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The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs.

The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use.

The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock'unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick.

The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is indicated for intravitreal use.

The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The LDS Needle and OcuSafe® LDS Needle have a removable cap that is removed prior to the needle's use. The SteriCap® LDS Safety Needle and VitreJect® LDS Safety Needle have a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Needle / SteriCap® LDS Needle are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needle and OcuSafe® LDS Needle are suitable for intravitreal use.

The provided text describes a 510(k) submission for several needle devices, primarily focusing on the addition of a "low dead space (LDS)" specification. The submission claims substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The primary new acceptance criterion mentioned is for "Low Dead Space (LDS)".

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

• Low Dead Space (LDS) Testing:

  • Sample Size: 58 samples (for 95% confidence and 95% reliability)
  • Data Provenance: Not specified (country/retrospective/prospective)

• Other Testing (Biocompatibility, Performance, Sterilization, etc.): The specific sample sizes for each of these tests are not provided in the summary. The text implies these tests were conducted as part of the overall validation process, often following international standards (ISO, USP, AAMI, ASTM). No information about data provenance (country, retrospective/prospective) is given for these tests. The text states these characteristics "did not change from devices under the respective previously cleared 510(k)s," suggesting that much of this data might be carried over from previous submissions for very similar devices.

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 device is a physical medical needle, not an AI or imaging device that requires expert interpretation for a "ground truth" establishment in the traditional sense of clinical studies. The "ground truth" for the performance characteristics (e.g., dead space volume, material strength, biocompatibility endpoints) is established through standardized laboratory testing and measurement against pre-defined engineering and biological criteria outlined in the referenced ISO, USP, AAMI, and ASTM standards. The summary does not specify the number or qualifications of individuals conducting these laboratory tests.

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

Not applicable. This is not a study requiring expert adjudication of diagnoses or findings. The "test set" here refers to physical samples undergoing laboratory measurements.

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 medical device (needle) and does not involve AI assistance 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 is a medical device (needle) and does not involve an algorithm.

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

The "ground truth" for verifying the device's characteristics is based on:

• Direct Measurement/Quantitative Analysis: For specifications like low dead space volume (≤ 5µL), needle length, gauge.
• Standardized Laboratory Tests: For biocompatibility endpoints (e.g., cytotoxicity, endotoxin levels), material properties, sterilization efficacy, and packaging integrity. These tests compare results against established thresholds defined by international standards (ISO, USP, AAMI, ASTM).
• Engineering Specifications: For physical characteristics and design integrity.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described in this summary.

9. 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 SteriCap Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick.

The VitreJect Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect Safety Needle is indicated for intravitreal use.

The VitreJect Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick.

The SteriCap Safety Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen hypodermic needle intended for use with a luer-tip syringe. The SteriCap Safety Needle has a spring-actuated, non-removable sliding cap that moves along the axis of the needle hub during clinical use and automatically re-covers the needle tip after use. The needle cap can be manually locked/unlocked. The SteriCap Safety Needle is intended for manual use by health care professionals for administration of drugs. The SteriCap Safety Needle is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas.

The VitreJect Safety Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen hypodermic needle intended for use with a luer-tip syringe. The VitreJect Safety Needle has a spring-actuated, non-removable sliding cap that moves along the axis of the needle hub during clinical use and automatically re-covers the needle tip after use. The needle cap can be manually locked/unlocked. The VitreJect Safety Needle is intended for manual use by health care professionals for administration of drugs. The VitreJect Safety Needle is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Safety Needle is suitable for ophthalmic use.

This document details the acceptance criteria and supporting studies for the OcuJect SteriCap Safety Needle and VitreJect Safety Needle.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OcuJect SteriCap Safety Needle and VitreJect Safety Needle are based on conformance to recognized international and internal standards, and performance against these standards. The subject devices are described as having "identical" characteristics where they match the predicate devices, and "meet design specification and conforms to standard" or "Passed bench testing for sharps injury prevention feature activation, access in the safe mode, and destructive force, and demonstrate 0% injury rate" for performance features.

• Internal Standards: The document refers to "Internal Standards" for certain performance aspects, particularly for the Sharps Injury Prevention Feature.
• Bench Testing Results: Demonstrating specific quantifiable performance metrics such as "0% injury rate" for the sharps injury prevention feature.
• Post-market data: Mentioned as recording a "0% injury rate" for the predicate devices.

8. Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument, not a machine learning model, and therefore does not involve a training set in the context of AI/ML.

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

This question is not applicable, as there is no training set for a physical medical device.

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The Vitrelect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use.

The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.

The VitreJect® / OcuSafe® Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The VitreJect® Needle has a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. The OcuSafe® Needle has a removable cap that is removed prior to the needle's use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The VitreJect®/OcuSafe® Needles are single use only, non-toxic, nonpyrogenic, and sterilized by ethylene oxide gas. The VitreJect®/OcuSafe® Needles are suitable for ophthalmic use.

The provided document is a 510(k) Premarket Notification for a medical device (VitreJect® Needle; OcuSafe® Needle), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of AI/device performance requiring human reader studies and expert adjudication. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts, MRMC studies, ground truth establishment methods for AI) is not applicable to this type of regulatory submission.

The document discusses non-clinical testing to confirm the safety and effectiveness of the device. The acceptance criteria are based on meeting established standards and demonstrating biocompatibility and performance similar to the predicate device.

Here's an attempt to answer your questions based on the available information, noting where information is not present or applicable:

Acceptance Criteria and Study for VitreJect® Needle / OcuSafe® Needle (K230959)

This 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (SteriCap® Mini Needle and Standard Needle, K212805) through comparison of technological characteristics and non-clinical performance testing, rather than a clinical trial involving human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are generally met by demonstrating compliance with recognized standards and proving that the device performs as intended and is biocompatible. The "reported device performance" is essentially the passing of these tests.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., how many needles were tested for dimension, strength, or biocompatibility). These are typically determined by relevant industry standards and statistical methods for device testing.
• Data Provenance: The data is generated from non-clinical laboratory testing performed by OcuJect, LLC (or their designated testing facilities) to support the regulatory submission. It is not patient data. It is retrospective in the sense that the testing was completed prior to the submission, but it is not from a real-world clinical patient population. The country of origin of the testing is not specified, but it would be expected to comply with US FDA requirements.

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

• This question is not applicable as the "test set" here refers to physical devices undergoing non-clinical performance and biocompatibility assessments, not a dataset requiring expert human interpretation or ground truth labeling in the context of AI or diagnostic studies.

4. Adjudication Method for the Test Set

• This question is not applicable as there is no human interpretation or ground truth establishment requiring adjudication for this type of device testing.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging diagnostic devices, not for a hypodermic needle.

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

• Not applicable. This device is a physical hypodermic needle, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Not applicable in the conventional sense of ground truth for AI/diagnostic studies. For this device, the "ground truth" is defined by compliance with established international and US standards (e.g., ISO, USP, ASTM) for medical device performance, safety, and biocompatibility. The "truth" is whether the physical properties and biological interactions of the needle meet these predefined, objectively measurable criteria.

8. The Sample Size for the Training Set

• Not applicable. This document describes a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As there is no AI or machine learning model, there is no training set or ground truth in this context.

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The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.

The Vitrelect Syringe is designed to provide a means of fluid injection and aspiration. It is a luer-tip piston syringe consisting of a 1 mL hollow barrel with gradient markings and a plunger with an incorporated plunger stopper. The VitreJect Syringe barrel component is available in two configurations, a luer-slip or luer-lock tip, for the fitting of a compatible hypodermic needle. The VitreJect Syringe plunger is available in two configurations: standard dead space or low dead space. It is intended for manual use by health care professionals. The VitreJect Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Syringe is suitable for ophthalmic use.

This document is a 510(k) Premarket Notification for a medical device called the "VitreJect Syringe." It aims to demonstrate that the VitreJect Syringe is substantially equivalent to a legally marketed predicate device (StaClear Syringe, K200242).

This document describes non-clinical performance and biocompatibility testing for a medical device (syringe), not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text.

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

The document doesn't present a single structured table explicitly labeled "Acceptance Criteria and Reported Performance" with quantitative thresholds for all tests. However, it lists a series of tests performed and states that the device "met the applicable requirements" or "met the established safety and performance characteristics." For some specific characteristics, it even provides the performance achieved.

Here's a summarized table based on the information provided:

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

The document does not specify the exact sample sizes (N numbers) used for each individual test. It generally states that "Performance testing was performed as per the design control system" and refers to ISO standards, which typically involve specific sample sizes.

