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The BD Vacutainer® Push Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for use in the general population by healthcare professionals experienced with venipuncture to obtain blood specimens from patients, including those patients with difficult vein access who may have small, fragile, and or non-palpable veins, into evacuated blood collection tubes and/or bottles. When used without the male Luer adapter, the device allows the clinician to obtain a blood specimen from the female Luer connector with a syringe, if necessary. The device can be used by healthcare professionals with infusion experience for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and is to remain under the direct supervision of a clinician.

The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

The BD Vacutainer® Push Button Blood Collection Set is a sterile, multiple-sample, single-use device used for venipuncture to obtain blood specimens from patients and may be used for the short-term intravenous administration of fluids. The BD Vacutainer® Push Button Blood Collection Set is a winged blood collection set with flexible tubing, a female luer connector and an optional male luer adapter. The BD Vacutainer® Push Button Blood Collection Set also contains a needle protector. The wingset is designed with a safety mechanism to protect against needlesticks. When the button is depressed by the user, the needle fully retracts and is enclosed and locked within the barrel of the device. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

The BD Vacutainer® Push Button Blood Collection Set consists of:

• Stainless steel cannula (Intravenous end and non-patient end of cannula)
• Stainless steel spring
• Hub, front and rear barrel
• Wings (color coded according to needle gauge)
• Tubing
• Female luer connector and an optional male luer adapter
• Intravenous (IV) needle protector (covers the needle before use)
• Pre-attached holder (connected by male luer adapter in some models)

The intravenous needle of the blood collection set is bonded to one end of the hub. The other end of the hub is bonded to the blood collection set tubing, the end of which is then bonded to a female luer connector with an optional attached male luer adapter. Some models come with a pre-attached holder connected to the male luer adapter for user convenience. A spring is loaded onto the front barrel of the hub. Once the sample is collected, and without removing the needle from the patient vein, the user depresses the raised push button on top of the hub which activates the spring mechanism to automatically retract the needle from the device. In this retracted (locked) position, the IV point of the needle is fully contained within the body of the device. This will prevent the needle from coming out of the front barrel once it has retracted as well as preventing accidental overriding of the safety feature.

The blood collection set with a male luer adapter contains threads for attachment to a Vacutainer® Brand Needle Holder, and a non-patient cannula for blood collection into evacuated blood collection tubes and/or blood culture bottles. For models without the pre-attached holder, the user is instructed to attach a holder before using the device. The pre-attached holder models come with the BD Vacutainer® Brand Holder pre-attached for user convenience. The non-patient end cannula of the luer adapter has a sleeve that recovers over the cannula to stop blood flow in between collection of multiple tubes.

When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe, if necessary. The device can be used for short-term, single infusions (up to 2 hours) with consideration given to patient size and appropriateness for the solution being infused.

The provided text describes a 510(k) premarket notification for a medical device, the BD Vacutainer® Push Button Blood Collection Set. A 510(k) notification aims to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets a new set of defined acceptance criteria in the way a novel AI/ML device would.

Therefore, the structure of the provided document doesn't align with the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" framework seen with AI/ML systems where performance metrics (e.g., sensitivity, specificity, AUC) are rigorously tested against pre-defined thresholds.

Instead, this document focuses on demonstrating that the subject device (BD Vacutainer® Push Button Blood Collection Set, K220212) is substantially equivalent to a predicate device (BD Vacutainer® Push Button Blood Collection Set, K030573) and performs as intended through a series of non-clinical bench tests, biocompatibility, and sterilization testing. Clinical literature is cited to support the expanded indications for use, rather than a de novo clinical study with a control group and specified primary endpoints designed to meet quantitative performance acceptance criteria.

However, I can extract the relevant information and present it in a similar structure, focusing on what was demonstrated for substantial equivalence rather than a detailed "acceptance criteria" table for novel device performance.

Device: BD Vacutainer® Push Button Blood Collection Set (K220212)
Predicate Device: BD Vacutainer® Push Button Blood Collection Set (K030573)

1. Table of Acceptance Criteria and Reported Device Performance (or Demonstration of Substantial Equivalence)

Since this is a 510(k) focusing on substantial equivalence, the "acceptance criteria" are generally that the subject device performs as intended and is as safe and effective as the predicate device, despite minor differences. The performance is demonstrated through various bench and materials testing, and by referencing clinical literature.

