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Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.

The subject device is a tamper evident female luer lock cap intended for use with male luer ports on syringes. Covering luer fittings on syringes helps reduce the risk of touch contamination and medication leakage. The user group consists of those involved in pharmacy compounding as well as health care professionals. The subject device's clear outer shell/housing provides tamper evidence if the cap or the contents of the container is tampered with prior to clinical administration. Once removed, the shell/housing cannot be replaced back onto the luer cap, thus making it obvious if someone has previously attempted to remove the cap and/or attempted to tamper with the contents of the syringe. The subject TrueCare Biomedix Tamper Evident Cap is packaged in a bulk pharmacy tray with 25 caps per tray and is provided sterile via ethylene oxide sterilization.

This document is a 510(k) premarket notification for a medical device, which is a submission to the FDA for review of a new device to determine if it is "substantially equivalent" to an already legally marketed device (predicate device). It is not a study report that directly provides acceptance criteria and performance data in the format requested.

Therefore, the requested information elements (1-9) cannot be fully extracted and formatted as a direct study report from the provided text. The document primarily focuses on establishing substantial equivalence based on indications for use, technological characteristics, and a summary of non-clinical tests to demonstrate safety and performance without providing specific acceptance criteria and detailed study results for each.

However, I can extract the relevant information regarding the tests performed to support the substantial equivalence claim.

Here's an interpretation of the available information in the context of your request:

Device: TrueCare Biomedix Tamper Evident Cap

Predicate Device: International Medical Industries Prep-Lock Tamper Evident Cap (K193192)

Indication for Use: Tamper Evident Caps are indicated for use as a sterile tamper evident cap for IV syringes.

Summary of Device Performance and Testing (Not a Direct Acceptance Criteria Table):

The document states that the subject device (TrueCare Biomedix Tamper Evident Cap) was tested and demonstrated to be in conformance with certain standards and internal methods. It does not provide specific numerical acceptance criteria alongside performance reports for each test, but rather mentions the standards or types of tests performed to deem the device safe and effective and substantially equivalent to the predicate.

Here's a breakdown of the testing mentioned:

1. Performance Testing:

• Standard Conformance: ISO 80369-7:2016 (Small-bore connectors for liquids and gases in healthcare applications - Part 7 Connectors for intravascular or hypodermic application).
• Specific Functional Tests (Internal Methods):
  • Pull-off force testing
  • Tamper evidence functional testing ("to demonstrate that if the housing feature has been removed or tampered with, that it is obvious to the user.")

2. Biocompatibility Testing (In accordance with ISO 10993-1):

• Classification: Limited duration, externally communicating device, Blood Path Indirect (<24hours).
• Tests Conducted:
  • Cytotoxicity
  • Sensitization
  • Intracutaneous Reactivity
  • Material Mediated Pyrogenicity
  • Acute Systemic Toxicity
  • Hemocompatibility

3. Sterility Testing:

• Validation Standard: ISO 11135 (Sterilization of healthcare products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices).
• Sterilization Method: Ethylene Oxide (EO)
• Sterility Assurance Level (SAL): 10^-6 (achieved using the half-cycle overkill method).
• EO and ECH Residual Testing: Per ISO 10993-7 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals).
  • Limits Met: < 4mg/device (for EO) and < 9mg/device (for ECH).
• Bacterial Endotoxins (Pyrogenicity) Testing:
  • Method: Limulus Amebocyte Lysate (LAL) test.
  • Limits Met: < 20 EU/device.
  • Additional: Material-mediated pyrogen testing was also conducted as part of biocompatibility.

4. Shelf Life Testing:

• Claimed Shelf Life: 3-year.
• Testing Basis: Shelf life verification testing.
• Packaging System Integrity Testing (Standards):
  • ISO 11607-1 (Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems)
  • ISO 11607-2 (Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes)
  • ASTM F1886 (Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection)
  • ASTM F1929 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)
  • ASTM F88/F88M (Standard Test Method for Seal Strength of Flexible Barrier Materials)
  • ASTM D4169 (Standard Practice for Performance Testing of Shipping Containers and Systems)
  • ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices)
  • ISTA 2A (Packaged-products weighing 150 lbs. (68kg) or less)

Addressing Specific Information Requests (based on available text):

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

2. Sample size used for the test set and the data provenance:
* Sample Size: Not specified in the provided text for any of the tests.
* Data Provenance: Not specified in the provided text. The tests were performed to support this 510(k) submission, implying they are part of the device manufacturer's internal validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not specified in the context of device performance testing. Ground truth in this context would typically refer to gold standard for diagnostic accuracy, which is not relevant for this type of device (tamper evident cap).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not specified. This relates to expert review for diagnostic AI, not simple device performance testing.

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 (cap), not an AI diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a medical device (cap), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not applicable in the AI/diagnostic sense. For the device, "ground truth" for performance is established by objective measurements based on engineering standards (e.g., ISO, ASTM) and functional criteria (e.g., visual evidence of tampering).

8. The sample size for the training set:
* Not applicable. This is a medical device (cap), not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:
* Not applicable. This is a medical device (cap), not an AI algorithm.

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