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Over a long period of time Used intravenously for chemotherapy, anti-biotics; anti-viral drugs, and for parenteral nutrition. They are also used for blood transfusions or blood sampling in small quantities.

The Celsite® Implantable Port with Valved Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993-1 and have been determined to be suitable for the intended use of this product.

This looks like a 510(k) summary for a medical device (Celsite® Implantable Port with Valved Catheter) and not a study with acceptance criteria for device performance in the way you might expect for an AI/Software as a Medical Device (SaMD).

Here's an analysis based on the provided text, addressing your points as much as possible:

Analysis of Provided Text for Acceptance Criteria and Study Information:

This document is a 510(k) Pre-market Notification, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study in the way a diagnostic AI might. The "safety and effectiveness" section provided describes quality control and manufacturing processes, not a performance study against predefined metrics.

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

Based on the provided text, there are no specific numerical acceptance criteria or reported device performance metrics in the context of a diagnostic or predictive device's accuracy (e.g., sensitivity, specificity, AUC).

The document states:

• "All finished products are tested and must meet all required release specifications before distribution."
• "The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)."
• "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."

These statements refer to manufacturing quality control and product design specifications, which are internal acceptance criteria for the manufacturing process to ensure the product is built correctly, rather than external performance criteria for a diagnostic function. The document confirms that these tests are performed and the product must meet them, but it doesn't list the specific criteria (e.g., tensile strength, flow rate) or the exact reported performance values from these internal tests.

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

Not applicable. This document does not describe a performance study involving a "test set" of data in the context of a diagnostic or AI device. The "testing" mentioned refers to manufacturing quality control of the physical device.

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. There is no diagnostic "ground truth" establishment described, as this is a physical medical device (implantable port) and not a diagnostic AI system.

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

Not applicable. No diagnostic ground truth or test set adjudication method is described.

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 device, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. There is no diagnostic ground truth mentioned. The "ground truth" for this type of device would generally be conformance to engineering specifications and biological compatibility (as indicated by ISO 10993-1 testing). The document mentions material testing according to ISO 10993-1, which is a standard for biocompatibility evaluation of medical devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" as this is not an AI/ML device.

Summary based on the provided text:

The provided document is a 510(k) submission for a physical medical device. It focuses on demonstrating "substantial equivalence" to a predicate device and adherence to manufacturing quality control processes. It does not present acceptance criteria or study results in the manner one would expect for a diagnostic device or an AI/ML-based medical device. The "testing" referred to is manufacturing quality control to ensure the device meets its design specifications and is biologically compatible.

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IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag)

The Chemo Mini Spike Plus is an IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag).

The provided text describes a 510(k) submission for a medical device called "Chemo Mini Spike Plus." It outlines the device's description, materials, and substantial equivalence to a previously cleared device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes.

The document focuses on regulatory approval based on substantial equivalence to an existing marketed device (I.V. Fluid Transfer Pin cleared under K925401).

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

1. Table of acceptance criteria and the reported device performance

*The document mentions "All finished products are tested and must meet all required release specifications before distribution." And "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." However, specific quantitative or qualitative acceptance criteria (e.g., fluid flow rate, leakage rate, material strength thresholds) and the actual performance data against these criteria are not provided in this 510(k) summary.*

2. Sample sized 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.
* Data Provenance: Not specified.
The document indicates "All finished products are tested," implying testing on production units, but details on sample size, origin, or study design (retrospective/prospective) are absent.

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 device is a component (IV additive dispensing pin) and a "ground truth" based on expert consensus for diagnostic accuracy is not relevant to its regulatory submission as described here. The evaluation is focused on manufacturing specifications and material compatibility, not diagnostic performance.

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

   • Not applicable/Not specified. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed for this 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

   • Not applicable. This is not an AI/diagnostic imaging device, and no MRMC study or comparative effectiveness study is mentioned.

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

   • Not applicable. This device does not involve an algorithm or AI.

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

   • For the "testing required for release" and "physical testing," the ground truth appears to be the product design specifications and established testing procedures and parameters. This is a functional and material conformance "ground truth." Not a clinical or diagnostic ground truth.

8. The sample size for the training set

   • Not applicable. This device does not involve machine learning or a "training set."

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

   • Not applicable. This device does not involve machine learning or a "training set."

Summary of the Study (as described in the document):

The "study" described in this 510(k) summary is not a clinical performance study in the traditional sense. Instead, it refers to:

• Materials Testing: "The Chemo Mini Spike Plus is composed of materials that have been tested in accordance with the EN Standard 30993 and have been determined to be suitable for the intended use of this product." This implies material biocompatibility and suitability testing.
• Product Release Testing: "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)."
• Quality Control Testing: "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."

Conclusion:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" based on materials, form, and intended use to a previously cleared predicate device, along with adherence to manufacturing quality control specifications. It does not contain the detailed performance data, acceptance criteria, study sizes, or ground truth establishment methods typically found in submissions for diagnostic or AI-enabled devices. The "study" mentioned refers to internal quality control and material testing rather than a formal clinical or in-vitro diagnostic performance study.

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