Search Results
Found 6 results
510(k) Data Aggregation
(50 days)
BLO2X Oxygen Blocker is intended to prevent negative contour in areas where oxygen inhibition of resin polymerization results in premature material loss. Use it before curing composites or luting to prevent the oxygen inhibition layer from forming. BLO2X Oxygen Blocker allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.
BLO2X Oxygen Blocker is a clear, glycerin-based gel containing a viscosity-inducing agent, producing a gel with similar viscosity characteristics to the predicate product.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria for the BLO₂X Oxygen Blocker.
The document is a 510(k) summary for a dental device, "BLO₂X Oxygen Blocker," which describes its intended use, technological characteristics, and comparison to a predicate device (DeOx®) to demonstrate substantial equivalence. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used, or sample size and ground truth establishment for a training set.
The document focuses on establishing substantial equivalence to a legally marketed predicate device based on intended use and technological characteristics, rather than presenting a performance study with specific acceptance criteria.
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(11 days)
Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.
The modified varnish has the following similarities to that which previously received 510(k) concurrence:
- Has the same active ingredient at the same concentration; .
- has the same indications for use; .
- incorporate the same or similar materials; .
- has the same shelf life, and; ●
- is packaged using the same materials and processes.
I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, study details, or ground truth establishment. The document is primarily a 510(k) summary and an FDA clearance letter for a dental varnish, outlining its substantial equivalence to a predicate device and its indications for use. It does not include the results of a clinical study or performance testing.
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(83 days)
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Zircon-F Prophylaxis Paste
The provided text is a 510(k) summary for the Zircon-F Prophylaxis Paste. It focuses on establishing substantial equivalence to predicate devices rather than presenting performance data from a specific study against predefined acceptance criteria. Therefore, most of the requested information about device performance, study details, and ground truth establishment is not available in the provided document.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report device performance in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "performance" assessment is implicitly an assessment of sameness in intended use, technological characteristics, and materials.
| Acceptance Criteria (Implicitly based on Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same Intended Use as predicate devices | Met: Zircon-F Prophylaxis Paste has the same intended use: "for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment" as cleared 510(k) devices. |
| Same Technological Characteristics as predicate devices | Met: "The technological characteristics for this product are the same as those for the predicate devices and other paste products currently on the market except for minor variations in the same or similar components." |
| Substantially Equivalent Materials to predicate devices | Met: "Descriptive information provided shows that the materials from which Pascal Co., Inc.'s Zircon-F Prophylaxis Paste is made are substantially equivalent (nearly identical with some) to those of similar products, used for identical purposes, currently on the market." The document explicitly references "Oral cavity abrasive polishing paste" (CFR 872.6030) as the originally classified device and lists specific 510(k) cleared products (K033449, K024343, K000169) as predicate devices for comparison. |
2. Sample sized used for the test set and the data provenance
Not applicable. The document does not describe a performance study with a test set. The assessment is based on a comparison to predicate devices and their established characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is described as there is no specific performance study.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a prophylaxis paste, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device (prophylaxis paste), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for a performance study. The "truth" in this context is the regulatory determination of substantial equivalence based on comparison to existing predicate devices' intended use, technological characteristics, and materials.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
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(89 days)
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Not Found
This is a tough one! I cannot find the acceptance criteria or study details within the provided text. The document is primarily an FDA clearance letter for a dental prophy paste, confirming its substantial equivalence to other legally marketed devices. It doesn't contain any information about performance studies, acceptance criteria, or specific metrics.
Therefore, I cannot generate the table or answer the questions you've posed. To provide that information, I would need a different type of document, such as a summary of safety and effectiveness data (SSE) submitted to the FDA, a clinical study report, or even the 510(k) submission itself which would contain the study details.
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(637 days)
Banicide® Advanced is a reusable liquid chemical sterilant/high level disinfectant intended to (1) sterilize medical instruments at an exposure time of 10 hours and an exposure temperature of 25℃ and a minimum effective concentration of 1.8% glutaraldehyde; and (2) provide high level disinfection at an exposure time of 45 minutes and an exposure temperature of 25°C and a minimum effective concentration of 1.8% glutaraldehyde. It may be re-used for a period of 30 days provided the solution remains above the MEC as confirmed by a chemical indicator test strip.
Single container glutaraldehyde solution for sterilization and high level disinfection
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details for the Banicide® Advanced device:
Acceptance Criteria and Device Performance
The acceptance criteria for Banicide® Advanced are derived from its intended use as a liquid chemical sterilant and high-level disinfectant, and its comparison to predicate devices. The study demonstrates the device's efficacy against various microorganisms under specified conditions.
Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (from intended use/predicate comparison) | Reported Device Performance (from efficacy tests) |
|---|---|---|
| Concentration (Active Ingredient) | Minimum Effective Concentration (MEC) of 1.8% glutaraldehyde | Tested at or below 1.8% MEC for sporicidal (full-scale re-test). Implicitly tested at 1.8% MEC for other efficacy tests as the product is stressed to simulate worst-case at 30 days of reuse. |
| Exposure Conditions for Sterilization | 10 hours at 25°C | Passed AOAC Sporicidal Test against B. subtillis and C. sporogenes in 10 hours at 22°C (Note: Difference in temperature, but the re-test will be at 25°C). |
| Exposure Conditions for High-Level Disinfection | 45 minutes at 25°C | - Passed AOAC Use Dilution Test (bactericidal) in 45 minutes at 22°C. |
- Achieved 6-log reduction in Mycobacterium bovis (tuberculocidal) in 45 minutes at 25°C.
- Killed Trichophyton mentagrophytes (fungicidal) in 45 minutes at 22°C.
- Effectively disinfected flexible fiber optic endoscopes (simulated in-use) after 45 minutes at 22°C.
- Shown to be effective against a range of viruses (virucidal) in 45 minutes at 25°C. |
| Reuse Period | Up to 30 days, provided glutaraldehyde concentration remains ≥ MEC | All performance testing (bactericidal, fungicidal, tuberculocidal, virucidal, simulated in-use) was conducted after 30 days of manual stressing to simulate worst-case reuse conditions. |
| Sporicidal Activity | Kill B. subtillis and C. sporogenes spores | Passed AOAC Sporicidal Test against B. subtillis and C. sporogenes in 10 hours at 22°C. D-value of approximately one hour for B. subtillis. |
| Bactericidal Activity | Kill S. aureus, P. aeruginosa, S. cholerasuis | No growth observed on carriers following 45 min exposure to 30-day stressed Banicide Advanced at 22°C. |
| Tuberculocidal Activity | Kill Mycobacterium bovis | Achieved six-log reduction in Mycobacterium bovis in 45 minutes at 25°C. |
| Fungicidal Activity | Kill Trichophyton mentagrophytes | Killed Trichophyton mentagrophytes within 45 minutes at 22°C. |
| Virucidal Activity | Effective against relevant viruses | Effective against Cytomegalovirus, Coxsackievirus B-6, Hepatitis A, Influenza A2, Poliovirus Type II, Rhinovirus Type 14, Rotavirus Type WA, Respiratory Syncytial Virus, Herpes Simplex Types I and II, Duck Hepatitis B, Human Immunodeficiency Virus (HIV), and Adenovirus Type S in 45 minutes at 25°C. |
| Material Compatibility | Compatible with medical instruments, including endoscopes | Documentation of general glutaraldehyde compatibility. Supplemental study showed compatibility with endoscopes under actual use conditions. |
| Chemical Indicator Test Strip | Test strip available to verify MEC (1.8%) | Pascal confirmed the 3M Cold Sterilog™ 2.1% test strip is compatible. Test strip readings: no positive readings obtained at 1.8% or 1.7% glutaraldehyde, indicating it accurately detects below MEC. |
Study Details
The provided text describes a series of laboratory and simulated-use studies conducted to demonstrate the efficacy of Banicide® Advanced. All efficacy tests were conducted after the device was "30-day stressed" to simulate worst-case reuse conditions.
-
Sample Size Used for the Test Set and Data Provenance:
- Sporicidal Tests:
- AOAC Sporicidal Test: Used "silk suture loops and porcelain penicylinders" for B. subtillis and C. sporogenes. Specific n not provided.
- End-point analysis: "porcelain penicylinder carriers" inoculated with C. sporogenes. Specific n not provided.
- Spore rate-of-kill (D-value): B. subtillis. Specific n not provided.
- AOAC Use Dilution Test (Bactericidal): "steel penicylinder carriers" dried with S. aureus, P. aeruginosa, and S. cholerasuis. Specific n not provided.
- AOAC Tuberculocidal Test: Tested against Mycobacterium bovis. Specific n not provided.
- AOAC Fungicidal Test: Tested against Trichophyton mentagrophytes. Specific n not provided.
- Simulated In-Use Test: "flexible fiber optic endoscopes". Specific n not provided.
- Virucidal Efficacy Tests: Tested against 12 different viruses (Cytomegalovirus, Coxsackievirus B-6, Hepatitis A, Influenza A2, Poliovirus Type II, Rhinovirus Type 14, Rotavirus Type WA, Respiratory Syncytial Virus, Herpes Simplex Types I and II, Duck Hepatitis B, Human Immunodeficiency Virus (HIV), and Adenovirus Type S). Specific n not provided for each virus test.
- In-Use Test: "a variety of endoscopes taken from an actual clinical setting." Specific n not provided.
- Indicator Strip Testing: "Sets of 60 test strips were tested at each of 6 different concentrations" (2.4%, 2.2%, 2.0%, 1.8%, and 1.7% glutaraldehyde). This totals
60 strips/concentration * 5 concentrations = 300 test strips. (Note: The text states 6 concentrations, but only lists 5 specific ones. Assuming 6 unique concentrations were tested for the overall study design.) - Data Provenance: The studies appear to be laboratory-based efficacy tests, likely conducted in the US. The "In-Use Test" used endoscopes from "an actual clinical setting," implying prospective data collection during clinical use for that specific test. The material compatibility study for endoscopes was "supplemental" and provided "under actual conditions of use."
