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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 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 FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are indicated for use in patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings and bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are fully flexible annular rings and bands designed to reduce and stabilize the valve annulus in patients undergoing mitral or tricuspid repair.

The rings and bands are made of braided polyester fabric. The ring and band contain a circumferential flexible radiopaque marker. The internal radiopaque marker provides radiographic visualization along the entire circumference.

The rings and bands are available in nine sizes: 24 mm; 26 mm; 28 mm; 30 mm; 32 mm; 34 mm, 36 mm, 38 mm and 40 mm. The size refers to the inner circumference between the green suture markers nearest the anterior location of the ring and band. FlexForm™ Sizers, Model FRBS, are used to determine the correct size of the ring or band.

The differences between the ring and band are as follows: The FlexForm™ Ring is a complete annular ring. Five markers are provided on the ring; two markers indicate the approximate location of the trigones; three additional markers are provided as an aid to suture placement in the posterior section.

The FlexForm™ Band is a partial ring, without an anterior segment. The key dimensions are the same as the FlexForm Annuloplasty Ring, except for the absence of the anterior segment. Five markers are provided on the band; two markers indicate the approximate location of the trigones; three markers are provided as an aid to suture placement in the posterior section.

The choice of ring or band is based on surgeon preference.

The provided text is a 510(k) summary for a medical device (FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is not typically found in a 510(k) summary like this one.

510(k) submissions primarily focus on:

• Comparison to a Predicate Device: Demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to an already cleared device.
• Non-Clinical Testing: Typically involves bench testing (e.g., tensile strength, fatigue, sterilization validation, biocompatibility) to show the device meets engineering specifications and standards, but not direct clinical outcomes or diagnostic performance.

Based on the provided text, here's what can be extracted, and what cannot be:

Information Available:

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

  • Acceptance Criteria (Implied): The device passed various performance tests to ensure it meets functional and performance requirements. The specific numerical acceptance criteria are not provided.
  • Reported Device Performance (as listed in "Non-Clinical Tests"):
    • Tensile strength of ring body materials
    • Tensile strength of construction sutures
    • Suture pull-out testing
    • (NOTE: The actual numerical results of these tests and how they compare to specific acceptance criteria are not included in this summary.)

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

  • N/A: This device is a physical annuloplasty ring/band, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device underwent "Functional and Safety Testing" which are non-clinical hardware tests.

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

  • For the non-clinical tests (tensile strength, suture pull-out), the "ground truth" would be the engineering specifications and established test methodologies for material properties. This is implicitly linked to industry standards and regulatory guidance for medical devices, rather than expert consensus on clinical data or pathology. Specific details are not provided.

• 8. The sample size for the training set:

  • N/A: This is a physical medical device, not an AI algorithm that requires a training set. The "samples" referred to are representative physical samples of the manufactured device used for non-clinical testing.

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

  • N/A: Not applicable for a physical device.

Information NOT Available in this Document:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • The document mentions "representative samples" for testing, but does not specify the number of samples for each test, nor the "data provenance" as this refers to clinical data, which was not used for this type of submission.
• 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)
  • N/A: No clinical study involving expert ground truth for a test set is described here. The "ground truth" for the non-clinical tests would be the predetermined engineering specifications, not expert clinical consensus.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • N/A: No clinical study or expert review of a test set is described.
• 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
  • N/A: This is a physical device, not an AI diagnostic tool, so MRMC studies and "human readers" improving with AI are not relevant.

In summary, as this is a 510(k) summary for a physical medical device, it relies on demonstrating substantial equivalence through non-clinical performance and material characterization, rather than clinical studies with human "readers" or algorithms that would involve the extensive details requested in your prompt.

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The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are for use in those patients undergoing surgery of diseased or damaged tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty Rings provide support for the tricuspid annulus and restrict expansion of the annulus.

The ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Rings Model 900SFC are implantable, semi-rigid, annular Rings. The Rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral valve repair. The body of the ring is made of flat braided Polyester. The ring contains an MP35N wire stiffener in the lateral and posterior segments. The wire stiffener is contained within a close-coiled MP35N spring. The two ends of the stiffener wire are fitted with miniature MP35N end caps at each trigone. These caps prevent the stiffener wire from poking through the end seam of the ring. The entire circumferential of the annuloplasty ring is radiopaque between trigones. The Rings are available in the following six sizes: 26mm, 28mm, 30mm, 32mm, 34mm, 36mm. The size refers to the inner major diameter of the ring.

This submission describes a medical device, the ATS TRI-AD™ Semi-Flexible Tricuspid Annuloplasty Ring Model 900SFC, and its equivalence to a predicate device. The document does not describe an AI/ML powered device, nor does it present any studies proving the device meets acceptance criteria related to AI/ML performance.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared device (ATS SIMULUS® Semi-Flexible Tricuspid Annuloplasty Ring Model 800SR) based on design, material composition, surgical technique, and intended use.

Here's an analysis of the provided text in relation to your request, highlighting the absence of AI/ML or related performance studies:

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

The document lists several mechanical tests, but these are for the annuloplasty ring's physical properties, not for any AI/ML performance. It states "All test results were satisfactory" without providing specific numerical acceptance criteria or detailed performance data.

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

The document does not specify sample sizes for the mechanical tests performed. Data provenance is not mentioned. As these are mechanical tests performed on components or complete bands, "country of origin of the data" and "retrospective or prospective" are not applicable in the typical sense for clinical or AI/ML studies.

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)

Not applicable. This document is about a physical medical device (annuloplasty ring) and its mechanical properties, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not described here.

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/ML system, and no MRMC studies are mentioned.

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

Not applicable. This is not an algorithm or AI/ML device.

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

Not applicable. The "ground truth" for the mechanical tests would be the measured physical properties or successful completion of a test according to a predefined standard, not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm, and therefore no training set.

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

Not applicable. As there is no AI/ML algorithm or training set, this question is irrelevant to the provided document.

In summary, the provided document is a 510(k) summary for a physical medical device (an annuloplasty ring) and focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, sterility, and biocompatibility. It does not involve any AI/ML components or related performance studies.

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The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

The ATS SIMULUS® Adjustable Flexible Annuloplasty Bands Model 735AC are implantable, adjustable flexible, annular bands (Figure II.1). The bands reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the band is made of tubular braided Polyester. The band contains circumferential flexible radiopaque markers. The entire circumference of the band is radiopaque.

The bands are available in the following six sizes: 25 mm, 27 mm, 29 mm, 31 mm, 33 mm, 35 mm, 37mm and 39mm. The size refers to the equivalent inner circumference of the band, trigone to trigone.

The provided text describes a medical device, the ATS SIMULUS® Adjustable Flexible Annuloplasty Band Model 735AC, and its clearance process through a 510(k) premarket notification. However, it does not contain the specific information requested regarding acceptance criteria, a study proving the device meets those criteria, or details about training and test sets as one would expect for an AI/CADe device.

The document is a 510(k) summary for a medical implant (an annuloplasty ring), which is a physical device, not a software or AI/CADe device. The "Testing Summary" section refers to mechanical testing, biocompatibility, and sterility validation, which are typical for implantable hardware. There is no mention of diagnostic performance metrics like sensitivity, specificity, or AUC, nor any reference to AI algorithms, ground truth establishment by experts, or sample sizes related to AI model development.

Therefore, I cannot populate the requested table and sections based on the provided text, as the information is not present. The document focuses on establishing substantial equivalence to a predicate device based on design, materials, surgical technique, and intended use for a physical medical product.

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The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are for use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral annulus and restrict expansion of the annulus.

