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The BD Eclipse™M Hypodermic Need for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse Hypodermic Needle is compatible for use with standard luer-lock syringes.

The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards accidental needle sticks during normal handling and disposal of the used needle/ syringe combination.

The BD Eclipse™ Hypodermic Needle is a device that is composed of a typical hypodermic needle with a one piece hub/adapter and pivoting cover that is connected to the adapter. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint making the product safe for disposal. These needles have a regular, short or intradermal bevel type. The needle assembly is protected with a polypropylene shield.

The Eclipse™ Hypodermic Needles are offered in a variety of gauge sizes (18-30 gauge) and needle length (½''- 1/2''). The needle hub is color-coded to the appropriate gauge needle per ISO 6009.

The BD Eclipse™ Hypodermic Needle hub incorporates a female 6% (Luer) connector which can be used with a compatible male 6% (Luer) connector. The BD Eclipse™ Hypodermic Needle is not to be used with luer-slip syringe as the needle may become disengaged from the syringe when activating the safety cover. This product is single use and provided sterile.

The change described in this submission is the replacement of current silicone based HCFC-containing needle lubricant with silicone based HCFC-free lubricant.

The provided document describes the FDA 510(k) summary for the BD Eclipse™ Hypodermic Needle (K161170). This document is for a medical device (hypodermic needle) and does not contain information related to an AI/ML powered device, nor does it describe a study involving human readers or ground truth established by experts/pathology for algorithm training or testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML powered device, as the document does not pertain to such a device.

The document discusses the substantial equivalence of the new BD Eclipse™ Hypodermic Needle (K161170) to a predicate device (K010188), primarily due to a change in the needle lubricant and some additional needle length/gauge sizes. The evaluations performed are typical for a conventional medical device modification, focusing on physical performance characteristics and biocompatibility.

Here's what can be extracted from the document, tailored as much as possible to the request, but highlighting the absence of AI-specific information:

Description of Acceptance Criteria and Studies (Conventional Device)

The device being reviewed is the BD Eclipse™ Hypodermic Needle, which is a conventional medical device (not AI-powered). The acceptance criteria and studies are related to the physical and functional performance of the needle, and its biocompatibility. The primary change in this submission is the replacement of a silicone-based HCFC-containing needle lubricant with an HCFC-free lubricant.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each test mentioned (e.g., Hub/Needle Bond Strength, Needle Penetration Test). It refers to "validation/verification/verification activities" and "Design Verification activities." The data provenance is internal to Becton, Dickinson and Company's testing procedures. It is implicitly "prospective" in the sense that the new device (with the changed lubricant) was tested, but the data itself is from internal laboratory testing, not clinical trials or population data from specific countries.

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

This information is not applicable to this submission. The "ground truth" for a hypodermic needle's performance is established by objective engineering specifications, international standards (e.g., ISO), and internal company specifications, not by human experts adjudicating clinical or imaging data.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" in the context of physical performance testing of a hypodermic needle. Results are measured against predefined numerical or qualitative standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human interpretation is involved. This is a hypodermic needle.

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

Not applicable, as this is not an algorithm or AI-powered device.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• International Standards: e.g., ISO 6009 for hub color coding, ISO 594-2 for leak testing, ISO 11135 for sterilization, ISO 10993-1 for biocompatibility, ISO 14971 for risk management.
• Internal BD Specifications: For characteristics like Hub/Needle Bond Strength, Needle Penetration Test, Needle Shield Removal Forces, cannula pull-out forces, activation/unlocking forces, impact resistance, and ship testing.
• Objective Measurements: Laboratory and engineering tests generate quantitative data that is compared against these predefined standards and specifications.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device.

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The BD Eclipse™ Needle with SmartSlip™ Technology is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse™ Needle with SmartSlip™ Technology is compatible for use with standard luer-slip and luer-lock syringes.

The BD Eclipse™ Needle with SmartSlip™ Technology contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

The BD Eclipse™ Hypodermic Needle (BD) Eclipse™ Hypodermic Needle 510(k): K010188 and K043397 with the metal clip) is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting safety cover that is connected to the adapter. The metal clip is inserted into the hub to minimize the incidence of needle detachment from a luer slip tip syringe.

The modified device, BD Eclipse™ Needle with SmartSlip™ Technology, has the same characteristics as the predicate devices except for the clip in the hub. The material of the clip has been changed from metal to plastic. The function of the plastic clip remains the same as the metal. When assembled into the hub. the clip ensures that the needle is attached to a luer slip syringe with sufficient force by the user. The pivoting safety cover can be manually rotated forward after use allowing for secure encapsulation of the needleroint making the product safe for disposal.

The basic needle dimensions (diameter, injection length, needle tip geometry, materials and lubrication) are the same for the BD Eclipse™ Needle with SmartSlip™ Technology modified device, the standard BD Hypodermic Needle and the predicate device BD Eclipse™ Hypodermic Needle with the metal clip.

The provided text describes the BD Eclipse™ Needle with SmartSlip™ Technology and its substantial equivalence to predicate devices, focusing on a material change in a clip within the hub. The document details performance testing specifically for this change.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size for the bench tests. It broadly states "Bench tests relating to the performance...were conducted."
• Data Provenance: Not explicitly stated, but given it's a submission to the FDA by Becton, Dickinson and Company (a US-based company), the testing was likely conducted in the US or under conditions acceptable for US regulatory submission. The document implies these were internal company tests. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not applicable to this submission. The "ground truth" for this device's performance is objective physical measurements and functional tests (e.g., force measurements, structural integrity after a drop test) against predefined engineering specifications, not expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" is based on objective physical measurements and performance against specifications, expert adjudication methods (like 2+1 or 3+1 for clinical assessments) are not relevant here. The tests likely involved standardized methods and measurement tools to determine compliance.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., radiologists reading images) and the AI's impact on their performance is being evaluated. This submission is for a medical device (a hypodermic needle) where performance is assessed through bench testing against engineering specifications, not through human interpretation of clinical cases.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent in its physical and mechanical properties.

