The Torque Device is an accessory device used to apply torsional and/or axial force to the guidewire to manipulate its distal end in the vasculature. It is designed to accommodate guidewires with diameters from 0.010 to 0.018 inches and is composed of three main components: 1.) a tubular collet contained within the body and cap assembly; 2.) a cap and 3.) a tubular body.

A guidewire is inserted through the Torque Device from the distal (cap) end. The Torque Device is positioned optimally on the guidewire at the desired location, and then secured by rotation of the cap. Once tightened, the torque device is used to apply torsional and axial force to the guidewire to manipulate its distal end in the vasculature.

AI/ML Overview

The provided text in K123624 is a 510(k) summary and an FDA clearance letter for a medical device called "Torque Device." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that fits the rigorous criteria outlined in the request. Therefore, most of the requested information regarding acceptance criteria, specific study design, and performance metrics will not be available in this type of submission.

Here's a breakdown based on the provided text, highlighting the absence of certain information:

Acceptance Criteria and Reported Device Performance

The submission states that "Design verification was performed to verify the performance and usability of the Torque Device remains substantially equivalent to the predicate device." It then lists the following tests:

Acceptance Criteria (Implied)	Reported Device Performance
Torque Slip Force	Verified to be substantially equivalent to predicate device
Pull Slip Force	Verified to be substantially equivalent to predicate device
Guidewire Deformation	Verified to be substantially equivalent to predicate device
Collet Release	Verified to be substantially equivalent to predicate device
Biocompatibility Testing: Latex	Verified to be substantially equivalent to predicate device

Note: The document does not provide specific quantitative acceptance criteria (e.g., "Torque Slip Force must be > X N-cm") or explicit numerical results for the device performance. The performance is broadly stated as "substantially equivalent" to the predicate.

Study Information Missing from the Provided Text:

The provided 510(k) summary explicitly states: "Clinical Evaluation was not required for this device." This means that the following information, which is typically associated with clinical or efficacy studies, is not present in this submission:

Sample size used for the test set and the data provenance: Not applicable as a clinical test set was not used. The design verification likely used physical samples of the device and guidewires.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth was established.
Adjudication method for the test set: Not applicable.
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. This is a non-AI medical device; MRMC studies are for evaluating AI's impact on human performance in diagnostic tasks.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the design verification tests (Torque Slip Force, Pull Slip Force, etc.), the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, against which the new device was compared.
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable.

Summary of the Study (Design Verification):

The "study" described is a non-clinical design verification aimed at demonstrating substantial equivalence. It involved:

Testing areas: Torque Slip Force, Pull Slip Force, Guidewire Deformation, Collet Release, and Biocompatibility.
Methodology: The tests were performed to ensure that the Torque Device's performance and usability are "substantially equivalent" to two predicate devices: SCIMED® Sideliner™ Torque Device (K922706) and Encore 26 Advantage Kit (K120694).
Ground Truth (implicit): The performance characteristics of the predicate devices.
Conclusion: The results of these non-clinical tests, along with material and manufacturing process comparisons, supported the claim of substantial equivalence.

In essence, this 510(k) describes engineering and materials testing, not a clinical study involving human subjects or AI performance metrics.

Summary

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K123624 Page 1 of 1

510(k) Summary per 21 CFR §807.92

	510(k) Summaryper 21 CFR §807.92	OCT 26 2012
Sponsor:	Boston Scientific CorporationOne Boston Scientific PlaceNatick MA 01760
Contact Person:	Rachel Owens
Phone Number:	763-494-1491
Fax Number:	763-494-2222
Prepared:	27 September 2012
Trade Name:	Torque Device
Common Name:	wire, guide, catheter
Classification:	II
Product Code:	DQX21 CFR 870.1330
Predicate Device:	SCIMED® Sideliner™ Torque Device (K922706; 10 December 1992)Encore 26 Advantage Kit (K120694, 03 April 2012).

Device Description:

Intended Use

The Torque Device is used for guidewire manipulation during general intravascular procedures.

Substantial Equivalence

The Torque Device design, materials, manufacturing process and intended use are substantially equivalent to the Sideliner Torque Device (K922706) and Encore 26 Advantage Kit (K120694).

Summary of Non-Clinical Testing

Design verification was performed to verify the performance and usability of the Torque Device remains substantially equivalent to the predicate device. Biocompatibility and sterility testing were also performed to verify the overall substantial equivalence to the predicates.

Specifically the following design verification testing was performed:

� Torque Slip Force
� Pull Slip Force
Guidewire Deformation �
� Collet Release
◆ . Biocompatibility Testing: Latex

Summary of Clinical Testing

Clinical Evaluation was not required for this device.

Boston Scientific Corporation Premarket Notification - Special 510(k)

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue White Oak Building 66 Silver Spring, MD 20993

OCT 2 6 2012

Boston Scientific Corporation c/o Rachel Owens Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K123024

Trade Name: Torque Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: September 27, 2012 Received: September 28, 2012

Dear Ms. Owens:

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 adviseration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Rachel Owens

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devises Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): -

Device Name: Torque Device

Indications For Use:

The Torque Device is used for guidewire manipulation during general intravascular procedures.

Over-The-Counter Use _ Prescription Use _ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Dhicion Sigh-Off)

Brocardiovascular Devk

Page 1 of 1

f Cardiovascular Device:
510(k) Number 4123024

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.