Search Results

X-Y Lubricating Jelly is a personal lubricant, for vaginal and/or penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

X-Y Lubricating Jelly is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The lubricant formulation consists of water, glycerin, hydroxyethylcellulose, and methylparaben. X-Y Lubricating Jelly is packaged in 35 g and 100 g polyethylene tubes with a flip-top closure. The tube is then packaged in a carton. X-Y Lubricating Jelly is a personal lubricant for over-the-counter (OTC) use.

Here's a summary of the acceptance criteria and study information for the X-Y Lubricating Jelly, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document provides details of specific tests, but does not explicitly state the sample sizes for each test or the data provenance (e.g., country of origin, retrospective/prospective). The study refers to:

• Real-time testing for shelf-life.
• Biocompatibility studies following ISO standards (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity).
• Condom compatibility testing following ASTM D7661-18.

Without further information, the exact sample sizes and provenance for these specific tests cannot be determined from this document. However, all these are typically prospective laboratory-based studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and study. The "ground truth" for a medical lubricant is established through objective laboratory testing against material and biological specifications, not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for studies involving human interpretation (e.g., radiologists reviewing medical images). The studies for this lubricant are laboratory-based, not interpretative.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This information is not applicable. MRMC studies are used for evaluating diagnostic imaging devices and the impact of AI on human readers. This document describes a lubricant, which is not a diagnostic device.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable. This device is a physical product (lubricating jelly), not an algorithm or AI. The performance studies are for the physical properties and biological interactions of the lubricant.

7. Type of Ground Truth Used

The ground truth used for this device's performance studies is based on:

• Established laboratory standards and specifications: From USP (United States Pharmacopeia) for pH, osmolality, viscosity, antimicrobial effectiveness, and microbial counts.
• International standards: ISO 10993 series for biocompatibility.
• Industry standards: ASTM D7661-18 for condom compatibility.
• Real-time product testing: For assessing shelf-life performance against all established specifications.

8. Sample Size for the Training Set

This information is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

This device is for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex condoms and not compatible with polyurethane and polyisoprene condoms.

Personal Lubricating Jelly is a water-based personal lubricant containing ingredients that are commonly used in vaginal lubrication devices, including water, glycerin, hydroxyethylcellulose, chlorohexidine glucono delta lactone, methylparaben, and sodium hydroxide. It is provided non-sterile.

The provided document is a 510(k) premarket notification for a medical device (Personal Lubricating Jelly) and is generally not the type of document that would contain detailed information about acceptance criteria and comprehensive study designs as requested in your prompt regarding AI/algorithm performance.

However, I can extract what limited information is available related to performance testing to address some of your points.

Here's an analysis based only on the provided text:

This device is a personal lubricating jelly, not an AI or algorithm-based device, so most of your requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) is not applicable or present in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, with one specific performance test conducted to support an added claim.

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

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

• Sample Size for Test Set: Not specified in the document for the condom compatibility testing. The ASTM D7661-10 standard would outline the required sample size, but the summary doesn't include it.
• Data Provenance: Not specified. The study was conducted to support a US FDA submission, but the location of the test facility is not mentioned. It was a prospective test as it was "collected in accordance with ASTM7661-10" to support a new claim.

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)

• Not applicable. This is not an AI/diagnostic device that requires expert ground truth. The condom compatibility test is a laboratory assay.

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

• Not applicable. This is a laboratory test with objective measurements as defined by the ASTM standard, not a subjective assessment requiring adjudication.

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 device is a personal lubricant, not an AI diagnostic tool.

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

• Not applicable. This device is a personal lubricant, not an AI algorithm.

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

• For condom compatibility: The "ground truth" is defined by the objective pass/fail criteria and measurements outlined in the ASTM D7661-10 standard, which evaluates the physical properties and integrity of the condom after lubricant exposure.
• For substantial equivalence (other aspects): The "ground truth" is established by the accepted safety and performance profiles of the legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This device did not involve machine learning or AI, and therefore no training set was used.

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

• Not applicable. No training set was used.

Ask a specific question about this device

The Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required.

Sion's Lubricating Jelly is used to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The lubricating jelly is clear, greaseless, odorless, water soluble and non-irritating to the skin, tissue and mucous membranes. Both product types (sterile and non-sterile) are packed in a bacterial barrier tubes or sealed laminated sachets. Sion's Lubricating Jelly is a body contact material and was evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2009.

