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The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.

The Terumo® Pen Injector Needle 34 is comprised of a double-tapered stainless steel needle cannula that is pointed at both the cartridge interface end, to puncture the cartridge for drug delivery, and the patient interface end, for injection into the patient's body tissue. The patient interface end features a 3-bevel, asymmetrical needle edge.

The cannula tapers from a 29G (0.33 mm) outer diameter at the cartridge interface end to a 34G (0.18 mm) outer diameter at the needle tip (patient interface end). It is normal-walled (min. 0.089 mm inner diameter) at the needle tip, and the internal diameter tapers like the outer diameter (wall thickness is uniform throughout the needle length). The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device).

The needle insertion length (from the glue mount on the hub to the tip of the patient interface end) is 4 mm (5/32"). The length of the needle cartridge side is 6.5 mm (1/4"). The patient interface end (needle tip) is covered by a white plastic needle protector cap (inner needle cap) which is then covered by a clear plastic outer case (outer needle case). The cartridge interface end is then covered with a sealing film.

Just prior to use, the outer needle case is removed and retained for recapping once the injection is completed. The inner needle cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer needle case so it can be safely removed from the pen injector and disposed of immediately.

This pen needle device is individually packaged and sterilized by electron beam. It is a manually operated, disposable device intended for single use only.

The provided document is a 510(k) summary for the Terumo® Pen Injector Needle 34. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results of the device meeting specific acceptance criteria in the way an AI/ML device submission would.

Therefore, the information requested in your prompt regarding acceptance criteria and studies (as they relate to AI/ML device performance, such as sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in this document. This document details non-clinical performance and biocompatibility testing for a medical needle, which are distinct from the types of studies typically conducted for AI/ML devices.

However, I can extract the available information regarding the non-clinical tests performed and their general results as presented in the document.

Here's a summary of the available information and a notation on what is not present:

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

The document provides a table of non-clinical tests performed and states whether the device meets the standard or acceptance criteria. Specific numerical acceptance criteria are generally not explicitly stated but are implied by adherence to ISO standards or established criteria based on predicate devices.

Regarding Biocompatibility Testing:
The device underwent biocompatibility testing in accordance with ISO 10993-1 and FDA guidance. All listed tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Pyrogenicity, Hemolysis, Physicochemical Profile) for non-aged and accelerated-aged devices demonstrated that the device is biocompatible.

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

This information is not provided in the document. The document describes non-clinical performance and biocompatibility tests on the device itself, not on patient data.

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)

This information is not applicable/provided. The tests are based on conformity to ISO standards and established engineering criteria, not expert consensus on medical images or clinical outcomes.

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

This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for the non-clinical device performance tests described here.

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 information is not applicable/provided. MRMC studies are used for evaluating diagnostic or treatment interpretation, often involving AI systems. This submission is for a physical medical device (pen injector needle) and does not involve AI.

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

This information is not applicable/provided. This device is a physical needle and does not involve an algorithm.

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

The "ground truth" for the non-clinical tests is based on International Organization for Standardization (ISO) standards and established internal acceptance criteria derived from predicate devices. For biocompatibility, it's based on ISO 10993-1 and FDA guidance.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable/provided. There is no "training set" for this device.

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The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (

The SURFLASH® Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter.
The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin, and catheter hub), needle assembly (needle, needle housing, transparent flash chamber (needle connecting part) with filter, and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, and junction cylinder).
The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

Here's a summary of the acceptance criteria and study information for the SURFLASH® Safety I.V. Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission declares that the device "complies with the acceptance criteria established based on the predicate" and that "No deviations from ISO standards were identified in the testing to standards." However, specific numerical acceptance criteria (e.g., minimum force for needle breaking shutter) are not explicitly stated in the provided text. The table below lists the performance tests conducted and confirms that the device conformed to the relevant standards or internal requirements.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for each performance test. It mentions that "Performance testing was conducted to ensure the safety and effectiveness... verify conformity to the applicable part of ISO standards, and demonstrate substantial equivalence to the predicate device." For the "Simulated Use Study," it refers to "study participants" without specifying their number.
• Data Provenance: The testing was non-clinical performance and biocompatibility testing. The data originates from internal testing conducted by Terumo Corporation's Kofu Factory in Japan, as indicated by the manufacturer's location and the context of the submission. The text implicitly suggests retrospective data collection as these are standardized tests assessing device properties.

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

• This section is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies requiring expert ground truth in a clinical setting (e.g., image interpretation). The "ground truth" for these tests consisted of established ISO standards and internal specifications.
• For the Simulated Use Study, "healthcare workers who use these types of Safety I.V. Catheters" were involved, but their number and specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical testing against established standards and internal requirements, not a study requiring adjudication of expert interpretations.

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 submission is for a physical medical device (I.V. catheter) and does not involve AI or human readers for diagnostic interpretation.

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

• Not applicable. This submission is for a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the non-clinical performance tests was rooted in established international standards (ISO standards), FDA guidance documents (e.g., for sharps injury prevention features), and internal specifications derived from the predicate device. For the biocompatibility tests, it was adherence to ISO 10993-1 and FDA G95-1 guidelines.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that would require a training set.

