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The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for subcutaneous injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse. It is a sterile, single-use, with a pre-attached single lumen hypodermic needle. Syringe volumes include 1 mL, 0.5 mL, and 0.3 mL. Needles range in size from 25G to 29G, with lengths of 3/8 inch to 1/2 inches. The InsoSAFE™ is provided individually wrapped, in shelf boxes of 100 units.

The provided text describes a 510(k) submission for the InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe. This document details the device's characteristics, intended use, and claims of substantial equivalence to predicate devices. It explicitly mentions "Verification and validation testing presented in this premarket notification includes testing to demonstrate conformance to standards and testing according to FDA guidance, 'Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Protection Features, December 2002'".

However, the document does not provide any specific acceptance criteria or detailed study results that prove the device meets these criteria. It states that testing was done to conform to standards and FDA guidance, but the actual results, sample sizes, ground truth establishment, or expert involvement are not included in this summary.

Therefore, I cannot populate the requested table or provide information about the study's specifics as those details are not present in the provided text.

Specifically, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sizes used for the test set and the data provenance: Not present. The text only mentions "testing" without any numbers or data source details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth is mentioned for a diagnostic or AI device. This is a medical device (syringe), not a diagnostic or AI product.
4. Adjudication method for the test set: Not applicable as no ground truth establishment is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI or diagnostic imaging device.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no ground truth for performance is detailed.
8. The sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable, as this is a physical medical device.

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

The 10 mL Bak'Snap DuoProSS™ Retractable Safety Syringe is a sterile, single-use, disposable and non-rcusable, manual, retractable safety syringe provided with or without needle. The modifications to the cleared product are the addition of a brand name, a change in syringe volume, and a change in a single syringe material.

The provided document is a 510(k) summary for a medical device (10 mL Bak'Snap DuoProSS™ Retractable Safety Syringe), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria in the context of an AI/algorithm-based device.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI device is not available in these documents. The document describes a traditional medical device (a syringe), not an algorithm or AI product.

Here's an attempt to address the prompts based only on the provided text, recognizing that it pertains to a physical device and not an AI algorithm:

Based on the provided K034031 510(k) Summary for the 10 mL Bak'Snap DuoProSS™ Safety Syringe, the detailed information typically required for an AI/algorithm-based device's acceptance criteria and proving study is not present. This document describes a traditional medical device (a syringe) and its substantial equivalence to a predicate device, rather than the performance of a diagnostic or predictive algorithm.

However, I can extract information related to the device's functional intent and general testing performed.

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

The document does not explicitly list quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, AUC) for an AI device, nor does it report specific performance values in that context. Instead, it focuses on demonstrating substantial equivalence based on intended use, design, and technological/operational characteristics, and conformance to standards.

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

Not applicable. The document refers to "verification and validation testing" but does not specify sample sizes for specific tests or the provenance of any 'data' in the context of an algorithm's test set. This is a physical device, and testing would involve physical samples, not a data test set for an algorithm.

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)

Not applicable. This information is relevant for AI/algorithm validation, not for the substantial equivalence demonstration of a physical medical device like a syringe.

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

Not applicable. This is typically used for resolving discrepancies in expert labeling or ground truth establishment for AI models.

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 study type is for evaluating the impact of AI on human performance, and this document pertains to a physical syringe, not an AI system.

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

Not applicable. This concept applies to the performance of an AI algorithm in isolation.

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

Not applicable in the context of an AI algorithm's ground truth. For a physical device like a syringe, "ground truth" would relate to whether the device meets its functional specifications and safety requirements (e.g., sterility, non-reusability, physical dimensions, retraction mechanism function), likely assessed through engineering tests and adherence to standards.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This information pertains to AI model development.

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The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSS™) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe provided with permanently attached needle. The Safety Tray Safety Allergy Syringe Tray consists of 25 Bak'Snap syringes within a single sterile barrier.

The provided text is a 510(k) summary for the Bak'Snap DuoPro™ Safety Syringe. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or the specific study details that would prove the device meets such criteria.

The "TESTING" section (under point 7) states:
"Verification and validation testing presented in this premarket notification includes testing to demonstrate conformance to standards, testing according to FDA guidance, biocompatibility per ISO 10993, and sterilization re-validation."

This statement confirms that testing was done, but it does not provide any specifics regarding:

1. A table of acceptance criteria and the reported device performance: There is no table or detailed description of performance metrics (e.g., retraction force, failure rate of safety mechanism, needle occlusion rate) or their corresponding pass/fail criteria.
2. Sample size used for the test set and the data provenance: No sample sizes are mentioned for any of the tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a physical medical device like a syringe. Ground truth would typically refer to a diagnostic or algorithmic outcome validation.
4. Adjudication method for the test set: Irrelevant, as ground truth establishment is not applicable in this context.
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: Irrelevant, as this device is a physical syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Irrelevant, as this device is a physical syringe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a physical device's performance testing (e.g., for biocompatibility, sterility, or safety mechanism function). Instead, performance is measured against engineering specifications and relevant standards.
8. The sample size for the training set: Irrelevant, as this device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Irrelevant, as this device does not involve a "training set."

In summary, the provided 510(k) summary confirms that testing was conducted to demonstrate conformance to standards, FDA guidance, biocompatibility, and sterilization. However, it does not elaborate on the specific acceptance criteria or the detailed results of these tests necessary to fulfill the request. This level of detail is typically found in the full submission to the FDA, not necessarily in the publicly available 510(k) summary.

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

The modified DuoPro™ Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, 3 mL or 5 mL retractable safety syringe, provided with or without needle in various product configurations.

The provided text is a 510(k) summary for a medical device called the DuoPro™ Safety Syringe (DuoProSS™). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on similarities in design, technological, and operational characteristics.

However, the document does not provide specific acceptance criteria or details of a study that proves the device meets such criteria in the format requested by the prompt. The "TESTING" section briefly states:

"Verification and validation testing provided in this premarket notification includes standards conformity, testing according to FDA guidance, biocompatibility, and measurement of latex protein. Testing shows that the performance of the modified DuoProSS™ is equivalent to predicate devices."

This is a high-level statement indicating that testing was performed and concluded equivalence, but it lacks the granular details requested, such as:

• A table of acceptance criteria and reported device performance metrics.
• Sample sizes for test sets, data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone performance.
• The type of ground truth used.
• Sample sizes and ground truth establishment for training sets (which would be relevant for an AI/ML device, but this appears to be a mechanical device).

Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions as the detailed information is not present. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for approval, rather than detailing a study against specific, quantified acceptance criteria for a new AI/ML device.

Summary of missing information based on the prompt's requirements:

The provided 510(k) summary does not contain the detailed information needed to fill out the requested table and answer the study-specific questions. The device in question appears to be a mechanical medical device (safety syringe), not an AI/ML powered device, which explains the absence of data provenance, expert adjudication, MRMC studies, or training/test set details typically associated with AI/ML device evaluations.

The document states "Verification and validation testing provided in this premarket notification includes standards conformity, testing according to FDA guidance, biocompatibility, and measurement of latex protein. Testing shows that the performance of the modified DuoProSS™ is equivalent to predicate devices," but no specific results or acceptance criteria are detailed.

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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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