- Sporicidal Tests:
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- The studies described are primarily laboratory-based microbiological efficacy tests following established AOAC (Association of Official Analytical Chemists) protocols. For such tests, the "ground truth" is typically the objective outcome of the assay (e.g., presence/absence of microbial growth, log reduction).
- The text does not mention the use of human experts to establish "ground truth" for the test set in the same way one might for diagnostic imaging studies. The interpretation of the test results (e.g., counting colony forming units, observing viability) would be performed by trained microbiologists or laboratory technicians, whose qualifications are implicit in their ability to conduct these standard scientific tests.
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Adjudication Method for the Test Set:
- Not applicable as the tests are objective microbiological assays with clear pass/fail criteria or quantitative outcomes (e.g., log reduction, D-value). No mention of human adjudication for conflicting expert opinions.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images with and without AI assistance). Banicide® Advanced is a chemical sterilant/disinfectant, and its effectiveness is measured through microbiological and chemical efficacy, not human diagnostic performance.
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Standalone (Algorithm Only) Performance:
- Yes, the performance tests described are inherently "standalone" in that they evaluate the efficacy of the chemical solution itself without human intervention in the germicidal process. The efficacy is attributed solely to the Banicide® Advanced product under the specified conditions. Human involvement is limited to product application and handling as per instructions, and laboratory personnel conducting the tests and observing results.
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Type of Ground Truth Used:
- Microbiological Assay Results: For all sporicidal, bactericidal, tuberculocidal, fungicidal, and virucidal tests, the ground truth is the objective outcome of the microbiological assays (e.g., absence of growth, specific log reduction, viral inactivation).
- Chemical Concentration Measurement: For the indicator strip testing, the ground truth is the actual measured glutaraldehyde concentration (e.g., 1.8%, 1.7%).
- Direct Observation (In-Use/Material Compatibility): For the in-use tests on endoscopes and material compatibility, the ground truth is the direct observation of microbial recovery post-disinfection and absence of material damage.
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Sample Size for the Training Set:
- Not applicable. Banicide® Advanced is a chemical product, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its formulation and the basis for its efficacy are derived from chemical properties and established antimicrobial principles of glutaraldehyde.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for this type of device. The efficacy is proven through direct testing rather than through an algorithmic learning process.
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(77 days)
Int inded for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive roc t surfaces.
Not Found
This 510(k) summary for K030488, "FLUORILAQ Fluoride Varnish," does not contain the detailed information required to describe acceptance criteria or a study proving the device meets those criteria in the way a contemporary medical device submission for an AI/ML product would.
The document is for a dental varnish, which is a Class II medical device, and its approval is based on substantial equivalence to existing predicate devices, not on performance metrics derived from clinical studies with ground truth establishment in the context of AI.
However, I can extract information related to how substantial equivalence was determined, which serves a similar purpose to demonstrating "meeting acceptance criteria" in this context.
Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
For this type of device (dental varnish), "acceptance criteria" are generally related to demonstrating similar intended use and technological characteristics to legally marketed predicate devices, rather than quantitative performance metrics like sensitivity, specificity, or accuracy.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Intended Use: Device has the same intended use as predicate devices. | Fluorilaq has the same intended use: as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements and exposed dentin on roots. |
| Technological Characteristics: Device has the same or similar technological characteristics as predicate devices. | The technological characteristics for Fluorilaq are the same as those for the predicate devices and other resinous products currently on the market, except for minor variations in the same or similar components. |
| Materials: Device is made from substantially equivalent materials as predicate devices. | Descriptive information provided shows that the materials from which Pascal Co., Inc.'s Fluorilaq is made are substantially equivalent to (nearly identical with some) those of similar products, used for identical purposes, currently on the market. |
| Safety and Effectiveness: No new questions of safety and effectiveness are raised by the differences between the device and the predicate. | Not explicitly stated as a "performance" metric, but the FDA's clearance implies this criterion was met as it found the device substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a dental varnish, substantial equivalence is typically established through a comparison of product specifications, materials, and intended use, often without a formal "test set" in the sense of a clinical or imaging study.
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 provided and is not applicable to a 510(k) submission for a dental varnish. No "ground truth" in the context of expert consensus was established for this device's approval process.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided and is not applicable.
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 provided and is not applicable. This is not an AI/ML driven device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. This is not an AI/ML driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
There was no formal "ground truth" used in the context of a clinical study for this device's 510(k) clearance. Substantial equivalence was based on comparison to legally marketed predicate devices by evaluating intended use, technological characteristics, and materials.
8. The sample size for the training set
This information is not provided and is not applicable. There was no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not provided and is not applicable. There was no "training set" or "ground truth" for it in the context of an AI/ML algorithm.
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