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510(k) Data Aggregation
(448 days)
Play and Joy Water-Based Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, 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, polyurethane, and polyisoprene condoms.
Play and Joy Water-Based Lubricant is a non-sterile, clear, semi-viscous water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of water, xantham gum, glycerine, Chondrus crispus extract, sodium hyaluronate, saccharide isomerate, hydroxyethylcellulose, citric acid, sodium citrate, lactic acid, 1,2-pentanediol, phenoxyethanol, iodopropynyl butylcarbamate, hydroxyacetophenone, gluconolactone, and sodium benzoate. Play and Joy Water-Based Lubricant is for over-the-counter use and is provided in volumes of 50 mL and 100 mL in polyethylene tubes closed with polypropylene caps.
The provided document is a 510(k) Summary for a medical device called "Play and Joy Water-Based Lubricant." It is a submission to the FDA demonstrating substantial equivalence to a predicate device.
This document does not contain the type of acceptance criteria and study information (such as AI performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods) typically found for AI/ML-driven medical devices.
The product described is a personal lubricant, and the performance testing focuses on its physical characteristics, biocompatibility, and condom compatibility, not on an AI algorithm's diagnostic performance. Therefore, I cannot extract the information requested in your prompt regarding AI device acceptance criteria and study data from this document.
However, I can provide the acceptance criteria and performance data for the mechanical/physical performance of the lubricant as reported in the document:
1. A table of acceptance criteria and the reported device performance
| Physical Specification | Acceptance Criteria (Specifications) | Reported Device Performance |
|---|---|---|
| Appearance | Clear, semi-viscous liquid | Clear, semi-viscous liquid |
| Color | Colorless | Colorless |
| Odor | Odorless | Odorless |
| PH@25° C (per USP <791>) | 4.92-5.38 | 4.92-5.38 (within range) |
| Viscosity (cps, per USP <912>) | 1727-3463 cps | 1727-3463 cps (within range) |
| Specific Gravity (per USP <841>) | 1.04-1.08 | 1.04-1.08 (within range) |
| Osmolality (mOsm/Kg, per USP <785>) | (944-984) mOsm/kg | (944-984) mOsm/kg (within range) |
| Antimicrobial effectiveness (per USP <51>) | Category 2 product: bacteria should show not less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days | Met criteria (demonstrated antimicrobial effectiveness) |
| Total yeast and mold count (TYMC, per USP <61>) | <10 cfu/g | <10 cfu/g (met criteria) |
| Total aerobic microbial count (TAMC, per USP <61>) | <100 cfu/g | <100 cfu/g (met criteria) |
| Absence of Pathogenic Organisms (P. aeruginosa, S. aureus, Salmonella/Shigella, E. coli, and C. albicans) | Absent | Absent (met criteria) |
| Biocompatibility: Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility: Sensitization (ISO 10993-10:2010) | Non-sensitizing | Non-sensitizing |
| Biocompatibility: Vaginal Irritation (ISO 10993-10:2010) | Non-irritating | Non-irritating |
| Biocompatibility: Acute Systemic Toxicity (ISO 10993-11:2017) | Non-systemically toxic | Non-systemically toxic |
| Condom Compatibility (ASTM D7661-10/(R)2017 -Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms) | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (no detrimental effect on condom integrity/performance) | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (demonstrated compatibility) |
| Shelf Life (Accelerated Aging Study) | Maintain all device specifications (as listed above in Table 1) for the stated duration. The predicate had 36 months, the subject device initially aimed for this but demonstrated 6 months. | 6 months (all device specifications from Table 1 met over this duration). The shelf life is reported as 6 months, which is lower than the predicate (36 months), but the document states this difference does not raise different questions of safety and effectiveness (S&E). |
Regarding the other points you requested, as they relate to AI/ML device studies, the document does not contain this information because the device is a physical product (personal lubricant), not an AI/ML diagnostic or therapeutic tool.
