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Ventris anterior cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Ventris anterior cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Ventris 2-screw anterior cages may be used as a stand alone device only when two (2) vertebral body bone screws are used. Ventris 4-screw anterior cages may be used as a stand alone device only when at least two (2) vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use Ventris anterior cages with fewer than two (2) screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used. Ventris anterior cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. When used to treat ASD, or when cages with more than 20° of lordosis are used, Ventris anterior cages must be used with a supplemental spinal fixation system cleared for use in the lumbosacral spine and cannot be used as a stand alone.

Ventris anterolateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Ventris anterolateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. Ventris anterolateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Ventris anterolateral cages are intended to be used with a supplemental spinal fixation system cleared for use in the lumbosacral spine.

Ventris lateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Ventris lateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. Ventris lateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Ventris lateral cages are intended to be used with a supplemental spinal fixation system cleared for use in the lumbosacral spine.

The Ventris system consists of intervertebral body fusion devices intended for lumbar interbody fusion using an anterior lumbar interbody fusion surgical approach (ALIF), anterolateral (i.e., oblique) lumbar interbody fusion surgical approach (AOLIF), or a lateral lumbar interbody fusion surgical approach (LLIF). The devices are intended to improve stability of the spine while supporting fusion. The Ventris constructs are intended for use at one or two contiguous levels in the lumbar spine (L2-S1). The components are offered in different shapes and sizes to meet the requirements of the individual patient's anatomy and are provided sterile.

Ventris cages are available in six configurations: Ventris Ti Interbody anterior four-hole constructs for ALIF approach, Ventris Ti FRA Interbody anterior fully round ALIF (FRA) constructs for ALIF approach, Ventris Ti Open Interbody anterior two-hole constructs for ALIF approach, Ventris Ti AL Interbody anterolateral (i.e., oblique) constructs for OLIF approach, Ventris Ti Lateral FX two-screw lateral constructs for LLIF approach, and Ventris Ti Lateral Interbody lateral constructs for LLIF approach. All cages are also available with increased surface area options that provide additional endplate surface area. For the increased surface area cages, the outer footprint remains the same, but the volume of the internal graft window is reduced, creating more endplate surface area.

Ventris cages are secured on the vertebral bodies using bone screws. A cover plate assembly prevents the screws from backing out after insertion. The cages and cover plates are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. The bone screw and cover plate screws are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. All anterior and anterolateral constructs are zero profile, reducing potential for vessel interference with the anterior column.

All Ventris cages and cover plates are manufactured using the L-PBF (laser powder bed fusion) additive manufacturing method. L-PBF allows for the formation of solid, non-porous cages with a layered porous lattice structure on the surfaces of the components, including the surfaces of the interior graft window. This intricate structure facilitates bone in-growth by providing a larger surface of implant/bone contact than a buffed surface. Interbody cages and bone screws may also be titanium anodized to allow for identification of various heights/sizes by color.

Ventris Ti Interbody cages, Ventris Ti FRA Interbody cages, Ventris Ti Open Interbody cages, Ventris Ti AL Interbody cages, Ventris Ti Lateral FX Interbody cages, Ventris Ti Lateral Interbody cages, and Ventris bone screws are also available with a Proximal HA Surface (hydroxyapatite) coating. Cages and bone screws are coated with 20mm HA layer composed of crystalline hydroxyapatite particles that mimic human bone tissue through shape, composition, and structure. This surface treatment increases implant anchoring by facilitating osseointegration and enhancing early bone growth. All Ventris devices are only available sterile packaged.

Non-sterile, reusable surgical instruments to support implantation of the system are provided for use with Ventris devices are provided in steam sterilization trays.

The provided FDA 510(k) clearance letter and summary for the Ventris IBFD focuses primarily on demonstrating substantial equivalence to predicate devices through non-clinical performance testing (mechanical, biocompatibility, sterilization, and packaging validation), rather than outlining specific clinical acceptance criteria for a diagnostic AI device or a direct human observational study.

Therefore, the requested information regarding human reader studies, training data, and ground truth establishment, which are typical for AI/diagnostic device clearances, is not present in the provided document. The Ventris IBFD is a physical intervertebral body fusion device, not a diagnostic AI or imaging analysis tool.

However, I can extract the acceptance criteria and performance related to the mechanical and physical properties of the device as described in the non-clinical testing.

Here's the information based on the provided text, with the understanding that this is for a physical medical implant and not a diagnostic AI system:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices or test articles for each mechanical test. The text mentions "worst-case subject device" and "all process steps, including HIP and Non-HIP test articles" were taken into account. This implies a selection of devices representing various configurations and manufacturing processes were tested.
• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer, Acuity Surgical Devices LLC, or a contract lab. The provenance is internal testing to establish product performance against industry standards. There is no mention of country of origin for test data, as it's not a clinical study. It's not retrospective or prospective in the clinical sense, but rather pre-market engineering validation.