This document describes the 510(k) premarket notification for Sion Biotext Medical's Lubricating Jelly. It is a Class I medical device intended to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a table of tests performed and relevant standards. The reported device performance is a general statement that "All tested devices met the tests' requirements and pre-defined acceptance criteria."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes for each test mentioned. It only states that "All tested devices met the tests' requirements." The data provenance is implied to be from Sion Biotext Medical Ltd. in Israel, as the company is based there and would conduct its own testing for device clearance. The studies appear to be prospective, designed to evaluate the physical and biological properties of the device against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is generally not applicable to laboratory or performance testing of a lubricating jelly. The "ground truth" for these tests is established by adhering to widely accepted international standards (e.g., ISO, USP, ASTM) and internal specifications, not by expert consensus on clinical interpretation. The tests are objective measurements of physical, chemical, and biological properties.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. The tests are typically pass/fail based on predetermined specifications or standard requirements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is evaluated. This is a lubricating jelly, and its performance is assessed through laboratory testing, not human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance tests of the device itself, without any human-in-the-loop evaluation of its performance in a diagnostic or interpretive capacity. The "algorithm" in this context would be the physical and chemical formulation of the jelly and the manufacturing process, and its performance is evaluated against predefined specifications.

7. The Type of Ground Truth Used

The ground truth for the device's performance is based on established industry standards (e.g., ISO 11737-2, USP , ASTM 1929, ISO 10993 series, ISO 11137-2, AAMI TIR 33, ISO 11607-1) and internal specifications set by Sion Biotext Medical. These standards and specifications define the acceptable ranges for properties like pH, viscosity, sterility, biocompatibility, etc.

8. The Sample Size for the Training Set

Not applicable. This device is a medical product (lubricating jelly), not an AI algorithm that requires a "training set" for learning. The development process would involve formulation and optimization, but there isn't a "training set" in the sense used for machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device. The formulation and characteristics of the lubricating jelly were likely developed based on scientific principles of chemistry and materials science, aiming to meet the performance criteria and safety standards required for medical devices.

Ask a specific question about this device

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

The Dukal Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly.

The provided document, K113689, describes a 510(k) premarket notification for the Dukal Sterile Lubricating Jelly. This is not for a software or AI-powered medical device, but rather a physical medical device. Therefore, many of the requested criteria (like sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set size, etc.) are not applicable in this context, as they relate to studies of diagnostic accuracy or performance of AI/software in interpreting data.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, aligning with the information that is present in the 510(k) submission for a non-AI device.

Acceptance Criteria and Device Performance for Dukal Sterile Lubricating Jelly

The submission for the Dukal Sterile Lubricating Jelly demonstrates substantial equivalence to a predicate device (Dynarex Sterile Lubricating Jelly, K092488) based on comparable technological characteristics, intended use, and safety/effectiveness profiles. The "acceptance criteria" here are implicitly the criteria for demonstrating substantial equivalence, primarily through direct comparison of features and performance to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For this non-AI medical device, the acceptance criteria are based on exhibiting similar technological characteristics and performance to the predicate device.

2. Sample Size for Test Set and Data Provenance

For physical medical devices undergoing a 510(k) submission based on substantial equivalence, the "test set" does not typically refer to a dataset of patient cases. Instead, it refers to samples of the device itself undergoing various physical, chemical, and biological tests.

• Sample Size for Test Set: Not specified in terms of number of units, but implies a sufficient number of samples of the Dukal Sterile Lubricating Jelly were used for the listed biocompatibility and sterilization validation tests.
• Data Provenance: The data arises from internal testing performed on the Dukal Sterile Lubricating Jelly and comparison to the publicly available characteristics of the predicate device (Dynarex Sterile Lubricating Jelly). It is retrospective in the sense that the predicate device's characteristics are already established.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This criterion is not applicable for this type of medical device submission. Ground truth, in the context of interpretation by experts, is relevant for diagnostic devices interpreting outputs like images or signals. For a lubricating jelly, "ground truth" is established through standardized laboratory testing (e.g., ISO standards for biocompatibility) and direct chemical/physical characterization, rather than expert interpretation of a test set.

4. Adjudication Method for the Test Set

This criterion is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data in diagnostic studies. For a physical device, performance is evaluated against objective standards and test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. These types of studies are for evaluating the performance of diagnostic systems (often AI-assisted) and human readers in interpreting clinical cases. This device is a lubricating jelly, not a diagnostic system.

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

No, this is not applicable. This applies to software algorithms without human intervention. The Dukal Sterile Lubricating Jelly is a physical product directly applied by a human user as part of a medical procedure.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on:

• Objective Laboratory Testing: Adherence to established standards for biocompatibility (ISO 10993 series for In-Vitro Cytotoxicity, Implantation, Irritation & Hypersensitivity, Systemic Toxicity).
• Sterilization Validation: Conformance to ISO/AAMI 11137 requirements for gamma irradiation sterilization with a specified Sterility Assurance Level (SAL).
• Chemical and Physical Characterization: Verification of ingredients and properties (e.g., water-soluble, non-staining, alcohol/fragrance-free) as listed on the label and compared to the predicate.

