The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

Device Description

The Confidence High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (20 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.

AI/ML Overview

This document, a 510(k) summary for the "Confidence High Viscosity Bone Cement," describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) process is primarily a demonstration of "substantial equivalence" to a legally marketed predicate device, not typically a full clinical efficacy or performance study against predefined acceptance criteria in the way a PMA (Premarket Approval) might require.

Therefore, I cannot populate the requested table and answer many of your questions based solely on the provided text.

Here's a breakdown of why and what I can or cannot answer:

1. A table of acceptance criteria and the reported device performance

No information in the provided text. The document describes the device's composition, intended use, and states its substantial equivalence to predicate devices based on various characteristics, but it does not specify quantitative acceptance criteria (e.g., "tensile strength must be > X MPa") or report specific performance data against such criteria.

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

No information in the provided text. This document is a regulatory submission for substantial equivalence, not a detailed study report. It does not mention any test set, sample sizes, or data provenance from a specific study.

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/No information in the provided text. Ground truth is typically relevant for studies evaluating diagnostic accuracy, machine learning algorithms, or clinical outcomes. This document does not describe such a study.

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

Not applicable/No information in the provided text. Same as above.

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/No information in the provided text. This device is a bone cement, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to its regulatory submission as described here.

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

Not applicable/No information in the provided text. This device is a physical product (bone cement), not an algorithm.

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

Not applicable/No information in the provided text. See points 3 and 4.

8. The sample size for the training set

Not applicable/No information in the provided text. This device is a physical product, not a machine learning model, so there is no "training set."

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

Not applicable/No information in the provided text. See point 8.

Summary of what the document does provide:

Device Name: Confidence High Viscosity Bone Cement
Applicant: Disc-O-Tech Medical Technologies Ltd.
Date Prepared: January 2006
Classification: Class II, PMMA Bone Cement (For Vertebroplasty), 21 CFR §888.3027
Predicate Devices:
- Kyphon Inc.'s KyphX® HV-RTM Bone Cement (K041584)
- Stryker Corp.'s Spineplex™ Radiopaque Bone Cement (K032945)
- Cook Inc.'s Vertefix™ Radiopaque Bone Cement (K042691)
Intended Use: For the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures, for painful vertebral compression fractures resulting from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
System Description: Radiopaque, self-curing, high viscosity PMMA bone cement, two-component system (powder + liquid), contains 30.07% barium sulfate.
Basis for Substantial Equivalence: Intended use, chemical composition, material properties, biocompatibility, principles of operation, technological characteristics, performance, and clinical application are substantially equivalent to predicate devices.

Conclusion:

The provided text serves as a 510(k) summary, demonstrating "substantial equivalence" of the new device to existing predicate devices. It focuses on comparing characteristics and intended use, rather than presenting a performance study against specific acceptance criteria. Therefore, the detailed information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth validation that you've requested is not present in this type of regulatory document.

Summary

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JUN 2 1 2006

510(K) Summary

Disc-O-Tech Medical Technologies Ltd. ¿ Confidence High Viscosity Bone Cement

Applicant Name

Disc-O-Tech Medical Technologies Ltd.

11 Ha'l-loshlim St..

Herzeliya 46724, Israel

Contact Person

Hila Wachsler-Avrahami

Disc-O-Tech Medical Technologies Ltd.

11 Ha'Hoshlim St., Herzeliya 46724, Israel

Tel: 972-9-9511511, Fax: 972-9-9548939

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

January 2006

Trade/Proprietary Name

Confidence High Viscosity Bone Cement

Common Name

PMMA Bone Cement

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K060300
Page 2 of 2

Disc-O-Tech Medical Technologies Ltd. Confidence High Viscosity Bone Cement 510(k)

Classification Name

Filler, Bone Cement (For Vertebroplasty)

Classification

Class II, per 21 CFR §888.3027

Predicate Devices

✔ Kyphon Inc.'s KyphX® HV-RTM Bone Cement (K041584)
V Stryker Corp.'s Spineplex "M Radiopaque Bone Cement (K032945)
✔ Cook Inc.'s Vertefix"M Radiopaque Bone Cement (K042691)

Intended Use

System Description

Substantial Equivalence

Based on the information provided in this premarket notification, the Confidence High Viscosity Bone Cement intended use. chemical composition, material properties, biocompatibility, principles of operation, technological characteristics, performance, and clinical application are substantially equivalent to those of the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.

JUN 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disc-O-Tech Medical Technologies, Inc. c/o Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K060300

Trade/Device Name: Confidence High Viscosity Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: PMMA Bone Cement Regulatory Class: II Product Code: NDN Dated: May 19, 2006 Received: May 19, 2006

Dear Mr. Kahan:

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

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Page 2 - Mr. Jonathan S. Kahan, Esq.

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hubert Humphrey

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: Confidence High Viscosity Bone Cement

Indication for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ く (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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 JODE)

Hulut Lener us

Division of General, Restorative, and Neurological Devices

510(k) Number K060300

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.”