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

As this is a 510(k) for a physical device, not an AI/ML diagnostic, there isn't a "test set" in the sense of a distinct dataset of medical images or patient records used to evaluate an algorithm's performance against a gold standard. Instead, performance is demonstrated through:

• Non-Clinical Bench Testing: Tests were performed on a sufficient number of device samples to ensure reproducibility and statistical validity, though specific sample numbers for each test are not detailed in this summary. These are laboratory-based tests on manufactured devices.
• Clinical Literature Review: Two literature articles are cited to support the expanded indications for use.
  • Ibarra AF and Villanueva, 2019: Clinical study showing phlebotomist preference and increased patient/phlebotomist satisfaction in a Mexican general hospital. The sample size for this specific study is not detailed, but it relates to the preference of the device rather than a ground truth for a diagnostic output.
  • Merrill, V.D. et al., 2021: Study on venipuncture blood draws for oncology outpatients. Sample size: 89 oncology outpatients (≥18 years of age).
    • Data Provenance: The Merrill study was conducted in an oncology outpatient clinic, implying a prospective collection of data for the purpose of the study. The location (country) is not specified but generally these studies would be in the US or similar developed healthcare systems given the context of FDA submission.

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

There is no "ground truth" derived from expert consensus in the context of an AI/ML device output for this 510(k). The clinical literature cited supports the usability and effectiveness for patient populations (e.g., DVA patients) and specimen quality, rather than establishing a diagnostic "ground truth."

For the Merrill study (2021), clinical outcomes (successful blood collection, specimen quality based on LDH, K, and plasma free hemoglobin levels) served as the "ground truth" or evaluative criteria, not expert interpretations. The healthcare professionals performing the venipuncture are the "experts" in the practical application.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring adjudication by multiple experts in the context described (e.g., for diagnostic AI device output). The clinical literature referenced presents outcomes data or user preference data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this is a physical blood collection device, not an AI/ML diagnostic system that assists human readers. The clinical summaries provided support the use and safety of the device for a broader patient population (DVA) and user preference, rather than an aid to diagnostic interpretation.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a physical medical device. There is no standalone algorithm.

7. Type of Ground Truth Used

For the clinical literature cited:

• Merrill et al., 2021: The "ground truth" for the device's performance in DVA patients was based on physiological outcomes data:
  • Successful blood collection from each patient.
  • Specimen quality assessed by laboratory measurements of LDH, K, and plasma free hemoglobin levels, compared against normal and acceptable analyte reference ranges.
• Ibarra AF and Villanueva, 2019: The "ground truth" was user (phlebotomist) preference and patient/phlebotomist satisfaction data.

For the non-clinical bench testing, the "ground truth" is adherence to engineering specifications and performance standards (e.g., force required for retraction, flow rate, leak integrity).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device; there is no AI/ML model requiring a training set.

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

Not applicable. There is no training set.

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BD BACTEC Myco/F Lytic culture medium when used with the BD BACTEC fluorescent series instruments is a nonselective culture medium to be used as an adjunct to aerobic blood culture media for the qualitative culture and recovery of mycobacteria, yeast and fungi from blood. This medium may also be used for the culture of sterile body fluids when veast or fungi are suspected.

BD BACTEC Myco/F Lytic culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens, and yeast and fungi from blood and sterile body fluids. Specific modifications were made to enhance the growth and recovery of mycobacteria, yeast and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent, and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism metabolism and growth. The sensor is monitored by the BD BACTEC fluorescent series instrument for increasing fluorescence, which is due to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.

BD BACTEC Myco/F Lytic Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.

This document is a 510(k) Substantial Equivalence Determination Decision Summary for the BD BACTEC Myco/F Lytic Culture Vials (plastic). It evaluates the device's performance against a predicate device (BD BACTEC Myco/F Lytic Culture Vials (glass)) to determine if it is substantially equivalent. The studies described are analytical performance comparisons rather than clinical trials with human subjects for diagnostic accuracy.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a bulleted or numbered list with corresponding reported performance values within a formal table. Instead, it presents performance data for the modified (plastic) device compared to the predicate (glass) device across various analytical parameters. The implicit acceptance criteria appear to be substantial equivalence, meaning the performance of the new plastic vial is "equivalent to or better than" the predicate glass vial.

