Intraosseous Infusion Needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids.

The Intraosseous Infusion Needles are intended for use as an alternative to intravenous access during pediatric emergencies, permitting infusion of drugs and fluids. Intraosseous Infusion Needles consist of two basic components - the needle (composed of a knob, a stylet luer-lock, and a beveled stylet) and the cannula (comprised of a hub, a base plate, and a cannula shaft). The cannula attaches to the needle by the stylet luer-lock and is supplied attached and ready to use. The Intraosseous Infusion Needles are available in the following configurations:

Intraosseous Infusion Needle (with Dieckmann Modification – Standard Hub Design)

Cannula Gauge: 14, 16, 18
Cannula/Stylet Length (cm): 14 Gauge: 3.0; 16 Gauge: 2.5, 3.0, 4.0; 18 Gauge: 2.5, 3.0
Stylet Length (cm): 14 Gauge: 4.6; 16 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula), 5.65 (for 4.0cm cannula); 18 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula)
Stylet Bevel Style: Trocar
Hub Material: Clear Polycarbonate (for 14 and 16 Gauge), Pink Polycarbonate (for 18 Gauge)

The provided FDA 510(k) clearance letter and summary for the Intraosseous Infusion Needles does not contain the detailed information necessary to answer most of the questions you've posed regarding acceptance criteria and study particulars.

This document focuses on justifying "substantial equivalence" to a predicate device, primarily by demonstrating that changes to the sterilization process do not negatively impact safety or effectiveness. It explicitly states that "No additional performance testing was conducted because the design of the subject device is identical to the predicate, K160887."

Therefore, I can only provide limited information based on the text.

Here's what can be inferred and what cannot:

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

The document does not explicitly state acceptance criteria or performance metrics for the device's primary function (intraosseous infusion). The "performance testing" described is related only to the sterilization process.

2. Sample sized 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 specified for any performance testing related to the device's functional use or even for the sterilization validation beyond general statements of "performance testing was conducted."
• Data Provenance: Not specified.

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. The document does not describe studies requiring expert ground truth for device performance related to patient outcomes or imaging. The testing focuses on sterilization process validation.

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

Not applicable. The document does not describe studies requiring adjudication.

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 medical needle, not an AI-assisted diagnostic tool.

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

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

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

For the sterilization validation, the "ground truth" would be objective laboratory measurements and adherence to international standards (e.g., ANSI/AAMI/ISO 11135 and ISO 10993-7) for sterility and residuals. It's not related to clinical "ground truth" like pathology or outcomes.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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The TSK SELECT™ Needle is indicated for subcutaneous injections of pharmaceutical products, or for withdrawal of fluids.

The TSK SELECT™ Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen needle intended for use with a luer-tip syringe. The TSK SELECT™ Needle consisting of a stainless-steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene, or polycarbonate, depending on the hub type, designed to be connected with a male luer fitting of a syringe. The TSK SELECT™ Needle is intended for manual use by health care professionals for administration of fluids. The TSK SELECT™ Needle is provided sterile, is single use only, non-toxic, non-pyrogenic, and sterilized by gamma irradiation.

There is no indication that the TSK SELECT™ Needle incorporates artificial intelligence (AI) or machine learning (ML). The provided 510(k) clearance letter and summary describe a physical medical device (hypodermic needle) and its non-clinical performance and biocompatibility testing.

Therefore, the specific information requested about AI/ML device acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert ground truthing, adjudication methods, MRMC studies, standalone performance, and effect size with AI assistance) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Indications for Use Comparison: Showing the new device has the same intended use as the predicate.
• Technological Comparison: Highlighting similarities and differences in materials, design, and features, and providing justification (e.g., "does not raise new or different questions of safety and effectiveness") for any differences.
• Non-Clinical Testing: Demonstrating compliance with recognized standards for physical performance, sterilization, and biocompatibility.

Since the request is specifically about AI/ML device criteria and studies, and this device is not an AI/ML device, I cannot provide the requested information based on the input. The document does not contain any data relevant to AI/ML performance metrics.

