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The intended use of the Patient Safe Syringe™ is to aspirate fluid and inject fluids into the body. Additionally, the unique design of the syringe protects the luer tip from contact contamination prior to injection, thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination.

The Patient Safe Syringe™ is a 3 piece piston syringe consisting of a calibrated hollow barrel and a movable plunger with a plunger seal. One end of the barrel has a male connector (nozzle) which permits attachment to a female (hub). The collar on the luer end is slightly extended to protect and prevent contact contamination of the luer tip and is compatible with most luer fittings.

Here's an analysis of the provided text regarding the Patient Safe Syringe™, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which is a premarket notification for a medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria as might be found for novel technologies or software. This particular document makes no mention of AI or machine learning.

The document emphasizes a comparison to a predicate device and states that "The manual operation, similar design and identical materials between the predicate device and the subject device do not raise new issues of safety and effectiveness." This strongly suggests that a formal study with quantitative acceptance criteria, in the way one might expect for a diagnostic or AI device, was not conducted or is not necessary for this type of submission. The focus is on the design change (the collar) and its protective function.

Acceptance Criteria and Device Performance (Based on provided text)

Given the nature of the 510(k) summary for a piston syringe and the lack of specific performance quantitative metrics, the "acceptance criteria" are implied by the claim of substantial equivalence and the intended benefit of the design change.

Study Details (Based on provided text)

The document does not describe a formal study with a test set, ground truth, experts, or statistical analysis in the way modern AI/ML device submissions would. The evaluation appears to be based on design comparison and engineering principles rather than clinical trials or reader studies.

1. Sample size used for the test set and the data provenance: Not applicable. No test set or associated data is mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review or ground truth establishment for a test set is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is described.
4. 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 mechanical piston syringe; there is no AI component or human-in-the-loop performance measurement.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or software component.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No formal ground truth for a performance study is described. The "ground truth" for this submission is essentially the predicate device's established safety and effectiveness, and the engineering rationale for the modification.
7. The sample size for the training set: Not applicable. No training set is mentioned as there is no AI/ML component.
8. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment is mentioned.

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The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.

The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, 3mL, 5mL, 10ml, auto-retracting safety syringe with a standard luer lock needle connection.

The provided K060002 510(k) premarket notification for the Ritract Safety Syringe does not contain the specific details about acceptance criteria or a dedicated study that proves the device meets such criteria.

This document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a detailed performance study with explicit acceptance criteria. The equivalence is primarily based on:

• Mode of operation: The Ritract Safety Syringe and the predicate (BD Integra Spring Based Syringe K011103) both use the action of the plunger bottoming out to release a compressed spring, retracting the needle.
• Function: Both devices are auto-retracting safety syringes intended for injecting fluids while reducing sharps injury and preventing reuse.
• Materials used, packaging, and manufacturing processes: The document states these are also equivalent.

Therefore, I cannot populate the requested table or answer most of the questions using the provided text. The submission implies that by being substantially equivalent to a predicate device, it inherently meets the performance standards expected for such devices, rather than establishing new, explicit acceptance criteria and proving them through a dedicated study within this document.

Here's what can be inferred or explicitly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., success rate percentage for needle retraction). The implicit acceptance criterion is that the device functions to auto-retract the needle upon full plunger depression, similar to the predicate.
• Reported Device Performance: The document states, "The Ritract Safety Syringe also uses the action of the plunger bottoming out to release the compressed spring. In the case of the Ritract Syringe the spring is held in compression by a collar system which as the plunger bottoms out the interaction of the plunger profile and the collar activates the release of the spring and draws the needle into the barrel of the syringe with no protrusion of the needle tip from the device." This describes the mechanism and successful retraction, but no quantitative performance data (e.g., 100% success rate across X number of trials) is provided in this summary.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned; no specific performance study data is included in this summary.

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

• Not applicable as no specific test set and ground truth establishment methodology are described in this regulatory submission.

4. Adjudication method for the test set:

• Not applicable.

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/software device.

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

• Not applicable. This is not an AI/software device.

7. The type of ground truth used:

• Not applicable, as no formal ground truth for a test set is described. The "truth" in this context is the successful demonstration of the device's mechanism of action (needle retraction) as described, which is considered equivalent to the predicate.

8. The sample size for the training set:

• Not applicable, as this is not an AI/software device with a distinct training set.

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

• Not applicable.

Summary of Device and Equivalence Statement:

The Ritract Safety Syringe is a sterile, single-use, disposable, non-reusable, 3mL, 5mL, 10mL auto-retracting safety syringe with a standard luer lock needle connection. It is indicated for the injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.

The submission claims substantial equivalence to the BD Integra Spring Based Syringe (K011103) based on:

• Similar mode of operation (plunger bottoming out activates a mechanism to retract the needle).
• Similar function (auto-retracting safety syringe).
• Similar materials, packaging, and manufacturing processes.

The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical trials or detailed performance studies with explicit, quantitative acceptance criteria in the summary document. The FDA's issuance of the 510(k) clearance (JUN - 2 2006) indicates they agreed with the substantial equivalence claim.

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