(77 days)
The Physio Flex Annuloplasty Ring, model 5300, is indicated for the correction of mitral valve insufficiency, or mixed mitral insufficiency, where treatment does not necessitate replacement of the natural mitral valve.
The Physio Flex annuloplasty ring is a semi-rigid, open, mitral annuloplasty ring with an asymmetrical open anterior segment. The ring has an asymmetrical open anterior segment corresponding to the mitral annulus below the aorto-mitral curtain. The complete portion of the ring begins at the anterolateral commissure and extends beyond the posteromedial commissure and the posteromedial trigone into the anterior annulus. The ring design has a rectangular Nitinol core which enables different flexibilities in-plane and out-of-plane. The ring flexibility progressively increases in-plane from size 24 mm to 30 mm. It remains relatively constant from size 30 mm to 40 mm. For each ring size, the out-of-plane flexibility is greater than the in-plane flexibility. The ring also has a progressive saddle height with a complete posterior saddle and an open anterior saddle. The ratio of the saddle height to the A-P (antero-lateral to postero-medial) dimension progressively increases from size 24 mm to size 36 mm. It remains constant from size 36 mm to 40 mm. The Nitinol core is covered with a silicone sleeve and an external, knitted, polyester cloth. The sewing cuff is designed for ease of needle penetration and suture placement. A green circumferential suture line placed between the outer perimeter of the ring and the outer perimeter of the Nitinol core identifies the suture placement area. The ring has two commissure markers and a mid-posterior marker to facilitate orientation during implantation. The ring incorporates a holder with a proximal arm for connection to handle models 1150 and 1151. The holder arm is designed with a section made of stainless steel that can be bent to facilitate access and positioning of the ring on the valve annulus. The Physio Flex annuloplasty ring is available in sizes 24, 26, 28, 30, 32, 34, 36, 38 and 40 mm. The Physio Flex annuloplasty ring is designed to be used with sizer model 1252.
The provided text describes a 510(k) premarket notification for the "PHYSIO FLEX Annuloplasty Ring, model 5300". This document reports on the substantial equivalence of the new device to a predicate device, K083470 Carpentier-Edwards Physio II annuloplasty ring, model 5200.
The document discusses functional/safety testing performed to support substantial equivalence, but it does not provide specific acceptance criteria or an analytical study involving human readers or AI-assistance. The tests mentioned are device-specific and relate to its physical properties and biocompatibility.
Therefore, most of the requested information cannot be extracted from the provided text as it is focused on a medical device (annuloplasty ring) and its physical performance, not on a diagnostic algorithm or image analysis tool.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists "Ring parachuting, Holder removal, Fatigue Life Analysis, Magnetic Resonance, Corrosion Resistance, Biocompatibility" as performance testing areas. However, it does not provide specific numerical acceptance criteria or the reported device performance for these tests. It only states that these data "demonstrate the device is substantially equivalent to the predicate."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "representative samples of the devices underwent testing," but does not specify the sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable and not provided. The device is a physical annuloplasty ring, not a diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. As above, the testing described is for physical device performance, not for diagnostic accuracy requiring adjudication.
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
This is not applicable and not provided. The document describes a physical medical device (annuloplasty ring), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. The document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for this device would be its physical and biocompatible properties meeting engineering specifications, rather than a clinical diagnosis.
8. The sample size for the training set
This is not applicable and not provided. As this is a physical device and not an AI algorithm, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable and not provided.
In summary, the provided text primarily focuses on establishing substantial equivalence for a physical medical device. It does not contain the detailed information about acceptance criteria or specific study methodologies that would be relevant for a diagnostic or AI-powered medical device.
§ 870.3800 Annuloplasty ring.
(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”