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Intended Purpose: The K-Pack Embrace™ Active Safety Needle, being a hypodermic needle with safety shield, is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The safety shield shall be manually locked (activated), after use, to cover the needle to minimize the risk of accidental needle stick.

Indications: The K-Pack Embrace™ Active Safety Needle is for general application – for treatment (injection of fluids) or diagnosis (withdrawal of fluids).

The K-Pack Embrace™ Active Safety Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The K-Pack Embrace™ Active Safety Needle is compatible for use with standard luer slip and luer lock syringes. The K-Pack Embrace™ Active Safety Needle is packed in a hard plastic container (cap and case) made of polypropylene and sealed with a label.

This device features a hinged safety shield, made of polycarbonate, attached to the needle hub. The safety feature is activated when the safety shield is manually pressed over the needle immediately after use and prior to disposal to minimize the risk of accidental needle stick injuries. The safety shield is activated with a one-handed operation, using the finger, thumb, or surface activation.

The K-Pack Embrace™ Active Safety Needle is sterilized by ethylene oxide.

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the K-Pack Embrace™ Active Safety Needle does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way you've requested (e.g., details about AI studies, sample sizes for training/test sets, expert adjudication, MRMC studies, and nuanced ground truth establishment).

The document is a standard 510(k) clearance letter for a medical device (a hypodermic needle with a safety shield) that demonstrates substantial equivalence to a predicate device. The "Non Clinical Test" section focuses on:

• Performance testing: Verification of the device's design against recognized international standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 6009, ISO 23908, ISO 11607-1, USP , and FDA guidance on sharps injury prevention). These standards define various physical and functional requirements for hypodermic needles and their safety features.
• Biocompatibility testing: Evaluation of the materials in contact with the body according to ISO 10993.
• Sterilization and shelf-life testing: Validation of the sterilization method (Ethylene Oxide) according to ISO 11135 and shelf-life studies according to ASTM F1980.

The document does not describe an AI/ML-based device or a study involving human readers, AI assistance, ground truth established by experts, or any of the elements typically associated with the kind of acceptance criteria you've detailed in your prompt (e.g., sensitivity, specificity, AUC for an AI model).

Therefore, I cannot populate the table or answer the specific questions related to AI/ML study design and expert review methodology based on the provided text. The device described is a physical medical device, not a diagnostic AI system.

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The purpose of this Guideline is to provide clarity and guidance regarding the use of a digital pathology system which utilizes artificial intelligence (AI)-based image analysis algorithms. It describes the intended use of the system and covers relevant considerations related to its functionality, setup, and use in a pathology laboratory environment. This includes the following:

• Clear indications for use, including the patient population, sample type, purpose of the analysis, and interpretation of the results.
• Description of the AI algorithms used, including their validation and performance characteristics.
• Guidelines for system setup and configuration, including hardware and software requirements, calibration procedures, and quality control measures.
• Recommendations for training and competency assessment of users.
• Instructions for data management and archiving.
• Considerations for potential limitations and risks associated with the use of the system.
• Reporting of results, including integration with laboratory information systems.
• Post-market surveillance and system updates.
• Adherence to relevant regulatory requirements and standards.

By following this Guideline, pathology laboratories can ensure the safe and effective use of AI-based image analysis in digital pathology, contributing to improved diagnostic accuracy and patient care.

A compact USB-C hub designed to expand connectivity options, featuring multiple ports including USB-A, HDMI, SD card reader, and a passthrough charging port, ideal for laptops with limited ports.

The provided FDA clearance letter for Terumo's Hypodermic Needle (K243309) does not describe a study involving acceptance criteria for device performance in the context of an AI/ML or diagnostic imaging device. Instead, this document is a 510(k) submission for a medical device (a hypodermic needle) that demonstrates substantial equivalence to a predicate device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to performance verification tests for a physical medical device (hypodermic needle), rather than the kind of AI/ML or diagnostic performance evaluation described in the prompt's request.

