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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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Memo 3D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or stenoinsufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

The use of the MEMO 3D ReChord device is indicated for use in patients suffering from congenital or acquired mittal insufficiencies or steno-insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation' breakage of the chordae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

The use of the Memo 4D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-insufficient with dilatation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation' breakage of the chordae tendineae and payillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

Like their predicate devices, the subject MEMO 3D, MEMO 3D ReChord and MEMO 4D Semirigid Annuloplasty Rings are supplied as sterile, nonpyrogenic ring pre-mounted on disposable holders.

Both the predicate and subject devices are manufactured by embedding a superelastic metallic alloy inner core with medical grade silicone.

The resulting silicone sheath around the inner core is then encased within a tubular knitted fabric coated with a thin layer of turbostratic carbon (Carbofilm™). The fabric is then sewn along its length with a Carbofilm™ coated polyester thread.

Both the predicate and subject devices MEMO 3D ReChord and MEMO 4D Semirigid Annuloplasty Rings feature a fully removable system (i.e., the ReChord System) in the posterior curve of the annuloplasty ring, composed by a series of loops made by a single piece of yellow surgical thread retained in place by a single piece of blue surgical thread.

The ReChord System is designed to provide a temporary reference element to facilitate the sizing of the artificial chord length at the annular plane level when performing replacement of mitral chordae tendineae in concomitance with the implant of the annuloplasty ring.

The MEMO 3D and MEMO 3D ReChord Annuloplasty Rings are manufactured in 8 different sizes, from 24 to 38 mm, with 2 mm increments.

The MEMO 4D Annuloplasty Ring is manufactured in 10 different sizes, from 24 to 42 mm, with 2 mm increments.

A complete set of accessories is available separately to properly size the annulus and implant the MEMO 3D, MEMO 3D ReChord and MEMO 4D annuloplasty ring.

The provided document is a 510(k) summary for the Memo 3D Semirigid Annuloplasty Ring, Memo 3D ReChord Semirigid Annuloplasty Ring, and Memo 4D Semirigid Annuloplasty Ring. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the way a clinical study report would.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on showing that changes in raw materials and manufacturing (alternative suppliers for PET fabric and suture thread, and a different sewing path) do not alter the fundamental characteristics or performance compared to the predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable in the context of a 510(k) submission primarily relying on non-clinical testing for material and manufacturing changes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
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: Not applicable. This device is an annuloplasty ring, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Performance Data Provided (Section VII):

The submission relies on the following non-clinical performance data to demonstrate substantial equivalence:

• Biocompatibility testing
• Mechanical characterization of the PET fabric from the alternative supplier.
• Mechanical characterization of the PET suture thread from the alternative supplier and the alternative sewing path.
• Mechanical testing of the final device manufactured with the new suppliers' materials and sewing path.
• Quality control testing to evaluate the Carbofilm™ coating on the PET fabric and suture thread from the alternative suppliers.
• LAL test to evaluate endotoxin contamination on the new materials and final devices.

Clinical Performance Data (Section VIII):

The document explicitly states: "No clinical testing was conducted in support of the subject devices, as the indications for use are equivalent to those of their predicate devices (K071327, K142221, K180411). The non-clinical testing referred to in this submission supports the substantial equivalence of these devices."

Therefore, the approval is based on the substantial equivalence of the modified devices to already cleared predicate devices, supported by non-clinical testing to ensure that the changes in raw materials and manufacturing methods do not adversely affect the safety and effectiveness of the device.

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The TruForm™ Sievers Annuloplasty Ring is indicated for the correction of mittal valvular insufficiency where the lessions are not so severe as to require total valve replacement.

The TruForm™ Sievers Annuloplasty Ring, Model TRH is a semi-flexible implantable annuloplasty ring designed to reduce and stabilize the valve annulus in patients undergoing mitral repair. The inner core of the ring is made of a titanium alloy. Silicone covers the inner core and a sewing cuff made of braided polyester encompasses the ring. Three points of the ring are marked with polyester suture to aid in suture placement for implantation. The ring is available in ten (10) sizes: 24 mm; 26 mm; 28 mm; 30 mm; 32 mm; 34 mm; 36 mm; 38 mm; 40 mm; and 42 mm.

The provided text describes the regulatory clearance for a medical device called the TruForm™ Sievers Annuloplasty Ring, Model TRH. It is a 510(k) premarket notification, which means the device is being declared substantially equivalent to existing, legally marketed predicate devices.