- Sample size used for the test set and the data provenance: Not applicable. For physical property testing and biocompatibility, samples of the lubricant itself were tested.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. Performance was measured against objective chemical/physical standards and biological endpoints using validated lab tests, not expert interpretation of AI output.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study... effect size of human readers improve with AI vs without AI assistance: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For physical/chemical properties, the ground truth is established by the specified reference standards (e.g., USP monographs). For biocompatibility, it's defined by the biological response as per ISO 10993 standards. For condom compatibility, it's the lack of degradation of condoms as per ASTM D7661.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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(493 days)
Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, 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 compatible with natural rubber latex, polyisoprene, and polyurethane condoms
Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, 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. Play & Joy InvisiLube Lubricant Capsule is a non-sterile, anhydrous silicone inner component encapsulated with a gelatin shell. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The inner component is composed of a blend of silicone with primary ingredients: Cyclopentasiloxane, Dimethiconol, and Dimethicone. The gelatin shell is composed of gelatin, glycerin, Phatic acid, and water.
The provided text is a 510(k) summary for a medical device called "Play & Joy InvisiLube Lubricant Capsule." This document is used to demonstrate substantial equivalence to a predicate device, not to showcase a study comparing human reader performance with and without AI assistance for tasks like image interpretation.
Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI assistance (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training/test sets) is not applicable to this specific document.
The document describes the non-clinical performance testing conducted for the Play & Joy InvisiLube Lubricant Capsule to demonstrate its safety and effectiveness relative to a predicate device. This includes:
1. A table of acceptance criteria and the reported device performance (Non-clinical Specifications):
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied to meet specification) |
|---|---|---|
| Appearance | Colorless | Colorless |
| Color | Clear | Clear |
| Odor | Odorless | Odorless |
| Viscosity | 75 - 201 cps | (Tested to be within this range) |
| Total Aerobic Microbial Count (TAMC, per USP <61>) | <100 cfu/g | <100 cfu/g |
| Total Yeast and Mold Count (TYMC, per USP <61>) | <10 cfu/g | <10 cfu/g |
| Water Activity | <0.3 Aw | <0.3 Aw |
| Presence of Pathogens (per USP <62>) | Absent | Absent |
| - Pseudomonas aeruginosa | Absent | Absent |
| - Staphylococcus aureus | Absent | Absent |
| - Candida albicans | Absent | Absent |
| - Escherichia coli | Absent | Absent |
| - Salmonella | Absent | Absent |
| Biocompatibility | Non-sensitizing, Non-irritation, Not systemically toxic | Met (Results demonstrate non-sensitizing, non-irritation, and not systemically toxic) |
| Shelf-Life | 6 months (maintains specifications) | Met (Demonstrated stability over 6 months) |
| Condom Compatibility | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms | Met (Showed compatibility with all three types) |
Regarding the other points, they are not relevant to this type of device and study:
- 2. Sample size used for the test set and the data provenance: Not applicable. The tests are laboratory-based performance and biocompatibility studies, not clinical studies with patient data.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for these tests is based on established testing standards (e.g., USP, ISO, ASTM).
- 4. Adjudication method: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used: For non-clinical tests, the "ground truth" is defined by the specific parameters and limits set by the referenced standards (e.g., sterility limits, pH ranges, cytotoxicity assays).
- 8. The sample size for the training set: Not applicable. This product does not involve machine learning or AI models with training sets.
- 9. How the ground truth for the training set was established: Not applicable.
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(159 days)
Playground For All Love Sesh 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Playground For All Love Sesh is a non-sterile, unscented, water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water. Glycerin, Propanediol, Bamboo Bioferment PF, Sodium Hyaluronate, CMC Cellulose, Citric Acid, Carubba Blend, Tocopheryl Acetate, Sodium Benzoate, Potassium Sorbate. Playground For All Love Sesh is for over-the-counter (OTC) use and is offered in 3.7 fl. oz PET bottles and 0.17 fl. oz PET/Foil packettes.