Therefore, the requested information (table of acceptance criteria and device performance for AI/ML, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is not applicable to this document.

The document primarily focuses on:

• Substantial Equivalence: Demonstrating that the new needle is as safe and effective as a previously cleared predicate device, despite a minor change (increased inner diameter/thin wall vs. regular wall).
• Non-Clinical Testing: Citing compliance with various ISO standards for hypodermic needles, biocompatibility, sterilization, and shelf-life, which are the "acceptance criteria" for this type of device.
• No Clinical Testing: Explicitly stating that clinical test data was not included because the changes were supported by non-clinical performance verification.

If this were an AI/ML or diagnostic device, the document would contain sections detailing sensitivity, specificity, AUC, human reader studies, etc., none of which are present here.

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The needle is used to access surgically implanted vascular ports.

Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.

In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle.

The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.

This submission is new design primarily involve changes to addition of new needle lengths and specifications.

The provided FDA 510(k) clearance letter and summary for the Promisemed Safety Huber Needles details a medical device that is a physical product (a needle), not a software-based AI/ML medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) does not apply to this specific device.

The 510(k) submission for the Promisemed Safety Huber Needles focuses on demonstrating substantial equivalence to a predicate device (K243332) primarily through non-clinical performance testing for physical and mechanical properties, and a comparison of technological characteristics.

Here's a breakdown of the relevant information provided in the document:

Device Description and Purpose:

The Promisemed Safety Huber Needle is a non-coring intravascular infusion set with a right-angle needle and a manually activated needle-stick prevention safety mechanism. It is used to access surgically implanted vascular ports and, for the high-pressure resistant model, can be used for high-pressure injection of contrast media for CT imaging. It is for adult use only.

Nature of This Submission:

This 510(k) submission is for a device modification that primarily involves:

1. Addition of new needle lengths (16mm, 17mm, 20mm) for Type D and Type E needles.
2. Addition of a new specification: "without lubrication" for the needle tip.

The manufacturer asserts that these changes "do not introduce new risks as the fundamental technology and operation remain the same" and that the device remains "substantially equivalent" to its predicate device.

Acceptance Criteria and Study for This Device:

Since this is a physical medical device and not an AI/ML system, the "acceptance criteria" are based on meeting established performance specifications and international standards for hypodermic needles and infusion sets. The "study" that proves the device meets these criteria is the suite of non-clinical (bench) tests performed.

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

The document lists the types of tests performed and the standards they adhere to, implying that the acceptance criteria are successful completion according to these standards. It does not provide specific quantitative acceptance thresholds (e.g., "puncture force must be X-Y Newtons") nor the raw performance data, but rather states that "All verification and validation tests passed without deviations."

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

• Sample Size: Not explicitly stated in the 510(k) summary. For physical device performance testing, sample sizes are typically determined by statistical methods based on specified confidence levels or are prescribed by the testing standards themselves (e.g., a certain number of units per lot).
• Data Provenance: The tests were conducted by Promisemed Hangzhou Meditech Co., Ltd. in China ("Promisemed Hangzhou Meditech Co., Ltd. completed the following non-clinical tests"). This is a retrospective collection of data for the purpose of the 510(k) submission.

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

• N/A. This concept applies to AI/ML device ground truth establishment, often involving clinical image interpretation. For a physical device like a needle, "ground truth" is established by adherence to engineering specifications and international standards, tested by qualified engineers and technicians using calibrated equipment.

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

• N/A. This concept relates to human expert consensus in clinical data annotation for AI/ML validation. Physical device testing relies on objective measurements against defined criteria.

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:

• N/A. An MRMC study is for evaluating the impact of AI assistance on human diagnostic performance. This device is a physical medical instrument, not an AI software.

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

• N/A. This pertains to AI algorithm performance. The device here is a standalone physical needle.