7. Type of Ground Truth Used

The ground truth used for these performance tests was based on objective engineering specifications and physical measurements. For example:

• Predefined "force requirements" for clip engagement.
• The criterion that the "clip must remain intact" after a drop test.

These are verifiable, quantitative, or qualitative outcomes determined by a product's design specifications.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is based on the physical design and material properties of the needle and its components.

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

Not applicable. As there is no AI/ML algorithm requiring training, there is no training set ground truth to establish.

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The Needle-Trap™ contains a mechanism that is used to cover the needle point after use of the syringe and needle for their intended functions. In the activated position the Needle-Trap™ guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

The Needle-Trap™ Needle Safety devices are substantially equivalent to the current marketed products

This 510(k) submission for the Needle-Trap™ / Needle Safety Label (K073206) is a pre-market notification for a medical device that claims substantial equivalence to previously marketed devices. It does not contain a study demonstrating acceptance criteria or device performance in the way typically expected for an AI/software as a medical device (SaMD) submission.

Instead, the submission focuses on demonstrating that the device (a syringe anti-needle stick accessory) has similar technological characteristics and performance to existing, legally marketed predicate devices. The "Performance Data" section in the 510(k) summary explicitly states: "Verification and Validation testing confirmed the products meet their specifications." However, it does not provide details on these specifications, acceptance criteria, or the study results themselves.

Therefore, many of the requested items related to a performance study (especially for AI/SaMD) cannot be extracted from this document, as this is a much older and different type of device submission.

Here's an attempt to address your points based on the provided text, while highlighting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided documents. The verification and validation testing mentioned would have used a sample, but the size is not disclosed.
• Data Provenance: Not specified. This type of device (physical accessory) generally undergoes bench testing and possibly human factor studies, rather than relying on patient data in the same way an AI device would.

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

• Number of Experts: Not applicable or not specified. For a physical device like this, ground truth would typically be established through engineering specifications, material testing, and functional performance tests rather than expert interpretation of data.
• Qualifications: Not applicable or not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. This typically applies to studies where multiple readers assess cases, which is not described here.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done or at least not described in these documents. This type of study is relevant for diagnostic imaging or similar AI applications where human readers' performance is augmented.

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

• Standalone Study: Not applicable. This device is a physical accessory, not an algorithm. Its function is to cover a needle after use, preventing needle sticks. Its performance is inherent to its mechanical design and materials, not a standalone algorithmic output.

7. The Type of Ground Truth Used

• Ground Truth Type: Not explicitly stated as "ground truth" in these documents. For a device like this, the "ground truth" would likely be defined by engineering specifications, functional requirements (e.g., ability to reliably cover the needle, resistance to accidental re-exposure), and safety standards (e.g., ISO standards for sharps injury prevention devices). Performance would be measured against these predefined specifications.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a "training set."

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

• Ground Truth for Training Set: Not applicable. As it's not an AI/ML device, there is no training set or ground truth in that context.

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The BD Eclipse™ Hypodermic Needle is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse™ Hypodermic Needle is compatible for use with standard luer-slip and luer-lock syringes.

The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

The BD Eclipse™ Hypodermic Needle (BD Eclipse™ Hypodermic Needle 510(k): K010188) is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting cover that is connected to the adapter. The hub of the modified device has a metal clip assembled in it to ensure that the BD Eclipse™ Hypodermic Needle is attached to a luer slip syringe with sufficient force by the user. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint making the product safe for disposal.

The basic needle dimensions (diameter, injection length, needle tip geometry, materials and lubrication) are the same for the BD Eclipse™ Hypodermic Needle, modified device, the standard BD Hypodermic Needle and the predicate device BD Eclipse™ Hypodermic Needle.

The document describes a 510(k) premarket notification for a modified BD Eclipse™ Hypodermic Needle. The primary focus of the submission is to demonstrate substantial equivalence to a predicate device, which is the original BD Eclipse™ Hypodermic Needle.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define quantitative acceptance criteria for specific performance metrics in a readily digestible table. Instead, it relies on demonstrating equivalence to a predicate device.

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

• Sample Size: The document does not specify the exact sample sizes for the "Bench tests" and "Simulated Use Test."
• Data Provenance: The data appears to be prospective, as new "Bench tests and Simulated Use Test" were conducted for the modified device. The country of origin is not explicitly stated, but the submission is to the US FDA and the manufacturer is based in New Jersey, USA, suggesting the tests were likely conducted in the US.

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

This type of information is not applicable to this device submission. The tests performed are engineering-focused (bench tests and simulated use) rather than clinical studies requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" for these tests would be objective measurements and observations of the device's physical performance, not expert consensus on medical findings.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially for assessing diagnostic accuracy where expert disagreement on ground truth might occur. The tests described are direct performance evaluations.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic aid (like AI) on physician performance. The BD Eclipse™ Hypodermic Needle is a physical medical device, not a diagnostic aid or software, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

This question is not applicable as the device is a physical hypodermic needle and not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the BD Eclipse™ Hypodermic Needle would be:

• Objective Engineering Measurements: For characteristics like needle dimensions, attachment force, and the functionality of the safety mechanism.
• Direct Observation and Verification: During "Simulated Use Tests" to confirm proper function, secure encapsulation, and protection against accidental needle sticks.
• Comparison to Predicate Device Performance: The primary ground truth is the established performance characteristics and safety profile of the legally marketed predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set.

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