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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.

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The Colonglide® Lubricant Is indicated for medical purposes for use to lubricate a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as an endoscope). This device is intended for use on order of a physician.

Colonglide® Lubricant is a clear, colorless, non-sterile, odorless, water-based patient lubricant. The subject device is packaged for individual use in a 250 mL round plastic bottle sealed with a screw cap with a foil induction innerseal liner.

The Colonglide® Lubricant is intended for medical purposes for use to lubricate a body orifice of a patient to facilitate the entry of a diagnostic or therapeutic medical device (such as an endoscope). This device is intended for use on order of a physician.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit quantitative acceptance criteria for each performance metric of the Colonglide® Lubricant. However, we can infer some criteria from the non-clinical and clinical testing performed to establish safety and effectiveness.

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

• Non-Clinical Tests:

  • pH Test: Colonglide® Lubricant and predicate devices were tested; specific number of samples not given, but formulations were compared.
  • Biocompatibility Testing (Sensitization and Irritation): Performed according to ISO 10993-I:2009. The predicate device, PDI® Sterile Lubricating Jelly, was used as a control. This generally involves animal models (e.g., guinea pigs for sensitization, rabbits for irritation), but specific numbers are not provided.
  • Provenance: Likely US-based laboratories given the FDA submission context. Retrospective for predicate data, prospective for Colonglide®.

• Clinical Testing (Pilot Study for Colonglide® Lubricant):

  • Sample Size: 30 patients.
  • Data Provenance: Not explicitly stated, but implies within the US, likely at collaborating medical centers (3 study investigators). Prospective study.

• Referenced Published Studies (Brocchi et al.): These studies provide supporting evidence for the general safety and effectiveness of lubricants in colonoscopy, rather than direct testing of Colonglide®.

  • Brocchi, et al. (2005): 346 subjects (170 in control group A, 168 in corn oil group B). Provenance: Likely Italy, as Brocchi is an Italian name and medical studies often originate from specific regions. Prospective, randomized, controlled study.
  • Brocchi, et al. (2008): 510 eligible subjects (170 in group A (standard), 170 in group B (corn oil), 170 in group C (warm water)). Provenance: Likely Italy. Prospective, randomized, controlled study.

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

• For Colonglide® Lubricant Pilot Study:

  • Number of Experts: Three study investigators.
  • Qualifications: "Study investigators enrolling 10 patients each into the study." These would presumably be physicians (likely gastroenterologists or colonoscopy specialists) qualified to perform and assess colonoscopies, but specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. They evaluated the effectiveness of the lubricant.

• For Brocchi et al. studies:

  • Not specified, but assumed to be qualified gastroenterologists/endoscopists performing and evaluating the colonoscopies.

4. Adjudication Method for the Test Set

• For Colonglide® Lubricant Pilot Study: Not explicitly stated, but since "three study investigators enrolling 10 patients each into the study" and each reported individually on effectiveness ("Each study investigator reported that Colonglide® Lubricant facilitated the colonoscopy in at least 50% of the patients"), it doesn't appear a formal adjudication process was used for their individual findings. The overall effectiveness was a simple aggregation (57% of total). It's possible there was internal consistency review or standard protocol application, but no formal adjudication method like "2+1" or "3+1" is described.

• For Brocchi et al. studies: As prospective, randomized controlled clinical trials, they would follow established clinical trial methodologies including blinding (if applicable and possible) and standardized assessment protocols, but specific adjudication methods are not detailed in this summary.

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

No, an MRMC comparative effectiveness study was not done for Colonglide® Lubricant.

• The Colonglide® clinical study was a pilot study with 3 investigators assessing individual patients. It was not designed as a comparative effectiveness study against other lubricants or unassisted procedures, nor did it involve multiple readers interpreting the same cases.

• The referenced Brocchi studies were comparative effectiveness studies between different lubrication methods (standard vs. corn oil vs. warm water) but did not involve "multi-reader" aspects in the sense of multiple independent readers evaluating the same cases, nor did they involve "AI assistance." They were clinical trials comparing interventions.

• Effect Size: Not applicable as no MRMC study with AI assistance was performed.

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

No, this is a patient lubricant device, not an AI/algorithm-based diagnostic or therapeutic device. Thus, there is no "algorithm only" performance to evaluate. The device's "performance" is its physical and chemical properties and its ability to facilitate a medical procedure, as observed by human practitioners.

