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The LILY Extension Tube and Needleless Connector is a sterile single patient use device for the administration of fluids from a container into the patient's vascular system through a vascular access device. It is for direct injection, continuous or intermittent infusion, aspiration and needle-free delivery of solutions during IV therapy.

The LILY Extension Tube and Needleless is a closed luer activated device and passively aids in the reduction of needle stick injuries. Fluid flow through the device is activated by the ISO male luer from standard administration set, extension sets and syringes. The LILY Extension Tube and Needleless Connector provide a solid, sealed, surface for effective disinfection in 3 seconds. It is non-hemolytic. The clear housing and open, fluid filled design of the LILY Extension Tube and Needleless Connector enhance flushing particles. There is less volume of interstitial or dead space internal to the device. The LILY Extension Tube and Needleless Connector may be sued with power injection procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second.

The LILY Extension Tube and Needleless Connector is a sterile single-patient-use device intended for the administration of fluids into a patient's vascular system. It facilitates direct injection, continuous or intermittent infusion, aspiration, and needle-free delivery of solutions during IV therapy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided document does not explicitly present a table of "acceptance criteria" for the LILY Extension Tube and Needleless Connector. Instead, it presents a comparison of the subject device's technological characteristics with a predicate device (MaxZero Extension Sets with Needleless Connector, K140831), and then details performance testing results against recognized standards and FDA guidance.

However, based on the provided "Comparison of Technology Characteristics with the Predicate Device" and "Performance Testing" sections, we can infer some of the implicit acceptance criteria and the device's reported performance against them.

