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The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures.

The indications for use are the following: imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh, hip, imaging the temporomandibular joint, imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, and imaging the head.

The S-scan Open device is a Magnetic Resonance (MR) system that produces cross-section images of the internal structures of the body. Images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift. When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

S-scan Open represents the evolution of its predicate device, the Esaote S-scan, cleared under K161973 (initial clearance K063207). Compared to the predicate device, the following modifications have been introduced:

• Changes to the external design and shape, and an update of the electronics.
• Integration of the new software version MRI EVOlution 25, which provides compatibility with updated electronics, improvements in cybersecurity management, bug fixing and optimization, and includes the following features: management of new coils, 3D viewer, prone patient positioning management, SPED sequence, updated operating system, new graphical user interface, flow compensation feature extension, operator-selectable gradients direction, DWI (Diffusion Weighted Imaging) sequence, 2D SST1 sequence, and HyperClarity. Note: the subject device integrates the AI-based algorithm HyperClarity (SwiftMR, K230854) without any modification. The algorithm is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission of the subject device.
• Introduction of a patient alert system.
• Addition of new receiving Coils: XL flex L-Spine coil 10, Flex Coil 11, Knee Coil 21.

S-scan Open is substantially equivalent to the predicate device with respect to intended use, technical specifications, fundamental scientific technology and principle of operation.

The provided FDA 510(k) clearance letter for K260746, S-scan Open, does not contain detailed information about the acceptance criteria and a specific study proving the device meets those criteria, particularly for an AI-based algorithm. The letter explicitly states that the integrated AI-based algorithm, HyperClarity (SwiftMR, K230854), is out-of-scope for this particular submission and is classified under a different regulation in its own 510(k) (K230854).

Therefore, based solely on the provided text for K260746, I cannot provide the requested information regarding the acceptance criteria and study proving the device's performance related to the AI component.

However, I can extract information about the overall device's (S-scan Open) non-clinical testing and the lack of clinical studies for this submission:

Based on the provided K260746 submission, for the S-scan Open MRI system as a whole (excluding the detailed performance of the integrated AI component which is out-of-scope for this submission):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or tabulated performance metrics for the S-scan Open device (beyond compliance with standards). It mentions that "predefined acceptance criteria were successfully met" through verification and validation activities, but these criteria themselves are not detailed.

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

• Sample Size: Not specified. The document states that "Sample clinical images acquired using the proposed updated device and reviewed by a U.S. board-certified radiologist have been included to demonstrate acceptable diagnostic image quality." However, the number of images or cases is not quantified.
• Data Provenance: The document does not specify the country of origin of the data. It mentions "clinical images acquired using the proposed updated device," implying they are retrospective or prospective images generated for the purpose of this submission, but does not clarify further.

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

• Number of Experts: "a U.S. board-certified radiologist" (singular).
• Qualifications: U.S. board-certified radiologist. No mention of years of experience.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or specified for this submission, as only one radiologist was mentioned for review of sample images. There's no indication of a consensus or multiple-reader process.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document does not mention an MRMC study comparing human readers with and without AI assistance. The AI component (HyperClarity) is explicitly stated as "out-of-scope" for this submission, suggesting its comparative effectiveness would have been established in its own K230854 filing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Not addressed in this submission for the S-scan Open system itself. For the integrated AI algorithm (HyperClarity), such a study would likely have been part of its independent 510(k) (K230854), but details are not provided here.

7. Type of Ground Truth Used

• Ground Truth Type: For the "sample clinical images" reviewed, the ground truth appears to be based on the expert opinion/review of a U.S. board-certified radiologist assessing "acceptable diagnostic image quality" in accordance with FDA guidance. There is no mention of pathology or outcomes data for this specific review.

8. Sample Size for the Training Set

• Sample Size: Not applicable/not provided for the 510(k) submission of the S-scan Open system as a whole. This information would be relevant for the AI component (HyperClarity, K230854) if it were the subject of the submission. The S-scan Open is an MRI hardware and software system, not solely an AI algorithm.

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

• Ground Truth Establishment: Not applicable/not provided for the S-scan Open system as a whole. This information would be relevant for the AI component (HyperClarity, K230854) if it were the subject of the submission.

Crucially, to get the detailed acceptance criteria and study information for the AI component (HyperClarity/SwiftMR), you would need to consult the 510(k) submission K230854. The K260746 document only states the S-scan Open integrates this already-cleared AI algorithm without modification, thereby deferring its evaluation to its own separate clearance.

