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The Permaseal device is composed of a delivery device and an implant that is deployed to facilitate access and closure. The deployment site is accessed via minimally invasive surgery or percutaneous surgery. The device is compatible with a 0.025" guide wire. The implant is designed to close punctures, incisions or ostomies in the cardiac apical tissue up to 30F, or 10mm in diameter.

The device features a handle designed to facilitate proper device placement and allow for singlehanded deployment of the implant. The handle contains a trigger that actuates the device and incorporates a mechanical safety. The handle functions as a tool to grip and position the device. It contains the actuating mechanism to control deployment of the anchor using a trigger mechanism.

The implant is composed of an array of eight polypropylene anchors connected by a 2-0 braided, coated polyester suture U.S.P, as seen in Figures 2 and 3. The suture was separately cleared to market through K021019.

The suture is threaded through the eyelets of the eight anchors in a circular pattern and terminates in a surgical knot. The excess suture provided is referred to as the loop limb. The opening that is formed in the center of the implant is referred to as the 'operative window.' The knot is tightened at the end of the procedure by advancing the knot pusher toward the implant. The knot pusher is shown in Figure 4. above. The knot pusher is affixed to the insertion tube by the knot pusher retainer and is removed from the tube before the implant is deployed.

Upon release of the safety and actuation of the trigger, a spring-loaded pusher tube connected distally to 8 pusher pins is released, transmitting the force of the spring through the pusher pins to the anchors, simultaneously embedding the 8 anchors firmly into the tissue at the target site.

The anchors are deployed at a pre-determined depth with the sutures resting on the surface of the heart. Once deployed, the polyester suture and eight anchors create an 'operative window' in a pattern approximating that of a purse-string suture pattern. The anchors provide a secure attachment site for the suture that connects the multiple anchors together. The suture serves as a means to bring the incised tissue edges into apposition so as to close the puncture. Advancing the surgical knot in the suture with the knot pusher creates sufficient tension on the anchors to pull them and the tissue together so as to close punctures, incisions or otomies in the cardiac apical tissue up to 30F, or 10mm in diameter.

AI/ML Overview

Below is a summary of the acceptance criteria and the studies that demonstrate the Permaseal device meets these criteria.

