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TransForm™ McCarthy Mitral Annuloplasty Ring (TF) is indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.

The TransForm™ McCarthy Mitral Annuloplasty Ring is an implantable, semi-rigid annuloplasty ring for mitral valve repair with the stiffened portions at the anterior and posterior segments. The ring is flexible at the commissure regions to allow physiological movement of the annulus. Stiffener placement allows the ring to maintain its "D" saddle shape during systole and a flat planar "O" shape in diastole. The stiffeners consist of MP35N 0.71 mm diameter (polished and formed) alloy. An elastic silicone core and braided polyester fabric form the ring body. The TransForm™ Annuloplasty Ring has four green radial markers: two markers at the left and right trigones and two markers at the mid-anterior and mid-posterior. The ring conforms to the natural mitral annulus throughout the cardiac cycle. The interrupted stiffeners within the silicone core provide semi-rigid elastic flexibility. Elasticity of the "D" to "O" or circular transformation, accommodates remodeling of the annulus, while creating inward forces to maintain circular annular geometry against physical expansion. The size range of TransForm™ is from 24mm to 40mm with 2mm increments. Size refers to the internal CC diameter of the ring. Rings are intended to be implanted on the patient's mitral annulus to reduce and stabilize the annulus.

This FDA 510(k) clearance letter details the review of a new medical device, the TransForm™ McCarthy Mitral Annuloplasty Ring, for substantial equivalence to a predicate device. However, the provided document does not contain information about the acceptance criteria and the study proving the device meets those criteria from an AI/algorithm performance perspective.

The entire document focuses on the mechanical and biocompatibility testing of an implantable medical device (an annuloplasty ring) to demonstrate its safety and effectiveness relative to a previously cleared predicate device. This is a common requirement for Class II medical devices such as this.

There is no mention of any AI or software component in the device description or the testing summary. Therefore, it is impossible to extract the requested information regarding AI acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment.

In summary, based solely on the provided text, the device in question is a physical annuloplasty ring, not a software or AI-driven diagnostic/therapeutic device.

Therefore, I cannot fulfill the request for information related to AI acceptance criteria and performance studies because the provided document does not pertain to an AI/software medical device.

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TransForm McCarthy Mitral Annuloplasty Ring is indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The ring provides support for and restricts expansion of the mitral annulus.

The TransForm™ McCarthy Mitral Annuloplasty Ring is an implantable, semi-rigid annuloplasty ring for mitral valve repair with the stiffened portions at the anterior and posterior segments. The ring is flexible at the commissure regions to allow physiological movement of the annulus. Stiffener placement allows the ring to maintain its "D" saddle shape during systole and a flastole. The stiffeners consist of MP35N 0.71 mm diameter (polished and formed) alloy. An elastic silicone core and braided polyester fabric form the ring body. The TransForm Annuloplasty Ring has four green radial markers at the left and right trigones and two markers at the mid-anterior and mid-posterior. The natural mitral annulus throughout the cardiac cycle. The interrupted stiffeners within the silcone core provide semi-rigid elastic flexibility. Elasticity of the "D" to "O" or circular transformation, accommodates remodeling of the annulus, while creating inward forces to maintain circular annular qeometry aqainst physical expansion. The size range of TransForm is from 24mm with 2mm increments. Size refers to the internal CC diameter of the ring. Rings are intended to be implanted on the patient's mitral annulus to reduce and stabilize the annulus.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, specifically regarding an AI/ML device. The document is an FDA 510(k) clearance letter for a medical device called the "TransForm McCarthy Mitral Annuloplasty Ring."

This document focuses on the substantial equivalence of this annuloplasty ring to existing predicate devices, outlining its design, materials, and non-clinical tests (e.g., tensile strength, sterilization, biocompatibility). It does not discuss AI/ML acceptance criteria, AI/ML device performance, ground truth establishment for AI/ML, sample sizes for AI/ML test/training sets, or MRMC studies.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and studies based on the provided text.

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WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.

The WellsForm™ Tricuspid Annuloplasty Band is an implantable ring intended for surgical repair of the tricuspid heart valve. WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.

The WellsForm™ Tricuspid Annuloplasty Band consists of a braided textile polyester body with a semi-rigid (stiflened) portion at the septal and aortic segments. The flexible section runs from the aortic segment, about half of the posteroseptal commissure to help remodel and stabilize the enlarged portion of the tricuspid annulus found in patients with functional tricuspid requrgitation.

The size range of the WellsForm Tricuspid Annuloplasty Band is from 26mm in 2mm increments (sizes: 26, 28, 30, 34, and 36).

I'm sorry, but the provided text describes a medical device submission (510(k)) for a Tricuspid Annuloplasty Band. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing (e.g., computational structural analysis, tensile strength, sterilization validation, biocompatibility tests like cytotoxicity, pyrogenicity).

The document does not contain information about:

• Acceptance criteria in the context of an AI/ML algorithm's performance.
• Clinical study design involving a test set, training set, or ground truth establishment by experts.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Stand-alone algorithm performance.
• Any form of artificial intelligence (AI) or machine learning (ML).

Therefore, I cannot extract the information required to answer your questions about acceptance criteria for an AI/ML device and the study proving it meets those criteria. The provided text is relevant to traditional medical device clearance, not AI/ML performance evaluation.

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