8. The Sample Size for the Training Set

Not applicable. This criterion refers to the dataset used to train an AI model. This submission is for a physical medical device and does not involve AI or machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI model, this criterion does not apply.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Walgreen's Personal Lubricating Jelly is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It can ease insertion of rectal thermometers, enemas and tampons. This product is compatible with latex condoms.

Walgreen's Personal Lubricating Jelly is a non-sterile, aqueous based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, nonirritating, non-greasy, gel-like liquid and is compatible for use with or without a condom during intimate sexual activity as evidenced by condom compatibility test results. Walgreen's Personal Lubricating Jelly is a water-based personal lubricant containing chlorhexidine digluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water. This product is designed in LDPE tube w/ plastic flip-top cap.

The Walgreen's Personal Lubricating Jelly is a personal lubricant. The provided information does not describe an AI/ML device, therefore, the requested information on studies, test sets, ground truth, and training sets is not applicable.

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

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

Not applicable. The submission is for a medical device (personal lubricant) and not an AI/ML device that would typically involve test sets or data provenance in this context. The product was tested by independent laboratories, but specific sample sizes and data provenance for these tests are not provided in the 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)

Not applicable. The submission is for a medical device (personal lubricant) and not an AI/ML device. Ground truth as typically understood for AI/ML validation is not relevant here.

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

Not applicable. This is not an AI/ML device.

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.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. The assessment relied on laboratory testing for condom compatibility, biocompatibility, and preservative effectiveness, and comparison of chemical ingredients and intended use to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device

Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.

PharmaPac Lubricating Jelly is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.

The provided text describes a 510(k) submission for a personal lubricant device and does not contain information about acceptance criteria, device performance metrics, or a study that typically involves ground truth, experts, or comparative effectiveness for an AI/ML device. The "Performance Data" section solely refers to stability and microbial studies for the lubricant.

Therefore, most of the requested information cannot be extracted from the given text.

However, I can extract what little "performance data" is mentioned:

1. Table of acceptance criteria and the reported device performance

Regarding the other requested information:

• Sample sized used for the test set and the data provenance: Not applicable. The "performance data" concerns product stability and microbial testing, not a test set for an AI/ML device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI/ML device.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Use Lubricating Jelly to lubricate condoms and for personal lubrication when vaginal dryness causes discomfort. It also eases insertion of rectal thermometers, enemas, and tampons.

The device is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone. glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.

Here's a breakdown of the acceptance criteria and study information for the San-Mar Laboratories Lubricating Jelly, based on the provided document:

This device (San-Mar Laboratories Lubricating Jelly) is a Class II medical device, and the documentation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a novel device. Therefore, many of the requested fields related to a clinical or AI-driven performance study are not applicable or cannot be extracted from this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This 510(k) summary does not describe a test set or data provenance for a performance study in the way it would for a diagnostic or AI-driven device. The "study" mentioned is a long-term stability study and a preservative effectiveness test, not a clinical performance trial with a test set of patient data.

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

• Not Applicable. This document does not pertain to a study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication method is described.

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 device is a personal lubricant, not an AI-driven diagnostic or image analysis tool, so an MRMC study is irrelevant here.

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

• Not Applicable. This is not an algorithm-based device.

7. The type of ground truth used

• Not Applicable in the traditional sense. For the stability and preservative effectiveness tests, the "ground truth" would be the pre-defined specifications for stability over time and the microbial kill rates/preservation efficacy against specific challenge organisms as per USP . These are objective chemical and microbiological measurements, not expert consensus or pathology.

8. The sample size for the training set

• Not Applicable. This document does not describe a training set as it would for a machine learning or AI device. The "study" focused on product samples for stability and preservative testing.

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

• Not Applicable. No training set is described.

Summary of the Study:

The primary study mentioned in this 510(k) summary is a 36-month long-term stability study and a preservative effectiveness test (in accordance with USP method ). These studies were conducted to confirm the labeled shelf life and the efficacy of the preservatives in the San-Mar Labs Lubricating Jelly. The results confirmed the stability throughout the 36-month shelf life and compliance with USP method . The core evidence for this 510(k) relies on demonstrating that the device's technological characteristics are identical to the predicate device (K-Y® Lubricating Jelly) and that it meets basic quality and shelf-life requirements.

Ask a specific question about this device