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The EasyPoint® Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure.

The EasyPoint® Blood Collection Plus is a blood collection tube holder with an attached needle, and is intended to facilitate blood collection from patients. The device contains a sharps injury prevention feature (needlestick prevention feature - chamber, utilizing automated retraction technology) which covers the entire needle when activated. The EasyPoint® Blood Collection Plus aids in the prevention of needlestick injuries during normal handling and disposal, and prevents re-use of a contaminated needle. The EasyPoint® Blood Collection Plus allows for multiple sample draws from a single venipuncture. After blood collection is complete, the retraction mechanism is activated and the device disassembles itself by retracting the contaminated needle into the safety chamber. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. The safety mechanism can be activated using one step and allows the user's hands to remain behind the sharp during activation.

This document is a 510(k) summary for the EasyPoint® Blood Collection Plus device, which is a blood collection tube holder with an attached needle and aims to prevent needlestick injuries. The document describes the device, its intended use, comparison to a predicate device (Vacutainer® Eclipse™ Blood Collection Needle), and performance data to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a direct table of "acceptance criteria" with a corresponding "reported device performance" per se. Instead, it describes various types of performance testing conducted and states that the device "meets requirements for its intended use" based on the results.

Here's an attempt to infer and organize the information into a table format based on the "VII. PERFORMANCE DATA" section:

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

• Sample Size for Test Set: The document mentions "Simulated Use Study" and "Mechanical Testing," but it does not explicitly state the numerical sample size for any of these tests. It refers to "Additional details and reports can be found in the body of this submission," implying these numbers would be in the full submission.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. The "Simulated Use Study" sounds like a prospective human factors validation study.

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

• Number of Experts: For the "Simulated Use Study," the document mentions "a variety of healthcare workers." It does not specify the number of experts or readers.
• Qualifications of Experts: It refers to "healthcare workers," but does not detail their specific qualifications (e.g., years of experience, specific roles).

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set, especially in the context of user studies or performance evaluations requiring subjective assessments. Since these are performance tests for a physical device, and not an AI model, expert consensus or adjudication in the traditional sense might not apply in the same way.

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 document is for a physical medical device (blood collection tube holder with needlestick prevention), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable and was not performed.

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

• As stated above, this is a physical device, not an algorithm. Therefore, a standalone performance evaluation of an algorithm does not apply and was not done. The mechanical and sterilization tests would be closest to "standalone" in that they test the device's inherent properties.

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

For a physical device, "ground truth" is established differently than for diagnostic algorithms.

• Biocompatibility: Ground truth is established by adherence to recognized ISO standards and FDA guidance, and the results of laboratory tests.
• Mechanical Testing: Ground truth is established by engineering specifications, ISO standards (ISO 7864, ISO 9626), and internal performance test criteria validated by the manufacturer (e.g., force measurements, leak tests).
• Simulated Use Study: Ground truth is established by observed performance of the device by healthcare workers against predefined safety, ease of use, and functionality metrics, with comparability to legally marketed predicate devices. This involves observed user actions and outcomes.
• Sterilization Validation: Ground truth is established by adherence to ISO standards (ISO 11135) and achieving the specified sterility assurance level (SAL).

8. The sample size for the training set

• This document is for a physical device, not an AI model. Therefore, there is no "training set" in the AI sense.

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

• Not applicable as there is no "training set" for this physical device.

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The Easy Point™ Needle is intended for use with syringes for general purpose fluid injection and/or aspiration, and venipuncture to obtain blood collection. The EasyPoint™ Needle aids in the prevention of needlestick injuries.