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

• Not applicable. For mechanical testing of a medical device, "ground truth" is established by adherence to recognized ASTM standards and validated testing methodologies. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the standard's specifications. The document does not specify their number or qualifications but implies standard engineering and regulatory expertise would be involved in such validation.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving multiple human readers for diagnostic interpretation. For mechanical testing, the "adjudication" is inherently built into the pass/fail criteria of the ASTM standards and the rigorous interpretation of raw data against these predefined limits.

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

• No. An MRMC study is not relevant for this type of device (an intervertebral body fusion device) which is a physical implant, not a diagnostic or AI-assisted system. No human readers or AI assistance are mentioned in the context of device performance improvement for an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical implant. There is no "algorithm only" performance to evaluate. Its "performance" is its mechanical integrity and biological compatibility when implanted.

7. Type of Ground Truth Used

• The "ground truth" for the non-clinical tests is based on established industry standards (ASTM F2077, ASTM F2267, ASTM F3001) for the mechanical, material, and performance characteristics of intervertebral body fusion devices. These standards define the acceptable range of performance for such devices.

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI model. There is no concept of a "training set" in the context of its validation for FDA clearance. The design and manufacturing processes are developed based on engineering principles and existing knowledge, not through machine learning training data.

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

• Not applicable. As there is no training set for an AI model, there is no ground truth, in that sense, to establish.

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The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.

The VMS+ 4.0 system is indicated for use where Left Ventricle (LV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.

The Ventripoint VMS+ 4.0 System is a medical imaging device designed to assist clinicians in evaluating cardiac function through 3D reconstruction of heart chambers. It uses a Knowledge-Based Reconstruction (KBR) algorithm to recreate the heart's shape by capturing 2D ultrasound images at specific angles and referencing a database of MRI heart shape catalogs. The reconstructed 3D heart models are used to calculate volumes of any of the four chambers at end-diastolic and/or end-systolic phases. The software can also be installed on a separate workstation to import 3D datasets, MRI studies, and VMS+ studies.

The system employs user-driven anatomical control point placement to generate 3D models. Users manually adjust control points based on an anatomical template aligned with the patient's ultrasound images. An edge detection algorithm refines these points to match detected anatomical boundaries, ensuring model precision.

The VMS+ system includes a hardware stand with a computer, position sensors to track the 3D orientation of the ultrasound transducer and patient movement, and software to handle image capture, landmark placement, and reconstruction. By leveraging its sensor system and statistical shape analysis, the VMS+ transforms 2D ultrasound data into accurate 3D models. The workflow takes approximately 15 minutes and provides detailed volumetric data and reports for clinical review.

Here's a summary of the acceptance criteria and study information for the Ventripoint Medical System Plus (VMS+) 4.0, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For the user validation study, 160 ultrasound images of the right ventricle were used.
• Data Provenance: Not explicitly stated for the ultrasound images used in the user validation. The document is from Canada (Ventripoint Diagnostics Ltd. is based in Toronto, ON, Canada), but the country of origin of the patient data is not specified. The studies are implicitly retrospective for the user validation ("160 ultrasound images...").

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

• Number of Experts: Not explicitly stated. The text mentions "expert consensus region" for anatomical points, implying multiple experts, but does not provide an exact number.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

• Adjudication Method: "Expert consensus region" is mentioned for the user validation study on anatomical point placement. This suggests that the ground truth for point localization was established by consensus among experts, but the specific method (e.g., 2+1, 3+1) is not detailed.

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

• MRMC Study: The document describes an "internal user validation study" comparing user performance with VMS+ 4.0 to the predicate (VMS+ 3.0). This is a form of comparative effectiveness study involving human readers.
• Effect Size of Human Reader Improvement: The study demonstrated that "user performance for final point localization using VMS+ 4.0 was at least as good as the predicate, when used by the same users for the same imaging set." It also notes that the automated point placement feature's accuracy was not evaluated and should only be viewed as a "first guess." Therefore, the improvement is primarily in workflow efficiency for initial point placement, not necessarily improved accuracy of human readers with AI vs. without AI, as users still manually adjust. The text implies no negative impact on the final accuracy achieved by human users.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No standalone (algorithm-only) performance study is explicitly described for the new automated first guess feature's accuracy. The document states: "However, the study did not evaluate accuracy of the initial point placed by the AI software, which should only be viewed as a first guess and used with caution." Performance is measured based on the user's final placement after adjustment.

7. Type of Ground Truth Used

• Ground Truth Type: For the user validation study, the ground truth for anatomical point placement was an "expert consensus region." For the overall system performance, the ground truth for volume measurements and ejection fractions would likely be derived from the KBR algorithm's established accuracy against other modalities (like MRI), which is the basis of the VMS+ system itself, but this is not specifically described for the 4.0 version's validation directly.

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly mentioned in the provided text. The VMS+ system uses a "database of MRI heart shape catalogs" for its Knowledge-Based Reconstruction (KBR) algorithm, but the size of this database (training set for the KBR) is not specified for VMS+ 4.0 or its predicate.

