The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including: Infection, Metal sensitivity or allergic reaction to foreign bodies, Any concomitant disease which may compromise the function of the implant, In those cases where avascular necrosis has rendered bone stock inadequate.

Device Description

The Kompressor bone screw implant is a two-piece fixation device intended for use in the reduction, stabilization, and internal fixation of small bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and compress bone segments. The implant is available in a variety of sizes to accommodate various fracture types and sites. Materials: Titanium; Ti-6A14V-ELI per ASTM F136. The system functions to draw bone fractures together, thereby facilitating fixation.

AI/ML Overview

The provided text is a 510(k) premarket notification for the KMI Kompressor Compression Screw System. This document focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, many of the requested details about acceptance criteria, study design, sample size, expert involvement, and ground truth are not available in the provided text.

Here's an attempt to answer the questions based on the available information, with clear indications where the information is not present:

Acceptance Criteria and Device Performance Study for the KMI Kompressor Compression Screw System (K040356)

The provided submission does not contain a study report with specific acceptance criteria and reported device performance as would be found in a clinical trial or performance study for a novel device. Instead, this 510(k) relies on demonstrating "substantial equivalence" to a legally marketed predicate device (KMI Kompressor compression screw, K024233).

The "acceptance criteria" in this context are implicitly the requirements for substantial equivalence, meaning the modified device should not raise new questions of safety or effectiveness and performs similarly to the predicate. The "reported device performance" is essentially that its mechanical features and intended use align with the predicate, with changes limited to size ranges and broadened indications.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as described in the 510(k))
Mechanical Features: Maintain equivalent mechanical features to the predicate device.	The modified Kompressor compression screw system employs the "same mechanical features as the predicate, legally marketed device in that the essential configuration consists of a leading and a trailing thread, the varying ratios between non-tapping and tapping may and bone segments."
Materials: Use equivalent or compatible materials to the predicate device.	Materials: Titanium; Ti-6A14V-ELI per ASTM F136 (This is the same material as commonly used for bone implants, implying equivalence to suitable predicate materials, though explicit comparison to the predicate's material is not detailed in the provided text, it's assumed to be equivalent).
Intended Use: Device is safe and effective for its intended use, which may be broadened from the predicate but without raising new safety/effectiveness concerns.	The intended use for reduction, stabilization, and internal fixation of small bone fractures is maintained. Indications for use have been broadened to include applications other than small bones of the hand and wrist, with no significant differences predicted to adversely affect use.
Safety and Effectiveness: No significant differences that would adversely affect the use of the product.	"There are no significant differences between the modified Kompression Screw There are no sigmineant arreters systems currently being marketed which would adversely and the product." Changes were limited to a new range of sizes and broadened indications, implying no adverse effect on safety or effectiveness.

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

Sample Size for Test Set: Not applicable / Not provided. This submission does not detail a test set from a performance study. It relies on a comparison to a predicate device.
Data Provenance: Not applicable / Not provided.

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. The submission focuses on comparing the new device's design to an existing, cleared device, not on evaluating its performance against a ground truth established by experts.

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. This is a submission for a mechanical implant, not an AI-assisted diagnostic device.

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

Not applicable / Not provided. This is a submission for a mechanical implant.

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

Not applicable. The "ground truth" for this 510(k) is effectively the regulatory clearance of the predicate device and the accepted scientific and engineering principles for medical implants. No new "ground truth" derived from clinical data or expert consensus for this specific device would typically be required for a substantial equivalence determination under 510(k), especially given the minor modifications.

8. The sample size for the training set

Not applicable / Not provided. This is a submission for a mechanical implant, not a machine learning algorithm.

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

Not applicable / Not provided.

Summary

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MAR - 1 2004

Modified KMI Kompressor Compression Screw System

For

1. Submitter:
  Kinetikos Medical, Inc. Suite 180 6005 Hidden Valley Rd. Carlsbad, CA 92009

Contact Person:

K040356
page 1 of 1

John G. Spampinato V.P., Quality Assurance Kinetikos Medical, Inc. Suite 180 6005 Hidden Valley Road Carlsbad, CA 92009 FAX (760) 448 1739 (760) 448 1706

Date Prepared: Feb 10, 2004

2. Trade Name:	Kompressor Compression Screw System
Common Name:	Compression Screw
Classification Name:	Orthopedic

3. Predicate or legally marketed devices which are substantially equivalent

-KMI Kompressor compression screw (K024233)

Description of Device 4.

Description of Device
The Kompressor bone screw implant is a two-picce fixation device intended for use in the reduction, stabilization, and internal fixation of small bone fractures. The 2-picce design icaucilon, stabilization, and trailing screw component. The implant utilizes a mouporates the use of a reading and trailing portions of the screw to reduce and variance in thread phen between and le in a variety of sizes to accommodate various fracture types and sites.

Materials: Titanium; Ti-6A14V-ELI per ASTM F136 Materials: The system functions to draw bone fractures together, thereby facilitating fixation.

5. Intended Use

The use of the Kompressor compression screw is generally indicated for the reduction and The use of the Rompressor vempression is is indicated for use in the internal fixation of fractures appropriate for the Silso indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including:

Infection ◆
Metal sensitivity or allergic reaction to forcign bodies .
Mour concomitant disease which may compromise the function of the implant .
In those cases where avascular necrosis has rendered bone stock inadequate .

Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:

There are no significant differences between the modified Kompression Screw There are no sigmineant arreters systems currently being marketed which would adversely and the product. The modified Kompressor compression screw system employs affect the use of the produce. The predicate, legally marketed device in that the essential the same mechanical leatures as the preasurios tegared and a trailing thread, the varying ratios contiguration consists of a leading, son tapping may and bone segments. Changes were limited to: a new range of sizes and the indications for use have been broadened to include applications other than small bones of the hand and wrist.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Mr. John Spampinato Vice President, Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road, Suite 180 Carlsbad, California 92009

Re: K040356

Trade/Device Name: Kompressor Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 10, 2004 Received: February 17, 2004

Dear Mr. Spampinato:

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 - Mr. John Spampinato

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,

iriam 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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Special 510(k) Notification - - Kompressor Compression Screw System

K040356

Device Name: Kompressor Compression Screw System

Indications for Use:

Infection .
Metal sensitivity or allergic reaction to foreign bodies J
Any concomitant disease which may compromise the function of the ● imolant
In those cases where avascular necrosis has rendered bone stock . inadequate

(PLEASE DO NOT WRITE BELOW THIS LINE - CONITINUE ON ANOTHER P. GE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
	Miriam C. Provost
	(Division Sign-Off)
	Division of General, Restorative,
Over-the-Counter Use	__________

and Neurological Devices

510(k) Number K040356

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.