Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation. The device is used temporary and is removed after the treatment has been completed. The device is for single use only.

Device Description

The MIS crest widener is used to widen a narrow alveolar crest which has sufficient height so as to prepare the ridge for implantation. With this technique. bone augmentation is avoided and the implant is placed in the correct lateral position. The Crest widener is made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The device consists of 4 arms, 2 on each side, connected with guiding pins and an activating screw. The Crest Widener is inserted after cutting 3 mucoperiosteal incisions (without stripping the bone) cutting and splitting the narrow alveolar crest. By rotating the activating screw, each pair of arms moves apart from the other 2 arms, thus pushing the buccal cortical bone apart. The device is supplied with a fine Titanium ligature for attachment to a neighbor tooth during the treatment period. Activating starts 5 - 7 days (latency period) after the insertion of the device. By separating the cortical plates, new bone is created in between (Distraction Osteogenesis). The device is not provided sterile and should be sterilized before use.

AI/ML Overview

Here's an analysis of the provided text regarding the MIS Crest Widener, addressing your requested information:

Summary of Acceptance Criteria and Device Performance (based on the provided document):

The provided 510(k) summary for the MIS Crest Widener does not contain specific quantitative acceptance criteria or a dedicated study demonstrating the device meets such criteria in terms of clinical performance metrics (e.g., success rates, bone growth measurement).

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. The "performance" being evaluated and asserted is primarily in terms of:

Intended Use: The device shares the same intended use as its predicate devices: "Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation."
Technological Characteristics: The device is made of similar materials (Titanium alloy complying with ASTM F136-02), has a similar mechanism of action (distraction osteogenesis via screw activation), and a similar duration of placement.

Therefore, the "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device performs as safely and effectively as legally marketed predicate devices without raising new questions of safety or effectiveness.

Key Missing Information:

It's crucial to note that the provided 510(k) summary does not include any clinical study data or performance metrics that would typically be found in a study proving a device meets specific acceptance criteria. This type of submission relies on the established safety and effectiveness of the predicate devices.

Given this, I cannot fill in precise quantitative values for acceptance criteria or device performance as they are not present in the document.

Detailed Breakdown of Your Requested Information:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category / Performance Metric	Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as stated in the document)
Intended Use	Must be the same as predicate devices.	"Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation." - Identical to predicates.
Technological Characteristics	Similar materials, mechanism of action, and duration of use to predicate devices, without raising new safety/effectiveness concerns.	Made of medical grade 5 Titanium alloy (ASTM F136-02). Consists of 4 arms, guiding pins, and an activating screw. Works via distraction osteogenesis. Temporary use.
Safety and Effectiveness	Must be as safe and effective as predicate devices.	"The MIS Crest Widener show equivalent performance capabilities comparing to its predicate devices." "The evaluation... does not raise any additional concerns regarding safety and effectiveness."

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

Sample Size: Not applicable. The document does not describe a clinical study with a "test set" of patients or data to evaluate the device's performance. The 510(k) pathway for this device relies on substantial equivalence to predicate devices, not on de novo clinical performance data.
Data Provenance: Not applicable, as no dedicated test set data is presented.

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

Not applicable. As there is no clinical test set described, there is no mention of experts establishing ground truth for such a set. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate devices, as deemed by prior FDA clearances.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set or data analysis requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a manual surgical instrument and does not involve any algorithms or standalone software performance.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the documented performance, safety profile, and regulatory history of the legally marketed predicate devices. The new device asserts equivalence to these established devices. This is not "expert consensus," "pathology," or "outcomes data" specifically generated for the MIS Crest Widener, but rather the established understanding of the predicates.

