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The SeQuent® Neo PTCA Dilatation Catheters are indicated for the balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon sizes 2.00-4.00mm are also indicated for post-delivery expansion of balloon expandable stents.

The SeQuent® Neo PTCA-Catheter is a balloon-tipped, rapid exchange catheter. The distal shaft (25 cm) consists of two (2) lumina. One lumen enables inflation and deflation of the balloon, the other permits the insertion of a guidewire. Two (2) radiopaque markers indicate the length of the cylindrical portion of the balloon. The 1.5 mm diameter balloon catheter has one (1) x-ray marker only. The balloon is protected with a removable sheath which protects the initial profile. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The two markers on the shaft of the catheter appear when the tip of the balloon-tipped catheter leaves the guiding catheter (brachial: 100 cm/femoral: 110 cm). The proximal section of the catheter is a single-lumen, stainless steel hypotube with a luer adapter connected to the balloon lumen. A needle with a luer port is included for flushing the distal guide wire lumen. SeQuent Neo has a hydrophilic coated surface at the distal catheter portion. Due to this, SeQuent Neo provides optimal gliding properties during intervention.

This document describes the premarket notification (510(k)) for the SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters, outlining the device's characteristics, intended use, and substantial equivalence to predicate devices. It focuses on non-clinical performance and biocompatibility evaluations.

Here is an analysis of the provided text, addressing your specific questions, noting that this document pertains to a medical device (catheter) rather than a software algorithm or AI, so some questions are not directly applicable.

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

The document does not explicitly present acceptance criteria in a quantitative table with corresponding reported performance values for each criterion. Instead, it states that "design verification and validation (DV&V) testing in accordance with the requirements of September 8, 2010 FDA guidance Class II Special Controls Guidance Document for Certain PTCA Catheters, including ISO 10993 compliant biocompatibility evaluations" were performed. The results "demonstrate the SeQuent Neo catheter is suitable for its intended use."

The evaluations performed are listed as follows:

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

The document primarily describes bench testing for a physical medical device. Therefore, a "test set" in the context of data used for an algorithm is not applicable here. The evaluations involved physical samples of the catheters. Specific sample sizes for each bench test are not provided in this summary. The data provenance is B. Braun Interventional Systems Inc., located in Bethlehem, PA, USA. The testing is considered prospective as it's part of the premarket submission process.

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

This question is not applicable as the document describes physical bench testing and biocompatibility assessments of a device, not an algorithm requiring expert-established ground truth from medical images or clinical data. Device performance is determined through standardized engineering and biological tests.

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

This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or for establishing ground truth from expert opinions on data, which is not the nature of the tests described for this physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a PTCA balloon catheter, not an AI or imaging-related product. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant in this context.

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

This question is not applicable. The device is a PTCA balloon catheter, not an algorithm. Standalone performance for an algorithm is not relevant here.

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

For the specific evaluations listed in the document:

• Biocompatibility: Ground truth is established through standardized laboratory tests (e.g., cell culture for cytotoxicity, animal models for sensitization/toxicity) as per ISO 10993 standards.
• Non-clinical (Bench) Evaluations: Ground truth is established by engineering specifications, physical measurements, and adherence to industry standards (e.g., ISO 14971, FDA guidance for PTCA catheters). For instance, "Balloon Rated Burst Pressure" has a defined pass/fail criterion based on pressure applied.

The document also mentions a "clinical literature evaluation ... to evaluate the benefits and risks of PTCA catheter clinical use." This literature review would draw upon existing outcomes data from previously marketed PTCA catheters.

8. The sample size for the training set

This question is not applicable as the document describes a physical medical device, not a machine learning algorithm that requires a "training set."

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

This question is not applicable for the same reason as above (no training set for a physical device).

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Celsite Access Ports are indicated for patient therapies requiring repeated access to the vascular system.

• Celsite / Celsite Concept Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.
• Celsite Discreet / Celsite Dual Venous / Celsite Brachial / Celsite Babyport / Celsite Babyport S Ports are recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.

The Celsite® Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.
Celsite family infusion port product lines include: Celsite Discreet, and Celsite Concept. Celsite product lines are offered in 'standard' or 'small' sizes.

• Celsite Access ports are manufactured with a low-profile design with titanium / polysulphone or titanium / epoxy materials. Catheters are available in either polyurethane or silicone materials. Some Celsite ports are available with pre-connected catheters.
• Celsite Discreet ports are manufactured with a low-profile design with a left or right off-set exit cannula that permits a vertical incision and a 90 degree port/exit cannula. Celsite Discreet ports are manufactured with titanium / epoxy materials. Catheters are available in either polyurethane or silicone materials.
• Celsite Concept ports are manufactured with a low-profile, light weight design and have three silicone suture areas, which provide the physician with flexibility in suturing. Celsite Concept ports are manufactured with titanium / polysulphone / silicone materials. Catheters are available in either polyurethane or silicone materials.

Here's a breakdown of the acceptance criteria and study information 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

The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The evaluations mentioned are "design verification testing" and "biocompatibility evaluations," which typically involve laboratory or bench testing rather than clinical trials with human subjects.

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

The document does not mention the use of experts to establish a "ground truth" for a test set in the context of human interpretation. The evaluations described are primarily engineering and material science tests.

4. Adjudication Method for the Test Set

Not applicable. The tests described are not subject to adjudication in the same way clinical image reviews or diagnoses would be. They are objective engineering and material tests.

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

No, an MRMC comparative effectiveness study was not done. The study focuses on design verification and biocompatibility of device components for substantial equivalence, not on human reader performance with or without AI assistance.

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

Not applicable. This device is an implantable access port system, not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the tests appears to be defined by:

• Engineering specifications and standards: For design verification tests like leakage, strength, etc.
• Biocompatibility standards and accepted scientific principles: For biocompatibility evaluations.

These are objective measures and established scientific methods, rather than expert consensus, pathology, or outcomes data in the traditional sense of medical image analysis.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set.

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

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

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