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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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For lubrication to provide easy insertion of catheters, endoscopes, or gloved fingers into bodily orifices. The device is intended for use on order of a physician. Non-prescription over-the-counter use.

Ultra Seal Sterile Lubricating Jelly patient lubricant is a water- based, clear, colorless, non-sticky, non-greasy, non-staining, nonirritating patient lubricant. It is a water soluble, high viscosity gel-like liquid for use as patient lubricant when a sterile field is required. Each tube or packet is terminally sterilized by gamma radiation. The product is sterile unless package is opened, damaged, or the seal for the packet product is not intact, with label directions to discard after use.
The product is packaged in a convenient 2 oz., 4.0 oz., and 4.2 oz aluminum tube with a cap and a puncture seal blind, or a 2 oz., 4.0 oz., and 4.2 oz foil laminate tube with a flip top and a peel seal, and 3 and 5 gram laminated film packets, the lamination being paper, polyethylene, foil, polyethylene. All tube configurations contain an aluminum barrier to preserve the product's properties and sterility. Stability has been performed on all tubes and packets and data from 3 months of accelerated studies supports an initial expiration term of 24 months from the date of manufacture. Expiration dating will be confirmed through concurrent room temperature stability studies.
This product is not a contraceptive and does not contain a spermicide.

The provided text describes information about the Ultra Seal Sterile Lubricating Jelly and its 510(k) submission, primarily focusing on its regulatory status, technical characteristics, and biocompatibility. However, it does not contain a study that proves the device meets specific performance acceptance criteria in the way a clinical trial or a statistically designed performance study would.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

1. Intended Use: Similar to existing devices.
2. Device Description: Water-based, clear, non-sticky, non-greasy, non-staining, non-irritating, sterile (gamma radiation), and similar packaging.
3. Technological Characteristics: Proprietary formula but uses GRAS (Generally Recognized As Safe) ingredients common in topical and ingested products, similar to predicate devices.
4. Biocompatibility: Studies demonstrating non-sensitizing, non-cytotoxic, and non-dermal irritant properties.
5. Sterility: Undergoing validation for sterility testing.

Therefore, the "acceptance criteria" discussed in the document are primarily related to safety and similarity to predicate devices, rather than specific quantitative performance metrics like efficacy in reducing friction or ease of insertion in a measurable way.

Based on the provided text, I cannot complete all sections of your request as a study proving device performance against quantitative acceptance criteria is not present. I can, however, extract related information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied to be safety and substantial equivalence to predicate devices. The document does not list quantitative performance metrics and their corresponding acceptance values.

However, it does report performance based on biocompatibility studies:

Study Information (Based on Biocompatibility)

The document describes biocompatibility studies, which are crucial for safety assessment.

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

   • Delayed Contact Dermal Sensitization Test (Buehler Method): Not specified.
   • In Vitro Cytotoxicity L929 Agar Overlay Test: Not specified.
   • Primary Dermal Irritation in Rabbits: Not specified (refers to "rabbits," implying multiple, but no number given).
   • Data Provenance: Conducted by "outside laboratories," in compliance with GLPs (Good Laboratory Practices). Country of origin is not specified, but GLPs are an international standard. The studies are prospective as they were conducted for the purpose of this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are laboratory tests with objective endpoints (e.g., presence or absence of sensitization, cytotoxicity, or irritation), not requiring expert consensus for ground truth on individual cases. The tests are designed to produce a measurable output that is then interpreted against established thresholds.

3. Adjudication method for the test set: Not applicable for these objective laboratory tests. Results are typically analyzed and reported directly by the testing laboratory.

4. 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 lubricant; it is not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

6. The type of ground truth used:

   • Biocompatibility Studies: The "ground truth" is derived from standardized laboratory assay results according to established international guidelines (e.g., ISO 10993 series for biocompatibility, though not explicitly cited here, GLPs imply adherence to such standards). For example, dermal irritation is determined by observing specific tissue reactions in rabbits.

7. The sample size for the training set: Not applicable. This is a physical device, not a machine learning algorithm.

8. How the ground truth for the training set was established: Not applicable.

Summary Regarding Overall Study (Substantial Equivalence)

The primary "study" in the context of this 510(k) submission is the comprehensive demonstration of substantial equivalence to predicate devices. This involves comparing the new device's intended use, technological characteristics, and safety profile (including biocompatibility) to those of already approved devices. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This determination by the FDA is the ultimate "proof" in this regulatory context.

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

Dynarex Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly. Typical packaging configurations for the Dynarex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available.

The provided document is a 510(k) summary for the Dynarex Sterile Lubricating Jelly, asserting its substantial equivalence to a predicate device (E-Z Lubricating Jelly, K041060). It does not describe an AI/ML device or a study involving acceptance criteria in the typical sense of measuring device performance against a predefined threshold.

Instead, the "acceptance criteria" here relate to demonstrating substantial equivalence for a Class I medical device (patient lubricant). This process primarily involves comparing the new device's characteristics to those of a legally marketed predicate device.

However, I can extract the information and present it in the requested format, interpreting "acceptance criteria" as the shared characteristics and test results that enable the claim of substantial equivalence.

Here's the breakdown based on the provided text, with "N/A" for information not present or not applicable to this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are the characteristics of the predicate device, which the new device (Dynarex Sterile Lubricating Jelly) must match or be substantially equivalent to. "Reported device performance" refers to the new device's characteristics and test results, demonstrating this equivalence.

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

• Sample size for the test set: Not explicitly stated as a "test set" in the context of performance metrics for an AI/ML device. For physical and biocompatibility testing, standard laboratory sample sizes would have been used, but specific numbers are not provided in this summary.
• Data provenance: The data is generated from testing of the Dynarex Sterile Lubricating Jelly and comparison to the predicate device. It is not "data" in the sense of patient records or imaging. The testing would have been conducted by the manufacturer or contracted laboratories. It is prospective testing on the device model. Country of origin not specified for the testing itself, but the submitter is based in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This concept is not applicable to a submission for a sterile lubricating jelly demonstrating substantial equivalence. There is no "ground truth" established by experts in the sense of clinical annotations or diagnostic interpretations. The "truth" is established by laboratory testing standards (e.g., ISO 10993 for biocompatibility).

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

• Not applicable. There is no "adjudication" in this context. The determination of "pass" for tests like biocompatibility or sterility would follow established testing protocols and expert interpretation of those results by the testing laboratory, aligning with regulatory 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 is not an AI/ML device, nor is it a diagnostic imaging device that would involve human readers.

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

• Not applicable. This is not an AI/ML algorithm.

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

• For this device, the "ground truth" (or basis for acceptance) primarily stems from established international standards and regulations for medical device safety and performance, specifically:
  • ISO/AAMI 11137 for sterilization validation.
  • ISO 10993 for biocompatibility testing.
  • Pharmacopoeial standards (implied for purity, viscosity, pH, preservative effectiveness).
  • The characteristics and regulatory history of the predicate device (E-Z Lubricating Jelly, K041060) serve as the benchmark for "truth" in the context of substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no training set.

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

• Not applicable. There is no training set.

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PDI Sterile Lube Jelly is intended for use to lubricant a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as a catheter, enema tip, or endoscope). The device is intended for use on order of a physician.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a sterile lubricating jelly. It primarily discusses the regulatory approval of the device and its intended use.

This document does not contain information about:

• Acceptance criteria and reported device performance from a study.
• Sample sizes, data provenance, or details about test sets.
• The number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text.

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