The provided document describes the "Playground For All Love Sesh" personal lubricant (K222567) and its clearance by the FDA based on substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device specifications outlined in Table 1 (page 4) indicate the acceptance criteria, and the "Summary of Non-Clinical Performance Testing" (pages 5 and 6) reports that the device meets these.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Gel | Gel (as per Table 1) |
| Color | Clear to hazy white cream | Clear to hazy white cream (as per Table 1) |
| Odor | Characteristic | Characteristic (as per Table 1) |
| Viscosity (per USP<912>) | 1000 – 6000 cps | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| pH (per USP<791>) | 4.0 - 5.5 | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Osmolality (per USP<785>) | 2000 – 6000 mOsm/kg | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Total Aerobic Microbial Count (TAMC, per USP <61>) | <100 cfu/g | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Total Yeast and Mold Count (TYMC, per USP <61>) | <10 cfu/g | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Pseudomonas aeruginosa | Absent | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Staphylococcus aureus | Absent | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Candida albicans | Absent | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Escherichia coli | Absent | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Salmonella/Shigella | Absent | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Antimicrobial Effectiveness Testing (Bacteria) | Meets USP <51> criteria for category 2. No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Antimicrobial Effectiveness Testing (Yeast and Molds) | No increase from the initial calculated count at 14 and 28 days | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic. (Implies non-cytotoxic based on ISO 10993-5 testing) |
| Biocompatibility (Sensitization) | Non-sensitizing | Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic. |
| Biocompatibility (Vaginal Irritation) | Non-irritating | Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic. |
| Biocompatibility (Acute Systemic Toxicity) | Not acutely, systemically toxic | Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic. |
| Shelf-Life | 6 months (maintains specifications) | Results from real-time testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life (6 months). |
| Condom Compatibility (Natural Rubber Latex) | Compatible | The results of this test showed Playground For All Love Sesh is compatible with natural rubber latex and polyisoprene condoms. |
| Condom Compatibility (Polyisoprene) | Compatible | The results of this test showed Playground For All Love Sesh is compatible with natural rubber latex and polyisoprene condoms. |
| Condom Compatibility (Polyurethane) | Not compatible | Results showed Playground For All Love Sesh is not compatible with polyurethane condoms. (This is stated as a product characteristic and consistent with the predicate, rather than a failure of an acceptance criterion for broader compatibility, as the device's indications of use already specify incompatibility). |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many batches were tested for viscosity, or how many samples for biocompatibility).
- Biocompatibility: Performed according to the 2020 FDA guidance document Use of International Standard ISO 10993-1. These are standard in-vitro and in-vivo tests that follow established protocols, but specific sample numbers (e.g., number of cells for cytotoxicity, number of animals for sensitization/irritation/toxicity) are not provided.
- Shelf-Life: "Real-time testing" was used, but the number of samples or batches tested longitudinally over the 6-month shelf-life is not specified.
- Condom Compatibility: Evaluated in accordance with ASTM D7661-10(R) 2017. This standard specifies methodological details, but the specific number of condoms or lubricant applications tested is not detailed in this summary.
Data Provenance: The studies are described as "Non-Clinical Performance Testing" conducted by the manufacturer or their designated labs as part of the submission to the U.S. FDA. The country of origin of the data is not explicitly stated but is implicitly tied to the U.S. regulatory process. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For non-clinical tests like those conducted for a personal lubricant, the "ground truth" is typically established by objective, standardized laboratory measurements and interpretations by trained laboratory personnel or toxicologists, rather than a panel of clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple readers or clinicians, to reach a consensus for ground truth. The tests performed here are laboratory-based, objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices, particularly AI-driven diagnostic tools, where multiple human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a personal lubricant, which does not involve human readers for interpretation.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
A standalone performance study was not done in the context of an "algorithm only" as this is not an AI/software device. The entire performance evaluation summarized (biocompatibility, shelf-life, condom compatibility, physical/chemical/microbiological specifications) represents the "standalone" performance of the product itself, without human-in-the-loop interaction in an interpretive sense.
7. Type of Ground Truth Used
The ground truth for the performance claims (e.g., viscosity, pH, microbial counts, biocompatibility outcomes, condom compatibility) is based on objective laboratory measurements and internationally recognized standard test methods (e.g., USP, ISO, ASTM). These standards define specific procedures and criteria for determining whether a product meets a particular specification.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The "Playground For All Love Sesh" is a physical product (a personal lubricant), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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(313 days)
Playboy Premium Silicone Lubricant is indicated for penile, vaginal and/or anal 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.
Playboy Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for penile, anal, and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of dimethicone. Playboy Premium Silicone Lubricant is sold as an over-the-counter (OTC) product and is provided in 88.7 mL LDPE bottles.