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

• Not applicable. This is not a machine learning or AI device that would require a training set.

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The SURFLASH® Plus Safety I.V. Catheter is inserted into the patient's vascular system for short term use (

The SURFLASH® Plus Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter. The devices consist of catheter assembly (catheter, caulking pin and catheter hub containing valve, seal component and plug), needle assembly (needle, needle housing, transparent flash chamber with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, junction cylinder). The SURFLASH® Plus Safety I.V. Catheter has a valve and a seal component inside the catheter hub to minimize the possibility of blood leakage at catheter hub after needle removal. The catheter hub is also provided with a plug inside which penetrates the valve to create a fluid path when a connector is inserted in the catheter hub. The fluid path is permanently opened once a secure luer connection is made. The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

The provided text is a 510(k) summary for the Terumo SURFLASH® Plus Safety I.V. Catheter. It outlines the device's description, intended use, non-clinical tests, and substantial equivalence to predicate devices. However, it does not describe an AI/ML-based medical device. Therefore, the information required to answer your questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present in the provided document.

To directly answer your request, here's what can be extracted from the document regarding the device (the I.V. catheter) meeting its intended performance, even though it's not an AI/ML device:

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

The document states that "Performance testing was conducted to ensure the safety and effectiveness of the SURFLASH® Plus Safety I.V. Catheter throughout the shelf life, to verify conformity to the applicable part of ISO standards and demonstrate substantial equivalence to the predicate devices." It also lists various performance tests conducted.

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

• Simulated Use Study: "study participants" (number not specified). "Healthcare workers who use these types of safety I.V. catheters."
• Other Performance Tests: Sample sizes are not explicitly stated for the enumerated tests (e.g., burst pressure, tensile strength).
• Data Provenance: The tests were conducted by Terumo Corporation, presumably within their facilities or via third-party labs on their behalf. The country of origin of the data is not specified beyond the manufacturer's location in Japan, with regulatory affairs in the US. The studies are prospective as they are tests performed on the device to demonstrate conformity.

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

This information is not applicable and therefore not provided in the document as this is a physical medical device, not an AI/ML-based device requiring expert annotation for ground truth. For the simulated use study, "healthcare workers who use these types of safety I.V. catheters" were participants, but their role was to evaluate usability and safety activation, not to establish a "ground truth" in the AI/ML sense.

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

Not applicable in the context of a physical device's performance testing. The simulated use study reported that "All participants were able to read and activate the catheter safety feature without further explanation or training." This implies a very high level of consistent success, not requiring an adjudication method.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device. The "simulated use study" evaluates the human-device interaction, confirming the safety feature's activation.

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

For the safety function, the "ground truth" is the successful activation of the sharps injury prevention feature and prevention of needle stick injuries during simulated use. This is determined by observation of the device's physical function and user interaction. For other performance tests, the "ground truth" is the established engineering and materials standards (ISO standards and internal standards) for the properties being measured.

8. The sample size for the training set:

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

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

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

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The TERUMO® Micro tapered pen needle is intended for use with a pen injector device for the subcutaneous injection of insulin. It is indicated for general use and for pediatric patients.

The Terumo® Micro tapered pen needle is comprised of a stainless steel needle pointed at both ends with a 28gauge outer diameter at the vial end and tapers to a 33gauge outer diameter at the needle tip i.e. patient end. The tapered length is 3.5mm from the tip. The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device). It is designed to fit type A universal insulin pen injectors. The exposed patient-end needle length is 3/16" (5mm). The needle tip is covered by a colored plastic protective cap which is covered by a clear outer plastic cap. Just prior to use, the outer plastic cap is removed and retained for recapping once the injection is completed. The colored cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer cap so it can be safely removed from the pen injector and disposed of immediately. This pen needle device is individually packaged and sterilized. It is a disposable device intended for single use only.

The provided text describes the Terumo Micro tapered pen needle and its FDA 510(k) clearance, but it does not contain a specific performance study with detailed acceptance criteria and reported results. Instead, it states that the device was "tested in accordance with ISO 11608-2: 2000" and that "None of the data raises any new issues of safety and effectiveness." It also mentions "injection force and penetration resistance" as other tested parameters.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment cannot be extracted directly from the provided text for a device that is not an AI/ML diagnostic system.

However, I can infer some information based on the context of a medical device submission and ISO standards.

Here's a breakdown of the available information and what cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The device is manufactured by Terumo Corporation in Japan, but where the testing was conducted or the origin of any clinical data (if applicable, which isn't clear here) is not stated. The submission was prepared by Terumo Medical Corporation in Maryland, USA.

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

• Not applicable. This device is a pen needle, not an AI/ML diagnostic device that requires expert ground truth for classification tasks. Performance testing likely involved engineering measurements and potentially usability testing, but not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

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

• No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant. The comparison is against predicate devices based on design and performance standards, not human reader performance.

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

• Not applicable. See point 3. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance would be established by engineering specifications, direct physical measurements, and adherence to established international standards (ISO 11608-2:2000) for pen needles. This includes criteria for dimensions, force, sterility, material properties, and compatibility. It also relies on the safety and effectiveness profile of the predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. See point 8.

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