Inferred Acceptance Criteria and Reported Device Performance

• CIC-006SN: ≥170 mL/min
• CIC-007NL: ≥100 mL/min
• CET-015S, CET-015SD, CET-SS02L0, CET-SS02S0: ≥100 mL/min
• CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: ≥75 mL/min |
  | | - Priming Volume: Within acceptable limits for intended use (FDA Guidance, ISO 80369-7:2021) | - CIC-005S: 0.25 mL
• CIC-006SN: 0.07 mL
• CIC-007NL: 0.04 mL
• CET-015S, CET-015SD: 0.55 mL
• CET-SS02L0, CET-SS02S0: 0.34 mL
• CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: 0.36 mL |
  | | - Residual Volume: Within acceptable limits for intended use (FDA Guidance, ISO 80369-7:2021) | - CIC-005S: 0.3 mL
• CIC-006SN: 0.07 mL
• CIC-007NL: 0.04 mL
• CET-015S, CET-015SD: 0.60 mL
• CET-SS02L0, CET-SS02S0: 0.34 mL
• CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: 0.36 mL |
  | | - Flush Volume: Meet specified requirements (FDA Guidance, ISO 80369-7:2021) | - CIC-005S, CET-015S, CET-015SD: 5mL
• CIC-006SN, CIC-007NL, CET-SS02L0, CET-SS02S0, CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: 3mL |
  | | - Displacement: Within acceptable limits (FDA Guidance, ISO 80369-7:2021) | - CIC-005S, CET-015S, CET-015SD: ≤0.05 mL
• CIC-006SN, CET-SS02L0, CET-SS02S0, CET-HS03L0: ≤0.003 mL
• CIC-007NL, CET-HS03S0, CET-HT03L0, CET-HT03S0: ≤0.001 mL |
  | | - Power Injection: Capable of 10mL/sec @ 325 PSI (FDA Guidance) | Pass (10mL/sec @325 PSI) |
  | | - Microbial Ingress: Prevent microbial ingress (FDA Guidance) | Pass |
  | | - Tensile Strength: Meet specified requirements for material strength (FDA Guidance) | Pass |
  | | - Particle Contamination: Meet USP requirements | Pass (USP ) |
  | | - Reducing (oxidizable) Matter: Meet specified requirements (FDA Guidance) | Pass |
  | | - Metal Ions: Meet specified requirements (FDA Guidance) | Pass |
  | | - Titration Acidity or Alkalinity: Meet specified requirements (FDA Guidance) | Pass |
  | | - Residue on Evaporation: Meet specified requirements (FDA Guidance) | Pass |
  | | - UV Absorption of Extract Solution: Meet specified requirements (FDA Guidance) | Pass |
  | Device Characteristics (Comparison) | - Indication for use: Administration of fluids from container into patient's vascular system through a vascular access device; for direct injection, continuous or intermittent infusion, aspiration, and needle-free delivery of solutions during IV therapy, similar to predicate device. | Matches predicate device in intended use and indications. |
  | | - Power Infusion Flow Rate: Capable of 10mL/sec @325 PSI, same as predicate. | Same as predicate. |
  | | - Hemolysis: Non-hemolytic, same as predicate. | Same as predicate. |
  | | - Use: Single Patient, same as predicate. | Same as predicate. |
  | | - Method of Disinfection: 70% IPA, same as predicate. | Same as predicate. |
  | | - Provided Sterile: Yes, same as predicate. | Same as predicate. |
  | | - Packaged Quantity: Single Unit Per Package, same as predicate. | Same as predicate. |
  | Differences from Predicate (with Rationale for Equivalence) | - Physical Specification: Different component configuration (needleless connector alone vs. extension set with connector). Acceptance: Performance tests (biocompatibility, bench testing) demonstrated substantial equivalence. Physical specs (tubing length/ID/OD) are in User Manual. | Differences in models and specific dimensions exist, but testing validated safety and effectiveness. |
  | | - Gravity Flow Rate, Priming Volume, Residual Volume, Flush Volume, Displacement: Different values from predicate. Acceptance: Minor differences, performance evaluated per standards, no new safety/effectiveness issues. Values are detailed in User Manual. | Device meets specified flow rates (per model), and priming/residual/flush/displacement volumes are documented and deemed safe. |
  | | - Number of Activations: Subject device has higher activation capacity for some models (600 vs. 200 for predicate). Acceptance: Microbial ingress testing demonstrated safety for expanded activation counts. Details are in User Manual. | Some models pass 600 activations, others 200, which is higher or equal to the predicate's 200. |
  | | - Sterilization Method: Ethylene Oxide vs. E-beam (Radiation) for predicate. Acceptance: Both are widely used, FDA recognized methods; functional evaluation post-sterilization showed no issues. | ETO sterilization is validated and found safe and effective. |
  | | - Sterile Barrier Packaging: Medical-Grade Papers vs. Tyvek Polyethylene for predicate. Acceptance: Both materials are suitable, and seal strength, dye penetration, burst, and creep tests demonstrated no issues. | Packaging materials and integrity tests (Seal Strength, Dye Penetration, Burst Test & Creep Test) passed. |

The Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed in the "Performance Testing" section of the 510(k) Summary. It consists of two main types of testing:

• Biocompatibility Testing: Conducted in accordance with ISO 10993-1 and FDA guidance for an External Communicating Device, Blood Path Direct Contact (Infusion Only), Prolonged Duration.
• Bench Testing (Functional Testing): Conducted against specific FDA guidance and recognized ISO/ASTM standards relevant to intravascular administration sets and luer activated valves.

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

The document does not specify the exact sample sizes (number of units tested) for each individual biocompatibility or bench test. It reports the results of these tests as "Pass."

The data provenance is from non-clinical data provided by LILY Medical Corporation, a manufacturer based in Taoyuan, Taiwan. The tests were likely conducted in laboratories associated with the manufacturer or certified testing facilities. The tests are "bench tests," making the concept of "country of origin of the data" less relevant in a clinical context; rather, it refers to the location where the physical tests were performed. These are non-clinical (pre-clinical) studies, not human subject studies.

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 as the document describes non-clinical performance testing (biocompatibility and functional bench testing), not a clinical study involving human readers or expert panels establishing ground truth for diagnostic or AI performance. The "ground truth" for these tests is defined by the acceptance limits of the scientific standards and FDA guidance used.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for diagnostic imaging, where expert consensus is needed to establish a definitive diagnosis (ground truth). The tests described here have objective pass/fail criteria based on physical properties and known biological responses.

