The BONE-LOK® MVP Cortical-Cancellous Compression Device is a double-helix screw with a compression-locking collar. It is available as 3.5mm or 4.5mm diameter device with a compression looking ochan 1978 - The BONE-LOK® MVP Cortical-Cancellous Compression Device is intended for single use only. Devices provided "STERILE" are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BONE-LOK® MVP Cortical-Cancellous Compression Device, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	Meet requirements of ASTM F-138 (stainless steel) or ASTM F-136 (titanium).	Materials meet ASTM F-138 (stainless steel) or ASTM F-136 (titanium).
Functional Performance	Satisfy functional performance requirements when used as indicated.	Performance test results indicate the device is safe and satisfies functional performance requirements.
Substantial Equivalence	Demonstrates substantial equivalence to the predicate device.	Test results demonstrate substantial equivalence to the predicate device.

Explanation of "Acceptance Criteria" in this Context:

It's important to note that the provided 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a detailed list of specific numerical acceptance criteria for clinical or performance outcomes. The acceptance criteria here are implicitly:

The materials used are biocompatible and commonly accepted for orthopedic devices.
The mechanical performance is comparable to the predicate device.
The device is safe for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not contain information about a test set with human or animal subjects, nor does it mention sample sizes for such a set. The document refers to "Performance test results" which are likely referring to mechanical or bench testing.

Sample Size for Test Set: Not mentioned, likely not applicable in the context of human/animal outcome data for this type of submission.
Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. As there's no mention of a clinical test set requiring human interpretation or ground truth establishment in the traditional sense (e.g., for diagnostic accuracy), this section is not applicable.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable, as there's no mention of a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study (often seen in diagnostic imaging for AI) is not relevant for a bone fixation device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical bone fixation screw, not a software algorithm or AI tool. Therefore, a "standalone algorithm performance" study is not relevant. The "performance data" mentioned refers to mechanical testing.

7. Type of Ground Truth Used

Based on the document, the "ground truth" for the device's performance is established through:

Compliance with Material Standards: Meeting ASTM F-138 (stainless steel) or ASTM F-136 (titanium) for biocompatibility. These are established industry standards for medical-grade materials.
Mechanical Performance Bench Testing: The statement "Performance test results indicate that the device is safe and satisfies functional performance requirements" implies benchtop mechanical testing (e.g., strength, compression, fatigue) against established engineering specifications or comparison to the predicate device's known performance.
Substantial Equivalence to Predicate Device: The ultimate "truth" for 510(k) clearance is demonstrating that the modified device is as safe and effective as a legally marketed predicate device.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical medical device, not an AI model or software algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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SEP 1 6 2004

t Notification Special 5 BONE-LOK® MVP Cortical-Cancellous Compression Device (Helical Compression Anchor System, Cannulated, Version 2)

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:	BONE-LOK® MVP Cortical-CancellousCompression Device
B.	Catalog Number:	TMCD-35-1520S to TMCD-35-4050STMCD-45-3040S to TMCD-45-6070S
C.	Common Name:	Bone Fixation Screw
D.	Classification Name:	Smooth or Threaded Metallic Bone FixationFastener
E.	Product Code:	HWC
F.	Device Panel:	Orthopaedic
G.	Device Class:	Class II (per 21 CFR 888.3040)

IDENTIFICATION OF MODIFIED DEVICE

The BONE-LOK® MVP Cortical-Cancellous Compression Device is similar in basic design and intended use to the Triage Medical Helical Compression Anchor System, Cannulated, Version 2 cleared under 510(k) K013903. The device modification includes devices fabricated from Titanium 6Al-4V alloy, which meets the requirements of ASTM F-136.

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DEVICE DESCRIPTION

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

INTENDED USE

The BONE-LOK® MVP Cortical-Cancellous Compression Device is indicated for use in the general management of fractures and reconstructive surgery.

TECHNOLOGICAL CHARACTERISTICS

The BONE-LOK® MVP Cortical-Cancellous Compression Device is similar in basic design, construction and mechanical performance to the previously cleared Helical Compression Anchor System, Cannulated, Version 2. The device modification includes devices fabricated from titanium alloy in addition to devices fabricated from stainless steel alloy.

BIOCOMPATIBILITY AND PERFORMANCE DATA

The materials the BONE-LOK® MVP Cortical-Cancellous Compression Device are made from meet the requirements of ASTM F-138 (stainless steel) or ASTM F-136 (titanium). These materials are currently being utilized in a myriad of legally marketed orthopedic devices. Because the inertness and biocompatibility of these materials have already been established, additional testing is not required.

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 BONE-LOK® MVP Cortical-Cancellous Compression Device 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 U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three curved lines. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Ms. Gayle Hirota Manager, Quality Assurance and Regulatory Affairs Triage Medical, Inc. 13700 Alton Parkway Irvine, California 92618

Re: K042244

Trade/Device Name: BONE-LOK® MVP Cortical-Cancellous Compression Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 16, 2004 Received: August 19, 2004

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.

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Page 2 - Ms. Gayle Hirota

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 Office of Compliance at (301) 594-4659. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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SECTION 1.6 INDICATIONS FOR USE FORM

Indications for Use

510(k) Number (if known):

BONE-LOK® MVP Cortical-Cancellous Compression Device Name: Device

The BONE-LOK® MVP Cortical-Cancellous Compression Indications For Use: Device is indicated for use in the general management of fractures and reconstructive surgery.

Prescription Use X (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)

Miriam C. Provost

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

510(k) Number K042244

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.