However, the document does not describe a study involving an algorithm or AI, nor does it present acceptance criteria for an AI device. The TruForm™ Sievers Annuloplasty Ring is a physical medical implant used for cardiac surgery.

Therefore, I cannot extract the information requested about acceptance criteria and studies proving the device meets them in the context of an AI device. The document focuses on the equivalence of a physical annuloplasty ring to its predicates through non-clinical testing and shared characteristics.

If there was a misunderstanding and the request was for a physical device, the acceptance criteria are generally met by demonstrating substantial equivalence to a predicate device through:

• Same intended use and indications for use.
• Similar technological characteristics.
• Addressing any differences that could raise new questions of safety and effectiveness through testing.

The non-clinical tests performed for this physical device to support substantial equivalence include:

• Biocompatibility
• Sterilization
• Computational Finite Element Analysis (FEA)
• Tensile strength of ring materials
• Suture pull-out testing
• MRI Compatibility
• Packaging
• Shelf-life

These tests demonstrate that the device is equivalent to the predicate and/or reference devices, implying it meets the safety and performance requirements for its intended use.

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The SimuPlus flexible annuloplasty ring and band are in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimulPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) and restrict expansion of the annulus.

The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring provides support for the mitral annulus and restricts expansion of the annulus.

The SimuPlus flexible annuloplasty ring (Model 7700FR) and band (Model 7700FB) consist of a flexible braided polyester fabric with a 3 mm cross-section. The ring or band may be implanted in the mitral annulus to stabilize the annulus following valve repair. The band may be implanted in the tricuspid annulus to stabilize the annulus following valve repair. The ring and band are marked at three points by colored sutures. Two markers correspond to the trigones (mitral valve) or septal commissures (tricuspid valve), and a central marker identifies the centerline of the ring or band. The individual ring or band size (26 mm to 42 mm increments) refers to the circumference between the green trigone markers on the ring or band. Silicone markers, impregnated with barium sulfate and tungsten, enable radiographic visualization. The ring and band are mounted to a holder to ease positioning and implantation.

The SimuPlus annuloplasty ring and band holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the holder opening above the typical area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chord knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.

The SimuForm semi-rigid annuloplasty ring (Model 7800RR) consists of a MP35N wire stiffener in the posterior segment, running from trigone to trigone. The ring stiffener is enclosed within a close-coiled MP35N spring that passes around the circumference of the annuloplasty ring. The spring is covered by a thin silicone sheath. Braided polyester fabric is used to cover and form the body of the ring. The ring has two green markers to indicate the anterior and posterior trigones. A green demarcation suture runs around the upper face of the ring. The individual ring size (24 mm to 40 mm in 2 mm increments) refers to the inner circumference between the green trigone markers on the ring. The internal spring and stiffener provide radiographic visualization around the circumference of the ring.

The SimuForm annuloplasty ring holder incorporates a chordal reference line to assist the surgeon during chordal repair procedures. A laterally stretched suture is present across the ring holder opening above the approximate area of leaflet coaptation. This suture helps approximate the level of the annular plane. If the surgeon decides to include artificial chords in the valve repair, the chordal reference line may be useful when determining the level at which to tie the artificial chords knots. The chordal reference line does not require any additional steps to remove. It is removed with the holder after the retention sutures are cut.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification for annuloplasty rings and bands, arguing their substantial equivalence to previously marketed predicate devices.

The key points from the document are:

• Device: SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring.
• Purpose: To gain clearance for these devices by demonstrating they are "substantially equivalent" to predicate devices (Simulus Flexible Annuloplasty Ring and Band, Simulus Semi-Rigid Annuloplasty Ring).
• Changes:
  • SimuPlus (Flexible): Updates to product name, indications (minor phrasing changes), labeled size range (to align with industry sizing, no change to implant construction or dimensions), handle compatibility, and language for instructions for use (eIFU/paper IFU).
  • SimuForm (Semi-Rigid): Updates to product name, handle compatibility, and language for instructions for use (eIFU/paper IFU). No change to the implantable ring, its intended use, principles of operation, or size range.
• Conclusion: "The modifications to the Simulus devices do not impact the intended use or alter the fundamental scientific technology of the devices. There is no change to the implantable rings and bands. The SimuPlus and SimuForm rings and bands are therefore substantially equivalent to the currently marketed predicate devices."
• Performance Data: "Performance testing was not required to support labeling changes made to align with standard industry sizing." This explicitly states that performance testing was not done for this submission, as the changes were deemed not to affect fundamental performance.

Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document. This document focuses solely on demonstrating substantial equivalence based on the nature of the changes made and comparison to predicate devices, rather than presenting new performance data against specific acceptance criteria.

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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.

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The NeoForm™ Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not so severe as to require total valve replacement.

The NeoForm™ Annuloplasty Ring, Model 4200 is a rigid implantable annuloplasty ring designed to reduce and stabilize the valve annulus in patients undergoing mitral repair. The inner core of the ring is made of a titanium alloy. Silicone covers the inner core and a sewing cuff made of polyester fabric encompasses the ring. Three points of the ring are marked with polyester suture to aid in suture placement for implantation. The ring is available in four sizes: 26 mm; 28 mm; 30 mm; and 32 mm.

This document describes the 510(k) summary for the NeoForm™ Annuloplasty Ring, Model 4200. This is a medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance metrics against specific acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested points, such as specific acceptance criteria related to AI performance, sample sizes for test sets in an AI context, expert qualifications for ground truth in AI, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this type of medical device submission.

Here's a breakdown of the relevant information from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present quantitative acceptance criteria for the performance of the annuloplasty ring in a numerical or statistical sense as one would expect for an AI algorithm. Instead, the "acceptance " is based on demonstrating substantial equivalence to a predicate device through functional and safety testing. The reported "performance" is that the device met these requirements and is equivalent to the predicate.

2. Sample size used for the test set and the data provenance

• Sample Size: The document states "representative samples of the devices underwent testing" for functional and safety tests. Specific sample sizes for each test are not provided.
• Data Provenance: The data provenance (e.g., country of origin, retrospective/prospective) is not specified in this summary.

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

This is not applicable as this is not an AI/algorithm-based device and does not involve establishing ground truth from expert readings in that context. The "truth" for the device's functional and safety performance is based on engineering and materials science standards and testing.

4. Adjudication method for the test set

This is not applicable as there is no expert reading or interpretation requiring adjudication in the context of an AI/algorithm.

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. This device is an annuloplasty ring, not an AI-assisted diagnostic or treatment tool.

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

This is not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this medical device is established by:

• Engineering specifications and design requirements: The device's physical properties, materials, and mechanical behavior.
• Performance against established standards: Biocompatibility standards, sterilization efficacy, material strength standards, etc.
• Comparison to a legally marketed predicate device: Demonstrating that the new device performs similarly or equivalently to a device already deemed safe and effective.

8. The sample size for the training set

This is not applicable as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/algorithm-based device.

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The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support and restricts expansion of the tricuspid annulus.

The Tri-Ad 2.0 Adams, Model 900SFC, consists of an MP35N polished and formed wire stiffener fitted with 2 end caps. The band is covered with a braided polyester fabric. The stiffener runs from the posteroseptal commissure to the anterior segment distal to the anteroposterior commissure. The stiffener helps remodel and stabilize the enlarged portion of the tricuspid annulus. The band has 3 radial green markers to locate the following 3 areas of the band:

• The end of the stiffener section at the posteroseptal commissure.
• The anteroposterior commissure. ●
• The end of the stiffener section in the anterior segment of the band. ●
  A green demarcation suture runs around the middle of the band in the stiffener region. The band size refers to the dimension of the band where the implantation sutures are placed, except in the stiffener region. The internal stiffener, and the radiopaque core in both fully flexible ends of the band, provide radiographic visualization along the entire circumference of the band is available in the following sizes: 26 mm, 28 mm, 32 mm, 34 mm, and 36 mm.

The provided document is a 510(k) summary for a medical device called the "Tri-Ad™ 2.0 Adams Tricuspid Band." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the way one might see for novel technologies or AI algorithms.

Therefore, the document does not contain the acceptance criteria or a study proving it meets those criteria in the traditional sense of a clinical trial or performance validation for an AI device. Instead, the submission describes the device, compares it to a predicate device, and lists the types of verification testing performed to demonstrate fundamental safety and performance.