8. The Sample Size for the Training Set

Not applicable. This device is a manual surgical instrument and does not involve machine learning algorithms that require a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

Summary

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DEC 1 7 2008

510(k) Summary:

MIS Crest Widener

Company Name -

MIS - Implants Technologies Ltd. POB 110 Shlomi Industrial Zone Shlomi 22832 ISRAEL Telephone: +972-4-980-9966 Fax: +972-4-980-9944

Establishment Registration Number: 3004203816

Contact Name: Iman Khorshid Quality Manager Telephone: +972-4-980-9966 Fax: +972-4-980-9944 E-mail: iman@mis-implants.com

US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 278 Broadway Elmwood Park, NJ 07407 Phone: (201) 797-9144 Fax: (201) 797-9145 E-mail: motti(@misimplants.com

Date prepared: February 10, 2008

Trade Name: MIS Crest Widener

Classification name: External mandibular fixator and/or distractor

Common/usual name: MIS Crest Widener

Product Code: MQN

Regulation No.: 872.4760

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Mis

Class: II

Panel identification: Dental Devices Panel

Predicate Device:

1. Alveolar Ridge Distractor from SYNTHES (USA). P.O.Box 1766, 1690 russell road , paoli, PA 19301 1222 cleared under 510(k) no. K043555.
1. TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY CALLUS DISTRACTION from KLS-Martin, L.P. 3234 ella ln., new port richey, FL 34655, cleared under 510(k) no. K002152
ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) from ORAL 3. OSTEODISTRACTION L.P., 962 allegro ln. apollo beach, FL 33572, cleared under 510(k) no. K042278.

Description of the device:

The Crest widener is made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02.

The device consists of 4 arms, 2 on each side, connected with guiding pins and an activating screw. The Crest Widener is inserted after cutting 3 mucoperiosteal incisions (without stripping the bone) cutting and splitting the narrow alveolar crest. By rotating the activating screw, each pair of arms moves apart from the other 2 arms, thus pushing the buccal cortical bone apart. The device is supplied with a fine Titanium ligature for attachment to a neighbor tooth during the treatment period.

Activating starts 5 - 7 days (latency period) after the insertion of the device. By separating the cortical plates, new bone is created in between (Distraction Osteogenesis) ..

The device is not provided sterile and should be sterilized before use.

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Indications for Use:

The MIS Crest Widener is intended to:

Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation.

The device is used temporary and is removed after the treatment has been completed.

Substantial Equivalence:

The MIS Crest Widener has the same intended use as its predicate devices:

1. Alveolar Ridge Distractor from SYNTHES (USA). P.O.Box 1766, 1690 russell road , paoli, PA 19301 1222 cleared under 510(k) no. K043555.
1. TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY CALLUS DISTRACTION from KLS-Martin, L.P. 3234 ella ln., new port richey, FL 34655, cleared under 510(k) no. K002152
1. ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) from ORAL OSTEODISTRACTION L.P., 962 allegro ln. apollo beach, FL 33572, cleared under 510(k) no. K042278.

The MIS Crest Widener show equivalent performance capabilities comparing to its predicate devices. The predicate devices are made either of Titanium or stainless steel and used to distract the mandible and / or the maxilla. The devices have the same distraction concept. The use of a screwdriver for activation is similar for all the devices. The devices remain in the body similar period of time until they are removed.

The MIS Crest Widener is therefore substantially equivalent to the predicate devices.

Conclusion -

The evaluation of the MIS Crest Widener does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEC 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Iman Khorshid Regulatory Affairs and Quality Assurance Manager MIS - Implants Technologies Limited P. O. Box 110, Shlomi Industrial Zone Shlomi ISRAEL 22832

Re: K080458

Trade/Device Name: MIS Crest Widener Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 7, 2008 Received: December 9, 2008

Dear Ms. Khorshid:

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.

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Page 2 - Ms. Khorshid

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 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) 276-0115. 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 the reporting 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sudite Y. Mrchiond

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K080458

INDICATIONS FOR USE

510(k) Number (if known):

K080458

Device Name:

MIS Crest Widener

Indications for Use:

The MIS Crest Widener is intended to:

. Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation.
The device is used temporary and is removed after the treatment has been completed. The device is for single use only.

Prescription Use X OR (Part 21 CFR 801 Subpart D)

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)

Susan Punser

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080452

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Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.