7. The Type of Ground Truth Used

• Non-Clinical Testing:

  • Chemical/Physical Properties (pH, Viscosity, Specific Gravity, etc.): Measured values against established chemical and physical standards or comparative values of predicate devices. This is objective measurement.
  • Biocompatibility: Established by standardized ISO 10993-I:2009 in vitro/in vivo testing protocols and controls.

• Clinical Testing (Colonglide® Pilot Study):

  • Effectiveness: Physician (investigator) assessment/observation during the procedure (e.g., did it facilitate, amount of external pressure, successful intubation, time to cecum). This is expert observation/assessment.
  • Safety: Physician observation and patient reporting of adverse effects/gastrointestinal problems. This is expert and patient-reported outcomes data.

• Referenced Published Studies (Brocchi et al.):

  • Effectiveness: Objective metrics (successful intubation to cecum, time to cecum, time for withdrawal) and patient-reported outcomes (level of pain, degree of difficulty).
  • Safety: Physician observation and patient-reported adverse effects, and observational assessment of instrument damage.

8. The Sample Size for the Training Set

Not applicable. This is a non-AI medical device (lubricant). There is no "training set" in the context of machine learning or AI. The development process involved formulation, non-clinical testing, and a pilot clinical study.

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

Not applicable, as there is no training set for an AI algorithm. The device development relied on scientific principles of chemistry and material science, then validated through standard non-clinical safety/performance tests and clinical observations.

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For Prescription Use: For easing the insertion of medical devices such as scopes and catheters into body orifices.

The subject device is a terminally gamma sterilized 10cc polypropylene plastic syringe filled with United Guardian lubricating jel and capped with a polypropylene plastic cap. United Guardian has a Master File Reference for its lubrication jel, Master File for Devices MAF-613 pertaining to Lubrajel RR. All components of the device are gamma irradiation stable.

The provided document describes a 510(k) premarket notification for a medical device, specifically a "Sterile Lube Jelly Pre-Filled Syringe," asserting its substantial equivalence to a legally marketed predicate device. The information details non-clinical performance data rather than a clinical study involving human patients or a complex AI algorithm. Therefore, many of the requested categories related to clinical trials, AI, ground truth, and expert evaluation are not applicable to this submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The device, the Nurse Assist Lube Jelly Pre-Filled Syringe, aims to demonstrate substantial equivalence to the predicate device, the Horizon Steri-Lub Lubrication Gel. The acceptance criteria are implicit in showing that the device's characteristics and performance are comparable to the predicate.

Study Details

This submission relies on non-clinical performance data and a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical study the way an AI/software device would.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the device undergoing various performance tests (e.g., syringe seal, stain, viscosity, accelerated aging, biocompatibility). The number of units tested for each specific non-clinical test is not provided in this summary. The data provenance is from internal testing conducted by Nurse Assist Incorporated.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical performance tests is established through standardized testing protocols (e.g., ISO 10993 for biocompatibility, physical property measurements for viscosity, pH, volume, etc.), not expert consensus in the diagnostic sense.
3. Adjudication method: Not applicable. Standard laboratory testing procedures would be followed.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. This device is a pre-filled lubricant syringe, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
6. The type of ground truth used: For the non-clinical performance tests, the "ground truth" is defined by established scientific and regulatory standards (e.g., specific viscosity ranges, pH levels, sterility tests, ISO 10993 for biocompatibility) that the device must meet.
7. The sample size for the training set: Not applicable. There is no AI training set.
8. How the ground truth for the training set was established: Not applicable. There is no AI training set.

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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.

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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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K-Y® Brand Vaginal Moisturizer is a personal lubricant, for 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 product is not compatible with natural rubber latex or synthetic condoms.

K-Y® Brand Vaginal Moisturizer is a non-sterile personal moisturizer formulated to supplement the body's own natural lubricating fluids to provide personal moisturization when vaginal dryness causes discomfort. K-Y® Brand Vaginal Moisturizer, is a stable, non-sterile, translucent, aqueous based, preserved, formulated product composed of a combination of emollients, gelling agents, preservatives, vehicles, and an antioxidant. It is non-fragranced, pH balanced, and contains Vitamin E. The proposed device is packaged in pre-filled applicators to facilitate insertion directly into the vagina.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the K-Y® Brand Vaginal Moisturizer:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

This document is a 510(k) summary for a medical device (K-Y® Brand Vaginal Moisturizer) seeking substantial equivalence to a predicate device. It describes the performed tests to demonstrate the device's safety and effectiveness. It's crucial to understand that this document primarily focuses on demonstrating substantial equivalence, not conducting a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as these are not relevant for this type of product and regulatory filing.