Acceptance Criteria and Reported Device Performance

Test/Characteristic	Purpose	Acceptance Criteria	Reported Device Performance/Results
Biocompatibility
Delivery System Cytotoxicity	Assessment of biological reactivity of mammalian cell cultures following incubation with test device extracts	Non-cytotoxic	Non-cytotoxic
Delivery System Sensitization	Determine the potential for the test device extract to elicit contact dermal allergenicity	Non-sensitizing	Non-sensitizing
Delivery System Irritation	Assess potential of the device to produce irritation following a single intradermal injection of specific extracts prepared from a test device	Non-irritant	Non-irritant
Delivery System Hemolysis	Evaluate the hemolytic potential of test articles	Non-hemolytic	Non-hemolytic
Delivery System Systemic Toxicity	Screen test article extracts or solutions for potential toxic effects as a result of a single-dose systemic injection in mice.	Non-toxic	Non-toxic
Delivery System Pyrogenicity	Evaluate the test device extract for leachates that have the potential to induce material-mediated pyrogenicity following a single dose injection	Not pyrogenic	Not pyrogenic
Implant Cytotoxicity	Evaluate an extract of a test article for cytotoxicity to mammalian cells in culture	Non-cytotoxic	Non-cytotoxic
Implant Sensitization	Evaluate the potential of test article to cause delayed dermal contact sensitization	Non-sensitizing	Non-sensitizing
Implant Irritation	Evaluate the local dermal irritation of a test article extract following intracutaneous injection in rabbits	Non-irritant	Non-irritant
Implant Acute Systemic Toxicity	Evaluate acute systemic toxicity of test article extract following injection in mice	Non-toxic	Non-toxic
Implant Pyrogenicity	Determine whether an extract of the test article induced a pyrogenic response following intravenous injection in rabbits	Non-pyrogenic	Non-pyrogenic
Implant Hemocompatibility	Evaluate the potential to cause hemolysis	Non-hemolytic	Non-hemolytic
Implant Genotoxicity	Evaluate the mutagenic potential of the device test article by measuring its ability to induce DNA reverse mutations in S. typhimurium and E. coli in the presence and absence of microsomal enzymes	Non-mutagenic	Non-mutagenic
Shelf Life/Sterility
Packaging Validation	Produce objective evidence that the package meets requirements for seal visual inspection, peel strength, burst values, and bubble/dye penetration.	Seal Visual Inspection: No burns, channels, voids, pleats or foreign matter; Peel Samples: Minimum peel force 1 lb/in; Burst Samples: Minimum burst values recorded; Bubble Samples: No seal leaks/seal bubbles accepted; Dye Samples: No complete seal dye penetration accepted	All tests passed
Sterilization Validation	Evaluate the sterilization procedure for the Permaseal device and its ability to achieve a Sterility Assurance Level of 10-6.	Bioburden, Bacteriostasis/Fungistasis, EO Residual, Bacterial Endotoxin, EtO Acceptable Limit met pre-identified criteria.	All tests passed
Shelf Life (1 year)	Evaluate the impact of one year real time aging on the Permaseal device.	Visual and Functional assessments (i.e., successful ex-vivo device deployment) at baseline and one year.	All visual inspections and functional tests passed
Environmental Conditioning & Package Integrity	Evaluate devices after being subjected to a range of temperatures, humidity and simulated distribution testing.	Verification testing, performance testing (i.e., successful deployment in porcine heart, compatibility with sheath, functionality of suture grip, knot pusher, knot and anchor eyelets), packaging verification testing, average peel force >1.0lbf/in.	All tests passed, any deviations appropriately explained
Package Integrity	Demonstrate that the Permaseal device packaging will provide sufficient protection ensuring device and package integrity are not compromised.	Seal Peel: No irregularities or delamination of the seals observed, peel strength greater than 1 lbf/in; Dye Penetration: No dye penetrates through seal.	All tests passed
Bench Performance Testing
Design Verification Testing	Ensure that the design meets the design inputs as defined in the Product Performance Specifications.	All acceptance criteria met, any deviations appropriately justified.	All passed
Device Weight	Ensure that the device weight meets specification.	Device weight meets specification.	All passed
Dimensional Verification	Ensure that overall device length, height, width; insertion tube length, diameter; anchor overall length; knot location on suture meet specification.	All specified measurements meet specification.	All passed
Color/Appearance Verification	Ensure that the handle, insertion tube and safety meet color/ appearance specifications.	Handle, insertion tube and safety meet color/ appearance specifications.	All passed
Device Operation Verification	Ensure that the device operates to specification by evaluating trigger safety functionality, guidewire compatibility, trigger pull force, safety disengagement force, inability to fire with an engaged safety, anchor deployment depth.	Device operates to specification for all listed parameters.	All passed
Implant Performance Verification	Evaluate if the implant meets criteria for accommodating intended sheath sizes, suture grip detachment, knot pusher functionality, suture knot functionality and slip force, anchor eyelet functionality, anchor barb extraction, and peak anchor insertion force.	Implant meets all listed criteria.	All passed
Performance Verification Testing	Conduct functional performance verification testing in porcine ex vivo hearts.	All criteria passed.	All criteria passed
Anchor Pull Out Test	No anchor pull out from the tissue at a tensioning force of 1N.	No anchor pull out from the tissue at a tensioning force of 1N.	Passed, no anchor pull out
Leakage Test	No leakage of solution shall occur at a pressure of 180 mmHg.	No leakage of solution shall occur at a pressure of 180 mmHg.	Passed, no leakage
Animal Study
Chronic Animal Study (30 Days)	Demonstrate the performance of the Permaseal Device compared to traditional mattress suture closure in facilitating transapical access and wound healing chronically in a porcine model.	Success in facilitating transapical access and respect to wound healing chronically (30-day survival) in a porcine model with no significant adverse clinical observations or procedural complications.	All animals survived to the designated endpoint with no significant adverse clinical observations or procedural complications related to the test devices. Pathological changes were minimal and expected.
Acute Investigational Analysis	Evaluate the performance of the Permaseal in an in vivo porcine model, assessing polypropylene anchors, suture/insertion tube interaction, tensioning for wound closure, implant deployment, sheath passage, and hemostasis.	Assessment of performance of polypropylene anchors, suture and insertion tube interaction during deployment, tensioning process for wound closure, implant deployment performance, passage of transapical sheath, and achieving hemostasis.	Three separate deployments were completed in one animal with acceptable results.
Clinical Study (STASIS)
Primary Effectiveness Endpoint	Rate of pulsatile bleeding requiring significant surgical intervention (more than one pledgeted suture) at discharge and at 30-day follow-up.	Literature derived performance goal was 15%.	6.5% (2/31), meeting the primary effectiveness endpoint target.
Safety Endpoint	All adverse events (AEs) and serious adverse events (SAEs) occurring during the TA-TAVR procedure and follow-up periods of 30 days, 90 days and 12 months, using VARC 2 definitions.	Favorable safety profile (low rates of deaths, myocardial infarctions, strokes; minimal device related SAEs).	No deaths, myocardial infarctions or strokes at 30 days. Favorable safety profile maintained at 90 days. Two device-related SAEs early in the study (resolved with training).

