a data-driven AI/algorithm. The "test set" would refer to the mechanical tests performed on the device. However, specific sample sizes for these tests are not provided in this summary. The data provenance would be from laboratory testing of materials and device mechanics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert consensus for ground truth.

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

Not applicable. This is not a study requiring adjudication of ground truth.

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-assisted diagnostic or imaging device.

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

Not applicable. This is a mechanical medical device.

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

For the mechanical performance and biocompatibility, the "ground truth" is defined by established material standards (e.g., ASTM, USP, ISO) and laboratory-based functional performance tests compared against the predicate device.

8. The sample size for the training set

Not applicable. This is a mechanical medical device, not an AI/algorithm that requires training data.

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

Not applicable. No training set is involved.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER INFORMATION

A.	Company Name:	Triage Medical, Inc
B.	Company Address:	13700 Alton ParkwaySuite 160Irvine, CA 92618
C.	Company Phone:	(949) 472-0006
D.	Company Facsimile:	(949) 472-0016
E.	Contact Person:	Gayle HirotaManager, Quality Assurance & RegulatoryAffairs

DEVICE IDENTIFICATION

A.	Trade Name:	4.5mm LS Facet Compression Device withPolymer Washer
B.	Catalog Number:	LSPW-45-3040
C.	Common Name:	Facet Screw
D.	Classification Name:	Unclassified
E.	Product Code:	MRW
F.	Device Panel:	Orthopedic
G.	Device Class:

IDENTIFICATION OF MODIFIED DEVICE

The 4.5mm LS Facet Compression Device with Polymer Washer is similar in basic design and intended use to the Triage Medical BONE-LOK® 4.5mm Facet Screw, cleared under 510(k) K043351.

DEVICE DESCRIPTION

Devices are provided "STERILE" and are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.

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INTENDED USE

The intended use of the 4.5mm LS Facet Compression Device with Polymer Washer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet ioint and into the pedicle. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for bilateral facet fixation, without bone graft, at single or multiple levels from L1 to Sl.

TECHNOLOGICAL CHARACTERISTICS

The 4.5mm LS Facet Compression Device with Polymer Washer is similar in basic design, construction and mechanical performance to the previously cleared BONE-LOK® 4.5mm Facet Screw. Device modifications includes washers fabricated from a polymer, as well as modifications to component shape/design and device implantation method.

BIOCOMPATIBILITY AND PERFORMANCE DATA

The materials the 4.5mm LS Facet Compression Device with Polymer Washer are made from meet the requirements of ASTM F-136 (titanium) or ASTM F-138 (stainless steel). The polymer washer meets the requirements of USP Class VI and ISO 10993-1. The titanium alloys, stainless steel, and polymer used are identical to a myriad of legally marketed orthopedic spinal fixation devices.

Performance test results indicate that the device is safe and satisfies functional performance requirements when used as indicated.

CONCLUSIONS DRAWN FROM STUDIES

The test results demonstrate that the modified 4.5mm LS Facet Compression Device with Polymer Washer is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 - 2005

Ms. Gayle Hirota QA/RA Manager Triage Medical, Inc. 13700 Alton Parkway, Suite 160 Irvine, California 92618

Re: K051949

Trade/Device Name: 4.5mm LS Facet Compression Device with Polymer Washer Regulatory Class: Unclassified Product Code: MRW Dated: July 13, 2005 Received: July 18, 2005

Dear Ms. Hirota:

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. 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

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Page 2 - Ms. Gayle Hirota

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 If you don't opportion as wollance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Hypt. Alvorke
A. Mark N. Malkerson, M.S.

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

Enclosure

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Kos 1949 510(k) Number (if known):

Device Name:

4.5mm LS Facet Compression Device with Polymer Washer

Indications For Use:

Prescription Use × (Part 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)

Stupt Rlurdu

Division of General, Restorative, and Neurological Devices

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510(k) Number K051949

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Regulation Number and Section

N/A