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The STRATAFIX™ Spiral PRONOVA™ Unidirectional Device is indicated for use in soft tissue approximation where the use of a non-absorbable barbed suture is appropriate, excluding closure of the epidermis.

The STRATAFIX™ Spiral PRONOVA™ Bidirectional Device is indicated for use in soft tissue approximation where the use of a non-absorbable barbed suture is appropriate, excluding closure of the epidermis.

The STRATAFIX™ Spiral PRONOVA™ Knotless Tissue Control Devices (KTCD) are monofilament, synthetic non-absorbable devices composed of a polymer blend of poly (vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene). The STRATAFIX™ Spiral PRONOVA™ KTCD are pigmented blue to enhance visibility in the surgical field. The STRATAFIX™ Spiral PRONOVA™ KTCD has two variations based on the orientation of the barbs and needle attachment: STRATAFIX™ Spiral PRONOVA™ Unidirectional KTCD and STRATAFIX™ Spiral PRONOVA™ Bidirectional KTCD.

The STRATAFIX™ Spiral PRONOVA™ Unidirectional KTCD consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PRONOVA™ Unidirectional Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PRONOVA™ Unidirectional Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

The STRATAFIX™ Spiral PRONOVA™ Bidirectional KTCD Design consists of barbed suture material, armed with a surgical needle on each end. The device also contains an unbarbed center transition zone that facilitates the initiation of the device use. The STRATAFIX™ Spiral PRONOVA™ Bidirectional Device barbs allow for tissue approximation without the need to tie surgical knots.

The subject devices are for single-use and are sterilized by Ethylene Oxide. The subject devices are available in various lengths and USP diameter sizes armed with various needle sizes. STRATAFIX™ Spiral PRONOVA™ KTCD is intended for use only by Healthcare Professionals who are trained in surgical suturing techniques.

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The FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:

• FLOWRUNNER Aspiration Catheter
• FLOWRUNNER Aspiration Sheath
• Vacuum Fitting
• High Flow Stopcock Connector
• Y-Connector with Hemostatic Valve
• Hand Actuator Clip

The FLOWRUNNER Aspiration System family is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. The extension of the device family includes smaller-diameter sizes of the FLOWRUNNER Aspiration System. The system is a single-use catheter-based device with the capability to infuse fluids.

FLOWRUNNER SP Aspiration System is over the wire system.

FLOWRUNNER Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The FLOWRUNNER Aspiration System is introduced to the site of the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

The FLOWRUNNER Aspiration System comes in 7F, SP 7F, 12F, and 14F compatible diameters and 60cm, 80cm, 100cm, 120 and 130cm lengths.

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The LASER THERMAL THERAPY KIT is used to direct laser energy to soft tissue, to vaporize, ablate, necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.

The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The energy is transmitted via the fiber optic, which is introduced into the skin and tissue site percutaneously using the introducer needle. The LASER THERMAL THERAPY KIT is composed of a Fiber Optic for PLA (272 m core quartz-quartz fiber with distal end outer diameter 420 m and NA 0.2, and 2 m length) and an introducer needle (21G). The device is sterile and single use. Fiber optic and Introducer are packed individually.

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The EnCore Impression Material is intended for dental impression techniques to reproduce the structure of a patient's dentition to fabricate patient matched night guards and mouthguards.

The EnCore Impression Material is an addition-cure impression material composed of vinyl polysiloxane impression and bite registration materials intended to allow dentists to take accurate impressions.

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The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures.

The indications for use are the following:

Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration) and upper abdomen (included only for "Open" configuration under option).

Magnifico device is a Magnetic Resonance (MR) system that produces cross-section images of the internal structures of the body. Images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift.

When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The updated Magnifico is the evolution of its predicate device, the Magnifico device cleared via K241133. Compared to the predicate device, the following modifications have been introduced:

• A new software version (MRI EVOlution 25), including:
  • The optional functionality "HyperClarity", an AI-based algorithm for MRI image enhancement (K230854), integrated without any modification. The algorithm is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission of the subject device.
  • Abdominal Imaging package for abdomen examination, which delivers:
    • Patient's breathing management (including respiratory movement reduction techniques)
    • ROTAR sequences
    • 3D FSE sequences
• Introduction of a patient breathing detection device (Respiratory Gating System)
• Introduction of a support for spontaneous movements of the knee (flexion/extension)
• A modification of the maximum gradient intensity
• New receiving Coils: DPA Shoulder Coil, Flex Coil, 4 ch. Foot/Ankle coil

Magnifico is substantially equivalent to the predicate device with respect to the fundamental scientific technology, technological characteristics and the principle of operation. The core components remain unchanged and are identical to those of the cleared Magnifico device.