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. The device is a physical medical device (extension tube and needleless connector), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant to this submission.

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

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

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

The "ground truth" for the performance testing described is established by:

• International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, ISO 11607-1 for packaging, ISO 8536-4 for infusion equipment, ISO 80369 series for small-bore connectors.
• National Standards: e.g., ASTM F1980-16 for accelerated aging, ASTM F756-17 for hemolysis, AAMI ANSI CN27:2021 for Luer activated valves.
• Pharmacopoeia Standards: e.g., USP , for pyrogenicity, USP for endotoxin, USP for particulate contamination.
• FDA Guidance Documents: Specifically, "Use of International Standard ISO 10993-1," "Intravascular Administration Sets Premarket Notification Submissions [510(k)]," which define acceptable performance and safety profiles for this class of device.

These standards and guidances provide the objective criteria and methodologies against which the device's performance is measured, effectively serving as the "ground truth."

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of physical medical device performance testing as described. Training sets are relevant for machine learning models.

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

This information is not applicable for the same reason as point 8.

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The AMSafe® NeuFloTM Needleless Connector are intended to use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

AMSafe® NeuFlo™ Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set.

The provided text is a 510(k) summary for the AMSafe® NeuFlo™ Needleless Connector. This document outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the provided text does not describe a study involving an AI/Machine Learning device, nor does it detail a study that proves a device meets acceptance criteria in the context of AI/ML performance metrics like sensitivity, specificity, or reader studies.

Instead, it details the acceptance criteria and results for a physical medical device. The criteria are based on compliance with established ISO standards and other tests to confirm physical, chemical, and biological performance. The "performance" described refers to the functionality and safety of the needleless connector itself, not AI model performance.

Therefore, I cannot fulfill the request as it pertains to AI/Machine Learning evaluation criteria, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or training set ground truth establishment in the context of an AI/ML device.

The document speaks to the following for the physical medical device:

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

The document provides a table under "g) Summary of Non-clinical testing (Bench)" listing tests, methods, acceptance criteria, and conclusions (Pass/Fail).

For the other points (2-9), as explained, the document pertains to a physical medical device and its compliance with standards, not an AI/ML device performance study. Thus, no information is available regarding:

• Sample size used for the test set and data provenance (in an AI/ML context).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc. for an AI/ML model).
• Sample size for the training set.
• How the ground truth for the training set was established.

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The PuraCath™ Firefly™ Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The PuraCath Firefly Needleless Connector, Model 9001, is a neutral displacement needleless connector intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids when using a vascular access device. The PuraCath Firefly Needleless Connector is a closed, luer activated device that eliminates the risk of needlestick injuries. The PuraCath Firefly Needleless Connector does not require a specific clamping sequence or technique in order to be used safely. The clear housing and open, fluid filled design enhances flushing practice. The Firefly Needleless Connector may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second. The Firefly Needleless Connector can be used for seven (7) days and 200 activations. The PuraCath Firefly Needleless Connector is designed to be disinfected using standard of care alcohol wipe down.

Here's a summary of the acceptance criteria and the study details for the Firefly Needleless Connector, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical bench testing as the study conducted to determine if the device is substantially equivalent to the predicate device. These tests covered biocompatibility testing and performance testing based on various international standards and FDA guidance documents.

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

The document does not specify the exact sample sizes (N-numbers) for each individual test conducted. It only states that "The following non-clinical data were provided in support of the substantial equivalence determination." and lists various test categories.

Regarding data provenance, the tests are non-clinical (bench testing), so there is no patient data involved from specific countries or retrospective/prospective collection. The provenance here refers to the standards and guidance followed (e.g., ISO, ASTM, USP, FDA Guidance).

