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The U.S. Technologies, Inc., Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety piston syringe which is intended for injection of fluids into the body while reducing the risk of a sharps injury and potential reuse of the syringe.

The U.S. Technologies, Inc., Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable 5 mL safety syringe, provided with a detachable 22 gauge, 11/4 inch needle.

The provided text describes the U.S. Technologies, Inc. Retractable Safety Syringe (K032247), a medical device, and its submission for 510(k) clearance. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, as typically presented with performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (E.N.S.I. Retractable Safety Syringe K003348, K000572) based on similarities in intended use, design, technological, and operational characteristics.

Here's what can be extracted and what is missing, based on your requested information:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document. The submission states: "Bench testing shows that the operation and performance of the U.S. Technologies, Inc., Retractable Safety Syringe is equivalent to the E.N.S.I. product." However, it does not present a table of specific performance metrics or acceptance criteria for either the new device or the predicate.

The document mentions "standards conformity" and "testing according to FDA guidance (including a simulated use test)" but does not detail the specific criteria or the results of these tests.

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

This information is not provided. The document mentions "bench testing" and "simulated use test" but does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

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. The assessment appears to be based on bench testing of physical characteristics and function, rather than diagnostic interpretation requiring expert consensus.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image reading), which doesn't seem to be the primary focus of this device's performance evaluation.

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 is not applicable to this device. This device is a retractable safety syringe, a physical medical device, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.

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

This is not applicable to this device. This device is a physical syringe and does not involve an algorithm.

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

The "ground truth" for this device would likely be its ability to perform its intended mechanical functions (fluid injection, needle retraction, preventing reuse) reliably and safely, as demonstrated by engineering and simulated use tests. However, the specific ground truth metrics or how they were established are not detailed in this summary. It relies on equivalence to a predicate device.

8. The sample size for the training set:

This is not applicable to this device. There is no "training set" as this is not a machine learning or AI-based device.

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

This is not applicable to this device.

In summary:

The provided 510(k) summary for K032247 focuses on demonstrating substantial equivalence to a predicate device based on design, intended use, and general operational characteristics, augmented by unspecified "bench testing" and "simulated use test." It lacks the detailed performance metrics, acceptance criteria, study designs, sample sizes, and expert panel information that would typically be provided for a comprehensive performance study, especially for devices where quantitative performance thresholds are critical for proving effectiveness. The nature of this device (a syringe) suggests that evaluation focused on mechanical reliability and safety features rather than diagnostic accuracy or human performance improvement.

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The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable 3 mL safety syringe, provided with or without needle in various product configurations.

The provided text describes a 510(k) submission for a medical device, the DuoPro Safety Syringe (DuoProSS™). However, it does not contain the detailed performance study results, specific acceptance criteria, or the methodology (like expert consensus, sample sizes for training/test sets, or MRMC studies) that would typically be associated with software or AI-driven diagnostic devices.

The document is a premarket notification for a physical medical device (a syringe) and focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and bench testing of performance, rather than a clinical study evaluating diagnostic accuracy.

Therefore, many of the requested categories for AI/software-driven device evaluation are not applicable or not explicitly stated in this document.

Here's an attempt to answer based on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document mentions "Bench testing" and "simulated use test" but does not provide the number of units tested.
• Data Provenance: Not applicable in the context of clinical data for an AI/software device. For the physical device, testing was conducted to demonstrate equivalence, likely in a lab setting by the manufacturer (M.K. Meditech Co., Ltd. in Taiwan).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic image or data set. The performance testing relates to physical device functions and safety mechanisms.

4. Adjudication method for the test set

• Not applicable. As noted above, this is about physical device performance, not diagnostic accuracy evaluation.

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 device is a physical syringe, not an AI software.

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

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

7. The type of ground truth used

• The "ground truth" for this device would be its functional specifications and safety requirements as defined by regulatory standards (e.g., ISO, FDA guidance) and the performance of the predicate device. For example, a "ground truth" for retraction would be successful, complete retraction every time without user error, as designed. For biocompatibility, it would be the absence of adverse biological reactions.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

In summary, the provided 510(k) summary focuses on demonstrating that a new physical medical device is "substantially equivalent" to an already legally marketed predicate device. This is primarily done through comparing design, intended use, technological characteristics, and showing that "bench testing" supports equivalent performance. It is important to note that the depth of detail requested for AI/software devices (e.g., sample sizes for training/test, expert consensus, MRMC studies) is not typically part of a 510(k) summary for a physical, non-diagnostic device.

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