The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are implantable, Semi-Rigid, annular rings. The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral valve repair. The body of the ring is made of flat braided Polyester. The ring contains an MP35N wire stiffener in the lateral and posterior segments. The wire stiffener is contained within a closecoiled MP35N spring, the two ends of which are joined together by a miniature MP35N coupler in the mid-anterior segment. The entire circumferential of the annuloplasty ring is radiopaque. The rings are available in the following six sizes: 24mm, 26mm, 28mm, 30mm, 32mm, 36mm, 36mm and 40mm. The size refers to the lateral diameter of the stiffener band.

The provided text is a 510(k) premarket notification for a medical device, the ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Ring Model 800SR. It describes the device, its intended use, and states that testing was performed. However, it does not contain the detailed results of specific performance studies or acceptance criteria for those studies.

The "Testing Summary" section notes: "Testing included LAL, Sterility Validation, and Class VI Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory."

This statement confirms that testing was done and the results were deemed satisfactory, but it does not provide the quantitative acceptance criteria or the specific performance metrics achieved. Therefore, I cannot generate the requested table or answer the detailed questions about the study design, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on establishing substantial equivalence to a predicate device (Genesee Biomedical Inc's. Sculptor® Semi-Rigid Mitral Annuloplasty Ring Model 605M (K905175)) based on design, material composition, surgical technique, and intended use, rather than presenting a detailed performance study against specific acceptance criteria.

In summary, the information required to answer your request (acceptance criteria, specific performance data, study design details etc.) is not present in the provided text.

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The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings Model 735AF are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

The ATS SIMULUS™ Adjustable Flexible Annuloplasty Rings Model 735AF are implantable, adjustable flexible, annular rings (Figure II.1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of tubular braided Polyester. The ring contains circumferential flexible radiopaque markers. The entire circumference of the ring is radiopaque. The rings are available in the following six sizes: 25 mm, 27 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner circumference of the ring, trigone to trigone.

The provided text is a 510(k) summary for the ATS SIMULUS Adjustable Flexible Annuloplasty Ring Model 735AF. It describes the device, its intended use, and states that certain tests were conducted. However, it does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for a software or AI-driven device performance study.

The document states:

• Testing Summary: "Testing included LAL, Sterility Validation, and Class VI Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory."

This indicates that the testing performed was primarily related to the physical properties, sterility, and biocompatibility of the annuloplasty ring as a medical implant, rather than a performance study involving diagnostic accuracy or similar metrics.

Therefore, many of the requested details cannot be extracted from this document, as they pertain to a different type of device evaluation (e.g., for AI/software).

Here's a breakdown of what can and cannot be answered based on the input:

In summary, the provided K071214 document is a 510(k) summary for a physical medical device (an annuloplasty ring), not a diagnostic or AI-driven device. As such, the testing described focuses on the device's physical and biological integrity, sterility, and safety, rather than performance metrics related to data analysis or diagnostic accuracy. The document states that all conducted tests were "satisfactory," which is the equivalent of meeting acceptance criteria for this type of submission, but it doesn't provide the detailed quantitative criteria or results typical of a performance study for software/AI.

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The ATS SIMULUS Annuloplasty Rings are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

The ATS SIMULUS Annuloplasty Rings are implantable, fully flexible, annular rings (Figure 1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of braided Polyester. The ring contains a circumferential flexible radiopaque marker. The entire circumference of the ring is radiopaque. The annuloplasty rings and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle. The rings are available in the following sizes: 23 mm, 27 mm, 31 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the ring. Green trigone markers are spaced at 120° from the radial seam, which is located midpoint of the posterior segment.

The provided text is a 510(k) Summary for a medical device called the ATS SIMULUS Annuloplasty Ring. It describes the device, its intended use, and indicates that testing was performed. However, this document does not contain the specific details about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The section "8. Testing Summary:" on page 1 states: "Testing included LAL, Sterility Validation, Class IV Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory."

This statement confirms that testing was done and that the results were "satisfactory," but it lacks the granular information required to complete the table and answer the specific questions about acceptance criteria and study methodology.