7. The type of ground truth used:

• Engineering Specifications and International Standards: For a physical device, "ground truth" is adherence to predefined engineering specifications (e.g., dimensions, material properties, force resistance) and compliance with internationally recognized standards (like ISO 7864, ISO 9626, ASTM F3212). The testing confirms that the device's physical properties and functionality meet these established objective benchmarks.

8. The sample size for the training set:

• N/A. This concept is relevant for AI/ML model development. This device does not involve a "training set" in the computational sense.

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

• N/A. As above, this applies to AI/ML.

Summary of Key Takeaways from the Document:

The 510(k) submission successfully demonstrated substantial equivalence by confirming through non-clinical testing that the modified Promisemed Safety Huber Needles:

• Maintain the same intended use, technological characteristics, and principle of operation as the predicate device.
• The added needle lengths and the "without lubrication" option do not introduce new safety or effectiveness risks.
• All required performance tests (appearance, dimensions, needle point, fragment, sheath/cap, puncture force) passed without deviations, confirming adherence to relevant ISO and ASTM standards.
• No clinical testing was deemed necessary for this type of modification, reinforcing that the changes were not considered to impact fundamental safety or effectiveness parameters requiring human clinical data.

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• The FROG device is a hypodermic needle and filter combination intended for use with syringes for general purpose fluid injection/aspiration and filtering.
• The FROG removable filter allows the device to first withdraw medications from glass ampules and filter out glass fragments prior to subsequent administration after the removal of the filter cover.
• The FROG device is intended to be used by health care practitioners supporting medical care of any patient where delivery of drug housed in a glass primary container (where there is potential for glass particulate to get into drug upon opening of said primary container) is required.

The FROG device is a prescription device intended for use by healthcare professionals in a healthcare or outpatient setting. The FROG device incorporates a removable filter, which surrounds the hypodermic needle and allows the filtered aspiration of glass-contaminated drug into the syringe. After aspiration, the filter is removed from the device, permitting injection with the hypodermic needle which is already attached to the syringe. Each package will include an assembled FROG device. The device is intended for single use and provided sterile.

The provided FDA 510(k) clearance letter and documentation for the FROG (Filter Removal of Glass) device focuses on demonstrating substantial equivalence to a predicate device, the BD Precision Glide Needle (K021475). The documentation outlines detailed testing performed to support this claim, especially concerning the unique filter feature of the FROG device.

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

Acceptance Criteria and Reported Device Performance

The documentation does not explicitly provide a table of quantitative acceptance criteria and corresponding reported device performance values in the typical sense of a clinical study assessing diagnostic accuracy (e.g., sensitivity, specificity). Instead, the performance evaluations are designed to demonstrate the device meets established engineering, biocompatibility, and sterilization standards, and that its unique filtering functionality is effective and comparable to a reference device.

The "Assessment of Equivalence" column in Table 5-1 implicitly serves as a form of "reported device performance" against the predicate and reference devices, indicating whether the FROG device met the functional and safety expectations.

Study Details

The provided document primarily details design verification and validation testing, not a traditional clinical study with patient data.

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

   • The document does not specify sample sizes for individual performance tests (e.g., filtration efficiency, residual volume, needle penetration, biocompatibility). It generally states "Performance Data" and lists categories of tests performed.
   • Data Provenance: The nature of the tests (e.g., ISO standard testing, biocompatibility) implies lab-based testing rather than patient data. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of patient data.

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

   • This concept is not applicable as the studies described are engineering and bench testing rather than clinical or diagnostic studies requiring expert review for ground truth establishment. The ground truth for these tests is defined by international standards (e.g., ISO 7864, ISO 10993-1) and objective measurements.

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

   • Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of patient data. This is not relevant to the engineering and bench testing described in this 510(k) summary.

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 MRMC study or any study involving human readers/AI assistance was conducted or described. The device is a physical medical device (hypodermic needle with a filter), not an AI-powered diagnostic tool.

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

   • Not applicable. This is not an algorithm-based device.