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

This information is not applicable (N/A) as the tests are non-clinical bench tests (e.g., material compatibility, mechanical performance) and do not involve human interpretation or clinical ground truth established by experts in the typical sense of a diagnostic device. The "ground truth" for these tests are the defined pass/fail criteria outlined in the referenced standards.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop studies or clinical trials where expert consensus is needed to establish ground truth for diagnostic decisions. In this case, the test results are objective measurements against predefined 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

There is no indication that an MRMC comparative effectiveness study was done. This device is a passive medical device (a needleless connector), not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.

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

This information is not applicable (N/A). The device is a physical medical device, not an algorithm, so standalone algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by objective measurements and observations performed according to recognized international standards (ISO, ASTM, USP) and FDA guidance documents. The acceptance criteria for each test are defined by these standards, and the device's performance is compared against these predetermined thresholds. For biocompatibility, this involves evaluating biological responses to materials. For performance, it involves mechanical, fluid dynamic, and durability assessments.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is a physical medical device and does not involve AI/machine learning, and therefore does not have a "training set" in that context. The "design" and "testing" of the device are based on engineering principles and regulatory standards.

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

This information is not applicable (N/A), as it's not an AI/machine learning device requiring a training set.

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The Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direction, intermittent infusion, continuous infusion or aspiration.

The proposed device, Needleless Connector, is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The proposed device is a needleless connector which can be activated by a male luer, and the flush volume for the device is 5ml. The device can be used for less than 7 days and 100 activations.

The Needleless Connector also suitable for power injection of contrast media into the central venous system only through IV line that is also indicated for power injection at a maximum pressure of 325psi and a flow rate of 10ml/s.

The provided text is related to an FDA 510(k) premarket notification for a "Needleless Connector." This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of technical characteristics, rather than a study of an AI-powered device. Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document.

The document details the device's technical specifications, materials, and non-clinical performance tests (e.g., biocompatibility, sterility, integrity, fluid dynamics) to show it is as safe and effective as a previously cleared device. It explicitly states: "No clinical study is included in this submission."

To address your request, I would need a document describing an AI device and its associated clinical or performance study.

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BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are intended to be inserted into a patient's vascular system for short term use to sample blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector devices are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter, and vent plug. The needle and catheter are protected by a needle cover. A MaxZero device with protective cover is provided in the unit package.

The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

These devices have BD Instaflash needle technology, allowing for immediate visualization of blood return along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm)=Yellow, 22 GA (0.9 mm)=Blue, 20 GA (1.1 mm)=Pink, 18 GA (1.3 mm)=Green).

The provided text describes specific performance tests for the BD Nexiva Closed IV Catheter System - Single Port with MaxZero Needleless Connector. However, it does not include the acceptance criteria or reported device performance for these tests in a detailed format that would allow for a direct creation of the requested table. It only states that the device "met all predetermined acceptance criteria."

Therefore, I cannot provide a table of acceptance criteria and reported device performance.

Furthermore, the document does not detail the following information regarding a hypothetical study proving the device meets acceptance criteria:

• Sample size used for the test set or the data provenance.
• Number of experts used to establish the ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
• Whether a standalone (algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with specific performance metrics and acceptance criteria for this particular device. It describes the types of tests performed (e.g., MaxZero Insertion Force, Cytotoxicity, Sensitization) and states that "the subject device met all predetermined acceptance criteria," but it doesn't quantify those criteria or the device's exact performance against them.

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The FLOSTAR Needleless Connector device is sterile, disposable, needle-less I.V. access valve for use in intravenous administration of fluids to a patient's vascular system. The FLOSTAR Needleless Connector device may aid in the prevention of needle stick injuries.

The FLOSTAR Needleless Connector is a sterile, disposable, needle-less I.V. access valve for use in general intravenous administration of fluids.

The provided text does not contain detailed information about specific acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity) for an AI/device, nor does it describe a study (including sample sizes, expert ground truth, adjudication methods, or MRMC studies) designed to prove the device meets such criteria.

Instead, the document is a 510(k) premarket notification for the "FLOSTAR Needleless Connector," a medical device, with a focus on demonstrating "substantial equivalence" to a predicate device.

