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The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum).

The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days.

There are two types of external CSF drainage catheters:

• Ventricular catheters
• Lumbar catheters

The catheter is provided sterile and with accessories to facilitate the surgical procedures and connectors. The external CSF drainage catheters need to be connected to collection systems.

The provided FDA 510(k) clearance letter and summary discuss the "External CSF Drainage" device. However, this document does not contain information related to a study proving the device meets specific performance acceptance criteria in the context of medical imaging or AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical, clinical, and biological safety comparisons, along with non-clinical bench testing. It does not describe a study involving human readers, AI assistance, ground truth establishment, or specific diagnostic performance metrics (like sensitivity, specificity, AUC) that would typically be associated with performance acceptance criteria for an AI or imaging device.

Therefore, I cannot fulfill the request to provide:

• A table of acceptance criteria and reported device performance specific to diagnostic accuracy or AI performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document details bench testing performed, which validates physical and mechanical properties of the device, but not its performance in a clinical diagnostic or AI-assisted setting.

The information available regarding acceptance criteria and testing from the provided document is as follows:

Acceptance Criteria (Implicit from Bench Testing):

Study Details from the document (focused on Substantial Equivalence and Bench Testing):

• Sample size used for the test set and the data provenance: Not applicable for diagnostic performance metrics. Bench testing was performed on "representative samples" of the product line. No information on data provenance (e.g., country of origin, retrospective/prospective) is associated with these bench tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench tests typically involves direct measurement against engineering specifications.
• Adjudication method: Not applicable for bench testing.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI/algorithm-driven device for diagnosis.
• The type of ground truth used: For the bench tests, the "ground truth" would be the engineering specifications and established test methodologies (e.g., ISO standards) for physical and material properties. For biocompatibility, established ISO standards and toxicological assessments.
• The sample size for the training set: Not applicable (not an AI/ML device).
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document from the FDA is for a physical medical device (External CSF drainage catheters) and demonstrates its safety and effectiveness through substantial equivalence to existing devices and extensive bench testing of its physical and material properties. It does not describe a study involving AI, image analysis, or human reader performance, and therefore, cannot provide the information requested for such types of studies.

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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 XABO Catheters are used for cerebrospinal fluid (CSF) shunting.

The XABO Catheters are manufactured using barium sulfate fillcone elastomer and are impregnated with clindamycin hydrochloride and rifampicin designed to be released over time from the exterior and inner lumen surface once implanted.

The XABO Ventricular Catheters will be offered in 18 cm in length with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. Lengths are marked in 1 cm intervals starting from the catheter tip, thus enabling the surgeon to qauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 16 flow holes around the catheter circumference.

Components supplied with the XABO Ventricular Catheter include a pre-loaded stainless steel stylet and depending on the confiquration may contain a deflector.

The XABO Peritoneal Catheters measure 60 cm or 120 cm in length, 1.2 mm in inner diameter, and 2.5 mm in outer diameter. There are no length markers or wall slits on the tip is open ended. The catheter may be trimmed to the proper length.

The XABO Catheters are 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 miniNAV valve, and the Miethke Shunt System (DSV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K110206/K030698/K011030).

The provided text focuses on the 510(k) premarket notification for the XABO Ventricular Catheter, XABO Peritoneal Catheter, and XABO Catheter Set. It primarily addresses the substantial equivalence of these devices to existing predicate devices. While it mentions performance bench testing and specific tests performed, it does not explicitly state specific acceptance criteria values or detailed study results that would allow for a complete fill of the requested table.

The document indicates that the devices were tested against "performance specifications" and that the results "confirm that the XABO Catheters meet performance specifications." However, the exact numerical or qualitative specifications themselves are not provided.

Therefore, the following information is extracted directly from the provided text, and where information is not explicitly stated, it is noted as "Not explicitly stated in the provided text."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The phrase "All testing was performed on the worst-case final finished device" could imply a limited number of samples, but a specific number is not given.
• Data Provenance: The studies are described as "Performance bench testing" and "Biocompatibility testing," suggesting laboratory-based testing, not human-patient data. The country of origin of the data is not specified. It is laboratory research, not retrospective or prospective patient data.

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

• Not applicable as the testing described is bench testing and biocompatibility, not studies requiring expert interpretation of clinical data for ground truth.

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

• Not applicable for the types of tests described (bench testing, biocompatibility).

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, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence through bench and biocompatibility testing, not AI-assisted human reading.

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

• Not applicable. This device is a physical medical device (catheter), not an algorithm or AI system.

