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The Edwards MC3 Tricuspid annuloplasty ring, Model 4900, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

The Edwards MC3 Tricuspid annuloplasty ring, model 4900, consists of two primary components: the implantable annuloplasty ring and the template/ lanyard assembly (or holder). The implantable annuloplasty ring is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber, covered with polyester velour cloth sewn with a single seam.

The Edwards MC3 Tricuspid annuloplasty ring can be used in tricuspid valve repairs. The oval tricuspid ring conforms to the configuration of a normal tricuspid orifice. The ring has one rectilinear segment corresponding to the septal leaflet and one long curved segment corresponding to the anterior and posterior leaflets. The ring is open at the anteroseptal commissure. The annuloplasty ring is provided on an integral template which holds the ring during the plication to the annulus. A feature of the Edwards MC3 Tricuspid annuloplasty ring is that the rigid template is designed not to interfere with the tying of sutures and contains a retrieval system during the removal process. After implantation, this rigid template is removed.

The model 1150 handle may be utilized to facilitate ease of suture placement and annuloplasty ring implantation. The snap-fit assembly of the handle and template/lanyard assembly allows for connecting and disconnecting of the two components.

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The Carpentier-Edwards Physio annuloplasty ring is intended for the correction of mitral valve insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve.

The Carpentier-Edwards Physio annuloplasty ring, Model 4450 is constructed of Elgiloy bands separated by polyester film strips and has a sewing ring margin that consists of a layer of silicone rubber covered with a woven polyester cloth.

The mitral annuloplasty ring conforms to the configuration of a normal mitral annulus. It is kidney-shaped with one long curved segment corresponding to the posterior leaflet annulus. A rectilinear portion corresponds to the anterior leaflet annulus. Transverse colored threads indicate the anterior and posterior commissures.

The ring exhibits characteristics of differential flexibility. While retaining stiffness, the annuloplasty ring is also flexible in the portion corresponding to the anterior leaflet. The flexibility is increased in the posterior regions of the ring. Along the annular plane the ring is stable with a saddle-shaped curve for apposition to the aortic root.

The design is intended to provide support after annuloplasty surgery. The ring maintains a fixed maximum annular dimension to prevent excessive distension of the natural valve annulus while adapting to the dynamic motion of the mitral annulus throughout the cardiac cycle.

The holder, designed to facilitate ring implantation, is manufactured from an amorphous polymer. The annuloplasty ring is mounted on the holder with three retaining sutures.

The handle, Model 1150, may be utilized in conjunction with the holder to facilitate ease of suture placement and implantation. The middle section of the handle is malleable, allowing the handle to be adjusted (bent) in a configuration convenient for use. The handle is packaged separately. The snap assembly of the handle and holder allows for connecting and disconnecting the two components at appropriate times during the surgical procedure.

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Indications for Use: This device is intended for use in patients who are morbidly obese and have failed to lose weight with diet and exercise.

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Here's a breakdown of the acceptance criteria and study details for the Hypertension Prediction Index (HePI) Algorithm, based on the provided FDA 510(k) letter:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported performance is for the overall datasets (N=1813 for Minimally Invasive, N=1351 for Non-invasive). All sub-categories (surgical/non-surgical) also met the acceptance criteria.

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

• Minimally Invasive Sensor:
  • US Patients: 1615 subjects
  • OUS Patients: 198 subjects
  • Total N: 1813 subjects
• Non-Invasive Finger Cuff:
  • US Patients: 464 subjects
  • OUS Patients: 887 subjects
  • Total N: 1351 subjects

Data Provenance: The study used retrospective clinical data from multiple independent datasets. Data was collected from both US and OUS (Outside United States) patients.

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

The provided document does not specify the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The provided document does not specify an adjudication method. The ground truth definition of a "hypertensive event" is clearly stated (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg), suggesting an objective, pre-defined criterion rather than expert consensus on individual cases that would require adjudication.

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

The provided document does not indicate that an MRMC comparative effectiveness study was done. The focus is on the standalone performance of the algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The results presented in Table 2 (AUC, Sensitivity, Specificity, PPV, NPV) are direct measures of the algorithm's performance in predicting hypertensive events based on retrospective clinical data, without human interaction.