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The document does not specify the country of origin for the data. The tests are "non-clinical testing" (in vitro and in vivo studies) performed by the manufacturer (OcuJect, LLC). It's a regulatory submission, so the data is likely manufacturer-generated to support the device's claims. The studies were prospective in the sense that they were conducted specifically for this regulatory submission to demonstrate device performance.

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

This question is not applicable as the device is a physical medical device (syringe), not an AI/ML diagnostic tool. Ground truth in this context refers to the measured physical and biological properties of the device, established through standardized testing methodologies, not expert interpretation of medical images or data.

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

This question is not applicable as the device is a physical medical device (syringe), not an AI/ML diagnostic tool. Adjudication methods are used in consensus labeling of data by human experts for AI models. The "ground truth" here is determined by direct measurement and standardized test results.

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 question is not applicable as the device is a physical medical device (syringe) and not an AI-powered diagnostic tool that assists human readers.

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

This question is not applicable as the device is a physical medical device (syringe) and does not involve an algorithm.

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

The "ground truth" for this medical device is established through:

• Standardized Physical and Chemical Measurements: Performed according to ISO, USP, and ASTM standards (e.g., dead space volume, operational force, particulate matter counts, dimensional specifications).
• Biological Testing (In vitro and In vivo): Biocompatibility tests such as cytotoxicity, sensitization, irritation (intracutaneous, ocular, intravitreal, intraocular), systemic toxicity, pyrogenicity, and hemolysis.
• Chemical Characterization and Toxicological Risk Assessment: To identify extractables/leachables and assess their risk.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device (syringe) and does not involve AI/ML requiring a training set.

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

This question is not applicable as the device is a physical medical device (syringe) and does not involve AI/ML requiring a training set.

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The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.

The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.

This document is a 510(k) summary for a medical device (MiniLoad Syringe) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide the detailed types of information requested in your prompt regarding AI model performance, training sets, ground truth establishment, or expert adjudication.

The document discusses acceptance criteria and device performance in the context of bench testing for a standard medical device (a syringe), not an AI-powered diagnostic or assistive technology.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document details:

• Acceptance Criteria and Device Performance (Bench Testing for a Syringe): The table on pages 4-5 compares the subject device to a predicate device regarding physical characteristics, materials, and some performance specifications. Page 6 lists general performance data categories and Biocompatibility standards used to support substantial equivalence.
• Sample Size, Data Provenance, Expert Information, Adjudication Method, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Sample Size/Ground Truth: None of this information is provided because the submission is for a physical medical device (syringe), not an AI/ML system. The "performance data" refers to standard mechanical and material tests for the syringe, not diagnostic accuracy based on human image interpretation.

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The SteriCap™ Mini Needle and standard needles are intended for use with a luer-tip syringe (e.g. luer-lock or slip-ip luer syringe) for the administration of drugs.

The SteriCap® Mini Needle ("SteriCap®") and Needles ("Needles") are devices intended to provide a means of fluid injection and aspiration to and from the body. The devices are a single lumen needle. For SteriCap® Mini Needle, the needle has a spring-actuated sliding cap, which protects the needle prior to use. For Needles, the needle is covered by a removable clear cap.

The additional gauges and lengths of the product family included in this submission are 30G/31G/33Gx 6mm and 31G / 33G x 4 mm. The additional gauges and lengths of the Needle included in this submission are 29G/30G/31G x 13 mm and 33G x 8 mm.

The provided text describes the submission of a medical device, the SteriCap™ Mini Needle and Standard Needles, for 510(k) premarket notification. The FDA's decision is that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain information about:

• A table of acceptance criteria and reported device performance related to an AI/ML or diagnostic imaging device.
• Sample sizes for test sets (beyond general mention of performance testing).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods for test sets.
• Whether an MRMC comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The text focuses on the physical characteristics and performance testing of a hypodermic needle, demonstrating its substantial equivalence to a predicate device. The performance data mentioned relates to:

• Dimensional and Physical Properties Verification (ISO 9626:2016, ISO 7864:2016)
• Needle quality (ISO 9626:2016, ISO 7864:2016)
• Color coding (ISO 6009:2016, ISO 7864:2016)
• Biocompatibility (ISO 10993-1, cytotoxicity, sensitization, irritation, acute systemic toxicity, materials mediated pyrogenicity)
• Sterility/Shipping and Shelf-life (ISO 11135:2014, ISO 10993-7, ASTM F1980-16, ASTM D4169-16, ASTM F2096-11, ASTM F88/F88M-15)

These are standard tests for medical devices, particularly those involving materials, sterility, and physical properties, and are not related to AI/ML device performance or diagnostic accuracy.