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

• For performance bench testing, the "ground truth" would be the pre-defined engineering specifications and standards (e.g., ISO 7197) that the device must meet.
• For biocompatibility testing, the "ground truth" is compliance with international standards (ISO 1099-1) and FDA guidance, ensuring that the device's biological interactions are within acceptable limits.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device that requires a training set and ground truth establishment.

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The Bactiseal Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Barium Striped Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

The Bactiseal Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter include a ventricular and/or distal (peritoneal) drainage catheter that are used as part of a CSF shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system, which is then implanted in the patient's brain. The ventricular catheter diverts the excessive CSF from the ventricles of the brain through the valve. After passing through the valve, the excessive CSF is drained through the distal (peritoneal) drainage catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Bactiseal silicone catheters have been shown in laboratory studies to reduce the colonization of gram-positive bacteria on the tubing surface. The catheters contain barium sulfate for radiopacity and have tantalum "dots" incorporated onto the silicone tubing to aid in positioning of the catheter. The Bactiseal Catheters and Bactiseal Endoscopic Ventricular Catheter are made of radiopaque silicone tubing, and the Bactiseal Barium Striped Catheters are made of clear silicone tubing with radiopaque striping. The Bactiseal Endoscopic Ventricular Catheter has a slit in the tip of the ventricular catheter in order for the catheter to be placed with the use of an endoscope.

This document is a 510(k) summary for modifications made to existing Bactiseal Catheters, Bactiseal Barium Striped Catheters, and Bactiseal Endoscopic Ventricular Catheters. The modifications primarily involve updates to MRI labeling and a change in the supplier of clindamycin hydrochloride.

Therefore, the submission focuses on demonstrating that these modifications do not introduce new questions of safety or effectiveness, rather than proving the initial efficacy of an entirely new device. This means that a conventional study with specific acceptance criteria, test sets, expert adjudication, and detailed ground truth establishment as typically seen for entirely new AI/CADe devices, is not applicable in this context. The document relies on bench testing and an equivalency assessment to the predicate devices.

Here's a breakdown of the requested information based on the provided text, with significant portions noted as "Not applicable" due to the nature of this 510(k) submission:

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

Explanation of Implied Acceptance Criteria: The document states that the testing "utilized well-established methods, including those from FDA consensus standards." For a "Pass" result in such tests, the device must meet the specific criteria outlined in those standards. For drug equivalency and effectiveness, the stated goal is to confirm the new supplier's clindamycin hydrochloride is "equivalent" and "continues to meet the same drug specifications" and efficacy. The biocompatibility assessment "determined that the introduction of the new supplier for clindamycin hydrochloride does not introduce any new issues."

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

• Sample Size for Test Set: Not specified. The document indicates "All testing was performed on production equivalent devices," but the number of devices or units tested for each benchmark is not provided.
• Data Provenance: Not applicable in the context of clinical data. The tests are benchtop performance tests. The specific labs or countries where these bench tests were conducted are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring expert-established ground truth.

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

• Not applicable. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance 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

• Not applicable. This is not an AI/CADe device.

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

• Not applicable. This is not an AI/CADe device.

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

• Not applicable in the conventional sense. The "ground truth" for the bench tests would be the established scientific and engineering principles, and the specifications of the predicate device/original drug, against which the modified device's performance is compared. For example, the ground truth for MRI safety is defined by the ASTM standards.

8. The sample size for the training set

• Not applicable. This is not an AI/CADe device, and no training set is mentioned or implied for its development or evaluation.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module: The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Oximetry Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric crtical care patients requiring of venous oxygen saturation (SvO2 and Scv02) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Pressure Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used. The Edwards Lifesciences Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

The HemoSphere Advanced Monitoring platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function. HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Technology Module (K190205 August 29, 2019). HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).

The provided FDA 510(k) summary (K221704) for the HemoSphere Advanced Monitoring Platform does not contain a table of acceptance criteria and reported device performance for the modifications made (specifically the Right Ventricular Pressure (RVP) algorithm). While it states that "All tests passed" and "demonstrated that the subject devices meet their predetermined design and performance specifications," specific numerical performance metrics and their corresponding acceptance criteria are not detailed in this document.

However, based on the information provided, here's a breakdown of the other requested information regarding the study supporting the device:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that "all performance verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications" and "All tests passed," but it does not specify the quantitative acceptance criteria or the numerical results achieved by the device against those criteria.

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

The document states: "Clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm."

