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An over the counter temporary Denture Reliner, intended to replace a worn denture lining.

ProSoft™ is an over the counter temporary Denture Reliner kit. The device contains a Polyethyl Methacrylate powder, a liquid Ethyl Alcohol, and a mixing stick. The material contains no Methyl Methacrylate Monomer, no Phtalate Plasticizer, no Bisphenol A, and no Cadmium colors.

The powder and the liquid are to be mixed together with the mixing stick to make the relining material. The relining material is then poured into the denture base and placed into the mouth to make the impression.

Once the impression has cured any excess material is trimmed with a sharp knife.

Can be easily removed with warm water or soaking in a solution of hydrogen peroxide and water overnight.

The provided text describes a 510(k) submission for a dental device, "ProSoft™ Denture Reliner." However, it does not include information about AI algorithms or studies that would typically relate to the acceptance criteria and performance metrics asked for in the prompt. The device is a physical product (denture reliner kit) and the evaluation focuses on substantial equivalence to predicate devices based on non-clinical bench testing, not AI performance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set size) are not applicable to the provided document.

Here's an analysis of what is available in the document, framed as closely as possible to your request:

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

Explanation of "Acceptance Criteria": For a 510(k) submission of this type of device, the primary "acceptance criterion" from a regulatory perspective is demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device is as safe and effective as the predicate. The document indicates that the device met this criterion through non-clinical bench testing and biocompatibility assessments.

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

• Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples used in the non-clinical bench testing. The document states "Bench testing was performed" and "Comparative testing data was provided" but does not specify the sample size of the materials or tests conducted.
• Data Provenance: The testing was "performed by a third party laboratory." The country of origin and whether the data was retrospective or prospective are not mentioned, but given it's a 510(k) in the US, it's presumed to be for the US market. The testing is implied to be prospective for the purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device does not involve a diagnostic or interpretive function that would require "experts to establish ground truth" as it would for an AI-powered image analysis device. The "ground truth" for its performance is assessed via established physical and chemical test methods.

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

• Not applicable. Adjudication methods like 2+1 are relevant for discrepancies in expert interpretations, which is not pertinent to this device's evaluation.

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. An MRMC study was not done. This device is a physical denture reliner, not an AI-assisted diagnostic tool or an imaging device. Clinical testing was explicitly not conducted ("Clinical testing was not conducted").

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

• Not applicable. This device is a physical product and does not have an AI algorithm.

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

• Type of Ground Truth: For the functionality and biocompatibility, the "ground truth" would be established by established scientific and engineering principles, material science standards, and accepted testing protocols (e.g., for strength, adhesion, biocompatibility through ISO standards or similar). The FDA Guidance Document "OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits" serves as a benchmark for what needs to be tested. The "ground truth" for showing substantial equivalence essentially means demonstrating that the new device's performance profiles, as measured by these tests, are comparable to those of the predicate device within acceptable limits.

8. The sample size for the training set

• Not applicable. This device is a physical product and does not involve AI/machine learning, therefore no training set is relevant.

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

• Not applicable. See #8.

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Spherical: ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.

Toric: ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.

ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are hemispherical shells of the lens material (phemfilcon A), which is a hydrophilic copolymer of 2hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate.

Once cured the rods are cut to buttons and then lathed to the proper spherical or toric configuration. The ProSoft contact lenses are made by adding Vat Green #1 dye to the finished lens using the CTL (custom tinting) process.

Prosoft lenses enhance perception of colored objects relative to other background colors. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye, on the tennis court, golf course or other background.

This document does not describe an AI medical device or a study involving an AI algorithm. Instead, it is a 510(k) premarket notification for a traditional medical device: "ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear."

The document details the device's indications for use, its physical and mechanical properties, toxicology, and compares it to predicate devices to establish substantial equivalence. It does not mention any artificial intelligence, machine learning, or automated diagnostic capabilities.

Therefore, I cannot extract the information required for an AI-specific study report, as the provided text relates to a conventional contact lens and its regulatory clearance process.

To directly answer your numbered points based on the provided text, if we were to interpret "device performance" in a general sense for a medical device rather than an AI device:

1. A table of acceptance criteria and the reported device performance:
   The document establishes "substantial equivalence" as the primary acceptance criterion, comparing the ProSoft lenses to predicate devices. Specific quantitative acceptance criteria or detailed performance metrics are mentioned in the context of physical, mechanical, and safety properties but not in a consolidated table format with explicit acceptance criteria vs. results.