Here's a synthesized table based on the provided data, comparing the plastic device's performance to the predicate:

Table: Summary of Device Performance Compared to Predicate (Implicit Acceptance Criteria: Equivalent to or Better)

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

The studies described are analytical performance studies performed in a laboratory setting, rather than clinical studies with patient samples. The samples used are seeded samples (i.e., known microorganisms inoculated into blood or sterile body fluid).

• Test Set (Seeded Samples):
  • Reproducibility: Not explicitly stated as a separate "test set" size, but involved testing across three lots of media with varying blood/SBF volumes and inoculum levels.
  • Microbial Detection Limit (MDL) - Blood:
    • Sample Size: 414 paired vials (plastic vs. glass). 2 pairs discarded due to contamination, resulting in 412 paired vials. (23 organisms x 3 lots x 3 blood vol x 2 inoculum levels x 1 instrument).
    • Data Provenance: This is in vitro analytical data obtained from controlled laboratory experiments, not from human patients or a specific country of origin.
  • Microbial Detection Limit (MDL) - Sterile Body Fluid (SBF):
    • Sample Size: 264 paired vials (plastic vs. glass). (3 organisms x 3 lots x 4 SBF volumes x 2 inoculum levels x 1 instrument x 2 SBF types) + (5 organisms x 3 lots x 4 SBF volumes x 2 inoculum levels x 1 instrument x 1 SBF type).
    • Data Provenance: In vitro analytical data.
  • Delayed Entry in blood (Mycobacteria):
    • Sample Size: Not explicitly stated as a total paired set number, but involved 8 strains of mycobacterium. Total number of vials for each delay condition (e.g., 72/72 for no delay, 70/70 for 12h @ 20-25C, etc.) is provided in Table 7. Each test used 3 lots and 1, 3, or 5 mL human blood.
    • Data Provenance: In vitro analytical data using human blood matrix.
  • Percent Recovery (Detection) - Blood (10-100 CFU/vial):
    • Sample Size: 207 paired sets (plastic vs. glass). (23 organisms x 3 lots x 3 blood volumes x 1 instrument).
    • Data Provenance: In vitro analytical data using blood matrix.
  • Percent Recovery (Detection) - SBF (10-100 CFU/vial):
    • Sample Size: 132 paired sets (plastic vs. glass). (3 organisms x 3 lots x 4 SBF volumes x 1 inoculum level x 1 instrument x 2 SBF types) + (5 organisms x 3 lots x 4 SBF volumes x 1 inoculum level x 1 instrument x 1 SBF type).
    • Data Provenance: In vitro analytical data using SBF matrix.
  • False Positive Rate - Blood:
    • Sample Size: 144 paired sets initially, 143 after contamination exclusion. (8 vials x 3 blood volumes x 3 lots x 2 instruments).
    • Data Provenance: In vitro analytical data using fresh blood.
  • False Positive Rate - SBF:
    • Sample Size: 432 paired sets initially, 425/424 after contamination exclusions. (8 vials x 3 SBF volumes x 3 lots x 2 instruments x 3 SBF types).
    • Data Provenance: In vitro analytical data using sterile body fluid.
  • False Negative Rate - Blood:
    • Sample Size: 619 combined paired sets from Recovery and MDL studies.
    • Data Provenance: In vitro analytical data.
  • False Negative Rate - SBF:
    • Sample Size: 396 combined paired sets from Recovery and MDL studies.
    • Data Provenance: In vitro analytical data.
  • Instrument Compatibility - Blood:
    • Sample Size: 54 paired sets for FX and 9050 each, 53 paired sets for FX-40 and 9240 each (total 214-216 paired sets for blood). (6 organisms x 3 blood volumes x 1 inoculum x 3 lots / 4 instruments).
    • Data Provenance: In vitro analytical data.
  • Instrument Compatibility - SBF:
    • Sample Size: 48 paired sets per instrument (total 192 paired sets for SBF). (4 organisms x 4 SBF volumes x 1 inoculum x 3 lots / 4 instruments).
    • Data Provenance: In vitro analytical data.

