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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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