Therefore, I cannot provide a detailed response to your request based solely on the provided text. The document is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than providing a detailed performance study report.

Here's what can be inferred and what information is missing:

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

• Acceptance Criteria: Not explicitly stated in the provided text. For LAL, Sterility Validation, Biocompatibility, and Mechanical Testing, there would be specific regulatory or internal acceptance criteria (e.g., LAL endotoxin levels below a certain threshold, sterility assurance level (SAL) of 10^-6, specific cytotoxicity or sensitization limits, certain force/stress limits for mechanical tests). These are not published here.
• Reported Device Performance: The text generically states, "All test results were satisfactory." This is not a quantitative or specific performance report.

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

• Sample Size: Not specified for any of the tests mentioned (LAL, Sterility, Biocompatibility, Mechanical).
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the testing would have been conducted by or for the applicant (Genesee Biomedical, Inc.) likely in the US, but this is an inference, not stated fact for the data origin. It would be retrospective for the submission, based on tests performed prior to filing.

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

• This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical assessments). The tests mentioned (LAL, Sterility, Biocompatibility, Mechanical) are laboratory-based and generally do not involve "expert consensus" for ground truth in the way clinical studies do. Standards and validated methods define the "ground truth" for these types of tests.

4. Adjudication method for the test set

• Not applicable for the types of tests described (LAL, Sterility, Biocompatibility, Mechanical).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, the document does not mention any MRMC comparative effectiveness study. These are typically for diagnostic devices where human readers interpret results.

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

• Not applicable. This device is an implantable annuloplasty ring, not an algorithm.

7. The type of ground truth used

• For LAL, Sterility, Biocompatibility, and Mechanical testing, the ground truth is established by validated laboratory methods and regulatory standards. For example, sterility is determined by absence of microbial growth in culture, LAL by an enzymatic reaction, biocompatibility by absence of adverse biological responses in standardized tests (e.g., ISO 10993 series), and mechanical performance by meeting engineering specifications under controlled conditions. It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense for these specific tests.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The "predicate device" is mentioned for some tests, but that's for demonstrating equivalence, not for training a model.

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

• Not applicable, as there is no training set for this type of device.

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The ATS SIMULUS FC Annuloplasty Bands are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

The ATS SIMULUS FC Annuloplasty Bands are implantable, fully flexible, annular bands (Figure 1). The bands reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the band is made of braided Polyester. The band contains a circumferential flexible radiopaque marker. The entire circumference of the band is radiopaque.

The annuloplasty bands and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle.

The bands are available in the following sizes: 23 mm, 27 mm, 29 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the band. Green trigone markers are spaced at 120° from the midpoint of the posterior segment, which is also indicated by a green marker.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ATS SIMULUS FC Annuloplasty Band:

The document (K052899) is a 510(k) premarket notification for a medical device. In this type of submission, the primary goal is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), rather than proving stand-alone effectiveness or a specific clinical benefit beyond what the predicate offers. Therefore, the information provided focuses on comparative aspects and safety/performance characteristics relevant to the predicate.

Based on the provided text, there is no clinical study presented that demonstrates the device meets specific performance acceptance criteria in the way you've outlined for an AI/device performance study.

Instead, the submission relies on:

• Equivalence to a predicate device: The ATS SIMULUS FC Annuloplasty Band is deemed equivalent to the K905175, PTI Annuloplasty Ring (now Genesee BioMedical, Inc. Sculptor® Annuloplasty Ring) based on design, material composition, surgical technique, and intended use. This is the core "proof" of acceptability for a 510(k) submission.
• Non-clinical testing: Safety and fundamental performance are addressed through laboratory and bench tests.

Here's a breakdown of the requested information, indicating where the document provides (or lacks) the specific details:

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

   This specific type of table, with quantitative performance metrics against predefined acceptance criteria, is not provided in the document. The general acceptance criteria are implied by the successful completion of the listed tests and the demonstration of substantial equivalence.