All data described is retrospective in the sense that it was collected as part of a pre-market submission process, likely after the plastic vial formulation was developed. It is not prospective clinical data from patient studies. The data provenance is internal laboratory studies, not patient data from a specific country.

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

The ground truth for these analytical studies is based on controlled, seeded experiments where the presence and identity of the microorganisms are known.

• The "ground truth" is the known inoculum (CFU/vial) of specific ATCC strains or clinical isolates of mycobacteria, yeast, and fungi.
• Detection by instruments (BD BACTEC fluorescent series instruments) is validated against the known presence/absence of these seeded organisms and further confirmed by subculture for discordant results (e.g., false positives/negatives), which is a standard microbiological method.
• No human experts (like radiologists) are mentioned or typically involved in establishing ground truth for in vitro diagnostic (IVD) culture media performance studies. The ground truth is intrinsically tied to the experimental design – what was precisely inoculated and subsequently confirmed by laboratory methods.

4. Adjudication Method for the Test Set

Adjudication, in the context of IVD performance, would typically involve resolving discrepancies between a device's result and a reference method/truth.

• For these studies, the primary comparison is the Time-to-Detection (TTD) and Percent Recovery of the plastic vial versus the glass predicate vial against the known seeded inoculum.
• For false positive/negative rates, discrepancies between instrument reads and definitive culture (subculture) results are identified. The report explicitly mentions how these were defined:
  • False Positive: "instrument positive but subculture negative."
  • False Negative: "instrument-negative at the end of protocol yet contains viable organisms upon subculturing onto appropriate culture media."
• There's no mention of a multi-observer or consensus-based adjudication process as one would see in image interpretation studies. The "adjudication" is inherent in the design of comparing instrument readouts to known inputs and standard microbiological subculture confirmation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

• MRMC studies are typically performed for medical imaging devices where human readers interpret images, and the AI's impact on their performance is evaluated.
• This submission concerns an in vitro diagnostic culture medium, which is an automated system for microbial growth detection. The "reader" is the BD BACTEC fluorescent series instrument, not a human.
• Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The comparison is between two different types of culture vials (plastic vs. glass), both processed by the same automated instruments.

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

Yes, in essence, standalone performance was evaluated.

• The device being assessed is the BD BACTEC Myco/F Lytic Culture Vial (plastic), which operates when placed into the BD BACTEC fluorescent series instruments.
• The performance metrics (TTD, Percent Recovery, False Positive/Negative rates) are generated by the instrument's automated detection algorithm based on the changes in fluorescence caused by microbial growth in the vial.
• Humans are involved in inoculating the vials and performing subcultures for confirmation, but the "performance" described is the direct, automated output of the integrated vial-instrument system. It is not an "AI" in the sense of an image interpretation algorithm, but an automated detection system where the organism's metabolism directly causes a measurable signal change detected by the instrument's programming (analogous to an algorithm).

7. The Type of Ground Truth Used

The ground truth used primarily in these analytical studies is an expert-determined, controlled, seeded panel.

• This involves known strains of mycobacteria, yeast, and fungi (e.g., ATCC strains and clinical isolates) at specified inoculum levels (CFU/vial).
• For discordant results (e.g., instrument negative but suspected positive), subculture onto appropriate culture media plates was used to confirm the presence of viable organisms, acting as a definitive microbiological reference method for the seeded content.
• It does not utilize pathology reports (which are for tissue diagnosis) or outcomes data (which would be clinical outcomes in patients).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or "training data" in the conventional machine learning sense.

• This is an IVD device validation, not an AI/ML software validation.
• The comparison is between a new device (plastic vial) and a predicate device (glass vial), demonstrating substantial equivalence based on a series of analytical performance studies.
• The "training" of the instrument's underlying detection algorithm (which interprets the fluorescent signals) would have occurred during its initial development and prior regulatory submissions (e.g., for K970333, K970512 for the predicate device). The current submission focuses on demonstrating that the change in vial material (plastic vs. glass) does not adversely affect this established performance.

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

As noted above, there is no explicitly defined "training set" for the vial in the context of this submission. The ground truth for the instrument's core detection capabilities would have been established historically during its development. This would also involve known, quantifiable microbial cultures and their characteristic growth patterns and metabolic activity in the media over time, likely confirmed by standard agar plate cultures or other gold standard microbiological methods.