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

   • For the engineering and performance tests, the "ground truth" is based on:
     • Defined specifications and standards: Adherence to ISO standards (e.g., ISO 7864 for needle requirements, ISO 10993-1 for biocompatibility).
     • Physical measurements: For parameters like filtration efficiency (e.g., 5-micron particle filtration) and residual volume, these are direct, objective measurements against defined targets.
     • Comparison to a reference device: The BBraun Filter Straw serves as a performance benchmark for the filtering capability and residual volume.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

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

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It is intended for use by health care professionals for puncture, drainage and fluid collection of the anterior chamber of the eye. Its operation is manual. The Disposable Aqueous Humor Collector is single use only. The Disposable Aqueous Humor Collector is suitable for ophthalmic use.

Disposable aqueous humor collector is composed of a liquid collecting needle sheath, a liquid collecting needle, a needle seat, a liquid collecting needle rubber sheath, a rubber plug, a liquid collecting tube, a cylinder body, a rubber ring, push rod and buckle structure.
Models: SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27
Volume: 50μL, 100μL
Needle Gauge: 25G, 27G

The provided FDA 510(k) clearance letter and summary for the "Disposable Aqueous Humor Collector" does not contain acceptance criteria or a detailed study description of device performance, beyond general statements about compliance with ISO standards and a brief mention of an OUS study.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (StaClear Syringe) by comparing specifications and stating that differences do not raise new safety or effectiveness concerns, supported by various non-clinical tests (biocompatibility, sterility, bench functional performance).

Therefore, I cannot fulfill the request to provide the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document refers to testing being performed, but does not present the specific acceptance criteria or the detailed results of those tests.

However, I can extract the information that is present and highlight what is missing based on your request:

Missing Information: The provided document states that "required testing was conducted to validate the cumulative modifications made to the subject devices" and that "Substantial Equivalence is being supported with full performance testing," including bench functional performance tests. It also mentions "An outside of the United States (OUS) study was performed demonstrating the effectiveness of the subject device to collect 50 uL of liquid with the 50 uL model." However, it does not detail the specific acceptance criteria for these tests, nor does it provide a full study report with reported device performance against those criteria.

Here is what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the tests.
• Data Provenance: The document mentions "An outside of the United States (OUS) study." This indicates a prospective clinical study conducted outside the US. No further details on the country of origin are provided. Bench and biocompatibility testing locations are not specified.

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

• Not Applicable. This device is a medical instrument (collector/syringe) for fluid collection, not an AI/diagnostic device that typically requires expert-established ground truth for its performance evaluation (e.g., image interpretation). Its performance is evaluated through physical and chemical property testing (e.g., volume accuracy, needle strength, sterility).

4. Adjudication Method for the Test Set

• Not Applicable. As noted above, this type of device does not involve expert adjudication for ground truth establishment.

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

• No. An MRMC study is typically for evaluating the performance of diagnostic devices, especially those involving human interpretation of data (e.g., radiology images) with and without AI assistance. This device is a manual fluid collector, so such a study is not relevant.

6. If a Standalone Performance Study Was Done

• Yes, implicitly. The bench functional performance tests (ISO 7886-1, ISO 9626, ISO 7864), biocompatibility tests, sterility tests, and the OUS study (which demonstrated effectiveness to collect 50 µL) all represent standalone performance evaluations of the device itself, without human interpretation as a variable.

7. The Type of Ground Truth Used

• Metrological and Biological Standards: The ground truth for this device's performance is established by reference to international standards (e.g., ISO for syringes and needles), specific quantitative measurements (e.g., needle force, volume, heavy metal limits, SAL for sterility), and established biocompatibility principles (ISO 10993 series). In the case of the OUS study, the "ground truth" for liquid collection would be the actual measured volume collected by the device.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware medical device, not an AI/software device that requires a training set.

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

• Not Applicable. As it's not an AI/software device, a training set and its associated ground truth are not relevant.

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The K-Pack Enhance Needle a sterile, hypodermic needle, for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The K-Pack Enhance Needle is for general application - for injection of fluids or withdrawal of fluids.