   Performance Aspect	"Acceptance Criteria" (Implied by equivalence)	Reported Device Performance
   Physical/Mechanical Properties	Equivalent to current lathed DuraSoft 3 UV lenses.	Measured properties show that the lathed lenses are equivalent to predicate lenses.
   Cytotoxicity	Meet USP requirements (no cell lysis/toxicity).	No evidence of causing cell lysis or toxicity. Test article met USP requirements.
   Systemic Injection	Meet USP requirements (no mortality/systemic toxicity).	No mortality or evidence of systemic toxicity from extracts. Each test article extract met USP requirements.
   Ocular Irritation	Not irritant to ocular tissue (rabbit model).	SC (sodium chloride) and CSO (cottonseed oil) test article extracts would not be considered irritants.
   Residual Analysis	No dye extractables detected.	No dye extractables detected.
   Lens Compatibility (Care Regimen)	Parameters within manufacturing tolerances; tint color evident after 30 cycles.	Any changes in parameters through 30 cycles were within manufacturing tolerances. Tint color still evident.
   Light Transmittance	No significant difference before and after cycling.	All variances within experimental tolerance. No significant difference before and after cycling.
   Microbiology	Sterilization identical to predicate device (DuraSoft 3 UV).	Manufacturing, packaging, and sterilization are identical to predicate device.
   Overall Conclusion	Substantially equivalent to DuraSoft® 3UV lenses and CustomEyes (bufilcon A) tinting.	ProSoft lenses are substantially equivalent to DuraSoft® 3UV lenses (K965052) and CustomEyes tinting (P850057).

2. Sample sizes used for the test set and the data provenance:
   The document does not explicitly state numerical sample sizes for each test listed (e.g., cytotoxicity, systemic injection). It mentions "samples of lenses were extracted" for residual analysis. The data provenance is internal to Wesley Jessen Corporation's testing for regulatory submission to the FDA (USA). The studies are preclinical and aim for substantial equivalence rather than clinical efficacy trials with patient cohorts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. The "ground truth" here is based on laboratory-derived measurements and established safety standards (e.g., USP requirements) and comparisons to predicate devices, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:
   Not applicable. The tests are laboratory measurements against established criteria, not expert adjudication of a test set.

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, as this is not an AI device.

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

7. The type of ground truth used:
   The ground truth for performance claims is based on laboratory measurements and established safety/material standards (e.g., USP standards for cytotoxicity, systemic injection, ocular irritation) and comparison to the physical/mechanical and safety profiles of legally marketed predicate devices.

8. The sample size for the training set:
   Not applicable, as this is not an AI device. There is no concept of a "training set" in the context of this device's development as described.

9. How the ground truth for the training set was established:
   Not applicable, as this is not an AI device.

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This product is intended for use with the Huntleigh DVT Flowtron pump to aid in the prevention of deep vein thrombosis in surgical, trauma and certain medical patients at risk for DVT formation. It is not intended for use on patients with known DVT or with any other intermittent compression device. This device is restricted to sale by or on the order of a physician.

The RTM DVT PS100 ProSoft Cuff is a cotton garment designed to be wrapped around the lower extremity (calf), secured with looped tape and connected to Huntleigh DVT Flowtron pump. The outer shell of the garment is a blend of cotton and linen and encases a plastic inflatable bladder that is connected to the pump via poly vinyl tubing.

This submission describes a medical device, the RTM DVT PS100 ProSoft Cuff, seeking substantial equivalence to a predicate device, the Huntleigh Flowtron DVT System L501 Garment. The "study" conducted for this submission focuses on demonstrating technological equivalence rather than clinical effectiveness against specific performance criteria related to DVT prevention.

Here's an analysis of the provided information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating substantial equivalence to a predicate device, the acceptance criteria are based on directly comparing the technological characteristics of the new device to the predicate device. There aren't explicitly stated numerical performance thresholds in the way one might see for a diagnostic device's sensitivity or specificity. Instead, the acceptance criterion is a qualitative assessment of "almost identical" or "virtually no differences detected."

2. Sample Size for the Test Set and Data Provenance

The documentation does not explicitly state a numerical sample size for the "Air Flow/Volume Test" or the "Cycle Test." It implies a comparison of one RTM DVT PS100 ProSoft Cuff bladder against one Huntleigh L501 bladder. For the "Cycle Test," it implies testing one of each cuff on "a person's calf."

• Sample Size: Not explicitly stated as a numerical value for multiple instances; implied n=1 for each device type in each test scenario (unattached bladder and attached to a calf).
• Data Provenance: The tests were conducted by RT Medical. The location of these tests is not specified, but it can be assumed to be within the United States, given that the company address is in Ohio. The data is prospective as it was generated specifically for this submission.

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

There were no external experts used to establish ground truth in the traditional sense for these technological tests. The "ground truth" was established by direct measurement of physical properties (inflation/deflation times) of the devices themselves. The comparison was against the predicate device, not an expert-annotated dataset.

4. Adjudication Method for the Test Set

No adjudication method was mentioned or necessary, as the "ground truth" was based on direct physical measurements and comparison between the two devices.

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

No, an MRMC comparative effectiveness study was not done. The study described is a technological comparison of the new device to a predicate device, not a study of clinical effectiveness or human reader performance. Therefore, there is no mention of effect size for human readers with or without AI assistance.

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

This question is not applicable to the RTM DVT PS100 ProSoft Cuff. This device is a mechanical compression cuff, not a software algorithm or AI-powered device. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

The "ground truth" used was the measured physical performance of the predicate device (Huntleigh L501 garment). The RTM DVT PS100 ProSoft Cuff's performance was compared directly to these measurements.

8. The Sample Size for the Training Set

There is no training set for this type of device submission. This is a physical medical device, not a machine learning model.

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

This question is not applicable as there is no training set for a physical medical device like the RTM DVT PS100 ProSoft Cuff.

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