Study Details: PERMASEAL Device

2. Sample Size and Data Provenance

Test Set (Clinical Study - STASIS):
- Sample Size: 34 patients were enrolled. 31 patients were included in the primary effectiveness analysis (1 roll-in and 2 protocol violations excluded).
- Data Provenance: Prospective, multi-center, conducted at five clinical sites in Germany and the Netherlands.

3. Number of Experts and Qualifications (for Ground Truth)

Clinical Study (STASIS): The document does not explicitly state the number or specific qualifications of experts used to establish "ground truth" for the clinical endpoints (e.g., diagnosis of pulsatile bleeding, assessment of AEs). However, it is implied that clinical trial investigators (most likely interventional cardiologists or cardiac surgeons) at the participating sites made these assessments based on standard clinical practice and the Valve Academic Research Consortium (VARC) 2 definitions for safety events. The study design is observational, and the endpoints are objective clinical outcomes.

4. Adjudication Method (for Test Set)

The document does not explicitly mention a specific adjudication method (e.g., 2+1, 3+1). Clinical events and outcomes would typically be recorded by the study investigators at each site. For Serious Adverse Events (SAEs), causality assessment (relation to device or procedure) was performed, indicating a review by the study team or an independent committee. The two device-related SAEs were attributed to user error and a need for additional training, suggesting internal review of events.

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

No, an MRMC comparative effectiveness study was not done. The STASIS study was designed to evaluate the Permaseal device's performance against a literature-derived performance goal (for the primary effectiveness endpoint) and observed clinical outcomes, rather than comparing human readers with and without AI assistance. The Permaseal is a physical medical device, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) study was not conducted. The Permaseal is a physical medical device for apical closure, not an algorithm or AI system. Its performance was evaluated in bench tests, animal studies, and a clinical study with human use.

7. Type of Ground Truth Used (for Test Set)

Clinical Study (STASIS): The ground truth for the primary effectiveness endpoint was based on clinical observation and intervention (rate of pulsatile bleeding requiring significant surgical intervention). For safety endpoints, the ground truth was based on clinical diagnoses and outcomes data as defined by the Valve Academic Research Consortium (VARC) 2 definitions, including mortality, myocardial infarction, stroke, vascular complications, etc.
Animal Studies: Ground truth was based on direct observation (e.g., survival, freedom from complications, pathological changes) and functional assessment in porcine models.
Bench Studies: Ground truth was based on engineering specifications and measurements and functional performance tests.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI algorithm, as the Permaseal is a physical device. All described studies are for evaluating the device's safety and performance itself.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for an AI algorithm. The studies described are for validation of the physical device.

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