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

• Training Set Ground Truth: The KBR algorithm references a "database of MRI heart shape catalogs." This implies that the ground truth for the training of the KBR algorithm (which reconstructs the heart's shape) is derived from MRI data, generally considered a gold standard for cardiac chamber quantification. However, the specific methodology for collecting and verifying this MRI data for the KBR training is not detailed for this device submission.

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The catheter is used for cerebrospinal fluid (CSF) shunting.

The ventricular catheter is part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for shunting of excessive CSF.

The ventricular catheter will be offered in lengths of 18 cm or 25 cm with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. The ventricular catheter contains five stripe depth markers at 3, 5, 7, 10 and 13 cm from the catheter tip. The ventricular catheter is manufactured using barium sulfate filled silicone elastomer.

The purpose of this submission is to seek clearance for modifications to the ventricular catheter which is part of the Miethke Shunt System (K020728). This submission proposes the following modification:

• adding stripe depth markers at 4, 6, 8, 9, 11 and 12 cm and point markers at 1 cm intervals on both sides of the tubing starting at 3.5 cm to 12.5 cm from the catheter tip.

The ventricular catheter is designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System, Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System, proSA Progammable Shunt System, Miethke Shunt System miniNAV valve, Miethke Shunt System Gravity Assisted Valve (GAV), and the Miethke Shunt System (DSV, ShuntAssistant, paedi-GAV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K120559/K110206/K103003/K062009/K031303/ K030698/K011030).

The provided text is a 510(k) summary for the Miethke Ventricular Catheter, which addresses a modification to an existing device rather than a new AI-powered diagnostic tool. Therefore, much of the requested information regarding AI study design, such as MRMC comparative effectiveness, standalone performance, training set details, and expert ground truth establishment, is not applicable to this document.

However, I can extract information related to the acceptance criteria and the study performed for this specific device, as it pertains to the physical catheter modification.

Here's the relevant information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated. The document mentions "All samples" in relation to meeting acceptance criteria, implying a test set was used, but the exact number is not provided.
• Data Provenance: Not explicitly stated, but it is implied to be from non-clinical laboratory performance testing.

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

• Not Applicable. This device is a physical medical device (catheter) and the testing performed relates to its physical properties (radiopacity) rather than diagnostic accuracy requiring expert interpretation for ground truth.

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

• Not Applicable. As mentioned above, this testing does not involve human interpretation or adjudication in the context of diagnostic accuracy.

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, not an AI-powered 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, not an AI-powered diagnostic tool.

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

• For the radiopacity testing, the "ground truth" would be established by the physical measurements and standards defined in the ASTM F 640-12 standard test methods. This is an objective measurement rather than a subjective interpretation requiring expert consensus or pathology.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI algorithm.

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

• Not Applicable. There is no training set for this type of device.

Study Details:

• Study performed: Non-clinical laboratory performance testing.
• Standard used: ASTM F 640-12 standard test methods for determining radiopacity for Medical Use.
• Purpose: To demonstrate that the modification (additional depth markers) to the ventricular catheter maintains its intended performance, particularly regarding radiopacity, and is substantially equivalent to the predicate device.

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The VMS+ 3.0 is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.

The VMS+ 3.0 is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired

The VMS+ was cleared under 510(k) (K173810) for use in evaluation where Right Ventricle (RV). Left Ventricle (LV). Right Atrium (RA), and Left Atrium (RA) volumes and eiection fractions are warranted or desired. The modified VMS+ (VMS+ 3.0) has the same operating principle and employs the same fundamental scientific technology to that of the cleared device.

The Ventripoint Medical System Plus (VMS+) 3.0 is a modified version of a previously cleared device (VMS+). The FDA letter and 510(k) summary do not detail a study involving AI assistance or a multi-reader multi-case (MRMC) comparative effectiveness study, nor do they specify acceptance criteria related to a general performance benchmark table or expert-based ground truth establishment as one might find for an AI/ML device.

Instead, the documentation focuses on demonstrating substantial equivalence to the predicate device (GE EchoPAC) and the reference device (VMS+) by showing that the modifications do not introduce new questions of safety or effectiveness and that the device performs as intended and as well as the predicate device(s).

Here's an breakdown of the information that is available and a note on what is not provided in the given text:

Acceptance Criteria & Device Performance:

The document broadly states that "Predefined acceptance criteria were applied during testing and were met" for specific types of nonclinical performance bench studies. However, the specific quantitative acceptance criteria for performance metrics (e.g., accuracy, precision) of volume measurements are not explicitly provided in a table within this document. It states that the device "delivers volume measurements that are equivalent in accuracy when compared with volumes obtained using the legally marketed VMS+."

Study Details (Based on the provided text):

1. Sample Size used for the test set and data provenance:

   • The document mentions "nonclinical performance bench study" and "software verification and validation testing" but does not specify the sample size (e.g., number of cases or patients) used for these tests.
   • The document does not specify the country of origin of the data or whether the data was retrospective or prospective. Given it's a bench study and software V&V, it likely refers to engineered test data or data from phantoms/previous device performance.

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

   • The document does not specify a number of experts, their qualifications, or their role in establishing ground truth for the test set as one might expect for a clinical performance study. The ground truth appears to be based on comparison to a previously cleared device's performance benchmarks.

