The B-Twin Bone Expander System (B-Twin BE System) is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus.

Device Description

The B-Twin BE System consists of the following components:

Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
Delivery system used for the insertion, expansion, and retrieval of the expandable tube.
Instrumentation Set a set of accessories to assist in insertion and location of the device.

AI/ML Overview

This 510(k) premarket notification for the B-Twin Bone Expander System focuses on substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a De Novo submission or a more comprehensive PMA. Therefore, most of the requested information regarding specific acceptance criteria, performance tables, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from the provided text.

Here's what can be inferred or explicitly stated from the document:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria in a quantitative or qualitative manner, nor does it provide a table of reported device performance against such criteria. The submission is based on the claim of substantial equivalence to predicate devices. This means the device is deemed acceptable if it is as safe and effective as a legally marketed device and shares similar technological characteristics and intended use.

2. Sample size used for the test set and the data provenance:

Sample size for the test set: Not provided. The submission focuses on claims of substantial equivalence rather than a new clinical study with a test set.
Data provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of submission, as a "test set" and "ground truth" as typically defined in performance studies for diagnostic devices are not described. The basis for approval is substantial equivalence to existing devices.

4. Adjudication method for the test set:

Not applicable for the reasons mentioned 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. The B-Twin Bone Expander System is a physical medical device (bone tamp), not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is entirely irrelevant.

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

Not applicable. The B-Twin Bone Expander System is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not applicable. The approval is based on substantial equivalence to predicate devices, not on proving effectiveness against a specific ground truth in a clinical trial setting detailed in this document.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI models that require a training set.

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

Not applicable for the same reasons as above.

Summary of available information related to equivalence:

The submission focuses on demonstrating "substantial equivalence" of the B-Twin Bone Expander System to currently marketed predicate devices.

Predicate Devices:
- KyphX Inflatable Bone Tamp (K981251, K010246) by Kyphon Inc.
- Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967, K023437) by Disc-O-Tech Medical Technologies, Ltd.
Basis for Substantial Equivalence:
- Intended use
- Design
- Material
- Technological characteristics
- Principles of operation
Specific Equivalence Claims:
- "In general, the B-Twin BE System intended use, design, material, technological characteristics and principles of operation are substantially equivalent to those of Kyphon's KyphX Inflatable Bone Tamp (K981251, K010246)."
- "In addition, with respect to certain issues like sterilization, equivalence is claimed to the different Fixion Intramedullary Nailing Systems (e.g., the Fixion PF - K010988, K012967, K023437)."
- "Expandable Tube material equivalence is claimed to polymeric tubes for medical applications."

In essence, the "study" proving the device meets "acceptance criteria" in this context is the comparison against the predicate devices for substantial equivalence, as documented in the 510(k) submission itself. The FDA's decision letter (K032358) confirms that, based on the submitted information, the device was determined to be substantially equivalent.

Summary

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032356

DEC 1 7 2003

Disc-O-Tech Medical Technologies, Ltd. B-Twin BE System 510(k)

510(K) Summary

Disc-O-Tech Medical Technologies Ltd.

B-Twin Bone Expander System

Company Name

Disc-O-Tech Medical Technologies, Ltd.

3 Hasadnaot St., Herzliya

Israel, 46728

Submitter's Name and Contact Person

1. Yael Rubin
  Disc-O-Tech Medical Technologies, Ltd.

3 Hasadnaot St. Herzliya, Israel, 46728

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

1. Jonathan S. Kahan, Esq. 555 Thirteenth Street, NW, Washington, DC
  20004

Tel: 202-637-5794, Fax: 202-637-5910

Date Prepared

July 2003

Trade/Proprietary Name

B-Twin Bone Expander System (B-Twin BE System)

Classification

Class II

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Predicate Devices

V KyphX Inflatable Bone Tamp (K981251, K010246), by Kyphon Inc.
V Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967, K023437) by Disc-O-Tech Medical Technologies, Ltd.

Intended Use

The B-Twin BE System is intended for use as conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine , hand, tibia, radius and calcaneus.

System Description

The B-Twin BE System consists of the following components:

Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
Delivery system used for the insertion, expansion, and retrieval of the expandable tube.
Instrumentation Set a set of accessories to assist in insertion and location of the device.

Substantial Equivalence

In general, the B-Twin BE System intended use, design, material, technological characteristics and principles of operation are substantially equivalent to those of Kyphon's KyphX Inflatable Bone Tamp (K981251, K010246). In addition, with respect to certain issues like sterilization, equivalence is claimed to the different Fixion Intramedullary Nailing Systems (e.g., the Fixion PF - K010988, K012967, K023437). Expandable Tube material equivalence is claimed to polymeric tubes for medical applications.

Page 50 of 53

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three stripes extending from its wing.

DEC 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032358

Trade/Device Name: B-Twin Bone Expander System (B-Twin BE System) Regulation Number: 21 CFR 888.1100, 21 CFR 888.4540 Regulation Name: Arthroscope; Orthopedic manual surgical instrument Regulatory Class: II Product Code: HRX, HXG Dated: October 3, 2003 Received: October 3, 2003

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave review four be 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 10 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 complics 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. 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 (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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INDICATIONS FOR USE

510(k) Number (if known): K032358

Device Name:

B-Twin Bone Expander System (B-Twin BE System)

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (Part 21 CFR 801 Subpart D) AND/OR

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)

Miriam C. Provost

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

510(k) Number K032358

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.