7. The Type of Ground Truth Used

The ground truth used is defined by objective physiological measurements and thresholds:
A "hypertensive event" is defined as:

• Mean Arterial Pressure (MAP) greater than 115 mmHg for at least 1 minute OR
• A MAP increase of more than 20% when current MAP is greater than 95 mmHg.

8. The Sample Size for the Training Set

The provided document does not explicitly state the sample size for the training set. It mentions that "Algorithm performance was tested using retrospective clinical data" and "Prospective analyses of retrospective clinical data from multiple independent datasets...were analyzed to verify the safety and performance of the subject device," referring to the test sets.

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

The provided document does not explicitly state how the ground truth for the training set was established. However, given the nature of the device and the ground truth definition for the test set, it is highly likely that the same objective physiological measurements and thresholds (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg) were used to establish ground truth labels for the training data.

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The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.

The provided text is an FDA 510(k) clearance letter and summary for the Swan-Ganz catheter. It primarily details the regulatory process, device description, and indications for use.

Crucially, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of proving device performance against specific metrics. The document explicitly states:

"The subject Swan-Ganz Base and Advanced catheters are identical to the predicate devices cleared in K160084 and K222117 in terms of design, performance specifications, and technological characteristics with the exception of the indications for use statement and other portions of the labeling. The are no changes to the design, technology, performance, materials, or specifications of the devices in this 510(k). The modifications to the subject devices are limited to labeling changes."

This indicates that the current submission (K233824) is for a labeling change only, and therefore, the performance of the device itself (its ability to accurately monitor hemodynamic pressures) would have been established during the clearance of the predicate devices (K160084 and K222117), not in this particular submission.

Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria or a study proving the device meets acceptance criteria related to its performance.

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The FusedCO Algorithm when used with Edwards' Swan-Ganz advanced technology pulmonary artery catheter and Acumen IQ sensor is indicated for use in adult critical care patients requiring of cardiac output and derived hemodynamic parameters in a hospital environment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment.

The FusedCO algorithm is a cardiac output (CO) algorithm available when operating with an Edwards' Swan-Ganz advanced technology pulmonary artery catheter and Acumen IQ sensor. The FusedCO algorithm uses cardiac output signals from a Swan-Ganz advanced technology pulmonary artery catheter and an Acumen IQ sensor (arterial line) to provide a fused cardiac output (FusedCO) and its derived parameters, cardiac index (CI), stroke volume (SV) and stroke volume index (SVI), every 20 seconds.

Here's an analysis of the acceptance criteria and study information for the FusedCO Algorithm, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds. Instead, it refers to the device having the "same performance specifications for the cardiac output measurement as the predicate device (K180881)."

Note: Without access to the predicate device's 510(k) submission (K180881), the specific numerical acceptance criteria for cardiac output measurement performance cannot be fully detailed. The statement "FusedCO algorithm passed all testing" suggests that it met the required performance standards, which are implied to be aligned with the predicate.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "patient data, including cardiac output from a Swan-Ganz advanced technology pulmonary artery catheter and arterial pressure waveforms."
• Data Provenance: Retrospective. The data was "collected retrospectively." The country of origin is not specified.

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

This information is not provided in the document. The method for establishing ground truth is mentioned, but not the number or qualifications of experts involved.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

• Not explicitly stated. The document describes "Algorithm Verification" and "Software verification" using patient data but does not mention a comparative effectiveness study involving human readers with and without AI assistance. The focus is on the algorithm's performance against reference data.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The "Algorithm Verification" section states: "The FusedCO algorithm performance was tested to ensure the safety of the device. The verification of the FusedCO algorithm was performed using patient data... The FusedCO algorithm passed all testing." This indicates testing of the algorithm itself without human interaction.

7. Type of Ground Truth Used

• The ground truth for the test set was established using "cardiac output from a Swan-Ganz advanced technology pulmonary artery catheter and arterial pressure waveforms." These are standard clinical measurement modalities. While not explicitly termed "expert consensus," these are considered the reference methods for measuring cardiac output in clinical settings, implying that values from these sources serve as the ground truth.

