The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

Device Description

The Mesh Introducer Needle is a combination of a Bone Access Assembly (Single Step Instrument) and a Mesh Assembly. The Bone Access Assembly comprises a cannula (acting as a working channel), a dilator-reamer, and a K-wire. The Mesh Assembly comprises a fabric-made mesh (pouch) through which the bone cement is introduced into the treatment site, mounted on a small diameter injection cannula, provided with a blunt edge stylet.

AI/ML Overview

The provided text is a 510(k) summary for the "Mesh Fenestrated Introducer Needle." This document is part of the FDA regulatory process for medical devices and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving performance against acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found within the provided text. The document describes the device's intended use and design, and states that its characteristics are substantially equivalent to predicate devices, but it does not include a performance study with acceptance criteria.

Here's a breakdown of why each requested point cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: This type of information is typically found in a detailed performance study report. The 510(k) summary provided here does not contain such a table or specific performance results.
Sample sizes used for the test set and the data provenance: No performance study details are provided, so no sample sizes or data provenance are mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This relates to a performance study with a test set, which is not included in this summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Again, this refers to a performance study that is not detailed in the provided text.
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: This type of study is specifically relevant to AI/diagnostic imaging devices. The device described (Mesh Introducer Needle) is a surgical instrument and not an AI-powered diagnostic device, so an MRMC study would not be applicable, and thus is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Similar to point 5, this is relevant to AI/algorithm-based devices, which this is not.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no performance study is detailed, no ground truth methodology is described.
The sample size for the training set: This is relevant for machine learning models, which are not part of this device.
How the ground truth for the training set was established: Again, this is relevant to machine learning models, which are not part of this device.

The 510(k) process for a device like the Mesh Introducer Needle primarily relies on demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) through comparisons of intended use, design, materials, and technological characteristics, as well as bench testing or sometimes limited clinical studies to ensure aspects like biocompatibility, sterility, and mechanical integrity. The provided text only covers the "substantial equivalence" argument, not a performance study against specific acceptance criteria.

Summary

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K071375

510(K) Summary

Disc-O-Tech Medical Technologies Ltd.

Confidence Bone Cement Delivery System - Mesh Introducer Needle

Submitter Name

Disc-O-Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel

Contact Person

1. Yael Rubin

Disc-O-Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel Tel: +972 9 9511511, Fax: +972 9 9548939

1. Jonathan S. Kahan, Esq.
  Hogan & Hartson L.L.P 555 Thirteenth Street, NW, Washington, DC 20004 Tel: (202) 637 5794, Fax: (202) 637 5910

Date Prepared

May 2007

Trade/Proprietary Name

Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)

Common Name

Needle

DEC 2 1 2007

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Classification Name

Orthopedic Manual Surgical Instrument

Predicate Devices

Confidence High Viscosity Bone Cements (K060300, K062424)
Confidence Fenestrated Introducer Needle (K063067)
V Super Revo® Herculine™ Suture Anchor, by Linvatec Corporation (K041713) (and Force Fiber™ Polyethylene Nonabsorbable Surgical Suture, by TeleFlex Medical (K033654)).

Intended Use

System Description

Substantial Equivalence

In general, the Mesh Introducer Needle intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Public Health Service

DEC 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disc-O-Tech Medical Technologies, Ltd. % Mr. Yael Rubin 11 Ha'Hoshlim Street Herzliya 46724, Israel

Re: K071375

Trade/Device Name: Mesh Fenestrated Introducer Needle (Mesh Introducer Needle) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: NDN, OAR Dated: September 20, 2007 Received: September 25, 2007

Dear Mr. Rubin:

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. Yael Rubin

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 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.

Mark M. Millman

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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Indication for Use

510(K) Number (if known):

Device Name: Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)

Indication for Use:

Prescription Use 2 (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brienin

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

510(k) Number_

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”