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

   • The document does not mention any adjudication method for a test set based on expert review.

4. 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, an MRMC comparative effectiveness study was not explicitly mentioned or detailed. The device appears to be an image analysis system, but the submission focuses on its equivalence to a previous version and predicate, not on human-AI interaction or improvement. The document explicitly states "No clinical tests were conducted to support substantial equivalence for the subject device."

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

   • The "nonclinical performance bench study" and "software verification and validation" would represent standalone performance assessments of the algorithm and system. The text states these tests demonstrate the device "performs as intended" and "delivers volume measurements that are equivalent in accuracy when compared with volumes obtained using the legally marketed VMS+." This implies an algorithm-only evaluation against established benchmarks from the reference device.

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

   • The "ground truth" for the nonclinical performance bench study was the "volumes obtained using the legally marketed VMS+" (the reference device). This implies a comparison to the established performance of a prior cleared device, rather than an independent expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • The document describes the VMS+ 3.0 as an updated version of a previous device utilizing a "Knowledge-Based Reconstruction (KBR) algorithm." It does not specify a separate "training set" in the context of machine learning model development. For "knowledge-based" systems, the "training" often refers to the creation and refinement of the underlying rules and models based on anatomical principles and potentially a dataset of examples. The document does not provide a sample size for a training set.

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

   • As this is described as a "Knowledge-Based Reconstruction (KBR) algorithm" and an update to an existing system, the concept of "ground truth for a training set" as typically applied to large-scale deep learning models is not explicitly detailed. The "ground truth" for developing such a knowledge-based system would involve meticulously defined anatomical landmarks and their relationships, likely established through anatomical studies or prior medical imaging analysis principles. The document does not provide details on how the original knowledge base was implicitly "trained" or how its "ground truth" was established.

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The VMS+ is an adjunct to existing ultraging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.

The VMS+ is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.

The VentriPoint Medical System was cleared under 510(k) K150628 for use in right ventricle evaluation where RV volumes and ejection fractions are warranted or desired. This current submission is intended to expand system use to Left ventricle (LV), Right Atrium (RA), and Left Atrium (LA) volumes and ejection fractions. LV, RA, LA evaluation is accomplished by the addition of KBR heart catalogs containing a variety of heart models for each chamber. VMS+ employs the same fundamental scientific technology to that of the cleared device.

The provided text describes the Ventripoint Medical System Plus (VMS+) and its substantial equivalence to a predicate device, the Ventripoint Medical System (K150628). The submission aims to expand the system's use from only the right ventricle (RV) to include the left ventricle (LV), right atrium (RA), and left atrium (LA) volumes and ejection fractions.

However, the document explicitly states that "The VMS+, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means that a clinical study proving the device meets specific acceptance criteria for clinical performance as an AI-powered diagnostic tool was not conducted or submitted for this particular expansion of indications for use. The focus of the provided text is on demonstrating substantial equivalence based on technological characteristics and the performance of its "catalogs" for LV, LA, and RA evaluation through bench testing.

Therefore, many of the requested elements for describing clinical acceptance criteria and a study proving their fulfillment cannot be directly extracted from the provided text for the expanded indications.

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

Based on the provided text, specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for LV, LA, and RA volume/ejection fraction measurement are not explicitly stated or reported.

The document mentions "Performance bench testing of the LV, LA, and RA catalogues was completed to verify suitability for left ventricle, left atrium, and right atrium evaluation. Testing of the LV, LA, and RA catalogs consisted of a robust series of automated and manual testing to verify reconstruction accuracy."
However, the results of this testing, in terms of quantitative performance against specific criteria, are not detailed in this submission summary.

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

The text mentions "Performance bench testing" but does not specify a "test set" in the context of human subject data, nor does it provide details on sample size, or data provenance. This is consistent with the statement that clinical studies were not required.

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, as a clinical test set with expert-established ground truth is not described.

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

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

No such study is mentioned or described in the provided text. The device is described as an "adjunct to existing ultraging systems" and a "computerized 3-dimensional image processing" system, implying it's a tool for measurement rather than an AI for interpretation that would typically require MRMC studies.

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

The "Performance bench testing of the LV, LA, and RA catalogues... to verify reconstruction accuracy" could be considered a form of standalone performance evaluation for the reconstruction accuracy component. However, the quantitative results and the specific methodology are not detailed.

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

For the "reconstruction accuracy" bench testing, the ground truth would likely be a known, precisely measured physical model or a highly accurate reference standard within the testing environment. The text does not specify the exact nature of this ground truth.

8. The sample size for the training set

The device uses "KBR heart catalogs containing a variety of heart models for each chamber." This refers to a "Knowledge Based Reconstruction database." The sample size or specific details of this "training set" (in the machine learning sense) are not provided. The term "catalogs" suggests a collection of models used by the system for its reconstruction process, rather than a dynamically trained AI model in the contemporary sense.

