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The HookSafe™ U-100 Insulin Syringe; models 0.5cc/ml and 1cc/ml, serves as the vehicle in which medication, insulin can be injected into the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.

The HookSafe™ U-100 Insulin Syringe is the Safety Syringe with the following functional advantage:

Single use, completely non-reusable, all parts and components can be safely discarded.

Fully meets anti-needlestick requirements and incorporates anti-reuse functionality. After the injection of insulin, it is at this stage where the anti-reuse function of our syringe begins, a mechanism within our syringe engages the needle hub and forms a lock. At this point, one simply needs to pull the syringe plunger back and the needle will be completely retracted into the barrel of the syringe. At this stage the syringe becomes completely harmless and fully meets its anti-reuse functionality.

The provided text is a 510(k) summary for the HookSafe™ U-100 Insulin Syringe. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a new device.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies are not available in the provided document.

Here's an attempt to answer the questions based only on the information provided:

Acceptance Criteria and Device Performance

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, particularly for devices demonstrating substantial equivalence to a predicate, the "acceptance criteria" largely revolve around showing that the new device is as safe and effective as the predicate. This often involves demonstrating compliance with relevant standards and functional equivalence. Explicit quantitative performance metrics are less common in the summary itself, unless the modifications significantly alter performance.

Study Details

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

   • Not Available. The document states "verification and validation tests contained in this submission," but does not detail the sample sizes for these tests or their provenance.

2. 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 / Not Available. This type of information is typically relevant for studies involving diagnostic or interpretive tasks. This submission concerns a physical medical device (syringe) where ground truth would relate to its mechanical function, safety features, and compliance with standards, rather than expert interpretation of data.

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

   • Not Applicable / Not Available. See above.

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

   • No. This is not an AI-assisted diagnostic or interpretive device, so an MRMC study is not relevant or mentioned.

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

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

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

   • Implied Functional/Mechanical Performance and Safety Compliance. For a syringe, "ground truth" would likely involve verifying proper mechanical function (e.g., plunger movement, needle retraction), integrity (no leaks), and successful activation of safety features (anti-needlestick and anti-reuse mechanisms) as per engineering specifications and relevant standards. The document states compliance to applicable standards and "verification and validation tests," but does not detail the specific "ground truth" methods used in those tests.

7. The sample size for the training set

   • Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in this context.

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

   • Not Applicable. See above.

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The BIOTOP HookSafe™ LUER-LOCK Safety Syringe; models 3cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.

The HookSafe™ LUER-LOCK series is the Safety Syringe with the following functional advantage: Single use, completely non-reusable, all parts and components can be safely inoperative and safely discarded. Fully meets anti-needlestick requirements and incorporates anti-reuse functionality as well. As with any normal syringe, after the injection process, the syringe plunger should be fully depressed to ensure complete injection of the serum. It is at this stage where the anti-reuse function of our syringe begins; a mechanism within our syringe engages the syringe needle and forms a lock. At this point, one simply needs to pull the syringe plunger back again and the needle will be completely retracted into the barrel of the syringe. Because the needle, when retracted, is in a stably-tilted position and forced against the inner shoulder of the syringe barrel. At this stage the syringe becomes completely harmless and fully meets its anti-reuse functionality.

The provided text does not contain detailed information about specific acceptance criteria and the results of a study designed to prove a device meets those criteria. Instead, it describes a 510(k) submission for the BIOTOP HookSafe™ LUER-LOCK Safety Syringe, focused on demonstrating substantial equivalence to a previously cleared predicate device.

The document highlights the following:

• No explicit acceptance criteria for "performance" beyond substantial equivalence: The core claim is that the new models are substantially equivalent to the predicate device despite a "small change in the needle change mechanism." The "discussion of non-clinical tests" simply states "Compliance to the applicable standards is completely identical to that of the device being modified." This suggests that the acceptance criteria for the new device are implicitly the same as those met by the predicate device, and the current submission relies on the predicate's established performance.
• "Verification and validation tests" are mentioned but not detailed: The text states, "Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate could maintain the same safety and effectiveness as that of cleared device." However, no specifics about these tests (e.g., protocols, sample sizes, failure rates, or specific performance metrics) are provided.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's a breakdown of what can be inferred or determined from the text, and what critically cannot:

1. Table of acceptance criteria and reported device performance:

Missing Information for Table: Specific quantitative acceptance criteria (e.g., "Needle stick injury rate

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The BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 3cc/mL, 5cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may help to prevent needlestick injuries as well as help to prohibit syringe reuse.

