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BD Vacutainer® Luer-Lok™ Access Device:

The BD Vacutainer® Luer-Lok™ Access Device is a sterile, single-use, noninvasive device intended to be used by healthcare professionals for safe, closed-system venous blood collection from a female Luer of a catheter port or blood collection set, directly into an evacuated blood collection tube(s) for in vitro diagnostic testing. This device may also be used with a blood collection set with a female Luer to collect blood cultures.

BD Vacutainer® Blood Transfer Device:

The BD Vacutainer® Blood Transfer Device is a sterile, single use, noninvasive medical device intended to be used by healthcare professionals for the safe, closed-system, needleless transfer of venous blood from a BD Luer-Lok™ tip syringe into evacuated blood collection tube(s) or blood culture bottle(s) for in vitro diagnostic testing.

The BD Vacutainer® Luer-Lok™ Access Device and the BD Vacutainer® Blood Transfer Device are sterile, single use, non-invasive devices for the safe transfer of blood into an evacuated BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle for in vitro diagnostic testing. The only difference between the devices is the BD Vacutainer® Luer-Lok™ Access device features a male Luer lock connection with compatible female Luer catheter port (blood collection set) and the BD Vacutainer® Blood Transfer Device features a female Luer lock for connection with BD Luer-Lok™ syringes.

The provided text describes a 510(k) premarket notification for two medical devices: the BD Vacutainer® Luer-Lok™ Access Device and the BD Vacutainer® Blood Transfer Device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (K200027, Luer Access Device-holder with Preattached Multiple Sample Adapter) through non-clinical performance testing.

Response to your specific questions:

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

   The document does not explicitly present a table of acceptance criteria and reported device performance in the format you requested, where specific quantitative values for acceptance criteria are listed alongside the measured performance. Instead, it states that the conducted tests verified that "the proposed devices met all design specifications and performance standards." For certain tests, it simply lists compliance with ISO standards.

   However, based on the non-clinical performance summary, we can infer some of the tests performed and general outcomes:

   Acceptance Criteria (Inferred from tests)	Reported Device Performance (Inferred from text)
   Compliance with ISO 594-1-1986	Compliant (Stated explicitly in comparison table)
   Compliance with ISO 594-2-1998	Compliant (Stated explicitly in comparison table)
   Compliance with EN ISO 9626:2016	Devices met design specifications and performance standards
   Compliance with EN ISO 15223-1:2016	Devices met design specifications and performance standards
   Compliance with EN ISO 14971:2012	Devices met design specifications and performance standards
   Compliance with EN ISO 11135:2014	Devices met design specifications and performance standards
   Compliance with EN ISO 11737-1:2019	Devices met design specifications and performance standards
   Compliance with ISO 11607-1:2019	Devices met design specifications and performance standards
   Compliance with ISO 11607-2:2019	Devices met design specifications and performance standards
   Compliance with ASTM F2096-11	Devices met design specifications and performance standards (Package Integrity test)
   Compliance with ASTM F88	Devices met design specifications and performance standards (Peel Strength Test)
   Compliance with ASTM F1980-16	Devices met design specifications and performance standards
   Compliance with ASTM D4169-16	Devices met design specifications and performance standards
   Compliance with ISO 10993 (Biocompatibility Suite)	Compliant (Stated explicitly in comparison table, and that differences in hub material do not raise new questions of safety or effectiveness due to this compliance)
   Torque to Break	Met all design specifications and performance standards
   Torque to Unseat	Met all design specifications and performance standards
   NP Cannula Pull Test	Met all design specifications and performance standards
   Air Leakage Test	Met all design specifications and performance standards
   NP Sleeve Function	Met all design specifications and performance standards
   Luer Compatibility as per ISO 594/80369-7	Met all design specifications and performance standards

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 specify the sample size for the individual non-clinical performance tests (e.g., number of devices tested for Torque to Break, Air Leakage, etc.). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned, as these are in vitro engineering performance tests rather than clinical studies.

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 is not applicable to the non-clinical performance testing described. These tests involve objective measurements against engineering and biocompatibility standards, not expert interpretation of clinical data.

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

   This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or imaging studies where expert consensus is required for diagnosis or interpretation. The tests described are objective engineering and laboratory tests.

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 MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Data: Not applicable," and the devices are for blood collection/transfer, not for interpretation or diagnosis requiring human readers or AI assistance.

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

   Not applicable. These are physical medical devices for blood collection, not an algorithm or AI system.

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

   The "ground truth" for the non-clinical performance tests is compliance with established international and ASTM standards (e.g., ISO 594, ISO 10993, EN ISO 9626, ASTM F88, ASTM F2096), as well as the manufacturer's own design specifications. There is no expert consensus, pathology, or outcomes data used as ground truth for these types of tests.

8. The sample size for the training set

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

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

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

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