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

The text states the device uses a "Knowledge Based Reconstruction database" for its 3-D reconstruction. For such a system, the "ground truth" for building these "heart catalogs" would typically involve precise anatomical measurements from a diverse set of real hearts (cadaveric, surgical, or high-fidelity imaging such as MRI/CT) to create a statistical model or library of normal and abnormal heart shapes and sizes. However, the specific methodology for establishing this ground truth for the KBR catalogs is not detailed in the provided document.

Summary regarding acceptance criteria and study details based solely on the provided text:

The submission for the VMS+ expanding its indications to LV, LA, and RA did not include clinical studies demonstrating performance against specific clinical acceptance criteria. The basis for substantial equivalence for these new indications rested on the device employing the "same fundamental scientific technology" as the cleared predicate and undergoing "Performance bench testing... to verify reconstruction accuracy" for the new LV, LA, and RA catalogs. No specific quantitative targets or results from this bench testing are provided in this summary, nor are details on the test set, ground truth derivation, or expert involvement for clinical validation.

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The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation and the VentriClear® II Ventricular Drainage Catheter have been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation consists of a VentriClear® Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closed-end configuration with 16 standard and 16 small sideports. The VentriClear® Ventricular Drainage Catheter has markings at 1 cm increments to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.

The VentriClear® II Ventricular Drainage Catheter consists of a VentriClear® II Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® II Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closedend configuration with 16 sideports. The VentriClear® II Ventricular Drainage Catheter has markings at 1 cm increments, starting at the 3 cm mark and extending to 33 cm, to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® II Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.

The provided text describes Cook Incorporated's VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation and VentriClear II Ventricular Drainage Catheter. This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously marketed predicate devices.

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or any other quantifiable performance indicators.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Spectrum® Ventricular Catheter K011812 and VentriClear® II Ventricular Drainage Catheter Set K071640) by comparing device characteristics and indications for use. The only difference noted is the addition of a contraindication for use in pregnant women for both the VentriClear and VentriClear II catheters.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this type of information is not present in the provided text.

The document explicitly states under "Nonclinical Testing": "There were no device changes, so no additional testing was required to support the determination of substantial equivalence to the predicate devices." This further confirms that a new performance study to establish acceptance criteria was not conducted or reported in this submission.

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The VMS system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.

The VMS system is indicated for use where RV volumes and ejection fractions are warranted or desired.

The VentriPoint Medical System was cleared under 510(k) K140153 for use in adult patients with Pulmonary Arterial Hypertension. This current submission is intended to expand system use to right ventricle evaluation where RV volumes and ejection fractions are warranted or desired in patients other than those diagnosed with PAH. Right ventricle evaluation is accomplished by the addition of a KBR heart catalog containing a variety of heart models that are not specific to PAH. All other system operational characteristics remain unchanged from the cleared device.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the submission as an expansion of use for the VentriPoint Medical System (VMS) to include a new "RV catalog" for evaluating right ventricle volumes and ejection fractions in patients beyond those diagnosed with Pulmonary Arterial Hypertension (PAH). The primary claim is substantial equivalence to the previously cleared device (K140153).

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum accuracy percentages, specific Bland-Altman limits of agreement) for the expanded use. Instead, it relies on the comparison to the existing predicate device and the rigor of the nonclinical testing for the new RV catalog.

However, we can infer the guiding principle for acceptance:

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

• Test Set for K150628 (Expanded Use): The document states, "Performance bench testing of the RV catalog was completed..." and "Testing of the RV catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy."

  • Sample Size: The specific number of cases or data points used in this "robust series of automated and manual testing" for the RV catalog is not specified in the provided text.
  • Data Provenance: This was nonclinical bench testing, meaning it likely involved simulated data, phantoms, or possibly previously acquired anonymized patient data used in a controlled laboratory setting. The document does not specify country of origin for this bench testing data. It is neither prospective nor retrospective clinical data.

• Test Set for K140153 (Predicate Device Clinical Testing):

  • Sample Size: The document refers to "Prior clinical testing was completed in adult Pulmonary Arterial Hypertension (PAH) patients which was the basis for pre-market notification K140153." The specific sample size for this clinical testing is not provided in this document.
  • Data Provenance: This was "clinical testing" in "adult Pulmonary Arterial Hypertension (PAH) patients." The country of origin is not specified, and it would have been prospective or retrospective clinical data related to PAH patients.

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

• For K150628 (Bench Testing for New RV Catalog): The document mentions "automated and manual testing to verify reconstruction accuracy." It does not explicitly state the involvement of human experts for establishing ground truth during this specific bench testing. If manual verification was performed, it would imply human review, but the number and qualifications are not specified.
• For K140153 (Clinical Testing for Predicate Device): The ground truth for the predicate device's clinical testing was "volumes derived from cardiac MRI." While cardiac MRI interpretation requires expert radiologists/cardiologists, the document does not specify the number of experts or their qualifications used to establish these MRI-derived ground truth values.

4. Adjudication Method:

• For K150628 (Bench Testing for New RV Catalog): The document describes "robust series of automated and manual testing." An explicit adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in manual testing, if any, is not specified.
• For K140153 (Clinical Testing for Predicate Device): Not specified.