The provided text describes a 510(k) submission for the "Playboy Premium Silicone Lubricant." This is a medical device approval document, not a study evaluating an AI/ML powered device. As such, the specific information requested in the prompt (acceptance criteria and a study proving an AI device meets them, including sample sizes, ground truth, expert opinions, MRMC studies, etc.) is not present in the given text.
The document focuses on demonstrating substantial equivalence to a predicate device (K-Y Silicone K173504) for a personal lubricant. It does this by comparing indications for use, technological characteristics, and non-clinical performance testing.
Here's how the available information relates to the prompt, with the understanding that it's for a traditional medical device, not an AI one:
1. A table of acceptance criteria and the reported device performance
The document provides "Device Specifications" which can be considered acceptance criteria for the physical and biological properties of the lubricant. It also implicitly reports the device performance by stating that it meets these specifications and compares them to the predicate device.
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implicitly met as per submission) |
|---|---|---|
| Appearance | Clear, free from suspended matter and sediment | Clear, free from suspended matter and sediment |
| Color | Clear | Clear |
| Odor | Odorless | Odorless |
| Viscosity | 315 – 385 cps | 315 – 385 cps |
| Total Aerobic Microbial Count (TAMC) | <100 cfu/g | <100 cfu/g |
| Total Yeast and Mold Count (TYMC) | <10 cfu/g | <10 cfu/g |
| Presence of Pathogens (Pseudomonas aeruginosa) | Absent | Absent |
| Presence of Pathogens (Staphylococcus aureus) | Absent | Absent |
| Presence of Pathogens (Candida albicans) | Absent | Absent |
| Presence of Pathogens (Escherichia coli) | Absent | Absent |
| Presence of Pathogens (Salmonella) | Absent | Absent |
| Biocompatibility | Met ISO 10993 standards | Met ISO 10993 standards (Tested and results support) |
| Shelf-Life | 36 months, maintaining specifications | 36 months (Real-time testing demonstrated maintenance) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the non-clinical performance tests (biocompatibility, shelf-life, condom compatibility). It only states that these tests were performed according to relevant standards (e.g., ISO 10993, ASTM D7661-10(R) 2017). The data provenance is implied to be from internal testing conducted by or for Thai Nippon Rubber Industry Public Company Limited. It's a prospective evaluation for the new device.
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 this type of device and submission. "Ground truth" established by experts is relevant to diagnostic or interpretative AI systems, which this lubricant is not. The evaluation here relies on standardized laboratory testing protocols, not expert interpretation of results.
4. Adjudication method
This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human readers/interpreters to reconcile differing opinions, which is not relevant here.
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
This is not applicable as the device is a personal lubricant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a personal lubricant, not an AI algorithm.
7. The type of ground truth used
For the physical and biological properties, the "ground truth" is based on objective measurements and laboratory test results against predefined specifications from recognized standards (e.g., USP <61>, USP <62>, ISO 10993, ASTM D7661-10(R) 2017). For example, a viscosity reading of 350 cps is a measured truth, not an expert's opinion.
8. The sample size for the training set
This is not applicable. The concept of a "training set" refers to data used to train an AI model. This document describes a traditional medical device, not an AI system.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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(143 days)
The Playboy 3 Contour Condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).
Not Found
I am sorry, but the provided text from the FDA letter about K211450 for the "Playboy 3 Contour Condom" does not contain information about acceptance criteria or a study proving the device meets those criteria, as it relates to device performance metrics typically found in AI/ML medical device submissions.
The document is a 510(k) clearance letter for a condom, outlining its regulatory classification, indications for use, and general controls. It's a standard FDA clearance document that confirms substantial equivalence to a predicate device, rather than a detailed report of performance studies against specific acceptance criteria for an AI/ML device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- MRMC study information or effect size.
- Standalone performance.
- Type of ground truth used.
- Training set sample size.
- How ground truth for the training set was established.
This information is typically found in pre-market submissions for AI/ML-powered medical devices, which undergo rigorous validation studies to demonstrate their diagnostic or prognostic capabilities. The provided text concerns a physical barrier contraception device, for which performance is assessed against different types of standards (e.g., burst strength, leakage, etc., though these specific tests are not detailed in this clearance letter).