Here's an analysis based on the information provided, explaining why certain sections cannot be filled:

1. A table of acceptance criteria and the reported device performance

   This information is not present in the document. The 510(k) summary focuses on demonstrating substantial equivalence through design characteristics and verification testing, rather than setting specific performance criteria (e.g., sensitivity, specificity, accuracy) that an AI device would typically have, or reporting specific clinical outcomes against quantitative targets.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   This information is not applicable/not present in the document. The "tests" mentioned (Visual Inspection, Biocompatibility, Sterilization, Design Validation / Human Factors Engineering) are engineering and technical verification tests, not clinical performance studies that would involve test sets of patient data.

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 information is not applicable/not present. Ground truth, in the context of clinical performance, is not discussed as there were no clinical performance studies involving interpretation of data by experts. The "ground truth" for the device's characteristics would be established through engineering specifications and material testing standards.

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

   This information is not applicable/not present. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth for a diagnostic or AI-assisted task. This document details a medical device, not an AI diagnostic tool.

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 information is not applicable/not present. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance. The Tri-Ad™ 2.0 Adams Tricuspid Band is an annuloplasty ring, a physical implantable device, and not an AI-powered diagnostic or assistive tool for human readers.

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

   This information is not applicable/not present. This refers to the performance of an AI algorithm in isolation. The described device is a physical medical implant.

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

   This information is not applicable/not present in the context of clinical performance. For the engineering tests mentioned (Biocompatibility, Sterilization, etc.), the "ground truth" would be established by validated test methods and established standards confirming material properties, sterility, etc.

8. The sample size for the training set

   This information is not applicable/not present. "Training set" refers to data used to train an AI model.

9. How the ground truth for the training set was established

   This information is not applicable/not present. This refers to the process for annotating data for AI model training.

Summary of Device Acceptance/Equivalency:

The document focuses on demonstrating substantial equivalence to a predicate device (Tri-Ad™ Semi-Flexible Tricuspid Annuloplasty Ring, K093903). The "acceptance criteria" are implied by the regulatory framework for 510(k) submissions: the device must be as safe and effective as a legally marketed predicate device.

The study that "proves" the device meets these (implied) criteria consists of:

• Comparison to Predicate Device: The document highlights that the Tri-Ad 2.0 Adams tricuspid band is "identical" to the predicate in Intended Use, Principles of Operation, Sterilization, Shelf Life, Packaging, and Size Range. Minor modifications are noted in product labeling but are deemed substantially equivalent.
• Verification Testing: A list of performed studies is provided:
  • Visual Inspection
  • Biocompatibility
  • Sterilization
  • Design Validation / Human Factors Engineering

The conclusion states that "Based upon the testing performed, the modifications to the Tri-Ad 2.0 Adams do not affect the intended use of the devices or alter the fundamental scientific technology of the devices. No change has been made to the implantable band. Therefore, Tri-Ad 2.0 Adams is substantially equivalent to the currently marketed predicate device."

In essence, the "acceptance criteria" here are regulatory (substantial equivalence), and the "study" is a combination of direct comparison to a predicate and basic engineering verification tests demonstrating that the device itself, and the minor modifications, do not introduce new questions of safety or effectiveness.

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MEMO 4D device is intended for correction of mitral insufficiencies or steno-insufficiencies.

The use of the Memo 4D device is indicated for correction of congenital insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

Like its predicate device (the MEMO 3D ReChord Semirigid Annuloplasty Ring, K142221), the MEMO 4D Semirigid Annuloplasty Ring is supplied as a sterile, non-pyrogenic ring pre-mounted on a disposable holder.

Both the predicate and subject device are manufactured by embedding a superelastic metallic alloy inner core with medical grade silicone.

The resulting silicone sheath around the inner core is then encased within a tubular knitted fabric coated with a thin layer of turbostratic carbon (Carbofilm™). The fabric is then sewn along its length with a Carbofilm™ coated polyester thread.

Both the predicate and subject device feature a fully removable system (i.e., the ReChord System) in the posterior curve of the annuloplasty ring, composed by a series of loops made by a single piece of yellow surgical thread retained in place by a single piece of blue surgical thread.

The ReChord System is designed to provide a temporary reference element to facilitate the sizing of the artificial chord length at the annular plane level when performing replacement of mitral chordae tendineae in concomitance with the implant of the annuloplasty ring.

The following changes were implemented:

The MEMO 4D is available in two new sizes: 40mm and 42mm.

The MEMO 4D features a larger silicone filler layer in the outer portion of the ring, intended to further facilitate ring suturing to the annulus.