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

• No, a MRMC comparative effectiveness study was not explicitly mentioned or described for either the current submission (K150628) or the predicate (K140153) in the provided text.
  • The K140153 clearance "demonstrated the substantial equivalence of VentriPoint Knowledge Based Reconstruction (KBR) with volumes derived from cardiac MRI." This suggests a comparison of the algorithm's performance to a gold standard, rather than a study comparing human readers with and without AI assistance.
  • For K150628, the justification for not conducting additional human clinical trials was that the RV catalog development was similar to the PAH catalog and that extensive bench testing was performed.

6. Standalone ("Algorithm Only") Performance Study:

• Yes, standalone performance was implicitly studied.
  • "Performance bench testing of the RV catalog was completed to verify suitability for right ventricle evaluation..." and "Testing of the RV catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy." This describes evaluating the algorithm's output directly against some form of ground truth or benchmark during bench testing.
  • Similarly, the K140153 clearance involving "substantial equivalence of VentriPoint Knowledge Based Reconstruction (KBR) with volumes derived from cardiac MRI" represents a standalone performance evaluation of the algorithm against a clinical gold standard. The device's description clarifies it's "computerized 3-dimensional image processing" and uses "Knowledge Based Reconstruction (KBR)" via a server, indicating an algorithmic analysis.

7. Type of Ground Truth Used:

• For K150628 (New RV Catalog Bench Testing): The ground truth for the bench testing was derived from methods used to "verify reconstruction accuracy" through "automated and manual testing." The exact nature (e.g., synthetic phantoms with known volumes, highly curated images with expert annotations) is not detailed, but it's related to the "Knowledge Based Reconstruction database."
• For K140153 (Predicate Device Clinical Testing): The ground truth was volumes derived from cardiac MRI. Cardiac MRI is generally considered a gold standard for cardiac chamber volume measurements.

8. Sample Size for the Training Set:

• The document mentions "Development of the RV catalog was conducted according to VentriPoint established procedures in the same way as the PAH catalog that was cleared as part of K140153." and refers to a "KBR heart catalog containing a variety of heart models."
• The specific sample size of data used to train or develop the "KBR heart catalog" or "RV catalog" is not provided in the document.

9. How Ground Truth for Training Set Was Established:

• The document mentions "Knowledge Based Reconstruction (KBR)" and the "KBR heart catalog." The KBR system fundamentally relies on a database of heart models. How these initial heart models and their associated ground truth (e.g., precise anatomical measurements, volumes) were established for the training/development of the original KBR system and the new RV catalog is not detailed in this summary. It would likely involve meticulously characterized anatomical data, potentially from diverse sources (e.g., cadaveric studies, high-resolution imaging modalities with expert segmentation).

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The VMS system is an adjunct to existing ultrasound imaging systems and is intended to record. analyze. store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS system is used to record a sequence of conventional cardiac 2-D ultrasound images with the transducer position recorded for each image acquired to compute right ventricular volumes and ejection fraction. Specific anatomic landmarks identified by the product user are transmitted by secure internet connection to a VMS server where 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension takes place using Knowledge Based Reconstruction (KBR). The results are then returned to the VMS system for display and further consideration or evaluation by the product user.

The VentriPoint Diagnostic System is a client/server platform consisting of the VentriPoint Medical System (client) and VentriPoint Services (server). The VentriPoint Medical System (VMS) is a cart based system consisting of CE Marked off-the-shelf subassemblies which accepts the digital video output from any 2-D ultrasound machine. A 3-D tracking system is connected to the ultrasound transducer using a custom sleeve. This system provides 3-D spatial coordinates for the 2-D images. After recording the 2-D images and associated 3-D spatial coordinates. a trained medical professional uses the VMS graphical user interface to place a series of points on the 2-D images corresponding to selected anatomical structures. Those points. along with their 3-D spatial coordinates, are sent bv secure internet connection to the VentriPoint Services. The VentriPoint Services use a Knowledge Based Reconstruction expert system to convert those 3-D points into a dense 3-D model of the right ventricle and sends the model back to the VMS svstem where the results are displayed on the screen. This initial rendering is reviewed for accuracy by the product user. The border contours generated from the previously placed points are displayed and may be adjusted by the user to achieve a precise fit. Improvements are made by adding. deleting or moving points on the image slices where needed. after which the information is sent by secure internet connection to the VentriPoint Services to be reconstructed. The review and reconstruction process may be repeated until the user is satisfied that the best contour fit has been made. Once the 3-D model has been approved by credentialed site personnel, quantitative right ventricle measurements are reported. The data produced by VMS is intended to support qualified licensed medical professionals in clinical decision making when used in conjunction with other patient test information.

The VentriPoint Medical System (VMS) is intended to record, analyze, store, and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is used to record a sequence of conventional cardiac 2-D ultrasound images with transducer position recorded to compute right ventricular volumes and ejection fraction. The system identifies anatomic landmarks, transmits them to a VMS server for 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension using Knowledge Based Reconstruction (KBR), and then returns the results for display and evaluation.