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(63 days)
For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)
For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3)
For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3)
For symptomatic relief and management of chronic, intractable pain associated with arthritis. (Choose TENS Mode P4)
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "PlayMakar Sport Muscle Stimulator, Model PRO-500." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Specifically, the document includes:
- Trade/Device Name: PlayMakar Sport Muscle Stimulator, Model PRO-500
- Regulation Number: 21 CFR 882.5890
- Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
- Regulatory Class: Class II
- Product Code: NUH, NYN, NYN, NGX
- Indications for Use:
- For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
- For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
- For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
- For symptomatic relief and management of chronic, intractable pain associated with arthritis.
- Type of Use: Over-The-Counter Use
Missing Information:
The document explicitly states that the FDA has determined the device is "substantially equivalent" to predicate devices. This type of clearance generally relies on demonstrating similarity in technological characteristics and performance to already legally marketed devices, rather than requiring new clinical studies to establish acceptance criteria for novel performance claims.
Therefore, I cannot provide the requested information, which typically pertains to performance studies and acceptance criteria for a device. This document does not describe such studies or criteria.
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(128 days)
Playtex® unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
The subject devices, which are modified from the predicate devices, are unscented menstrual tampons consisting of a tampon (pledget with string) and an applicator. The tampons are made of rayon fiber and have absorbency ranges: regular (6-9 grams) and super (9-12 grams). The applicators are made of polyethylene and polypropylene and have four color versions.
The provided text is a 510(k) Summary for the Playtex Stella™ Tampons. It details the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted. However, it does not contain the specific acceptance criteria or the full study details that you requested.
Here's what I can extract and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document mentions "color leaching studies" and their analysis using "Tolerable Intake (TI) analysis of each component in the colorant formulation using ISO 10993-17:2002." This implies that the acceptance criteria for these studies would be that any leached components are within tolerable intake levels as defined by ISO 10993-17:2002. However, the specific quantitative acceptance criteria (e.g., maximum allowable concentration of a leached substance) and the actual reported performance (e.g., the measured concentrations) are not provided in this document.
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: The document states "The color leaching studies were conducted for new applicators." It does not specify the number of applicators or samples tested.
- Data provenance: Not specified.
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)
This section is not applicable as the studies described are non-clinical (chemical analysis for leaching, biocompatibility leverage) and do not involve human expert interpretation of data like medical imaging would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the studies described are non-clinical, involving chemical analysis rather than human interpretation 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
This section is not applicable. The device is a menstrual tampon, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a menstrual tampon, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the color leaching studies, the "ground truth" would be the established Tolerable Intake (TI) levels for each component, as defined by ISO 10993-17:2002. For the biocompatibility, the ground truth is based on historical data from the predicate device (K132819) which presumably met biocompatibility standards.
8. The sample size for the training set
This section is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This section is not applicable. There is no mention of a "training set."
In summary:
The provided document describes non-clinical testing (color leaching and leveraging biocompatibility data) for a physical medical device (menstrual tampon). It mentions the methodology used (LC-MS, GC-MS, ISO 10993-17:2002 for tolerance) but lacks specific quantitative acceptance criteria or detailed study results and sample sizes that would typically be found in a full study report. The request for information related to AI or expert adjudication is not relevant to this type of device and submission.
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(30 days)
Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow < 6 grams (Light)
Absorbs menstrual flow 6-9 grams (Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Scented (or scented deodorized) and unscented menstrual tampons for the absorption of menstrual fluid. The tampon consists of a pledget, string and applicator (barrel and plunger).
The provided text is related to a 510(k) submission for menstrual tampons, specifically regarding a change in the applicator color. It is not an AI/ML device, and therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.
