The dS FootAnkle Coil 8ch 1.5T is intended to be used in conjunction with Philips Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

Device Description

The dS FootAnkle Coil 8ch 1.5T is a phased-array, receive-only coil with rigid volume consisting of 8 elements. This coil is a ski-boot-shaped coil designed for optimum coverage and highresolution visualization of the ankle and entire foot down to the toes. The coil design and element lavout allow for either large field of view (FOV) imaging of the whole foot or small FOV high resolution imaging of ankle joints. The coil is easy to set up and can be used with the patient's foot positioned vertically. These coils are used independently and cannot be combined with any other coils and are available for 1.5T Prodiva/ MR 5300 MR Systems.

AI/ML Overview

The provided text is a 510(k) summary for the dS FootAnkle Coil 8ch 1.5T. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/software device meets specific performance acceptance criteria through a clinical study.

Therefore, many of the specific details requested in your query (e.g., acceptance criteria for diagnostic algorithm performance, multi-reader multi-case studies, ground truth establishment methods for training sets of AI, sample sizes for AI test/training sets, adjudication methods) are not present in this document because the device in question is an MR coil, not an AI diagnostic software.

However, I can extract information related to the performance testing that was performed to support the substantial equivalence of the MR coil.

Here's what can be gathered from the provided text, with explanations where information is not applicable:

Acceptance Criteria and Device Performance for the dS FootAnkle Coil 8ch 1.5T

This document describes the regulatory submission for an MR coil, not an AI diagnostic software. As such, the "acceptance criteria" and "device performance" are related to the physical and imaging characteristics of the coil, not the diagnostic performance of an AI algorithm. The study described is a demonstration of equivalence and image quality for an MR coil.

1. Table of Acceptance Criteria and Reported Device Performance

The document references two FDA guidance documents for performance criteria:

"Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016" (General MR Device Guidance)
"Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020" (Specific Coil Performance Guidance)

While the specific numerical acceptance criteria from these guidances are not explicitly listed in the 510(k) summary, the document states that the device "met all criterion in the guidance" and that "No new safety or efficacy concerns are raised".

Acceptance Criteria Category (Implied by Standards/Guidance)	Reported Device Performance
Non-Clinical Performance
General electrical/mechanical safety (IEC 60601-1)	Met
EMC Immunity, electrostatic discharge (IEC 60601-1-2)	Met
Basic safety/essential performance of MR equipment (IEC 60601-2-33)	Met
Image uniformity and signal-to-noise ratio (NEMA-MS-1, 3, 9, 14)	Met
Determination of essential image quality parameters (IEC62464-1)	Met
Biological safety evaluation (ISO 10993-1)	Met
Cleaning and disinfection validations (ISO 17664)	Met
Clinical Performance (Image Quality for Interpretation)
Images sufficient quality for diagnostic use	Confirmed by experts

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

Sample Size: The document does not specify the exact number of cases or images used for the "Clinical Performance" assessment. It only states "Acquired Image quality was assessed..." The extent of this "assessment" (e.g., number of patients/scans reviewed) is not detailed.
Data Provenance: Not explicitly stated (e.g., specific country, retrospective/prospective). However, the experts used were "U.S. Board Certified radiologists," suggesting data consistent with US clinical practice.

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

Number of Experts: Two
Qualifications: "U.S. Board Certified radiologists." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

Not applicable/Not described. The assessment was to "confirm images produced on the subject coil are sufficient quality for diagnostic use," implying a qualitative assessment by the two radiologists, rather than a quantifiable "ground truth" establishment requiring adjudication for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was not an MRMC study comparing human readers with and without AI assistance. It was an assessment of image quality from an MR coil by two readers.

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

Not Applicable. This is an MR coil, not a standalone algorithm. The performance is inherently linked to the image acquisition process.

7. The Type of Ground Truth Used

For the "clinical performance," the "ground truth" was the qualitative assessment by two U.S. Board Certified radiologists that the "images produced on the subject coil are sufficient quality for diagnostic use." This is not a diagnostic "ground truth" for disease presence, but rather a performance "ground truth" for image utility.

8. The Sample Size for the Training Set

Not Applicable. This is an MR coil, not an AI device that undergoes training.

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

Not Applicable. As above, this is an MR coil, not an AI device.