A re-shaping of the MEMO 4D annuloplasty ring was implemented for sizes 34 to 42 mm. These sizes maintain the same core cross-sectional diameter and commissure-to-commissure dimension as the predicate MEMO 3D ReChord, but feature a gradual increase of the ring antero-posterior dimension and an out-of-plane "saddle" shape in the anterior ring portion. The ring re-shaping creates a differentiated design for the MEMO 4D with respect to the MEMO 3D ReChord. The design includes a rounder shaped implant to accommodate cases of excess leaflet tissue which may be indicative of degenerative mitral disease.

Minor design changes to the disposable holder to adapt to the modified ring shape and a new injection molding supplier for the holder were also introduced. The MEMO 4D packaging system was redesigned, introducing a double nested blister to replace the polysulfone containers used for the predicate MEMO 3D ReChord.

A complete set of accessories is available separately to properly size the annulus and implant the MEMO 4D annuloplasty ring.

The provided text is a 510(k) Summary for the MEMO 4D Semirigid Annuloplasty Ring, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device already on the market. In this context, "acceptance criteria" and "device performance" don't refer to typical clinical performance metrics for a diagnostic AI device, but rather to the engineering and design characteristics that demonstrate equivalence to the predicate device and ensure safety and efficacy.

Therefore, the requested information elements (1-9) need to be interpreted in the context of a medical device submission based on substantial equivalence, rather than a study validating an AI diagnostic algorithm.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "device performance" results in the manner one might expect for a diagnostic AI study. Instead, it details the verification and validation (V&V) testing performed to demonstrate that the MEMO 4D device maintains the safety and effectiveness profile of its predicate device, the MEMO 3D ReChord Semirigid Annuloplasty Ring (K142221).

The "acceptance criteria" are implied to be that the MEMO 4D performs comparably to the predicate or meets established engineering standards for such devices. The "reported device performance" is the successful completion of the non-clinical tests, indicating that the design changes did not negatively impact safety or efficacy.

Previous testing on the predicate device for suture pull-out, corrosion resistance, and long-term biocompatibility remains valid for MEMO 4D due to similar materials, design, and manufacturing technologies.

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

The document does not specify a "test set sample size" in terms of clinical cases or patient data, as this was a non-clinical submission. The "test set" refers to the physical devices and materials used in the various non-clinical engineering and biological tests (e.g., computational models for FEA, physical rings for tensile strength, fatigue, and extraction tests, materials for biocompatibility, etc.).

• Sample Size: Not explicitly stated for each test, but typically, these tests involve a sufficient number of samples as per recognized engineering standards (e.g., ISO, ASTM) to provide statistical confidence.
• Data Provenance: The testing was conducted by Sorin Group Italia S.r.l. and appears to be internal validation data. The country of origin for the testing would be Italy, where Sorin Group Italia S.r.l. is located. The nature of the data is retrospective in the sense that it's laboratory-generated data for product validation, not prospective clinical trial data.

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

This is not applicable as there was no clinical "test set" requiring expert ground truth in the traditional sense. The "ground truth" for non-clinical performance relies on established engineering principles, materials science, and regulatory standards. The experts involved would be engineers, material scientists, and regulatory specialists within Sorin Group Italia S.r.l., along with those at the FDA reviewing the submission. Their qualifications are inherent in their professional roles, but not detailed here.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for diagnostic accuracy, where multiple readers interpret cases and a consensus is reached. The performance data presented here is from non-clinical engineering and material property tests.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was conducted in support of the MEMO 4D Semirigid Annuloplasty Ring, as the indications for use are equivalent to those of its predicate device MEMO 3D ReChord." Therefore, there is no effect size for human readers improving with or without AI assistance.

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

This question is not applicable to a physical medical device like an annuloplasty ring. This question is relevant for AI algorithms. The MEMO 4D is an implantable device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering Standards and Specifications: For mechanical properties, durability, material compatibility, and packaging integrity.
• Biocompatibility Standards: In vitro and potentially in vivo (from predicate) tests to ensure the materials are safe for implantation.
• Regulatory Precedent: The predicate device (MEMO 3D ReChord) having a proven safety and efficacy record on the market established the "ground truth" for the device type, allowing for substantial equivalence without new clinical data.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an AI algorithm or a machine learning model for this medical device submission. The device is a physical product designed and manufactured based on established engineering principles, not trained on data.

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

This is not applicable as there is no training set for an AI algorithm. The device's design and manufacturing rely on established medical device development processes and regulatory compliance rather than machine learning "ground truth" establishment.

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