The K-Pack Enhance Needle is a sterile hypodermic needle for single use consisting of a stainless steel cannula with nominal outside diameter of 0.33 mm or 0.40 mm and a length of 12 mm. The cannula is sharpened at one end and has 45° cut at the other end, which is joined to a female luer connector (hub) made of polycarbonate (PC) designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The K-Pack Enhance Needle is packed in a hard plastic container (cap and case) made of polypropylene and sealed with a label. The case serves as needle protector. The needle is non-toxic, nonpyrogenic and sterilized by ethylene oxide.

This document is a 510(k) clearance letter for the K-Pack Enhance Needle, which is a hypodermic single lumen needle. This device is a physical product and not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and how training set ground truth was established, are not applicable.

Here's the breakdown of the acceptance criteria and performance information that is relevant to this type of medical device:

Acceptance Criteria and Device Performance for K-Pack Enhance Needle

The K-Pack Enhance Needle is a physical medical device (hypodermic needle). Its acceptance criteria are based on various international and national standards for such devices, ensuring its safety, effectiveness, and substantial equivalence to a predicate device. The performance of the device against these standards is demonstrated through non-clinical testing.

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)

This device is a physical medical product, not an AI/ML powered device. Therefore, the concept of a "test set" in the context of data for an algorithm does not apply. Performance was evaluated through non-clinical testing (laboratory and bench testing) of the physical device as manufactured. The specific sample sizes for each non-clinical test (e.g., how many needles were tested for tensile strength, flow rate, or EO residuals) are not detailed in this summary document, but such testing would be performed on representative samples per relevant standards. Data provenance, in this case, would refer to the materials and manufacturing location (Terumo Europe N.V., Belgium) and the testing being conducted in accredited laboratories following international standards.

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 is a physical medical device. "Ground truth" expertise would involve engineers and quality control specialists performing direct measurements and assessments against specified technical standards.

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

Not applicable. This is a physical medical device. Performance is determined by objective physical and chemical testing against defined standards.

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 physical medical device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a physical medical device.

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

Not applicable. For a physical device, "ground truth" equates to adherence to established engineering specifications, material properties, and performance benchmarks defined by national and international standards (e.g., ISO, USP, ASTM).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML powered device.

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

Not applicable. This is a physical medical device.

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SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.

The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.

SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (EO gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

The SureFine Pen Needle device, K250658, is a Class II hypodermic single lumen needle intended for use with a pen injector for the subcutaneous injection of insulin. The information provided is from an FDA 510(k) Clearance Letter.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SureFine Pen Needle are based on compliance with international standards ISO 9626, ISO 11608-2, and ISO 10993-1, 10993-4, 10993-5, 10993-7, 10993-10, and 10993-11 for biocompatibility and sterilization validation according to ISO 11135.

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

The document does not explicitly state the specific sample sizes for each test mentioned (ISO 9626, ISO 11608-2, Biocompatibility). However, it indicates that "Bench tests for the device's performance were conducted" and "Biocompatibility of the SureFine Pen Needle was evaluated". The testing was conducted by Shina Med Corporation, a company based in the Republic of Korea. The nature of these tests (bench testing, lab-based biocompatibility) suggests they are prospective tests performed on manufactured samples of the device. The data provenance is primarily from internal testing and validation by the manufacturer, following international standards.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the "test set" in the context of device performance. The testing performed is against established international standards (ISO 9626, ISO 11608-2, ISO 10993 series), which themselves represent a form of "ground truth" for device safety and performance criteria. The evaluation results are reported as "Pass" or "Met," implying adherence to these predefined standards rather than an expert panel establishing a de novo ground truth for each specific test.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method (such as 2+1, 3+1, none). The evaluation is based on objective measurements and established criteria set forth by the ISO standards. For instance, a flow rate test would have a pass/fail threshold, not require expert adjudication in the traditional sense.

