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The POLYSITE implanable infusion Port is indicated for long term access to the central venous system and allows for repeated vascular access.

POLYSITE Implantable Infusion venous access ports are used to administer chemotherapy, antibiotics and antiviral drugs. They can also be used for parenteral nutrition, collection of blood samples and transfusion of blood products.

A non-coring needle must be used to access POLYSITE Implantable Infusion Ports.

Some references of POLYSITE Pressure Injectable Implantable Infusion Port-PI references) can be used for high pressure injection of contrast media during diagnosic studies. The maximum flow rate of power injector equipment used with the pressure injectable port may not exceed 5 ml/s.

For high pressure injection of contrast media, a high pressure needle must be used to access the POLYSITE Pressure Injectable implantable Infusion port. The manufacturer recommends the use of PPS PI Pressure Injectable Safety Huber needle.

POLYSITE Implantable Infusion Port is composed of a radiopaque dome or housing and a self sealing septum, connected to a radiopaque catheter by a connecting ring (supplied unassembled). The port is accessed percutaneously by using a non-coring needle.

The POLYSITE® Implantable Infusion Port is indicated for long-term access to the central venous system and for repeated vascular access. It can be used to administer chemotherapy, antibiotics, and antiviral drugs, for parenteral nutrition, and for collecting blood samples and transfusions. Some references of the POLYSITE Pressure Injectable Implantable Infusion Port-PI can also be used for high-pressure injection of contrast media during diagnostic studies, with the maximum flow rate of power injector equipment not exceeding 5 mL/s.

The device's acceptance criteria and performance data are based on safety and functionality testing and biocompatibility assessments, rather than a clinical study. The device did not require a clinical trial to demonstrate safety and effectiveness because it was found to be substantially equivalent to previously marketed predicate devices (PowerPort isp Implantable Port with attachable 8Fr. Chronoflex Polyurethane Catheter (K072215) and Slimport Titanium implantable port with attachable 6F Chronoflex Open-ended single-lumen venous catheter (K870260)).

Here are the details regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The information provided specifies that "Performance data included with this submission" consisted of Biocompatibility testing according to ISO 10993-1: 2009 and Safety and functionality testing "in accordance with the FDA's 'Guidance on 510(k) Submissions for Implanted Infusion Ports' dated October 1990." These are laboratory/bench tests, not studies with human subjects. Therefore, the concept of a "test set" in the context of clinical data, or data provenance (country of origin, retrospective/prospective clinical data) and human sample size, is not applicable here. The data provenance would be the testing laboratories in France where Perouse Medical performed these in vitro and bench tests.

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

This is not applicable since no clinical studies involving expert interpretation of data or ground truth establishment from patient cases were conducted or required. The "ground truth" for the performance data comes from the objective results of the specified physical and biological tests.

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

This is not applicable as there was no clinical test set requiring expert 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

No such study was done. The device is a physical medical device (implantable infusion port), not an AI-powered diagnostic or assistive technology.

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

This is not applicable as the device is a physical medical device and does not involve an algorithm.

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

The "ground truth" for the device's performance was established through:

• Standardized laboratory protocols and measurements for physical and mechanical properties (e.g., leak testing, tensile strength, flow rate).
• Internationally recognized biocompatibility standards (ISO 10993-1: 2009) for biological safety.
• FDA guidance documents for specific performance testing related to implanted infusion ports.

8. The sample size for the training set

This is not applicable as there was no "training set" in the context of an algorithm or machine learning. The device design and testing are based on engineering principles and regulatory standards.

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

This is not applicable for the same reason as above.

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The SEAL ONE Radial compression Device is used for coronary angiography and angioplasty procedures practiced in a radial approach to compress the puncture site.

The SEAL ONE® may be used on the right or left wrist. The device placement time should be set on the time indicator, which should subsequently be locked. Wrist strap is secured by a strap which is clipped. The wrist strap can be twisted in to shorten it. Compression is applied by turning the compression knob clockwise. Decompression is done by pressing simultaneously on the safety button and turning the compression knob anticlockwise. It is possible to write on the wrist strap with ballpoint pen or indelible felt pen, to indicate the times at which the device was checked and steps during decompression. The dedicated positions for this are shown by the following symbols at the ends of the wrist strap.

The PEROUSE MEDICAL SEAL ONE® Radial Compression Device is intended for use in coronary angiography and angioplasty procedures to compress the puncture site when a radial approach is used. The device's performance was evaluated through various preclinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The provided summary describes a submission for 510(k) clearance, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (TR BAND™) and thorough preclinical testing rather than a clinical trial with a large test set of patient data.

• 2. Sample size used for the test set and the data provenance:
  The document does not specify a patient-based test set size or data provenance for evaluating the device's performance through a clinical study. The performance data listed (biocompatibility, safety and functionality bench testing, and "used on a patient in the coronary and angiography environment") appear to be from preclinical and possibly limited clinical observations (without formal study design details). The reference to "used on a patient" is vague and does not indicate a structured sample size.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  This information is not provided. Given the nature of the tests (bench testing), external expert adjudication of ground truth in the traditional sense would not be applicable in the same way it would be for diagnostic AI. The "ground truth" for bench tests is adherence to design specifications and functional requirements.