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The BD AutoShield Duo™ Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

The product has two safety shields, which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.

The pen needle assembly consists of a double-ended cannula that is assembled onto an injection molded hub. The internal threads allow the subject device to be screwed onto a pen injector device, further enabling the non-patient end of the cannula to penetrate through the septum of the pen injector cartridge.

The patient and non-patient ends of the cannula are visible prior to attachment to the pen injector device. The BD AutoShield Duo™ Pen Needle has safety mechanisms on both the patient and non-patient ends of the needle, allowing the needle to be shielded and locked after use, which is designed to reduce the occurrence of accidental needle-stick injuries. The BD AutoShield Duo™ Pen Needle is a single use disposable device and is provided sterile. The subject device is non-toxic and non-pyrogenic.

The provided document describes the FDA 510(k) clearance for the BD AutoShield Duo™ Pen Needle. It focuses on demonstrating substantial equivalence to a predicate device (K110703) rather than a comprehensive study proving the device meets specific acceptance criteria for a novel functionality.

Therefore, much of the requested information regarding detailed acceptance criteria and a study to prove meeting them, particularly in the context of AI/ML or comparative effectiveness, is not directly applicable or available in this document. This submission is for a medical device that has minor administrative updates to its intended use statement, harmonizing it with other existing pen needles, and confirms its continued safety and effectiveness through non-clinical testing.

Here's an attempt to extract and infer the information based on the provided text, while noting the limitations:

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

The document doesn't present a specific table of acceptance criteria with corresponding performance metrics as would be typical for a new device claiming specific performance against a novel metric. Instead, it refers to compliance with established international standards and internal BD test requirements. The "performance" is generally stated as "passed" or "met requirements".

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

The document does not explicitly state the sample sizes for each specific test conducted (e.g., number of needles tested for each ISO standard). It generally mentions that testing was conducted to validate the design.

• Sample Size: Not specified in the provided text for individual tests.
• Data Provenance: The testing was conducted by BD (Becton, Dickinson and Company) as part of its design control process, implying internal, prospective testing for regulatory submission. The country of origin of the data is not specified beyond being generated by Becton, Dickinson and Company in Franklin Lakes, New Jersey.

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 to the type of tests described. The "ground truth" for these tests (functional performance, biocompatibility, sterility) is established by adhering to widely accepted international standards (ISO, ASTM, USP) and internal engineering/quality requirements, rather than expert consensus on subjective evaluations.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, measurable parameters against defined standards, not requiring an adjudication method like those used for subjective clinical assessments or AI model evaluations.

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. The BD AutoShield Duo™ Pen Needle is a physical medical device (pen needle), not an AI/ML software device or a diagnostic tool that involves human readers or AI assistance in interpretation. No MRMC study was mentioned or implied.

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

Not applicable. This is not an algorithm or AI product.

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

As mentioned in point 3, the ground truth for the non-clinical tests is based on the specifications and acceptance criteria defined within established international standards (ISO, USP, ASTM) and the manufacturer's own validated internal requirements for device function, safety, and sterility. For example:

• Functional: Compliance with dimensional tolerances, force measurements, safety mechanism activation as per ISO standards.
• Biocompatibility: Absence of toxicological responses as per ISO 10993 series.
• Sterility: Sterility assurance level (SAL) of 10-6 as per ISO 11137-2.

8. The sample size for the training set

Not applicable. This is not an AI/ML product that utilizes a training set.

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

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

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The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.

BD PosiFlush™ SafeScrub is a sterile, single use pre-filled saline syringe with integrated Disinfection Unit (DU). The polypropylene syringe contains 0.9% sodium chloride (USP) solution with a tip cap that is modified at the distal end to accommodate DU. The DU has high density polyethylene housing with 70% Isopropyl Alcohol (IPA) solution in low density polyethylene foam. The pre-filled syringe with modified syringe tip cap is sterilized by moist heat and the DU is sterilized by gamma irradiation. The subject device is available only in 10mL syringe configuration.