The EasyPoint™ Needle is intended for general purpose percutaneous injection or aspiration of fluids and venipuncture to obtain blood collection. The device contains a sharps injury prevention feature (needlestick prevention feature-chamber) that covers the entire needle after use. Initially available in sizes of 23G and 25G x 1" and 25G x 5/8" for use with 3mL syringes or smaller.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the EasyPoint™ Needle:

This device is a Class II medical device (Needle, Hypodermic, Single Lumen), and the submission is a 510(k) Premarket Notification (K133635), indicating a pre-market pathway based on substantial equivalence to existing predicate devices, rather than a de novo approval or PMA which would typically involve more extensive clinical studies and a focus on specific performance metrics. Therefore, the "acceptance criteria" here primarily refer to demonstrating safety and effectiveness by being substantially equivalent to the predicate devices and meeting relevant engineering standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Engineering Testing: The text does not specify the exact sample sizes for each engineering test (e.g., how many needles were tested for liquid leakage). It generally states that "Performance testing... was performed according to applicable design requirements" and "Additional performance tests were developed."
• Simulated Use Study: The text does not specify the exact sample size (number of healthcare workers) for the simulated use study.
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Retractable Technologies, Inc. The nature of the studies (engineering, simulated use) suggests prospective data collection for the purpose of this submission.
• Biocompatibility & Sterilization: These are standard laboratory tests, and sample sizes are typically defined by the specific ISO standards.

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

• Engineering Testing: Ground truth is established by the defined engineering standards (ISO) and the measurement systems used. No external experts are mentioned for establishing ground truth beyond standard engineering practices.
• Simulated Use Study: The study involved "a variety of healthcare workers." The number and specific qualifications (beyond "healthcare workers") are not provided. The ground truth here would be the observed safe and effective use of the device by these users.

4. Adjudication Method for the Test Set:

• Not applicable in the traditional sense for this type of submission. The performance against engineering standards is objective. For the simulated use study, the assessment would likely be observational, without a formal adjudication committee as might be found in a clinical trial.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic imaging devices where multiple readers interpret cases to assess diagnostic accuracy with and without AI assistance. The EasyPoint™ Needle is a medical device for fluid injection, aspiration, and blood collection, not a diagnostic imaging tool.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

• Not applicable. This device is a manual device (hypodermic needle) with a passive safety mechanism. There is no "algorithm" or AI component to assess standalone performance for. The "safety feature" is mechanical and integrated into the design.

7. Type of Ground Truth Used:

• Engineering Testing: Defined by international standards (ISO) and internal test protocols.
• Biocompatibility: Defined by ISO 10993 standards and laboratory results.
• Sterilization: Defined by ISO 11137 standards and validation results.
• Simulated Use Study: Observational assessment of safe and effective use by target users (healthcare workers).

8. Sample Size for the Training Set:

• Not applicable. This device is a mechanical medical device, 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 intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients.

The VanishPoint® Blood Collection Set is also indicated for intermittent or short-term intravenous administration of fluid (up to 2 hours). It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.

The VanishPoint® Blood Collection Set is safety device that is sterile and non-pyrogenic and is designed for collection of blood specimens or intravenous administration of fluid. The device will initially be available with either 7" or 12" tubing, ¼" length needles and gauge sizes of 19, 21, 23 and 25.

The provided text describes a 510(k) premarket notification for the "VanishPoint® Blood Collection Set". The submission focuses on adding an additional indication for intermittent or short-term intravenous administration of fluid, as the device was previously cleared for blood collection only.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device for the new indication. The performance is described qualitatively.

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

• Test Set Sample Size: The document mentions a "simulated use study utilizing healthcare professionals" but does not specify the sample size for this study.
• Data Provenance: The study was a simulated use study, implying a controlled environment rather than real-world patient data. The country of origin is not explicitly stated, but the submission is to the FDA in the USA, suggesting the study was likely conducted in the USA or in a manner compliant with US regulatory guidelines. The study appears to be prospective in nature, designed specifically to evaluate the new indication.

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

• The document states "a simulated use study utilizing healthcare professionals".
• Number of experts: Not specified.
• Qualifications of experts: The general term "healthcare professionals" is used, but specific qualifications (e.g., nurses, phlebotomists, years of experience) are not detailed. Their role in establishing "ground truth" would likely be as evaluators of the device's performance in a simulated setting, providing feedback on usability, safety, and effectiveness.