Summary

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August 12, 2024

Philips Medical Systems Nederland B.V. Ketaki Bendre Regulatory Affairs Manager Veenpluis 6 Best. 5684 PC Netherlands

Re: K242096

Trade/Device Name: dS FootAnkle Coil 8ch 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: July 17, 2024 Received: July 18, 2024

Dear Ketaki Bendre:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

D. Ray Kennon

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K242096

Device Name

dS FootAnkle Coil 8ch 1.5T

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

( Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K242096

510(k) Summary

The 510(k) Summary was prepared in accordance with 21 CFR §807.92(c).

Preparation date:	July 9, 2024
510(k) Owner:	Philips Medical Systems Nederland B.V.
	Veenpluis 6
	5684 PC Best
	The Netherlands
	Establishment Registration # 3003768277
Contact person:	Ketaki Bendre (primary)
	Regulatory Affairs Manager
	Philips Medical Systems Nederland B.V.
	Phone: +91 9372065130
Trade Name:	dS FootAnkle Coil 8ch 1.5T
Classification Name:	Coil, Magnetic Resonance, Specialty
Regulation Number:	21 CFR 892.1000
Review Panel:	Radiology
Device Class:	Class II
Product Code:	MOS
Predicate Device Trade Name:	MODEL FAC-63 Foot and Ankle Coil (K050514)
Predicate Classification Name:	Coil, Magnetic Resonance
Predicate Regulation Number:	21 CFR 892.1000
Predicate Device Class:	Class II
Predicate Product Code:	MOS

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Device description

Indications for use

The dS FootAnkle Coil 8ch 1.5T is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

Fundamental Scientific Technology:

Based on the information provided above, the subject dS FootAnkle Coil 8ch 1.5T is considered substantially equivalent to the primary predicate device MODEL FAC-63 Foot and Ankle Coil (K050514) in terms of fundamental design, material and scientific technology. At a high level the dS FootAnkle Coil 8ch 1.5T and the predicate coil are based on the following equivalent elements:

. Similar Indications for use
Prescription Use Only .
Anatomy of interest is the foot and ankle. .
Same magnetic field strength (1.5T) ●
Rigid housing design that allows each imaging element to be independently . positioned and configured for each patient
Energy source from the MR scanner .

The following technological differences exist between the subject and predicate device:

The design of the housing is more simplified than the marketed primary predicate . device
The subject device is compatible with Philips Prodiva and MR 5300 MR systems. ● whereas the predicate is compatible with the Ingenia family of MR systems.
There is no 3.0T version of the subject Foot Ankle Coil .

Clinical and non-clinical testing demonstrates that the safety and effectiveness requirements as outlined in FDA guidance Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020 were met. No new safety or efficacy concerns are raised as a result of these differences.

Summary of Non- Clinical and Clinical Performance Data:

The subject dS Foot Ankle Coil 8ch 1.5T has undergone the following testing in accordance with FDA-recognized consensus standards and as recommended in FDA guidance documents Submission of Premarket Notifications for Maqnetic Resonance Diagnostic Devices, issued November 18, 2016 and Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020:

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Performance Testing - Non-Clinical:

IEC 60601-1 General electrical/mechanical safety
IEC 60601-1-2 EMC Immunity. electrostatic discharge testing -
IEC 60601-2-33 Particular requirements for the basic safety and essential performance of maqnetic resonance equipment for medical diagnosis
NEMA-MS-1, 3, 9, 14 Image uniformity and signal-to-noise ratio testing -
IEC62464-1 International Standard: Magnetic resonance equipment for medical imaging --Part 1: Determination of essential image quality parameters
-ISO 10993-1 Biological safety evaluation
ISO 17664 Cleaning and disinfection validations to support reprocessing instructions -

Performance Testing - Clinical:

Acquired Image quality was assessed by two U.S. Board Certified radiologists to confirm images produced on the subject coil are sufficient quality for diagnostic use.

Substantial Equivalence Conclusion:

Substantial equivalence of the dS FootAnkle Coil 8ch 1.5T is demonstrated through the Safety and Performance Based Pathway for magnetic resonance (MR) receive-only coils.

The subject device has the similar indications for use and technological characteristics as the predicate device. Substantially equivalent performance is demonstrated by meeting all criterion in the guidance "Magnetic Resonance (MR) Receive-only Coil -Performance Criteria for Safety and Performance Based Pathway" issued on December 11, 2020.

The summary includes the conclusions drawn from the nonclinical and clinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device according to 807.92(b)(3).

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.