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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 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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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 safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

This document is a 510(k) summary for a medical device called "Safety Winged Blood Collection Sets" (K243806) from Promisemed Hangzhou Meditech Co., Ltd. It declares substantial equivalence to a predicate device (K211293).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the format usually seen for AI/ML performance. This is because the device is a physical medical device (blood collection set), not an AI/ML diagnostic system. The "acceptance criteria" here are implied by adherence to recognized international standards and successful completion of non-clinical tests.

However, based on the provided text, we can infer some "acceptance criteria" and "performance" statements related to the modifications made (specifically the addition of model RBC and changes in needle sizes/materials).

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

• Sample size: The document does not specify a numerical sample size for any of the non-clinical tests conducted. Statements like "Visual inspections were conducted on unit packaging" and "Full performance was tested" indicate tests were performed but don't provide the number of units tested.
• Data provenance: The data provenance is from the manufacturer's internal non-clinical testing. It is implicitly "prospective" in the sense that the tests were conducted specifically to demonstrate the performance of the modified device for this 510(k) submission. No specific country of origin for the data is mentioned other than the manufacturer's location in China.

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

This section is not applicable as this is a 510(k) for a physical medical device (blood collection set), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling in that sense. The "ground truth" for these types of devices is established by adherence to engineering specifications and international performance standards.

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

This is not applicable for the same reason as above. No "adjudication" or consensus reading by experts is required for the non-clinical performance and design verification tests reported.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is not an AI/ML system, nor does it involve human readers or cases in an interpretive diagnostic context.

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

This is not applicable as the device is not an algorithm or AI system.

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

The "ground truth" for this medical device is adherence to established technical specifications, engineering drawings, and relevant international performance standards (ISO 6009, ISO 8536-4, ISO 9626, ISO 23908). Biocompatibility is "ground-truthed" by ISO 10993 series testing (e.g., in vitro cytotoxicity).

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm requiring a training set.

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

This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.

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The ACE Cannula is intended to inject fluids intradermally.

The ACE Cannula is provided as a single-use, sterile device. It is comprised of needles, hub and cap. This device comes in a variety of needle gauges and lengths. This device offers AN type and B type within the package. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector(hub) designed to mate with a male connector(nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/medications/drugs to a patient.

The provided document is a 510(k) summary for a medical device called the "ACE Cannula." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than providing the results of a clinical study or performance data based on human-in-the-loop or standalone AI performance.

Therefore, most of the requested information regarding acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment (for training and test sets) is not applicable to this type of submission. This document outlines bench testing for physical characteristics, material safety (biocompatibility), and sterility, all of which are laboratory-based and do not involve patient data or expert reader studies in the way you've described for AI/CADe devices.

Here's an analysis based on the information that is present in the document:

Device: ACE Cannula
Purpose: Intended to inject fluids intradermally.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACE Cannula are based on compliance with international standards for medical devices, specifically hypodermic needles and cannulas, and biocompatibility. The "reported device performance" is the manufacturer's assertion that the device "Pass"ed all these tests.

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

• This is a 510(k) submission for a conventional medical device (a cannula), not an AI/CADe device. The "test set" here refers to samples of the device undergoing laboratory bench testing according to various ISO standards.
• The document does not specify the exact sample size for each individual bench test (e.g., how many cannulas were tested for bond strength). However, it implies that sufficient samples were tested to demonstrate compliance with the relevant standards.
• Data Provenance: The tests were conducted by Ace Medical Industry Co., Ltd. (Korea, as per company address in the 510(k) summary) or a qualified third-party lab under their direction. These are prospective tests performed on newly manufactured devices to demonstrate compliance.

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

• Not applicable. This device's performance is evaluated through physical, chemical, and biological laboratory tests against pre-defined, objective engineering and safety standards (e.g., ASTM, ISO standards). It does not involve subjective human interpretation of data (like medical images), so no human experts are needed to establish "ground truth" for a test set in the clinical sense.

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

• Not applicable. As above, the testing is objective and based on engineering/scientific measurements, not subjective human assessments 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 relates to AI/CADe devices assisting human clinicians. The ACE Cannula is a physical, sterile, single-use device for fluid injection, not an AI or imaging device.

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

• Not applicable. This relates to the performance of an AI algorithm. The ACE Cannula does not have an "algorithm" in this context. Its "performance" is its mechanical, material, and biological properties.