Here's a breakdown of what the document does provide, and what is missing based on your request:

What is present in the document:

• Device Type: FLOSTAR Needleless Connector (not an AI-driven diagnostic or image analysis device).
• Intended Use: Sterile, disposable, needle-less I.V. access valve for intravenous fluid administration and aid in preventing needle stick injuries.
• Predicate Device: Safe-Connect Valve.
• Demonstration of Substantial Equivalence: The document states the FLOSTAR Needleless Connector is substantially equivalent to the Safe-Connect Valve because they:
  • have the same intended use.
  • use the same operating principle.
  • incorporate the same final design configuration.
  • are both labeled as single patient use.
  • are packaged and labeled using the same materials and processes.
• Summary of Testing (General): "All materials used in the fabrication of this FLOSTAR Needleless Connector were evaluated with the original design through physical testing and biocompatibility testing." This is a general statement about material and design testing, not performance metrics based on clinical data or AI evaluation.

What is missing from the document (as it pertains to your request for AI/device performance criteria and studies):

1. A table of acceptance criteria and the reported device performance: This document does not provide specific performance metrics (like accuracy, sensitivity, specificity, etc.) with corresponding acceptance criteria. It primarily focuses on equivalence to a predicate device in terms of design and material.
2. Sample size used for the test set and the data provenance: Not applicable, as no such performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided document is a 510(k) notification demonstrating substantial equivalence for a physical medical device (a needleless connector), not an AI-driven device requiring performance evaluation based on clinical data, ground truth establishment, or specific diagnostic metrics as envisioned by your detailed request. Therefore, it does not contain the information needed to fill out the requested table regarding acceptance criteria and study details for an AI-enabled device.

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Churchill Medical Systems Vial Access Spike with Needleless Connector is used in I.V. therapy to pierce glass and plastic stopper top vials for the transfer of medical fluids. This device climinates the use of metal hypodermic needles to reduce the chance of inadvertent needle sticks.

The Churchill Medical Systems vial access device is a sterile, single use, one piece shrouded plastic cannula designed to penetrate septums covering plastic or glass medication vials. The device is intended to be marketed with and without needleless connector port permanently attached.

The provided text describes a 510(k) summary for a medical device called the "Universal Vial Access Spike with Needleless Connector" by Churchill Medical Systems, Inc. However, the document does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and performance studies.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device is manufactured and tested in accordance with certain physical, chemical, and biological specifications. It references standards but does not provide specific quantitative acceptance criteria or detailed results.

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

• Sample size: Not specified.
• Data provenance: Not specified, but generally, such studies for 510(k) submissions are conducted internally by the manufacturer or their contracted labs. Given the device type, it's likely physical and chemical lab testing, not patient data. Retrospective or Prospective: N/A (not applicable as it's not a clinical study with 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 provided in the document. The nature of the device (a vial access spike) suggests that "ground truth" would be established through laboratory testing against predefined specifications rather than 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 provided. Given it's a device for fluid transfer and needle stick prevention, not diagnostic imaging, adjudication methods like 2+1 or 3+1 are not typically 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. This type of study (MRMC for AI assistance) is not applicable to this device. The device is a physical medical instrument, not an AI-powered diagnostic tool.

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

• No. This is not an AI algorithm. Its performance is evaluated based on its physical and material properties and its ability to prevent needle sticks, which is a standalone function of the device itself.

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

• The "ground truth" for this device would be the specific, quantifiable parameters defined by the referenced industry standards (ISO 10993, USPXX111, ISO 11607-1, ISO 11135, USP Pyrogenicity test requirements) and internal physical testing requirements. For example, burst pressure for the spike, material compatibility, sterility assurance level, and ability to prevent needle sticks in simulated use.

8. The sample size for the training set:

• N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

• N/A. This device does not involve a "training set" or "ground truth" for training in the machine learning sense. The "ground truth" for its physical performance characteristics is established by adherence to recognized standards and validated internal test methods.

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