4. Adjudication method for the test set:

• The document does not specify an adjudication method. For a simulated use study, "adjudication" in the sense of resolving discrepancies in expert interpretations of images or clinical findings is less applicable. The evaluation would likely involve collecting structured feedback or success/failure rates from the healthcare professionals.

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, an MRMC comparative effectiveness study was not done. This submission is for a medical device (blood collection set), not an AI-powered diagnostic or assistive tool involving human readers interpreting cases. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.

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

• No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an algorithm or software. Its performance inherently involves human interaction (healthcare professionals using it).

7. The type of ground truth used:

• For the simulated use study, the "ground truth" would be established by the observation and assessment of the device's performance by the healthcare professionals according to predefined criteria for safe and effective use during the simulated procedures. This would likely involve direct observation of usability, deployment of the safety mechanism, fluid administration rates if applicable, and absence of malfunctions. It is not based on pathology, expert consensus on a diagnostic finding, or long-term outcomes data in the usual sense.

8. The sample size for the training set:

• Not applicable. This device is a physical medical instrument, not an AI model or algorithm that requires a "training set" in the computational learning sense.

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

• Not applicable. As stated in point 8, there is no "training set" for this type of medical device.

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The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients. It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.

The VanishPoint® Blood Collection Set is designed to collect blood specimens from patients. The VanishPoint® Blood Collection Set aids in the prevention of needlestick injuries through its retraction mechanism. The device will initially be available with either 7" or 12" tubing, ¾" length needles and gauge sizes of 19, 21, 23 and 25.

The provided text describes a 510(k) submission for the VanishPoint® Blood Collection Set, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria based on studies involving AI or complex statistical analysis typical for diagnostic algorithms.

Therefore, many of the requested fields are not applicable to this document. The "acceptance criteria" here are that the device performs as expected and is substantially equivalent to a predicate device in terms of safety and effectiveness.

Here's the information based on the provided text, with explanations for non-applicable sections:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the engineering tests or biocompatibility. For the simulated use study, the sample size of healthcare professionals is not specified, nor is the number of "uses" performed.
• Data Provenance: Not specified. Given the nature of a 510(k) submission, the studies are typically conducted by or for the applicant (Retractable Technologies, Inc.), likely in the USA where the company is based. The studies would be considered prospective for the purpose of this 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)

• Number of Experts: For the simulated use study, it states "healthcare professionals" were utilized. The specific number is not provided, and no "ground truth" in the diagnostic sense was established by experts. Their role was to determine suitability for use.
• Qualifications of Experts: Not specified beyond "healthcare professionals."

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

• Adjudication Method: Not applicable. This document describes performance and safety testing for a physical device, not a diagnostic algorithm requiring adjudicated ground truth.

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

• MRMC Study: No. This is not applicable. The device is a blood collection set, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. The device is a physical medical device, not an algorithm. Its performance is inherent in its design and function.

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

• Type of Ground Truth: For engineering tests, the "ground truth" is adherence to predefined engineering specifications and functional requirements (e.g., specific force values, absence of leakage). For biocompatibility, it's compliance with established biocompatibility standards. For the simulated use study, the "ground truth" was a subjective assessment by healthcare professionals that the device was "suitable for the intended use."

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not a machine learning or AI device.

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

• Ground Truth for Training Set: Not applicable. This is not a machine learning or AI device.

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The intended use of the Patient Safe® Luer Cap is to cover male luer fittings (luer lock and luer slip), to reduce the risk of touch contamination and medication leakage.

The Patient Safe® Luer Cap is for use on luer tips of other devices to prevent leakage and contact and/or environment contamination during transport to patient area.

The Patient Safe® Luer Cap is designed to cover male luer fittings (luer lock and luer slip) to reduce the risk of touch contamination and medication leakage.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

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

Liquid Leakage Testing:

• Sample Size: Not explicitly stated, but performed "in accordance with FDA Recognized Standard ISO 594-1." This standard would dictate the required sample size for such testing.
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Retractable Technologies, Inc. (prospective).