   Acceptance Criteria	Reported Device Performance
   Functionality: Support mitral/tricuspid annulus, restrict expansion of the annulus	Implied: Device description states it "reduce[s] and stabilize[s] the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair." Indications for Use state it "provide[s] support for the mitral or tricuspid annulus and restrict[s] expansion of the annulus." Equivalence to predicate (K905175) based on design, material, surgical technique, and intended use implies similar functionality.
   Biocompatibility: Safe for implantation, no adverse biological reactions	Reported: "Class IV Biocompatibility tests on the predicate device." "All test results were satisfactory." (The document states these tests were done on the predicate device, implying the new device, being substantially equivalent in materials, would also be biocompatible.)
   Sterility: Supplied sterile, nonpyrogenic	Reported: "LAL, Sterility Validation" were performed. "All test results were satisfactory." "The ATS SIMULUS FC Annuloplasty Bands are supplied STERILE (sterilized by gamma radiation) and nonpyrogenic..."
   Mechanical Integrity/Durability: Withstand surgical implantation and in-vivo forces without failure	Reported: "Mechanical testing was carried out on complete modified bands and band components." "All test results were satisfactory." (Specific criteria like tensile strength, fatigue life, etc., are not detailed, but implied to be acceptable based on the "satisfactory" statement and equivalence to predicate.)
   Radiopacity: Entire circumference visible for post-implant assessment (for the FC model)	Reported: "The band contains a circumferential flexible radiopaque marker. The entire circumference of the band is radiopaque." (This is a design feature, and successful visualization would be implicitly confirmed by mechanical/design verification, though no specific imaging study is mentioned as a "performance test" in the summary.)
   Packaging Integrity: Maintain sterility until expiration date	Reported: "The bands will remain sterile until at least the expiration date provided the package is unopened and undamaged." (Successful sterility validation would cover this, but specific packaging test data is not detailed as a separate item beyond sterility validation.)
   Substantial Equivalence: To predicate device (K905175)	Reported: "Equivalence can be seen in the design, material composition, surgical technique and intended use." FDA confirmed: "...the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is the overarching "performance" criterion for a 510(k) and was met.

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

   • Sample Size: Not specified for any of the tests (LAL, Sterility, Biocompatibility, Mechanical). These are typically laboratory or bench tests with samples taken from manufacturing lots, not patient-based test sets.
   • Data Provenance: Not specified, but generally, for a 510(k), these would be internal laboratory tests conducted by the manufacturer or contracted third-party labs. They are not clinical studies in the sense of patient data.

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

   • This question is not applicable as there is no "test set" in the context of human data or expert review mentioned. The tests are lab-based.

4. Adjudication method for the test set

   • Not applicable. No expert adjudication of a test set is mentioned.

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

   • No. This device is an annuloplasty band (implantable medical device for valve repair), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

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

   • No. This question is not applicable as the device is not an algorithm or AI system.

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

   • For the non-clinical tests:
     • Biocompatibility: Established scientific standards for biological reactivity (e.g., ISO 10993 series).
     • Sterility: Established microbiology standards (e.g., USP, ISO 11137 for gamma sterilization).
     • Mechanical Testing: Engineering specifications and performance comparisons to the predicate device, likely based on established ASTM or ISO standards for medical device materials and components.
     • Functionality: Implied by design, material, and equivalence to the predicate device.

8. The sample size for the training set

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable. There is no "training set."

In summary:

The K052899 submission for the ATS SIMULUS FC Annuloplasty Band relies on demonstrating substantial equivalence to an existing predicate device (K905175, PTI Annuloplasty Ring / Sculptor® Annuloplasty Ring) and fulfilling standard non-clinical safety and performance testing requirements. The device is a physical implant, not an AI or diagnostic software, so many of the questions regarding clinical studies, expert review, training sets, and AI performance are not relevant to this type of device submission.

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