However, I can extract the relevant "acceptance criteria" and the "study" that proves the device meets them from the document in the context of this specific regulatory submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from Submission Goal) | Reported Device Performance/Conclusion |
|---|---|
| Safety: No adverse impact on safety due to applicator color change. | Risk Assessment & Leaching Studies: "As confirmed by our risk assessment and leaching studies, the proposed modification on the applicator colorant has no impact on the safety... of the device." (Conclusion) Additionally, "Biocompatibility Tests: Deemed not applicable for the modified device based on the results of the Leaching Studies. Biocompatibility testing was performed on the predicate device to confirm the tampon material safety." |
| Efficacy: No adverse impact on efficacy (absorbency) due to applicator color change. | Syngyna Testing: "No changes were made to the tampon pledget. Syngyna testing was performed and the results confirmed that the absorbance ranges are the same as the predicate device and comply with 21 CFR §801.430(f)(2)." (Performance Testing) "As confirmed by our risk assessment... the proposed modification on the applicator colorant has no impact on the... efficacy of the device." (Conclusion) |
| Substantial Equivalence: Device remains substantially equivalent to the predicate device. | Conclusion: "The proposed device is substantially equivalent to the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a regulatory submission for a physical medical device (menstrual tampon) with a minor change (applicator color), not an AI/ML device relying on test sets of data. The "tests" mentioned are laboratory tests (Leaching Studies, Syngyna testing) performed on the device itself or its materials, not on a data set.
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)
This information is not applicable. Ground truth, in the context of expert consensus, is relevant for AI/ML diagnostic or measurement devices. For this physical device, "ground truth" refers to established scientific/regulatory standards for material safety and absorbency, measured through laboratory methods, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical trials or studies for AI/ML devices or human reader performance. The studies performed here are laboratory tests.
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
This information is not applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a menstrual tampon.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no algorithm involved in the performance or evaluation of this menstrual tampon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on established regulatory standards and scientific methodologies for biocompatibility (evaluated through leaching studies, indirectly confirming safety) and absorbency (Syngyna testing against 21 CFR §801.430(f)(2)). It's not based on expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML devices.
8. The sample size for the training set
This information is not applicable. There is no AI/ML algorithm requiring a training set for this device.
9. How the ground truth for the training set was established
This information is not applicable. Since there is no training set, there's no ground truth to establish for it.
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(146 days)
Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Absorbency Ranges:
Absorbs menstrual flow < 6 grams (Slender Light)
Absorbs menstrual flow 6-9 grams (Slender Regular, Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Absorbs menstrual flow 15-18 grams (Ultra)
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
The Playtex® Gentle Glide Scented and Unscented Tampons (K120245) have specific acceptance criteria related to absorbency, which were verified through performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Absorbency Range per 21 CFR §801.430(f)(2)) | Reported Device Performance (Absorbency Grams) |
|---|---|
| Slender Light | < 6 grams (Absorbs menstrual flow) |
| Slender Regular, Regular | 6-9 grams (Absorbs menstrual flow) |
| Super | 9-12 grams (Absorbs menstrual flow) |
| Super Plus | 12-15 grams (Absorbs menstrual flow) |
| Ultra | 15-18 grams (Absorbs menstrual flow) |
The device meets these acceptance criteria, as stated in the performance testing section: "Syngyna testing was conducted in accordance to 21 CFR §801.430(f)(2) to verify that the modified tampons met absorbency ranges as specified in the regulation."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the "Syngyna testing" (absorbency testing) or the biocompatibility tests. It only mentions that these tests were "conducted." The data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this device is a menstrual tampon and the primary performance testing involves absorbency measurements, there isn't a "ground truth" derived from expert consensus in the same way it would be for a diagnostic AI device. The ground truth for absorbency is established by the standardized Syngyna testing method itself, as defined by 21 CFR §801.430(f)(2).
For the biocompatibility tests (preclinical and clinical), these are standard in vitro and in vivo tests that would be conducted by trained laboratory personnel, but not "experts" in the sense of clinicians establishing ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set
Not applicable. The absorbency tests are objective measurements, and biocompatibility tests involve standardized protocols and observations. There is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This is a medical device (menstrual tampon), not a diagnostic AI software. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the absorbency performance is based on objective measurements obtained through the standardized Syngyna testing method, as mandated by federal regulation (21 CFR §801.430(f)(2)).
For the biocompatibility tests, the ground truth is established through standard laboratory test results (e.g., cytotoxicity, irritation, sensitization, TSS).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of its development and testing as described in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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(233 days)
Playtex scented or scented deodorized menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid; Playtex unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
This document describes the regulatory submission for Playtex Sport Tampons with OdorShield™, not a medical device that uses artificial intelligence or requires a clinical study with image data. Therefore, many of the requested categories for AI/clinical study information are not applicable.
