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The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.

The SafeTouch PSV winged Infusion Set with/without filter consists of a winged needle (25 gauge x 3/4 inch) with an integrated safety mechanism connected to PVC tubing and a female luer connector with cap. An optional filter has been added to prevent the flow of particulate matter.

The provided text describes a 510(k) submission for the "SafeTouch PSV winged Infusion Set with/without filter." This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It explicitly states that no clinical testing was required or performed.

Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, multi-reader studies, and training/test set details are not applicable to this submission.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists the types of performance tests conducted but does not provide specific acceptance criteria or quantitative results for each test in a table format. It only states that "The results and conclusions of these tests are included in this submission" and that these tests "verify that the device is safe and effective for its intended use" and "demonstrate that the SafeTouch PSV performs equivalent to the predicate device."

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

• Sample Size: Not specified in the provided text, as the testing was non-clinical (bench testing).
• Data Provenance: Not applicable, as no human data was used. The testing was non-clinical bench testing.

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. Ground truth was established through non-clinical test methods and device specifications, not expert human evaluation.

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

• Not applicable. There was no human adjudication for a test set.

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. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (infusion set), not an AI-assisted diagnostic tool.

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

• No. This is not an algorithm or AI device. The testing was standalone in the sense that it was non-clinical bench testing of the physical device.

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

• The "ground truth" for this device's performance was based on engineering specifications and established test methods for medical devices (e.g., penetration force, leakage, material strength).

8. The sample size for the training set:

• Not applicable. There was no training set, as this is not an AI/machine learning device.

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

• Not applicable. There was no training set.

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The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.

The SafeTouch PSV winged Infusion Set with/without filter consists of a winged needle (25 gauge x 3/4 inch) with an integrated safety mechanism connected to PVC tubing and a female luer connector with cap. The tubing material is DEHP-free PVC and the filter has been added to prevent the flow of particulate matter.

Here's a breakdown of the acceptance criteria and study information for the Nipro SafeTouch PSV winged Infusion Set with/without filter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "The results and conclusions of these tests are included in this submission," and concludes that the device is "safe and effective when used as intended," implying that the device met the acceptance criteria for all listed tests. Specific numerical acceptance criteria and performance values are not provided in this summary.

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The tests conducted are "Non-clinical tests," implying bench testing. The country of origin for this testing is not specified, but the applicant (Nipro Medical Corporation) is located in Miami, FL, USA. The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not as a continuous monitoring process.

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

• Number of Experts: Not applicable. This was bench testing, not a study requiring expert clinical assessment for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Not applicable, as this was bench testing.

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 comparative effectiveness study was done. The document explicitly states: "No clinical testing was required or performed in support of this 510k submission." This is not an AI-based device, so a human-reader improvement metric is irrelevant.

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

• Not applicable. This device is a medical instrument (infusion set), not an algorithm or AI system. Its performance is evaluated through physical and functional bench tests.

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

• The "ground truth" for the bench tests would be the pre-defined engineering specifications, industry standards, and established test methodologies for medical devices of this type. It's based on engineering validated criteria rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

• Not applicable. This device is not an AI/ML 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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The SafeTouch sheet and marking pen are used to mark the location of breast lumps that a woman may find while doing her monthly breast selfexamination.

SafeTouch® Breast Exam Recording Sheet

The provided FDA 510(k) summary for the "SafeTouch® Breast Exam Recording Sheet"does not contain information about acceptance criteria or a study proving device performance against such criteria.

This document is a letter from the FDA determining substantial equivalence for marketing the device. It typically does not include detailed performance studies, which are usually found in the original 510(k) submission itself or in separate technical documentation.

Therefore, I cannot extract the requested information from the provided text.

To answer your questions, I would need access to the actual 510(k) submission document, which would detail any performance testing conducted for the SafeTouch® device.

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SafeTouch is intended as an aide in relocating points of interest discovered upon the human body, once they are found. A typical application would be to indicate the location of discovered human breast lumps.

Thin plastic film with a preprinted numbered grid and orientation markings

The provided text describes a 510(k) premarket notification for a device named "SafeTouch," a Breast Exam Recording Sheet. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, the requested information regarding a formal study proving the device meets acceptance criteria is largely not present in the provided text.

Specifically, the document states: "In our tests, a soft, supple film is necessary for the performance of the device and for patient comfort and acceptance. The preprinted, numbered grid greatly improves the reproducibility of the findings and allows for the use of a new grid sheet with each examination if desired by the examiner or the patient." This statement is a general claim about the device's characteristics and perceived benefits, not a report of a structured study with quantifiable acceptance criteria.

Below is an attempt to address your request based only on the information available in the provided text, highlighting where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The text mentions "In our tests," suggesting internal evaluation, but provides no details on the number of cases or subjects involved.
• Data Provenance: Not specified. Given the nature of the claim ("In our tests"), it is likely internal and could be retrospective or prospective, but no details are provided.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• No information provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. The document describes a comparison between SafeTouch and Docuform based on device features (preprinted grid, orientation marks, size, process for transferring marks), not a comparative effectiveness study involving human readers with and without AI assistance. The device itself is a physical recording sheet, not an AI system.

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

• Not applicable. This device is a physical tool intended to be used by humans, not an algorithm.

7. The Type of Ground Truth Used

• Not specified. Given the intended use, "discovered breast lumps," the ground truth would presumably relate to the actual, confirmed location of such lumps. However, how this was established for any "tests" is not detailed.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This is a physical non-AI device.

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

• Not applicable/Not specified.

Summary of Missing Information:

The provided 510(k) summary focuses on device description, intended use, and comparison to a predicate device to establish substantial equivalence. It does not provide details of a formal performance study with quantifiable acceptance criteria, sample sizes, expert involvement, or ground truth establishment. The mention of "In our tests" is qualitative and lacks the specific data points requested. This is typical for a Class I or unclassified device seeking 510(k) clearance, where substantial equivalence is often based on design features and intended use rather than extensive clinical performance data.

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