The HookSafe™ series is the Safety Syringe with the following functional advantage:

• The syringe and components can be completely self-destroyed and safely discarded.
• Fully meets anti-needlestick requirements and incorporates anti-reuse functionality as well. As with any normal syringe, the syringe plunger should be fully depressed to ensure complete injection into the bloodstream. It is at this stage where the anti-reuse function of our syringe begins; a mechanism within our syringe engages and forms a lock. At this point, one simply needs to pull the syringe plunger back again and the needle will be completely retracted into the syringe. Because the needle, when retracted, is in a safely tilted pose against the inner shoulder of the syringe, the syringe becomes completely harmless and fully meets its anti-reuse functionality.

The provided text describes a 510(k) summary for the BIOTOP HookSafe™ Safety Syringe, but it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for testing, ground truth establishment, or human reader studies.

The document primarily focuses on establishing substantial equivalence to a predicate device (BIOTOP DJT-A) for regulatory clearance. It describes the device's function and intended use, and states that non-clinical tests were performed. However, it does not provide the results of those non-clinical tests or the specific acceptance criteria used.

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth methodology, or human reader studies.

The document concludes that the "non-clinical tests performed" demonstrated the device could maintain the same safety and effectiveness as the cleared predicate device. This implies that testing was done to ensure the safety features worked as intended (anti-needlestick and anti-reuse), but the specific metrics and targets for these tests are not included.

Summary of what can be gleaned and what is missing:

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

   • Acceptance Criteria: Not explicitly stated in the document. The general acceptance criterion is likely "maintaining the same safety and effectiveness as the predicate device" in terms of its anti-needlestick and anti-reuse functionality.
   • Reported Device Performance: Not numerically reported. The document states that "non-clinical tests performed demonstrated [the device] could maintain the same safety and effectiveness as that of [the] cleared device." This implies the tests passed, but no specific results (e.g., success rate of retraction, force required to re-engage needle) are provided.

2. Sample sized used for the test set and the data provenance: Not mentioned in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device does not involve expert interpretation or diagnosis for most of its functional tests (e.g., anti-needlestick, anti-reuse). If "ground truth" refers to the verification of the safety mechanism, it would typically be factory or lab testing, not expert consensus.

4. Adjudication method for the test set: Not applicable based on the information provided.

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 a mechanical safety syringe, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used: For a device like this, "ground truth" for its safety features (anti-needlestick, anti-reuse) would typically be established through engineering specifications, validated mechanical testing protocols, and perhaps simulated use testing. The document does not elaborate on these.

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.

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The BIOTOP DJT-A Safety Syringe (3cc/mL) serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.

The BIOTOP DJT-A Safety Syringe is a single-use hypodermic syringe that is very similar to a traditional syringe, except it possesses an integral needle retracting mechanism. Upon employing traditional syringe injection techniques, the needle can be manually retracted back inside the syringe barrel.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the BIOTOP DJT-A Safety Syringe:

Note: This document is a 510(k) Summary, which is a premarket notification for medical devices. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific performance acceptance criteria through extensive clinical trials as might be required for a PMA (Premarket Approval). Therefore, the "acceptance criteria" here are framed within the context of demonstrating equivalence.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated. The document mentions "Performed bench testing" and "simulated field test" without providing specific sample sizes for these tests.
   • Data Provenance: The submitting company is BIOTOP Technology Co., Ltd. from Taiwan. The testing was conducted as part of their 510(k) submission. It's implied these were prospective tests conducted to support the submission.

2. 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. The ground truth for performance was established through bench testing and simulated field testing, where the device's technical specifications and functional performance were compared to a predicate device. There is no mention of human expert evaluation in the establishment of ground truth for these tests.

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

   • Not applicable. This type of adjudication is typically used for clinical studies involving human interpretation or subjective evaluations. The described performance testing (bench and simulated field tests) are objective measurements without the need for human adjudication in this context.

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 safety syringe, not an AI software or diagnostic imaging device. Therefore, MRMC studies are not relevant.

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

   • Not applicable. This is a physical medical device, not an algorithm. The performance described is "standalone" in the sense that the device itself was tested, not an algorithm.

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

   • The "ground truth" was the performance of the predicate device (M.K. Meditech's DuoPro Safety Syringe) and the established engineering and safety standards (as per FDA guidance for sharps injury prevention features). The BIOTOP DJT-A Safety Syringe's performance was compared against these.
   • Specifically for the safety features, the ground truth relates to the physical mechanism effectively limiting accidental needle sticks and prohibiting reuse, which would be evaluated against engineering specifications and industry standards for safety syringes.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not a machine learning model. There is no "training set" in the context of device development as described here.

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

   • Not applicable, as there is no training set mentioned for this type of device submission.

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