Simulated Use Study:

• Sample Size: The device was attached to "six (6) different types of luer tips." The number of unique clinicians or repeated trials per luer tip is not specified.
• Data Provenance: Conducted by Retractable Technologies, Inc. (prospective, internal study). The country of origin is implicitly USA, where Retractable Technologies, Inc. is based.

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

• Number of Experts: Not applicable. The studies described are engineering and simulated use studies involving objective measurements and evaluations against a protocol, rather than subjective expert interpretation of data.
• Qualifications of Experts: N/A

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

• Adjudication Method: Not applicable. The studies described (liquid leakage and simulated use) appear to involve objective measurements and evaluation against predefined criteria from a protocol, rather than a consensus-based adjudication of subjective findings.

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

• MRMC Study: No. This device is a passive mechanical luer cap, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not relevant here.

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

• Standalone Study: Yes, in effect. The liquid leakage testing and the simulated use study represent standalone performance evaluations of the device itself (analogous to "algorithm only" in the context of a physical device), without direct human intervention impacting the performance metrics being measured (though human clinicians were involved in the use during the simulated use study, their individual performance wasn't being measured, rather the device's ability to protect the luer tip).

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

• Liquid Leakage Testing: The ground truth for leakage was established by the requirements and measurement methods defined in FDA Recognized Standard ISO 594-1. This is an objective, standardized metric.
• Simulated Use Study: The "ground truth" for success was defined by the "requirements of the protocol" which addressed protection from touch contamination, liquid leakage, and ease of use. These are objective criteria established by the manufacturer.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is a passive mechanical component, 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, as there is no training set for this type of device.

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The intended use of the VanishPoint® I.V. Cathcter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). t The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.

The VanishPoint® I.V. Catheter is a safety device. The retracting introducer places the catheter portion in a vascular vessel in the same way as a conventional catheter, but upon removal of the placement needle, the caregiver activates a safety mechanism which retracts the needle completely into the handle/introducer assembly. In this way, if properly performed, it does not expose the caregiver to an accidental stick from a contaminated needle. The energy to retract the needle and chamber is provided by a spring interacting between the housing and the needle chamber assembly. Once the needle/chamber is retracted, the retracting introducer assembly is no longer required and taken away from the patient.

The provided text describes a 510(k) submission for a medical device (VanishPoint® I.V. Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new study to prove device performance against specific acceptance criteria. Therefore, several of the requested sections below cannot be fully populated as they pertain to such a study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (VanishPoint® I.V. Catheter, K051355) rather than presenting new performance data against specific acceptance criteria for a novel device. The text states:

• "The subject VanishPoint I.V. Catheter and the VanishPoint I.V. Catheter predicate device are very similar in design and technological characteristics."
• "The different materials are equivalent and the intended use is identical."
• "There is no substantive differences between the predicate device and subject device that would raise new issues of safety and effectiveness."

Therefore, the "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate device, which the new device is claimed to match. No specific performance metrics or their corresponding acceptance thresholds are listed.

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

No specific test set or study with a defined sample size is described. The submission relies on the established safety and effectiveness of the existing predicate device.

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

Not applicable. No new clinical or performance study requiring expert adjudication for ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. No MRMC study is mentioned. The device is a physical medical device (catheter), not one that typically involves human readers interpreting data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical device demonstrating substantial equivalence, not a machine learning model requiring a training set.

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

Not applicable.

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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 intended use of the VanishPoint® I.V. Catheter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint® I.V. Catheter aids in the prevention of needlestick injuries.

Not Found

The provided text is a 510(k) clearance letter for the VanishPoint I.V. Catheter, which is a medical device. It does not contain any information about acceptance criteria or a study proving device performance as typically understood for AI/ML or diagnostic devices.

The letter states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination implies that the device meets the safety and effectiveness requirements for its intended use, but it doesn't detail performance metrics in the way you've requested.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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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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