The provided FDA 510(k) clearance letter and summary for the Magnifico Open MRI System (K251901) describes an updated version of a previously cleared device. While it mentions the integration of an AI-based algorithm called "HyperClarity" for MRI image enhancement, the document explicitly states that this algorithm is "out-of-scope from the current submission of the subject device" as it was cleared under a separate 510(k) (K230854).

Therefore, the acceptance criteria and study details for the Magnifico Open MRI System itself primarily focus on demonstrating substantial equivalence to its predicate device (K241133) and the safety and effectiveness of its new features (abdominal imaging, breathing management, gradient intensity modification, new coils, etc.). The document indicates a "validation based on radiologists' expert opinions" for HyperClarity, but the specifics of that study are not included in this submission.

Based on the provided document, here's a breakdown of the requested information for the Magnifico Open MRI System (K251901) as a whole, with the caveat that the detailed study for HyperClarity is referenced but not fully described here:

Acceptance Criteria and Device Performance (Magnifico Open MRI System K251901)

The document does not explicitly present a table of quantitative acceptance criteria for the entire Magnifico Open MRI system in the same way one might find for a standalone algorithm. Instead, the acceptance is implied by meeting safety and performance standards and demonstrating diagnostic image quality.

Study Information (for Magnifico Open MRI System K251901)

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

   • Test Set Sample Size: Not explicitly stated as a numerical count of patients or images. The document mentions "Sample clinical images" and "A comparative evaluation."
   • Data Provenance: Not explicitly stated in terms of country of origin. The document refers to "clinical images acquired using the proposed updated device." It does not specify if the studies were retrospective or prospective, though the nature of acquiring "sample clinical images" suggests either freshly acquired images or a selection from an existing dataset.

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

   • Number of Experts: "a U.S. board-certified radiologist" (singular, for image quality review).
   • Qualifications of Experts: "U.S. board-certified radiologist." Specific years of experience are not mentioned.
   • For the HyperClarity feature, it mentions "radiologists' expert opinions" (plural), but further details are not provided within this document.

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

   • Not specified. For the general image quality review, a single radiologist is mentioned, suggesting "none" in the sense of consensus or arbitration.

4. 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:

   • MRMC Study: Not explicitly mentioned for the Magnifico Open MRI System itself. The document refers to "A comparative evaluation of conventional images and images acquired using the Respiratory Gating System" to demonstrate clinical benefit, which likely involved comparison but not necessarily a formal MRMC study with AI assistance.
   • For the HyperClarity AI feature, the document mentions "validation based on radiologists' expert opinions," which could imply a comparative aspect (with and without the enhancement), but the details (including effect size or MRMC design) are not provided in this specific submission. Given HyperClarity is out-of-scope for this 510(k), that information would be in K230854.

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

   • The Magnifico Open MRI System is a hardware device (MRI scanner) with integrated software and features, not a standalone algorithm. Its performance is intrinsically tied to producing images for human interpretation.
   • For the HyperClarity AI feature, its performance as an image enhancement algorithm would be considered in a standalone context (algorithm output vs. original image), but the details are not part of this 510(k).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Expert Opinion/Clinical Review: For diagnostic image quality, the ground truth was established by the "U.S. board-certified radiologist's" review of the images.
   • For respiratory motion artifact reduction, the clinical benefit was demonstrated through "comparative evaluation," implying expert assessment of artifact presence.
   • For the HyperClarity feature, it refers to "radiologists' expert opinions."

7. The sample size for the training set:

   • The document describes the Magnifico Open MRI System (K251901), an MRI scanner, not a machine learning algorithm that undergoes a "training set" in the conventional sense. The "training set" concept would apply to the HyperClarity AI algorithm (K230854), but that information is not part of this submission.

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

   • This question is not applicable to the Magnifico Open MRI System itself, as it's a hardware device. For the HyperClarity AI algorithm, this information would be detailed in its own 510(k) submission (K230854).

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