• 4. Adjudication method for the test set:
  An adjudication method like 2+1 or 3+1 is not applicable as there was no formal clinical study with a test set requiring independent assessment of outcomes. The evaluation involved successful completion of predefined internal protocols for bench testing and potentially observational use.

• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size of human readers improve with AI vs without AI assistance:
  No MRMC comparative effectiveness study was performed or is relevant to this device. This device is a radial compression device, not an AI-assisted diagnostic tool.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
  This question is not applicable as the SEAL ONE® is a physical medical device, not a software algorithm.

• 7. The type of ground truth used:
  The "ground truth" for this device's performance was based on engineering specifications, functional requirements, and internal test protocols. For biocompatibility, it would be adherence to relevant ISO standards. For functionality, it was the successful operation of the device as designed during bench testing.

• 8. The sample size for the training set:
  This question is not applicable as there is no mention or implication of a training set, as the device is a physical medical device, not a machine learning algorithm.

• 9. How the ground truth for the training set was established:
  This question is not applicable for the reasons stated above.

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The PPS PI® curved safety Huber needle is indicated for:

• Administration or withdrawal of fluids through implanted ports.
• Pressure injection of contrast media into the central venous system only with an implantable infusion port that is also indicated for pressure injection.
  -The maximum recommended infusion rate at 11,8 cPs is :
• 5mL/sec. for 19 Ga. needle
• 5 mL/sec. for 20 Ga. needle
• 2 mL/sec. for 22 Ga. needle.
• The PPS PI® Curved Safety Huber needle is indicated to PPS PI® Curved Safety Huber needle does not protect against other routes of blood-borne pathogen transmission.

The PPS PI® Pressure Injectable Safety Huber Needle is a curved safety Huber needle mounted with one connection line ideal for accessing pressure injectable ports. This device allows pressure injection of contrast media during CT (computerized tomography) scans or MRI (computerized tomography) and is MR Conditional. The PPS PI® curved Huber needle is available in various lengths and diameters; with or without a lateral injection site. Luer-Lock connectors, are provided, on which closed protective caps are screwed (end of the main line and of the Y site) which must not be used as sealing caps. One clamp is also provided (2 clamps for references with "Y" site) PPS PI® Pressure Injectable Safety Huber Needle is single use

The provided 510(k) summary (K120261) describes the PPS PI® Pressure Injectable Safety Huber Needle. This document does not contain the level of detail required for a comprehensive description of acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML powered device. This device is a medical instrument (needle) and not an AI/ML algorithm.

Therefore, many of the requested fields cannot be filled. However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format typically seen for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, performance is demonstrated through general safety and functionality testing and biocompatibility.

• 5 mL/sec. for 20 Ga. needle
• 2 mL/sec. for 22 Ga. needle. |
  | Needle Stick Prevention | Indicated to prevent blood-borne pathogen exposures caused by accidental needle punctures. |

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

This information is not provided in the 510(k) summary. The document generally states "Performance data included with this submission" which typically refers to internal test reports, but the specifics of sample sizes, data provenance (e.g., country of origin, retrospective/prospective nature) for the safety and functionality tests are not disclosed in public-facing summarized documents like the 510(k).

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

This information is not applicable/provided. For a physical medical device like a Huber needle, ground truth is typically established through engineering specifications, material testing standards, and in vitro or in vivo (if applicable) performance testing against defined physical and mechanical benchmarks, not by expert consensus in image interpretation or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable/provided for this type of device. Adjudication methods like 2+1 or 3+1 are relevant for studies where human readers are making subjective interpretations, typically in diagnostic imaging with AI.

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

No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. MRMC studies are typically used to evaluate the impact of AI on human reader performance, which is not relevant for this physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device would be based on:

• Engineering Specifications: Adherence to design tolerances, material properties, and mechanical strength requirements.
• Biocompatibility Standards: Evidence that the materials used do not elicit adverse biological responses.
• Functional Testing: Verification that the needle delivers fluids at specified rates, the safety mechanism activates correctly, and the luer-lock connectors function as intended.
• Predicate Device Equivalence: Comparison to legally marketed predicate devices in terms of intended use, materials, design, and functionality.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is not an AI/ML algorithm, so there is no "training set."

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

This information is not applicable/provided. As above, there is no "training set" for a physical medical device.

Summary regarding the device and AI/ML criteria:

The K120261 submission pertains to a physical medical device, the PPS PI® Pressure Injectable Safety Huber Needle. As such, the concept of "acceptance criteria" and "studies" as typically applied to AI/ML powered devices (e.g., diagnostic accuracy, sensitivity, specificity, MRMC studies) are not directly relevant. The performance data focuses on biocompatibility, safety, functionality, and specific flow rates, which are typical for this class of device. The primary method of demonstrating effectiveness and safety, and therefore meeting acceptable criteria, is through comparison to predicate devices and adherence to general device testing standards.

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