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

The document does not explicitly state the specific sample sizes for each test listed (e.g., Agar Overlay Cytotoxicity, Rabbit Vaginal Irritation, Human Repeat Insult Patch Test, In-Home Consumer Use Study). It only mentions that these tests were "performed."

• Data Provenance: The studies were conducted by the applicant, Johnson & Johnson Healthcare Products. The location of the studies (e.g., country of origin) is not specified, but the applicant's address is in Morris Plains, NJ, USA. The studies would be considered prospective as they were conducted specifically for this regulatory submission.

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

Not applicable. This device is a personal lubricant, not an diagnostic imaging or AI-driven decision support system that requires expert interpretation for ground truth establishment. The "ground truth" here is determined by direct laboratory tests and human safety assessments.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies and establish a consensus "ground truth." This is not relevant for the types of tests described for a vaginal moisturizer.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging systems where human readers interpret data with and without AI assistance. K-Y® Brand Vaginal Moisturizer is a physical product (lubricant), not an AI system.

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

No, a standalone (algorithm only) performance study was not done. This concept applies to AI algorithms. K-Y® Brand Vaginal Moisturizer is a physical product.

7. The type of ground truth used

The "ground truth" for this product is established through:

• Laboratory Testing: For factors like lubricity, stability, and condom compatibility.
• Biocompatibility Testing:
  • Agar Overlay Cytotoxicity (in vitro lab test).
  • Rabbit Vaginal Irritation (in vivo animal model).
• Human Safety Studies:
  • Exaggerated Human Use (Human Repeat Insult Patch Test) – direct observation of human skin reactions.
  • In-Home Consumer Use Study – direct user feedback on safety and performance.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

Not applicable, as there is no "training set" for this type of product.

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The gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Lubrication Gel (Sterile)". This type of document is for a medical device approval and typically does not contain information about software algorithms, AI performance, or clinical study details as requested in your prompt.

Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment can be found in this document.

This letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It's a regulatory approval, not a technical performance report for an AI/software 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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OraLube is a water-soluble, viscous liquid coating intended to be used an intraoral and perioral release agent for the following clinical situations:

• Taking an impression, in which OraLube is placed on the gums and inside the lip (areas not critical to the final outcome of the prosthesis) to facilitate the release of impression material and is applied to the lips and the skin around the mouth to prevent adherence of impression material;
• Using a dental cement or adhesive, in which OraLube is applied to adjacent hard and soft tissue and to the lips and skin around the mouth to prevent adherence of the cement or adhesive;
• Placement of a rubber dam, in which OraLube is brushed on the tooth to facilitate slipping the rubber dam over it.
• Long procedures, in which OraLube can be used to protect the lips from drying out and cracking.

Pulpdent OraLube is a water-soluble, viscous liquid coating intended to be used as an intraoral and perioral release agent, slip agent, lubricant, lip and skin protector.

The provided text describes a 510(k) summary for a dental device called "Pulpdent OraLube." The 510(k) process is for demonstrating substantial equivalence to a predicate device, rather than performing a de novo study with acceptance criteria and performance metrics.

Therefore, the input text does not contain the specific information required to answer the questions regarding acceptance criteria, device performance, study details, or ground truth establishment. It primarily focuses on comparing the new device to a predicate device ("Pulpdent Separating Medium K 896653") to establish "substantial equivalence" in performance, intended use, safety, and effectiveness.

Here's a breakdown of why this information is missing based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission relies on "substantial equivalence" to a predicate device that has been "on the market and used successfully by dental professionals for many years with no serious safety or effectiveness problems." This implies an existing track record for the predicate, not new performance data for OraLube against specific criteria.

2. Sample sizes used for the test set and the data provenance: Not applicable or provided. No specific test set or study data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. No ground truth establishment activity is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or provided.

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 water-soluble lubricant; it is not an AI-assisted diagnostic tool or an imaging device, so MRMC studies are irrelevant.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or provided.

8. The sample size for the training set: Not applicable or provided. No training set is mentioned as this device is not an AI/ML product.

9. How the ground truth for the training set was established: Not applicable or provided.

In summary, the provided document is a 510(k) summary for a Class I medical device, which typically relies on demonstrating equivalence to existing legally marketed devices rather than presenting extensive new performance study data against pre-defined acceptance criteria. Therefore, the information requested in your prompt related to clinical trials, expert review, training sets, and ground truth is not found in this type of submission.

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