Here's an analysis based on the provided text:
Device: Playtex Sport (Unscented/Scented) Tampons with OdorShield™
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity: ISO Agar Overlay | - Evaluated according to FDA guidance and applicable standards. Results indicate compliance. |
| - Sensitization: Human Repeat Insult Patch Test | - Test articles (polar and non-polar extracts) evaluated for sensitization potential under occlusion (9 patch induction, 2-week rest, challenge, 72-hour monitoring) on a panel of women. Results indicate compliance. | |
| - Irritation & Acute Systemic Toxicity: Human Vaginal Irritation Study | - Both scented and unscented tampons provided to a panel of women over 2 menstrual cycles in a randomized double-blind study. Expert assessments (colposcopy) made at baseline, midpoint, and termination indicated compliance. | |
| Microbiology | - Zone of Inhibition | - Testing conducted. Results indicate compliance. |
| - TSST-1 Testing | - Results indicate compliance. | |
| Odor Absorption | - Testing to demonstrate effectiveness of OdorShield™ Technology | - Expert panel assessment on OdorShield™ Technology performed. |
| - Validated in consumer testing. (Specific quantitative results not provided in the summary, but implied to meet acceptance.) | ||
| Absorbency (Syngyna Testing per 21 CFR 801.430(f)(2)) | - Regular: Absorbs 6-9 grams of menstrual flow | - Syngyna testing conducted. Playtex Sport Regular tampons met the absorbency range of 6-9 grams. The tampons are labeled in accordance with these ranges. |
| - Super: Absorbs 9-12 grams of menstrual flow | - Syngyna testing conducted. Playtex Sport Super tampons met the absorbency range of 9-12 grams. The tampons are labeled in accordance with these ranges. | |
| - Super Plus: Absorbs 12-15 grams of menstrual flow | - Syngyna testing conducted. Playtex Sport Super Plus tampons met the absorbency range of 12-15 grams. The tampons are labeled in accordance with these ranges. | |
| Overall Substantial Equivalence | - The new tampon has the same technological characteristics as the predicate device (K060981) and the odor absorbing technology is already used in a currently marketed device (K070745). The only difference is the modified use of the odor absorbing technology. | - "Results of performance testing indicate that the subject tampon is substantially equivalent to the predicate devices." (Implied that all characteristics, including the modified odor absorbing technology, demonstrate equivalence or acceptable performance for safe and effective use.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Biocompatibility (Sensitization): A panel of women was used for the Human Repeat Insult Patch Test. Specific number not provided, but the description implies a prospective study involving human subjects.
- Biocompatibility (Irritation & Acute Systemic Toxicity): A panel of women of appropriate age was provided with tampons over 2 menstrual cycles. Specific number not provided. This was a randomized double-blind study, indicating a prospective design.
- Odor Absorption: An "expert panel" was used, followed by "consumer testing." Specific sample sizes for both are not provided. The study design (expert panel, consumer testing) suggests prospective data collection.
- Syngyna Testing: This is an in vitro laboratory test, not involving human subjects. The sample size would refer to the number of tampons tested, which is not specified. Data provenance would be laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Biocompatibility (Irritation & Acute Systemic Toxicity): "Expert assessments were made at baseline, midpoint and termination of study by colposcopy." The number of experts is not specified, but they are implied to be medical professionals capable of performing and interpreting colposcopic exams.
- Odor Absorption: An "expert panel" was used for assessment. The number of experts and their specific qualifications are not provided beyond being an "expert panel."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method like 2+1 or 3+1 for resolving discrepancies in expert assessments. It only mentions "expert assessments" and "expert panel assessment."
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 a physical product (tampon) and not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical product and does not involve any algorithms or standalone AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility:
- Sensitization: Human physiological response (skin reaction/sensitization).
- Irritation & Acute Systemic Toxicity: Medical expert (colposcopy) assessment of vaginal health, and implied absence of acute systemic toxicity symptoms.
- Microbiology: Laboratory results (Zone of Inhibition, TSST-1 detection thresholds).
- Odor Absorption: Expert panel consensus and consumer perception.
- Absorbency (Syngyna): Gravimetric measurements of liquid absorption against established regulatory standards.
8. The sample size for the training set
Not Applicable. This is a physical product, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no training set, this question is not relevant.
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