8. Sample Size for the Training Set

• The sample size for the training set is not explicitly stated. The document mentions that the algorithm uses existing data by fusing cardiac outputs from different sources, but it doesn't separate training data from verification data or provide sizes for either. The phrase "collected retrospectively" generally refers to the data used for verification/testing rather than an explicitly defined training set.

9. How Ground Truth for the Training Set Was Established

• This information is not explicitly stated for a dedicated training set. Given that the algorithm fuses existing cardiac output signals from a "Swan-Ganz advanced technology pulmonary artery catheter and an Acumen IQ sensor (arterial line)," it's implied that these established clinical measurement methods constitute the "ground truth" or reference data for both training (if applicable) and verification. The document doesn't detail a separate process for establishing ground truth specifically for training data beyond these established measurement techniques.

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The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and is not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter.

The Acumen Hypotension Prediction Index parameter (HPI) provides the clinician with the likelihood that the patient may be trending toward a hypotensive event. The Acumen HPI feature is intended for use in surgical or non-surgical patients. By default, the software defines a hypotensive event as mean arterial pressure (MAP) < 65 mmHg for at least one minute in duration. This MAP target is adjustable and can be changed to 55, 60, 70, 75, 80 or 85 mmHg.

The Edwards Acumen Hypotension Prediction Index (HPI) software feature was evaluated through algorithm verification and a usability study. The key aspects of the evaluation are as follows:

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on verifying that the changes to the HPI algorithm (adjustable MAP targets) and the expansion to non-surgical patients did not negatively impact its safety and effectiveness. Specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) are not explicitly stated in the provided text. Instead, the document states:

• "The results establish that the usage of the HPI algorithm with the adjustable Mean Arterial Pressure (MAP) targets for hypotension (55, 60, 70, 75, 80, 85 mmHg) did not adversely affect the safety and effectiveness of the subject device."
• "The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm."

Without specific performance metrics and their corresponding acceptance thresholds, a table of acceptance criteria versus reported performance cannot be fully constructed from the provided text. The overall reported performance is that the device meets the implicit acceptance criterion of not adversely affecting safety and effectiveness with the modifications.

2. Sample Size and Data Provenance for Test Set:

• Algorithm Verification: The algorithm verification was performed using "clinical data." For the expanded non-surgical indication, "non-surgical clinical data collected retrospectively" was used.
• Sample Size: The document does not specify the sample size for the clinical data used in the algorithm verification test set.
• Data Provenance: The data used for the non-surgical indication was "retrospectively" collected. The country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for the test set.

4. Adjudication Method:

The document does not specify any adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size of human readers improving with AI vs. without AI assistance. The HPI is an "Adjunctive Predictive Cardiovascular Indicator" providing "additional quantitative information" and is "not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter," suggesting it is an aid rather than a replacement for human decision-making. However, the exact nature of human-in-the-loop studies, if any, is not detailed.

6. Standalone Performance:

Yes, a standalone (algorithm only) performance evaluation was done through the "Algorithm Verification" section. The verification confirmed that the modified algorithm, with adjustable MAP targets, did not adversely affect safety and effectiveness. This indicates an evaluation of the algorithm's performance independent of real-time human interaction.

7. Type of Ground Truth:

The ground truth used for algorithm verification appears to be based on observed "hypotensive events" defined by Mean Arterial Pressure (MAP) falling below user-defined thresholds (e.g., < 65 mmHg for at least one minute). The document mentions "clinical data" and "non-surgical clinical data," which implies real physiological measurements and outcomes from patients, rather than expert consensus on images or pathology.

8. Sample Size for Training Set:

The document does not specify the sample size for the training set. It mentions that the subject and predicate devices "have the same core predictive algorithm," but details on the original training of this algorithm are not provided in this submission summary.

9. How Ground Truth for Training Set was Established:

The document does not provide information on how the ground truth for the training set was established. It refers to the "core predictive algorithm" being the same as previously cleared devices (DEN160044 and K203687), suggesting that the original algorithm's development and training methods would be detailed in those previous submissions. This current submission focuses on verifying that modifications to the existing algorithm do not negatively impact its performance.