The provided text describes the acceptance criteria and the results of various tests conducted for the BD PosiFlush™ SafeScrub device (K213955). This device is a pre-filled saline syringe with an integrated disinfection unit.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the 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)

The document does not explicitly state the sample sizes for each test in the provided table. It mentions "BD validated force" for several tests, implying internal validation studies by the manufacturer. The document details that "The subject device is also evaluated throughout its shelf life by bench performance testing to ensure that the device meets the predetermined acceptance criteria."

The data provenance is not specified regarding country of origin or whether it's retrospective or prospective, but it implies a prospective testing approach as part of the device's development and regulatory submission.

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 section is not applicable. The tests performed are primarily bench performance, engineering, chemical, and biological evaluations, not requiring human expert interpretation in the way, for example, a medical imaging AI product would. The "ground truth" for these tests is based on established scientific and regulatory standards (e.g., ISO, ASTM, USP guidelines) rather than expert consensus on diagnostic interpretations.

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

Not applicable. As described in point 3, these are objective physical and chemical tests, not requiring human interpretation or adjudication panels. The "Pass" results are based on meeting predetermined quantitative or qualitative criteria from recognized 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 device is a medical product (a pre-filled syringe with a disinfection unit), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improve with AI" are not relevant to this submission.

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

Not applicable. As mentioned, this is not an AI algorithm. The performance of the device itself (standalone) is what was tested through the various bench performance tests, antimicrobial efficacy, and biocompatibility studies.

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

The "ground truth" for the various tests relies on:

• Established scientific and engineering principles: e.g., for container closure integrity, leakage, torque, pull force.
• Recognized industry standards and guidelines: ISO 10993 series for biocompatibility, ASTM F2096 for package integrity, USP <788> for particulate ingress, USP 43-NF38 <161> for LAL Endotoxin.
• Predetermined chemical concentrations: 70±7% for IPA concentration.
• Microbiological reduction targets: ≥ 4-log reduction for antimicrobial efficacy, based on established efficacy standards for disinfectants.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

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BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses.

BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.

BD PureHub™ Disinfecting Cap is a sterile, single use disinfectant cap designed for needle-free Luer connectors. It has high-density polyethylene housing and polyester urethane sponge saturated with 70% Isopropyl Alcohol (IPA) solution. PureHub™ disinfects needle-free Luer connectors one minute after application and acts as a physical barrier for up to seven days, if not removed. It is available in two packaging configurations - Bulk Single Unit and IV Pole Strip.

The BD PureHub™ Disinfecting Cap is intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses. It will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" alongside specific numerical targets and then directly compare them to reported device performance in a single table for each test. Instead, it states that "The subject device met all the predetermined acceptance criteria for the above listed performance tests and demonstrated substantial equivalence to the predicate device."

However, we can infer some criteria and reported performance from the comparison table and the list of non-clinical tests:

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not provide specific sample sizes for each non-clinical test. It lists the types of tests performed.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. The tests were performed "in accordance with 21 CFR §820.30" and various ISO standards, implying controlled laboratory conditions rather than human clinical trials.

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

This information is not applicable as the study involved non-clinical performance and biocompatibility testing, not expert-adjudicated clinical ground truth. The "ground truth" for these tests would be established by the methodologies defined in the respective ISO standards (e.g., ISO 10993 for biocompatibility) and internal specifications.

4. Adjudication Method for the Test Set:

Not applicable. The tests are laboratory-based and follow standardized protocols, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical disinfecting cap, not an AI-powered diagnostic or assistive tool for human readers.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance):

Yes, a standalone study was performed, as the device is a physical product and its performance (e.g., antimicrobial efficacy, physical barrier, biocompatibility) was evaluated directly through laboratory testing without human intervention being part of the device's function.

7. Type of Ground Truth Used:

The ground truth for the non-clinical tests was established by:

• Established Test Methods and Standards: e.g., ISO 10993-1 for biocompatibility, ISO 11137-2:2013 (VDmax25) for sterilization, USP 788 for particulate matter.
• Defined Performance Criteria: For tests like antimicrobial efficacy, the "ground truth" is a measurable reduction in microorganism count (> 4-log reduction).
• Internal Specifications: Tests were performed "to an internal specification or a Standard."

8. Sample Size for the Training Set:

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

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

Not applicable. (See #8)

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