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

• For the tests performed, the "ground truth" is defined by the objective pass/fail criteria established within the referenced international standards (e.g., ISO, USP, ASTM). For example, "pass" for patency of lumen means the lumen was unobstructed as per the standard's definition; "pass" for cytotoxicity means the extracts did not cause a cytotoxic effect beyond the acceptable limits defined in ISO 10993-5. It is based on objective, measurable criteria rather than expert consensus or clinical outcomes data relevant to AI/CADx devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of device. The device is manufactured and then tested for compliance with established standards. There is no machine learning model being trained.

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

• Not applicable. As there is no training set for an AI model, there is no ground truth established for it. The product's design and manufacturing rely on engineering principles, material science, and established quality control practices.

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Verifine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of drugs.

Verifine® Pen Needles, manufactured by Promisemed Hangzhou Meditech Co., Ltd, are designed for use with pen injectors for the administration of drugs. These are standard pen needles without integrated safety features. The devices are single-use, non-pyrogenic, and maintain a Sterility Assurance Level (SAL) of 10 °. The differences between the PromiseMed current cleared common type needle pen and the new design primarily involve changes to the trade name, the addition of new models, and modifications in some materials and dimensions. Key updates include a change in the trade name, the introduction of new models (FPN and NPN), the addition of new needle sizes and a 5-bevel needle tip option, and a shift from a specific intended use (administering insulin) to a general intended use (administering drugs). The materials used have also been slightly modified, such as changing the needle shield material from polypropylene (PP) to polyethylene (PE) for certain models, which only contact intact skin, ensuring no increased risk. These devices are intended for over-the-counter (OTC) use and require manual insertion by the user during drug administration.

The provided text is a 510(k) summary for a medical device (Verifine® Pen Needles). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device meets acceptance criteria through a clinical or performance study that quantifies specific metrics like sensitivity, specificity, accuracy, or human reader improvement with AI assistance.

The context of your request (acceptance criteria, effect size, MRMC studies, ground truth) is typical for the evaluation of AI/ML-enabled medical devices, especially those involving image analysis or diagnostic support. The provided document describes a physical medical device (hypodermic needle) where the primary concerns are mechanical performance, biocompatibility, and compatibility with existing pen injectors. Therefore, information related to AI/ML device evaluation criteria is largely not applicable to this document.

Here's a breakdown of why many of your excellent questions cannot be answered by this document, followed by what can be extracted:

Why most questions are not applicable:

• AI/ML Device Evaluation: The document does not describe an AI/ML device. It's a pen needle. Therefore, concepts like "effect size of human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "number of experts for ground truth," "adjudication method," "sample size for training set," or "data provenance" (in the context of image data) are irrelevant.
• Clinical Performance Data: The summary explicitly states: "No clinical data was necessary to determine the substantial equivalence of this device." This means there was no human-centric clinical study (like an MRMC study) performed to evaluate the diagnostic or treatment benefits in a clinical setting against a "ground truth" established by experts.

What can be extracted or inferred from the document regarding acceptance criteria and device performance for this physical device:

The "acceptance criteria" here are implied by the standards and bench testing performed to demonstrate substantial equivalence to the predicate device and compliance with relevant ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating that changes to the device (new models, sizes, material change, labeling updates) do not raise new questions of safety or effectiveness and that the modified device still meets the performance attributes of the predicate and relevant standards.

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

• Test Set Sample Size: Not explicitly stated in terms of a "test set" as one would for an AI/ML model or a clinical trial. However, non-clinical performance and biocompatibility testing were conducted. The sample size for these specific engineering tests (e.g., how many needles were tested for dose accuracy) is not detailed in this summary.
• Data Provenance: The tests were "completed by Promisemed Hangzhou Meditech Co., Ltd." (China). The data origin is thus the manufacturer's testing facilities. The tests are "non-clinical" (benchtop/lab-based), not from patients. It's not retrospective or prospective in the sense of clinical data collection.

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. Ground truth, in the AI/ML sense (e.g., expert consensus on clinical images), is not relevant here. Performance is measured against engineering specifications and international standards (ISO).

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

• Not Applicable. No adjudication method for expert review of data is mentioned or relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC study was NOT done. This type of study is specifically for evaluating diagnostic performance of AI/ML systems with human readers. The device is a physical pen needle, not an AI diagnostic tool.

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

• Not Applicable. There is no algorithm or software being evaluated for standalone performance. Performance tests are against ISO standards for the physical device.

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

• For this device, the "ground truth" or reference for performance is established by international standards (e.g., ISO 11608-2 for pen needles, ISO 10993-1 for biocompatibility) and the manufacturer's engineering specifications/drawing requirements. It is not clinical diagnostic ground truth.

8. The sample size for the training set:

• Not Applicable. The concept of a "training set" is for AI/ML models. This is a physical device.

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

• Not Applicable. Same as above.

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