• Sample Size for Test Set: Not specified. The document does not provide the number of patients or waveforms used for the clinical data collection for the RVP algorithm validation.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable/Not specified. The document mentions the collection of "clinical data (waveforms)" for the RVP algorithm validation, but it does not describe a process involving human experts to establish ground truth from this data. The RVP algorithm likely derives its parameters directly from physiological waveform data obtained from the Swan-Ganz Module and Pressure Cable, rather than relying on expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not specified. As there is no mention of human expert-established ground truth, an adjudication method is not described.

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

No. The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance in a comparative context. The device focuses on monitoring physiological parameters rather than image interpretation or diagnostic tasks involving human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The validation of the RVP algorithm described in the document is a standalone performance assessment. The statement "Clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm" implies that the algorithm's performance was evaluated based on this collected data. The conclusion that the device "has successfully passed functional and performance testing, including software and algorithm verification and validation and bench studies" further supports that the algorithm's performance was assessed. However, specific standalone performance metrics are not provided.

7. Type of Ground Truth Used for the Test Set

The ground truth for the RVP algorithm's validation would be the physiological waveform data itself, specifically from the Swan-Ganz Module and Pressure Cable. The algorithm processes this raw physiological data to derive parameters like SYSRVP, DIARVP, MRVP, PRRVP, RV dp/dt, and RVEDP. The validation would involve comparing the algorithm's derived parameters against established methods or calculations from the same direct physiological measurements (e.g., from the Swan-Ganz catheter and pressure sensors).

8. Sample Size for the Training Set

Not specified. The document mentions "clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm," but it does not differentiate between data used for design/training and data used specifically for validation (test set), nor does it specify the sample size for any such training.

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

Not specified/Not explicitly described. Given that the RVP algorithm processes physiological signals from existing, cleared hardware, the "ground truth" for any potential training would inherently be the raw physiological signals themselves, as measured by the Swan-Ganz Module and Pressure Cable. The algorithm's development would likely be based on established physiological principles and signal processing techniques to derive the mentioned RVP parameters. The document does not detail a specific "training set" or a separate process for establishing ground truth for training data beyond the intrinsic nature of the physiological measurements.

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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 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

The 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is intended for use as a stereotaxic image guided surgical navigation system during cranial surgical procedures. The Cranial Application software assists in guiding surgeons during cranial surgical procedures such as biopsies, tumor resections, and Ventricular Catheters placement. The Cranial Application software works in conjunction with 7D Surgical Machine Vision Guidance System which consists of clinical software, optically tracked surgical Pointer, a reference frame instrument and platform/computer hardware which is substantially equivalent to K181041. Image guidance tracks the position of instruments in relation to the surgical anatomy and identifies this position on DICOM images or intraoperative structured light images of the patient. The Cranial software functionality is described in terms of its feature sets which are categorized as imaging, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

The 7D Surgical System Cranial Application is comprised of 5 major components:

1. Cart
2. Arm
3. Head
4. Tracked 7D Surgical System Cranial Instruments
5. Software

Here's a breakdown of the acceptance criteria and study information for the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document states that device performance tests were conducted "on phantom models in a clinical simulated environment." It does not specify the exact sample size (number of phantom models or individual measurements) for the TRE and ATE testing.
   • The data provenance is from non-clinical studies conducted by 7D Surgical Inc. There is no information regarding country of origin for the data or if it was retrospective or prospective in the context of clinical data, as this was a non-clinical study.

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

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the non-clinical phantom model testing. It mentions that TRE and ATE evaluate "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a physical measurement standard was used as ground truth rather than expert consensus on images.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was established by physical measurement on phantom models, not by expert review requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is a surgical navigation system, not an AI-based diagnostic imaging tool that would typically involve human readers interpreting images. The document explicitly states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application."

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

   • The "Non-Clinical Accuracy" testing, specifically the TRE and ATE measurements on phantom models, represents a standalone performance evaluation of the system's accuracy in tracking and reporting positions without a human surgeon's interaction being part of the measurement of error. The system itself is designed to be used with a human surgeon.

6. The type of ground truth used:

   • For the non-clinical accuracy testing (TRE and ATE), the ground truth was established by physical measurement on phantom models. The document states it's "the ground truth position measured physically or otherwise."

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of machine learning. The 7D Surgical System uses "Machine Vision Guidance System" and structured light imaging. While these technologies involve algorithms, the submission focuses on the performance verification of the integrated system and its components. It does not detail the development or training of specific machine learning models with a distinct training dataset.

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

   • As no specific "training set" for machine learning is detailed in the document, information on how its ground truth was established is not provided. The system uses pre-calibrated geometry of instruments and structured light scanning, which inherently rely on engineering and metrological standards for accuracy rather than a labeled training dataset in the typical AI sense.

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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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