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The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The TruWave Disposable Pressure Transducer is a sterile, single-use device that is used to monitor intravascular, intracranial, and intrauterine pressures. The pressure transducer has a straight, flow-through design across the pressure sensor, and is available with or without the integral flush device. The pressure sensor is a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A transparent fluid path with an integral stopcock at one end and an integral flush device (either 3mL or 30mL) at the other end encloses the sensor. The enclosure of the TruWave Disposable Pressure Transducer has a pathway for air to enter the housing and acts as a vent. A disposable cable (available in 10-inch/25 cm and 48-inch/120 cm lengths) attached to the pressure transducer housing interfaces with an Edwards Lifesciences reusable cable that is specifically wired for the monitor being used. The TruWave Disposable Pressure Transducer can be mounted on the patient's arm using an arm strap or it may be mounted on an IV pole in a holder. The TruWave Disposable Pressure Transducer may be a component in various pressure monitoring kits or systems.

The provided text describes a 510(k) premarket notification for a medical device, the TruWave Disposable Pressure Transducer. The information primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests.

However, the question asks for details related to acceptance criteria, device performance, and study information that would typically be found in a clinical study report or a more detailed performance study. The provided document does not contain a table of acceptance criteria with reported device performance metrics in a quantitative sense, nor does it detail a clinical study with human patients, ground truth establishment by experts, or MRMC studies.

Instead, the document states: "All device acceptance criteria were met. Results of non-clinical testing show that the subject device TruWave Disposable Pressure Transducer meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." It then lists types of non-clinical testing performed.

Therefore,Based on the provided text, the following information can be extracted regarding acceptance criteria and the study:

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

The document states "All device acceptance criteria were met" and that the non-clinical testing demonstrated the device "meets its intended use and demonstrate that the device is as safe, as effective, and performs as well as the predicate device." However, a specific table outlining quantitative acceptance criteria and their corresponding reported device performance values is not provided in the excerpt. The text mentions several types of testing performed to demonstrate equivalence and safety/effectiveness.

2. Sample size(s) used for the test set and the data provenance:

The document refers to "non-clinical testing" and does not specify sample sizes in terms of number of devices or data points for each test category. No information on data provenance (e.g., country of origin, retrospective or prospective) is provided, as these are non-clinical (laboratory/bench) tests.

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

This information is not applicable and not provided. The testing described is non-clinical performance and safety testing against established standards, not a clinical study requiring expert consensus for ground truth. The "usability/human factors" evaluation was performed by "healthcare provider users," but without details on the number or specific qualifications.

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

This information is not applicable and not provided, as it pertains to clinical studies with expert reviewers and not the non-clinical testing 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:

This information is not applicable and not provided. The device is a physical pressure transducer, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided, as the device is a physical pressure transducer, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" relates to compliance with established international and national standards (e.g., ISO 10993-1, IEC 60601 series, ANSI/AAMI BP22, ASTM F2503) and the manufacturer's internal design requirements. This is based on standardized measurement and testing protocols, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

This information is not applicable and not provided. The described tests are for device verification and validation, not for training a model or algorithm.

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

This information is not applicable and not provided, as there is no "training set" in the context of the reported non-clinical device testing.

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The QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bypass.

The Edwards Lifesciences QuickDraw venous cannula kit includes a wirewound cannula, introducer(s), guidewire, connector hub, and percutaneous insertion components. The cannula and introducer(s) have tapered tips to aid in insertion and advancement into the femoral vein. The cannula is marked at 5 cm intervals from the first marker band to indicate the depth of insertion. The soft, clear tubing near the barbed end of the cannula allows visualization of air and blood and provides a non-reinforced clamp site. The cannula connector is a 3/8 in. (9.5 mm) barbed connector. The introducers accept a 0.038 in. (0.97 mm) guidewire for assistance in cannula insertion. The connector hub secures and immobilizes the introducer within the cannula for easier, one-person insertion of the cannula/introducer assembly. For percutaneous insertion, percutaneous insertion components are provided.