Here's an analysis of the acceptance criteria and study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity). However, the study aims to assess the accuracy of RV volumes and EF obtained with the VMS system compared to Cardiac Magnetic Resonance Imaging (MRI). The conclusion states that the VMS system is an accurate method of measuring RV volume and EF when compared with MRI analyzed using Simpson's method, implying that the performance met an internal or implicit accuracy standard.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: A clinical study was conducted with 75 consenting adults with Pulmonary Arterial Hypertension.
• Data Provenance: The data was collected from prospective clinical study participants. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the study likely took place in the U.S. or under U.S. regulatory standards.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with X years of experience). It mentions:

• "Analysis of the patient imaging data was completed by independent imaging core labs." This implies that qualified professionals were involved in analyzing the MRI data for ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method beyond stating that "Analysis of the patient imaging data was completed by independent imaging core labs." This suggests that the core labs provided the ground truth measurements. It does not mention multiple readers, consensus meetings, or other specific adjudication processes like 2+1 or 3+1.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this summary. The study focused on the standalone performance of the VMS system against a standard of care (MRI). The document does not describe human readers using the AI with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The clinical study assessed "the accuracy of right ventricle (RV) volumes and ejection fraction (EF) obtained with the VMS system" by comparing "Analysis of the patient imaging data... completed by independent imaging core labs" using Cardiac Magnetic Resonance Imaging (MRI) as the comparator. This indicates that the VMS system's output (an algorithm-driven result after user contouring) was directly compared to the ground truth.

7. Type of Ground Truth Used

The ground truth used was Cardiac Magnetic Resonance Imaging (MRI) analyzed using Simpson's method. MRI is considered a gold standard for cardiac chamber quantification.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for the training set for the Knowledge Based Reconstruction (KBR) expert system.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established for the Knowledge Based Reconstruction (KBR) system. It only states that the VMS system uses a "Knowledge Based Reconstruction expert system" and makes a comparison to Siemens' "Knowledge Based Reconstruction database (only Velocity Vector Imaging (VVI) component)." This implies that the KBR system would have been developed using a dataset with known RV volumes and EF values, likely derived from methods like MRI or other established volumetric measurements, but the specifics are not detailed.

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The Ventrio™ Light Hernia Patch is indicated for use in the reconstruction of soft tissue in procedures involving soft tissue repair where weakness exists, such as for the repair of hernias. The TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device.

The proposed Ventrio Light Hernia Patch with TRM Antimicrobial Coating is a selfexpanding, nonabsorbable, sterile prosthesis. It contains two primary layers of monofilament polypropylene mesh to form a positioning pocket. This pocket is stitched with a polytetrafluroethylene (PTFE) monofilament thread to an expanded polyfluoroethylene (ePTFE) sheet. The two primary layers of polypropylene mesh are constructed of a lighter weight, "larger-pore" (as defined below), knitted polypropylene monofilament approximately 0.0043" in diameter. The polypropylene mesh used in the proposed device weighs approximately 51% less per unit area than the polypropylene mesh used in the posterior layer of the predicate Ventrio Hernia Patch (0.024 g/in' versus 0.049 g/in2). The pore size of the mesh used in the proposed product is 0.082 in2 as compared to 0.019 in for the mesh used in the posterior layer of the predicate Ventrio Hernia Patch. The device contains SorbaFlex™ Memory Technology, which provides memory and stability to the device, facilitating ease of initial insertion, proper placement, The SorbaFlex Memory Technology is comprised of an extruded and fixation. polydioxanone (PDO) monofilament that is contained within a knitted polypropylene mesh sleeve. The PDO monofilament is dyed violet with D&C Violet No. 2 and fully degrades in vivo by means of hydrolysis with absorption essentially complete in 6-8 months.

The proposed Ventrio Light Hernia Patch surfaces are coated with TRM Antimicrobial Coating, which is comprised of a bioresorbable L-tyrosine succinate polymer (T) and antimicrobial agents rifampin (R) and minocycline (M). The coating is shaded orange in color due to the color of the antimicrobial agents. The TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device during the initial healing process for up to 7 days following surgery. The bioresorbable L-Tyrosine succinate polymer is essentially absorbed in 6 - 8 months based on in vitro studies.

The fascial side of the Ventrio Light Hernia Patch (polypropylene) allows a prompt fibroblastic response through the interstices of the mesh, allowing for tissue in-growth into the device. The visceral side of the device (ePTFE) has a submicronic porosity to minimize tissue attachment to the device.

Acceptance Criteria and Device Performance for Ventrio™ Light Hernia Patch with TRM Antimicrobial Coating (K113229)

This submission (K113229) outlines the substantial equivalence of the Ventrio™ Light Hernia Patch with TRM Antimicrobial Coating to its predicate devices. The "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate devices, particularly regarding its modified characteristics and the addition of an antimicrobial coating. The study performed aims to support this substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present acceptance criteria in a quantitative table format with corresponding performance results. Instead, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices across various attributes, particularly that differences do not adversely affect safety and effectiveness. The "reported device performance" is a summary of the outcomes of the various tests conducted to support this claim.

