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The function of the VanishPoint® Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

The 1cc Tuberculin VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997 and the 1cc Allergy and Insulin Syringes were introduced in November 1997. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user.

The provided text describes a 510(k) submission for the VanishPoint® Syringe, a safety syringe designed to prevent needlestick injuries. However, the document does not contain specific acceptance criteria or the details of a study with numerical performance data for this device.

Instead, the submission primarily focuses on establishing "substantial equivalence" of the 1cc Tuberculin VanishPoint® Syringe to previously marketed versions of the VanishPoint® Syringe (3cc, 5cc, 10cc, 1cc Allergy and Insulin). This is a common pathway for medical devices seeking FDA clearance, where the device's safety and effectiveness are demonstrated by showing it is as safe and effective as a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text.

Based on the available information, here's what can be gathered, with many fields explicitly marked as "Not provided in the text" due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not provided in the text.
• Data provenance: Not provided in the text. The submission relies on the established safety and effectiveness of predicate devices.

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

• Number of experts: Not applicable/Not provided in the text. This type of information is typically found in performance studies, which are not detailed in this 510(k) summary.
• Qualifications of experts: Not applicable/Not provided in the text.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not provided in the text.

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

• MRMC study: Not provided in the text. This type of study is more common for diagnostic imaging AI systems comparing human reader performance.
• Effect size: Not applicable/Not provided.

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

• Standalone performance study: Not applicable/Not provided in the text. This device is a mechanical syringe, not an algorithm. Its operation inherently involves human interaction.

7. The Type of Ground Truth Used

• Type of ground truth: Not applicable in the context of this 510(k) summary. For devices relying on substantial equivalence, the "ground truth" is essentially the demonstrated safety and effectiveness of the predicate device(s) as cleared by the FDA. The safety claim for this specific device is "protection from accidental needlesticks" through needle retraction.

8. The Sample Size for the Training Set

• Training set sample size: Not applicable/Not provided in the text. This is a mechanical device, not an AI/ML algorithm that requires training data.

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

• Ground truth for training set: Not applicable/Not provided in the text.

Study Description (as inferred from the 510(k) Summary):

The "study" that proves the device meets its (unstated) acceptance criteria is based on the concept of Substantial Equivalence. The submission argues that the 1cc Tuberculin VanishPoint® Syringe is simply a "smaller version" of existing, previously cleared VanishPoint® syringes (3cc, 5cc, 10cc, and 1cc Allergy and Insulin versions). The implicit assumption (and the basis of the FDA clearance) is that if the design and function are sufficiently similar to devices already on the market and deemed safe and effective, then the new device also meets those standards without requiring new, extensive performance studies.

The document states: "No new issues of safety or effectiveness when prepared. The 1cc Tuberculin VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint®... the 5cc and 10cc VanishPoint® Syringes... and the 1cc Allergy and Insulin Syringes..."

This indicates that the "proof" is a comparative analysis to already-cleared devices, rather than a de novo performance study with specific acceptance criteria and detailed quantitative results.

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The function of the VanishPoint® Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint® Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected form accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

The 1cc VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, and the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997.

The provided text is a 510(k) submission for a medical device, the VanishPoint™ Syringe, seeking clearance from the FDA. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics as might be found for a novel device.

Therefore, the information required for items 1 through 9 in your request is largely not present in the provided document, as it's not typically part of a 510(k) summary focused on substantial equivalence for a Class II device like a syringe.

Here's a breakdown based on the given text:

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

• Absent. This document does not detail specific acceptance criteria or quantitative performance metrics for the device. The "Safety and Effectiveness" section states: "No new issues of safety or effectiveness when prepared. The 1cc VanishPoint® Syringe is a smaller version and is substantially equivalent to the original 3cc VanishPoint® which was introduced into the market in December 1995, and the 5cc and 10ccVanishPoint® Syringes which were introduced May 1997." This indicates a claim of equivalence rather than a report of specific test results against predefined criteria.

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

• Absent. No information is provided regarding a test set, sample sizes, or data provenance. The substantial equivalence argument relies on the existing predicate devices.

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)

• Absent. Ground truth establishment by experts is not described, as the submission does not detail a clinical study where such an assessment would be necessary.

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

• Absent. No adjudication method is mentioned.

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

• Absent. This is not relevant to a syringe device. MRMC studies are typically for diagnostic imaging devices involving interpretation by multiple readers.

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

• Absent. This is not relevant to a syringe device.

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

• Absent. No ground truth is described for the device performance. The "ground truth" for this submission concerns the functionality and safety profile of similar, already cleared devices, suggesting that the new device has "no new issues of safety or effectiveness."

8. The sample size for the training set

• Absent. No training set is mentioned, as this is not an AI/machine learning device.

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

• Absent. Not applicable.

Summary of what the document does provide regarding acceptance/equivalence:

The core of this 510(k) submission is the assertion of substantial equivalence to existing predicate devices.

• Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria in a 510(k) relevant to device safety and effectiveness are that the new device (1cc VanishPoint™ Syringe) does not raise new issues of safety or effectiveness compared to its predicate devices, and that it has the same intended use and similar technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.

• Study Proving Equivalence (Described implicitly): The "study" is the comparison to the predicate devices.

  • The 1cc VanishPoint® Syringe is stated to be a "smaller version" of the original 3cc VanishPoint® (introduced Dec 1995), and also compared to 5cc and 10cc VanishPoint® Syringes (introduced May 1997).
  • The document states: "No new issues of safety or effectiveness when prepared."

In essence, for this type of device and submission, the "proof" is the demonstrated similarity and lack of new risks compared to already cleared devices on the market. Clinical trials or detailed performance studies with explicit acceptance criteria are generally not required for such 510(k) submissions unless the device has novel technology or raises new safety/effectiveness concerns.

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The function of the VanishPoint™ Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user.

This document is a 510(k) premarket notification letter from the FDA regarding the VanishPoint™ Syringe. It confirms substantial equivalence and allows marketing of the device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory approval letter.

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