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The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (

The SURFLASH® Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter.
The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin, and catheter hub), needle assembly (needle, needle housing, transparent flash chamber (needle connecting part) with filter, and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, and junction cylinder).
The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

Here's a summary of the acceptance criteria and study information for the SURFLASH® Safety I.V. Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission declares that the device "complies with the acceptance criteria established based on the predicate" and that "No deviations from ISO standards were identified in the testing to standards." However, specific numerical acceptance criteria (e.g., minimum force for needle breaking shutter) are not explicitly stated in the provided text. The table below lists the performance tests conducted and confirms that the device conformed to the relevant standards or internal requirements.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for each performance test. It mentions that "Performance testing was conducted to ensure the safety and effectiveness... verify conformity to the applicable part of ISO standards, and demonstrate substantial equivalence to the predicate device." For the "Simulated Use Study," it refers to "study participants" without specifying their number.
• Data Provenance: The testing was non-clinical performance and biocompatibility testing. The data originates from internal testing conducted by Terumo Corporation's Kofu Factory in Japan, as indicated by the manufacturer's location and the context of the submission. The text implicitly suggests retrospective data collection as these are standardized tests assessing device properties.

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

• This section is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies requiring expert ground truth in a clinical setting (e.g., image interpretation). The "ground truth" for these tests consisted of established ISO standards and internal specifications.
• For the Simulated Use Study, "healthcare workers who use these types of Safety I.V. Catheters" were involved, but their number and specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical testing against established standards and internal requirements, not a study requiring adjudication of expert interpretations.

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 submission is for a physical medical device (I.V. catheter) and does not involve AI or human readers for diagnostic interpretation.

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

• Not applicable. This submission is for 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 non-clinical performance tests was rooted in established international standards (ISO standards), FDA guidance documents (e.g., for sharps injury prevention features), and internal specifications derived from the predicate device. For the biocompatibility tests, it was adherence to ISO 10993-1 and FDA G95-1 guidelines.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that would require a training set.

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

• Not applicable. This is not a machine learning or AI device that would require a training set.

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The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (

The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin and catheter hub), needle assembly (needle, needle housing, transparent flash chamber with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, junction cylinder). The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

A non-clinical performance testing study was conducted to demonstrate the safety and effectiveness of the SURFLASH® Safety I.V. Catheter, its conformity to applicable ISO standards, and substantial equivalence to predicate devices. This study included:

• Compliance to ISO Standards: Tests were performed to confirm conformance with relevant parts of ISO 10555-1, ISO 10555-5, and ISO 23908, as detailed in the table above.
• Testing by Internal Standard: Additional performance tests, not covered directly by the listed ISO standards, were conducted against internal standards.
• Simulated Use Study: This study was conducted in accordance with FDA's Guidance For Industry and Staff, Medical Devices with Sharps Injury Prevention Features (August 9, 2005).

Detailed Information on the Study:

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

• Test Set Sample Size: Not explicitly stated for each individual test. However, the document mentions "study participants" for the simulated use study but does not quantify them. For other physical and material tests, a specific sample size is not provided, but it is implied that a sufficient number were tested to demonstrate compliance with standards.
• Data Provenance: The tests were conducted internally by Terumo Medical Corporation and its Kofu Factory in Japan. The data is retrospective in the sense that it reflects tests completed for the premarket submission.

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):

• Simulated Use Study: Healthcare workers (implied to be experts or trained professionals in I.V. catheter use) were the "participants" in the simulated use study. The number of participants and their specific qualifications (e.g., years of experience) are not explicitly stated, but the intent was to verify proper activation by those who use such devices.
• Physical/Material Tests: These tests rely on standardized methods and equipment, not expert consensus on individual cases. The "ground truth" for these tests is the quantitative measurement against defined ISO or internal standard thresholds.

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

• For the simulated use study, the "adjudication" was based on direct observation of whether "All safety features activated effectively and there were no de-activations after discarding" and if "All participants were able to read and activate the catheter safety feature without further explanation or training." This implies direct observation and evaluation against predefined criteria, not a specific 2+1 or 3+1 expert consensus method.
• For the physical and material tests, adjudication is based on whether the measured performance falls within the specified limits of the ISO standard or internal standard.

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 MRMC study mentioning AI was performed or reported. This device is a manual medical device (intravascular catheter with a passive safety feature), not an AI-assisted diagnostic or interpretative system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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. It is a physical medical device.

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

• Physical/Material Tests: The ground truth is the objective measurement of physical properties and performance characteristics against established technical standards (ISO) and the manufacturer's internal specifications.
• Simulated Use Study: The ground truth was based on the observable successful activation of the safety feature and the user's ability to follow instructions and operate the device effectively in a simulated environment. This represents a form of performance outcome directly observed.
• Biocompatibility Tests: The ground truth for biocompatibility is whether the materials meet predefined safety criteria as per ISO 10993 and FDA G95-1, assessed through specific biological tests (e.g., cytotoxicity, sensitization, systemic toxicity).

8. The sample size for the training set:

• Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. Performance is based on engineering design, material properties, and physical testing.

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

• Not applicable. See point 8.

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