The provided text is a 510(k) premarket notification for a medical device called the "QuickDraw Venous Cannula." It states that the subject device is identical to a previously cleared predicate device, with only the addition of a contraindication and a warning to the Instructions for Use.

Because the device itself is identical and the changes are only to the labeling (adding contraindications and warnings), the description explicitly states:

"Functional and safety testing were not applicable for this changed device as the change is only adding a contraindication and warning to the Instructions for Use."

Therefore, there is no performance study described in this document to demonstrate that the device meets acceptance criteria. The 510(k) submission relies on the substantial equivalence to the predicate device, which would have undergone performance testing for its initial clearance.

As such, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria based solely on the provided text, as no such study was conducted or described for this particular 510(k) submission.

To directly answer your prompt based on the provided text, and acknowledging the lack of a performance study for this specific submission:

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

• Acceptance Criteria: Not applicable for this submission as no new performance testing was conducted. The criteria would have been established and met for the predicate device.
• Reported Device Performance: Not applicable for this submission as no new performance testing was conducted. The performance essentially mirrors that of the identical predicate device.

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

• Not applicable; no new test set was used for performance evaluation in this 510(k).

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

• Not applicable; no new test set requiring ground truth establishment was used for performance evaluation in this 510(k).

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

• Not applicable; no new test set requiring adjudication was used for performance evaluation in this 510(k).

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 is a physical medical device (cannula), not an AI-assisted diagnostic tool.

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

• Not applicable; this is a physical medical device (cannula), not an algorithm.

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

• Not applicable; no new performance study was conducted requiring ground truth.

8. The sample size for the training set:

• Not applicable; this is a physical medical device (cannula), not an algorithm that requires a training set.

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

• Not applicable.

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Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.

The Edwards Femoral Access Venous and Arterial Cannulae are wire-reinforced thin-wall polyurethane or PVC cannulae. The wire reinforcement is intended to prevent kinking during use. The clear proximal section of the cannula is unreinforced for clamping and terminates in either a barbed connector for ¼" or 3/8" tubing connection. The cannulae are available in various sizes and lengths. Each cannula is furnished with one, or in some cases two, dilator(s). In the case of cannulae supplied with two dilators, one is solid and the other is hollow. The hollow dilator will pass over guidewires up to 0.038" (0.97 mm) in diameter. The guidewire, when used, facilitates percutaneous insertion, or insertion under direct visualization. The cannulae tips are tapered for easy insertion. Some cannulae feature incremental depth markings to aid in proper placement and positioning. Some versions have, as an additional aid to placement, the clear tip section of the cannula contain two radiopaque barium strips for visualization. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or cardiopulmonary bypass procedures. Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.

This document is an FDA 510(k) premarket notification for Edwards Lifesciences LLC's Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, and FemTrak Femoral Venous Cannula (K200358).

The key takeaway is that this submission is not for a new device requiring extensive performance studies to prove it meets acceptance criteria. Instead, it is a modification to the Instructions for Use (IFU) of an already legally marketed device (predicate device K140208). Therefore, the information typically found in a standard performance study proving acceptance criteria for a new device is not present in this document.

The document explicitly states:

• "No functional/safety testing was performed for the Femoral Access Venous and Arterial Cannulae. The only changes being made are modifications to the Instructions for Use."
• "The devices, with the proposed modification statements, have the identical design, materials, technology, and operating principles as the current legally marketed version of the devices, and as such no performance testing was conducted."
• "The current legally marketed version of the Femoral Access Venous and Arterial Cannulae complies will all applicable design practices and regulations and was most recently cleared by FDA via K140208 (SE March 5, 2014) for modifications of its packaging."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, experts, adjudication methods, MRMC studies, standalone studies, or ground truth establishment relevant to this specific 510(k) submission because such studies were not conducted for this submission.

The acceptance criteria for market clearance in this case would have been satisfied by demonstrating substantial equivalence to the predicate device, primarily by showing that the modification to the IFU did not introduce new questions of safety or effectiveness, and that the device itself remains unchanged from its previously cleared version.

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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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