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

No. The document describes bench tests and biocompatibility evaluations for a medical device (pen needle), not a diagnostic or AI-assisted system that would typically undergo an MRMC comparative effectiveness study involving human readers. Therefore, there is no mention of an effect size of human readers improving with or without AI assistance.

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

No. This device is a physical medical instrument (a pen needle), not a software algorithm or AI system. Therefore, the concept of "standalone performance" in the context of algorithms is not applicable here.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's performance is adherence to established international standards and regulatory requirements:

• ISO 9626: Specifies requirements for stainless steel needle tubing for the manufacture of hypodermic needles.
• ISO 11608-2: Specifies requirements and test methods for single-use needles used with pen-injectors.
• ISO 10993 series: Biological evaluation of medical devices, covering various aspects of biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity).
• ISO 11135: Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.
• ISO 10993-7: EtO residual limits.
• LAL testing: To ensure absence of bacterial endotoxins.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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The needle is used to access surgically implanted vascular ports.

Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.

In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention which reduces the risk of accidental needlestick injuries by sheathing the needle.

The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Yinjection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.

This submission is new design primarily involve changes to the type C name, the addition of new needle lengths and new type E.

The FDA 510(k) submission document for the Promisemed Safety Huber Needles details the device's characteristics and its substantial equivalence to a predicate device (K230715). The document does not describe a study involving an AI/software device that requires extensive acceptance criteria, an MRMC study, or the establishment of ground truth by multiple experts.

The provided document is a 510(k) premarket notification for a Class II medical device, specifically a hypodermic single lumen needle. This type of device approval primarily relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than a clinical study with complex AI performance metrics.

Therefore, many of the requested details, such as the number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training sets, are not applicable to the content of this document.

However, based on the non-clinical testing described, we can extract information relevant to the device's acceptance criteria and how its performance was verified.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance for Promisemed Safety Huber Needles

The acceptance criteria for this device are primarily based on meeting established industry standards and design specifications, ensuring the new design (specifically Type D and Type E, and changes in needle lengths for Type D) is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Appearance
• Dimension
• Safety mechanism operation | Full performance was tested, including appearance, dimension, safety mechanism, etc., and found to comply with:
• ISO 7864 (Sterile hypodermic needles for single use)
• ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices)
• ASTM F3212-16 (Standard Test Method for Performance of Safety Mechanism on Needles Used for Accessing Implanted Ports)
• ISO 23908 (Sharps injury protection features for single-use containers, sharps disposal containers and medical sharps)
  Result: Complied with all specified standards. |
  | No New Risks (Safety and Effectiveness) | The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device. |

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of needles) used for each non-clinical test (visual inspections, dimensional measurements, and performance tests). It generally states "verification and validation tests passed without deviations."
• Data Provenance: The document implies that the testing was conducted by Promisemed Hangzhou Meditech Co., Ltd. in China ("No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China."). The testing is described as "Nonclinical test," which typically refers to laboratory-based evaluations rather than human subject data. These tests are retrospective in the sense that they are performed on manufactured devices to prove compliance, not prospective data collection from clinical use.

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

• Not applicable. This is not an AI/software device requiring human expert annotation or ground truth determination based on clinical interpretation. The "ground truth" here refers to compliance with engineering specifications and recognized international standards (ISO, ASTM).

4. Adjudication Method for the Test Set

• Not applicable. As noted above, this isn't a study involving human interpretation or AI output that would require adjudication. Compliance is determined against quantitative and qualitative engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• Not applicable. This is a physical medical device (needle), not an AI algorithm. Therefore, an MRMC study is irrelevant.

6. 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.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on adherence to international consensus standards (ISO, ASTM) and the manufacturer's internal design specifications and drawing requirements. This includes:
  • Dimensional accuracy (e.g., outer diameter and length of needles).
  • Functional performance of the safety mechanism.
  • Material properties and biocompatibility (implied by compliance with standards for medical devices).
  • Labeling accuracy.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for a physical medical device in this context, as no AI model is being trained.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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