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The Jianerkang Sterile Lubricating Jelly is intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.

The Jianerkang Sterile Lubricating Jelly is a clear, greaseless, watersoluble sterile lubricating jelly.

The provided document describes a medical device, the Jianerkang Sterile Lubricating Jelly, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study that assesses its performance against such criteria.

The document focuses on demonstrating that the Jianerkang Sterile Lubricating Jelly is substantially equivalent to the Dynarex Sterile Lubricating Jelly (predicate device K092488) based on technological characteristics and safety testing (biocompatibility and sterilization validation). This type of submission (510(k)) for a Class I device typically relies on demonstrating equivalence rather than establishing new performance benchmarks through clinical or extensive performance studies with specific statistical acceptance criteria.

Therefore, many of the requested fields cannot be answered as the information is not present in the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria for performance or report specific device performance metrics beyond stating that it "provides effective lubrication" and meets biocompatibility and sterilization standards. The comparison is based on shared technological characteristics.

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

• Cannot be provided. No specific "test set" for performance evaluation is mentioned. The biocompatibility tests (ISO 10993) would have involved samples, but the specific sample sizes for those tests or their provenance are not detailed in this summary.

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)

• N/A. This question is typically relevant for studies evaluating diagnostic or AI-driven systems where expert consensus is used to label data. This is not applicable to a sterile lubricating jelly's submission.

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

• N/A. Not applicable for this type of device submission.

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

• N/A. This is an AI-specific question and not relevant to a sterile lubricating jelly.

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

• N/A. This is an AI-specific question and not relevant to a sterile lubricating jelly.

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

• Cannot be directly answered in the context of performance. For biocompatibility, the "ground truth" would be the established ISO 10993 standards and their interpretation by qualified testing laboratories. For sterility, it's validation against ISO/AAMI 11137. These are not "ground truth" in the sense of clinical outcomes or expert consensus on diagnostic images.

8. The sample size for the training set

• N/A. This is an AI-specific question and not relevant to a sterile lubricating jelly.

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

• N/A. This is an AI-specific question and not relevant to a sterile lubricating jelly.

Summary of available information related to "acceptance criteria" and "study":

The "acceptance criteria" can be inferred from the comparison to the predicate device and the regulatory standards met.

• Acceptance Criteria (Inferred):

  • Technological Characteristics: Must match or be equivalent to the predicate device (e.g., composition like purified water, carbomer thickeners, parabens; labels for water-soluble, colorless, alcohol/fragrance-free; container material).
  • Sterility: Must be sterile, validated according to ISO/AAMI 11137 with an SAL of 10^-6.
  • Biocompatibility: Must pass ISO 10993 standards including In-Vitro Cytotoxicity, Implantation, Irritation & Hypersensitivity, and Systemic Toxicity. Specifically, In-Vitro Cytotoxicity - Pass* Grade 2 Result Response.
  • Intended Use: Must align with the intended use of the predicate device.

• "Study" (Supporting Information):

  • Biocompatibility Testing: The device underwent ISO 10993 testing, resulting in "Pass" for In-Vitro Cytotoxicity, Implantation, Irritation & Hypersensitivity, and Systemic Toxicity, specifically a "Grade 2 Result Response" for In-Vitro Cytotoxicity.
  • Sterilization Validation: The device is sterilized by gamma radiation, validated according to ISO/AAMI 11137 requirements with an SAL of 10^-6.
  • Technological Characterization: A direct comparison table is provided, showing the Jianerkang product's characteristics are identical to the predicate device.

The study presented is not a comparative clinical trial, but rather a set of tests to demonstrate adherence to established safety and material standards and physical-chemical similarity to an already approved device.

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