Note: The document focuses on demonstrating that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use, and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The specific quantitative acceptance limits for each test are not provided in this summary.

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

• Laboratory Bench Testing: Not specified.
• In vivo Porcine Study: The sample size is not explicitly stated in the summary.
• In vivo Dorsal Rabbit Infection Model Studies: "Two in vivo dorsal rabbit infection model studies" were performed. The number of animals per study is not specified.
• Analytical and in vitro testing (speed to kill, KDR, drug content/impurity, polymer degradation): Not specified.

Data Provenance:

• The studies mentioned (porcine, rabbit) are "in vivo" studies, implying prospective animal studies designed specifically for this submission.
• The country of origin for the data is not specified, but given the US FDA submission context, it is presumed to be conducted either in the US or in facilities compliant with relevant US regulations for animal studies.

3. Number of Experts and Qualifications for Ground Truth

The provided document describes non-clinical performance testing (bench, animal, in vitro) for substantial equivalence. It does not involve human clinical data, diagnostic interpretation, or visual assessment by experts defining ground truth in the way an AI/ML device study would. Therefore, this section is not applicable to this 510(k) summary. No radiologists, pathologists, or similar experts were used to establish ground truth in this context.

4. Adjudication Method

As this is a non-clinical device submission not involving human interpretation or diagnosis, an adjudication method for a test set is not applicable.

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

No MRMC study was conducted. This device is a surgical mesh, not a diagnostic imaging or AI-assisted interpretation device. Therefore, a study to measure human reader improvement with or without AI assistance is not applicable.

6. Standalone Performance Study

The primary studies conducted (laboratory bench testing, in vivo animal studies, analytical and in vitro testing) assessed the standalone performance of the device's physical properties, biological interactions, and antimicrobial efficacy. These are not "algorithm only without human-in-the-loop performance" in the context of AI, but rather directly evaluate the device's functional characteristics.

7. Type of Ground Truth Used

The "ground truth" for the various tests was established through:

• Direct physical measurements and engineering specifications: For bench testing of physical and functional characteristics.
• Histopathological analysis and visual observation: For in vivo animal studies (peritoneal tissue attachment, mesh contracture, tissue in-growth, host inflammatory response, microbial colonization, abscess formation). This would involve trained veterinary pathologists or researchers.
• Chemical and microbiological assays: For analytical and in vitro testing of antimicrobial efficacy (speed to kill, KDR, drug content, impurity) and polymer degradation.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for AI/ML models. This submission is for a physical medical device (surgical mesh), not an AI/ML device. Therefore, a "training set" in this context is not applicable. The device's design, materials, and manufacturing processes are developed through traditional engineering and R&D, not machine learning training.

9. How Ground Truth for the Training Set Was Established

As there is no AI/ML training set, this question is not applicable.

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The Ventrio ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias.

The proposed device, Ventrio ST Hernia Patch, is a self-expanding bioresorbable coated, partially absorbable, sterile prosthesis, containing 2 distinct layers stitched with PTFE monofilament, forming a positioning pocket. The top layer is knitted polypropylene mesh, 0.004" in monofilament diameter, and the bottom layer is Sepramesh IP Mesh. Sepramesh IP Mesh is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for tissue ingrowth into the mesh. The visceral side of the mesh is a bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

The device contains Sorbaflex Memory Technology, which provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The Sorbaflex Memory Technology is comprised of an extruded polydioxanone (PDO) monofilament that is contained within a knitted polypropylene mesh tube. The extra large oval size patches contain two separate Sorbaflex PDO monofilaments. The Sorbaflex PDO monofilament fully degrades in vivo by means of hydrolysis. Absorption is essentially complete in 6-8 months.

This document describes a 510(k) summary for the Ventrio ST Hernia Patch, a surgical mesh, seeking substantial equivalence to existing predicate devices. It does not contain information about a diagnostic AI device or associated studies. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies for an AI device.

The provided text focuses on:

• Device Description: The composition and characteristics of the Ventrio ST Hernia Patch, detailing its layers (polypropylene mesh, Sepramesh IP Mesh with PGA and bioresorbable coating), and Sorbaflex Memory Technology (PDO monofilament).
• Intended Use: Reconstruction of soft tissue deficiencies and repair of hernias, identical to predicate devices.
• Similarities and Differences: Comparisons to predicate devices (Ventrio Hernia Patch and Sepramesh IP Mesh), highlighting the replacement of certain layers with Sepramesh IP Mesh.
• Performance Data: Mention of laboratory bench testing for physical characteristics (mesh weave, pore size, density, thickness, stiffness), performance evaluations (burst strength, suture pullout strength, etc.), and preclinical studies (pig study for tissue attachment, contracture, ingrowth; rat study for degradation).
• Biocompatibility Testing: Conducted per ISO 10993 standards.

The document concludes that the Ventrio ST Hernia Patch is substantially equivalent to predicate devices based on this testing, indicating safety and effectiveness for its intended use. There is no information about AI, algorithm performance, or human reader studies.

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