Therefore, I cannot provide the requested information based on the given input, as it describes a physical medical device (hypodermic needle) and not an AI/ML-based diagnostic device.

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The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.

The MiniLoad Syringe is a device intended to provide a means of general use fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component has a male slip tip end for the fitting of a compatible needle. The device is available in a 1ml volume.

The provided document is a 510(k) Premarket Notification for the MiniLoad Syringe, not an AI/ML device. Therefore, the information typically requested for AI/ML device studies (such as acceptance criteria for AI model performance, sample sizes for AI test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance) is not available in this document.

The document focuses on demonstrating substantial equivalence to a predicate device (NORM-JECT Syringe) for a traditional medical device (piston syringe). The "performance data" section in the document refers to physical and biological performance characteristics of the syringe itself, not the performance of an AI/ML algorithm.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The MiniLoad Syringe is described as a device comprised of a hollow barrel with gradient markings and a plunger, used for fluid injection and aspiration. There is no mention of any artificial intelligence or machine learning component.
• Performance Data Type: The "Performance Data" section (VII.) details testing for characteristics like freedom from extraneous matter, lubricant quantification, plunger stop detachment, leakage, piston operational force, biocompatibility, sterility, and shelf-life. These are all tests related to the physical and material properties of a syringe, not the accuracy or performance of an AI algorithm.
• Ground Truth: For a traditional device like a syringe, "ground truth" relates to physical measurements and laboratory testing results adhering to specific standards (e.g., ISO 7886-1 for syringes, ISO 10993 for biocompatibility, USP for particulate matter). There is no "expert consensus" or "pathology" ground truth as would be used for image analysis AI/ML.

Therefore, since the core premise of your request is about an AI/ML device, and the provided document is for a non-AI/ML device, I cannot fill in the table or answer the specific questions related to AI/ML device acceptance criteria and study design.

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The Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs into the body.

The Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in 30G, 32G and 33G sizes with a 5.5mm exposed length. The distal end of the needle has a spring-loaded needle cap, which shields the needle prior to use.

The provided document is a 510(k) premarket notification for a medical device called "Mini Needle." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the context of an AI/ML or diagnostic device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic performance (e.g., sensitivity, specificity, F-measure, sample sizes for test/training sets, expert consensus, MRMC studies) is not applicable to this document.

This document describes a conventional medical device (hypodermic single lumen needle) and its premarket notification process. The "Performance Data" section details engineering and biocompatibility tests performed to ensure the device performs as intended and is safe, rather than a clinical performance study with AI/ML-specific metrics.

Here's a breakdown of the available information in the context of the device described:

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

The document lists performance tests, but it does not provide quantitative acceptance criteria or numerical reported device performance in the format typically seen for AI/ML or diagnostic studies. Instead, it states that "The Mini Needle met all specified criteria and did not raise different safety or performance questions."

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

• Sample Size for Test Set: Not explicitly stated for each test. The document mentions "All testing was performed on test units representative of finished devices," implying a sample size appropriate for engineering validation but not specified numerically.
• Data Provenance: Not applicable in the context of AI/ML data. The tests are laboratory-based engineering and material science tests.

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

This concept is not applicable to the engineering and biocompatibility testing described. Ground truth established by medical experts is relevant for diagnostic or AI/ML performance, not for verifying physical and material properties of a needle.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic or AI/ML studies, which is not relevant 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:

Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• For Dimensional and Physical Properties, Bond and Material Strength, Sterilization Validation, and Packaging Validation, the "ground truth" would be established by the engineering specifications and relevant ISO/ASTM standards.
• For Biocompatibility Testing, the "ground truth" is based on the biological response observed in accordance with ISO 10993 standards, determining if the material is non-toxic or non-irritating.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/ML device.

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

Not applicable. This device does not involve a training set.

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