Search Results
Found 38 results
510(k) Data Aggregation
(338 days)
The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant.
The Premier Resolution System is intended for Professional Laboratory Use only.
The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech.
The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings.
For In Vitro Diagnostic Use.
The Premier Resolution System consists of a high performance liquid chromatographic analyzer, reagents, analytical column and software which allows for the fractionation and quantitation of fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with fractionation and presumptive identification of abnormal hemoglobin variants. This is accomplished using the principles of ion-exchange (IEX) high performance liquid chromatography (HPLC).
This document describes the performance data for the "Premier Resolution System," an automated High Performance Liquid Chromatography (HPLC) system for hemoglobin analysis. The study aims to demonstrate that the device is substantially equivalent to a predicate device, the Bio-Rad Variant II ß-thalassemia (K991127).
1. Acceptance Criteria and Reported Device Performance:
The document outlines comparative performance against a predicate device (Bio-Rad Variant II ß-thalassemia) and precision studies. The acceptance criteria are implicitly defined by demonstrating comparability and acceptable precision, rather than explicit thresholds for each metric. The reported device performance includes:
| Acceptance Criteria (Implicit) | Reported Premier Resolution System Performance (Quick Scan Assay) | Reported Premier Resolution System Performance (High Resolution Assay) |
|---|---|---|
| Correlation (Method Comparison) - Mean Bias vs. Predicate (Bio-Rad Variant II) | ||
| HbF comparability | -0.3 bias (1.1 to 48.9% interval) with 160 patient results | -0.4 bias (1.1 to 46.6% interval) with 158 patient results |
| HbA comparability | 0.7 bias (2.5 to 89.7% interval) with 682 patient results | 2.4 bias (3.5 to 90.5% interval) with 586 patient results |
| HbA2 comparability | 0.1 bias (1.6 to 6.1% interval) with 602 patient results | 0.1 bias (1.6 to 6.0% interval) with 598 patient results |
| HbS comparability | 0.3 bias (6.8 to 67.1% interval) with 106 patient samples | 1.3 bias (1.9 to 67.9% interval) with 110 patient samples |
| HbC comparability | -1.1 bias (9.5 to 82.8% interval) with 49 patient results | -1.0 bias (10.2 to 82.5% interval) with 49 patient results |
| HbD-LA comparability | 1.6 bias (11.6 to 82.7% interval) with 17 patient results | 2.7 bias (11.7 to 84.1% interval) with 17 patient results |
| HbE comparability | -3.0 bias (5.5 to 70.4% interval) with 25 patient results | -4.9 bias (5.3 to 66.7% interval) with 25 patient results |
| Precision (Single Site) - Within-Laboratory %CV | ||
| HbA (High) | 3.61% | 3.63% |
| HbA (Mid) | 0.89% | 1.37% |
| HbA2 (Mid) | 2.23% | 7.22% |
| HbA2 (Low) | 5.99% | 7.15% |
| HbF (High) | 1.05% | 3.49% |
| HbF (Mid) | 3.26% | 9.10% |
| HbS (High) | 0.89% | 1.33% |
| HbS (Mid) | 0.98% | 1.69% |
| HbC (High) | 0.78% | 1.15% |
| HbC (Mid) | 1.75% | 2.03% |
| HbD (High) | 1.88% | 2.20% |
| HbD (Mid) | 2.04% | 1.32% |
| HbE (High) | 2.84% | 4.63% |
| HbE (Mid) | 3.06% | 3.14% |
| LoD/LoQ (Quick Scan) | ||
| HbF LoD | 0.2% | 0.1% |
| HbF LoQ | 1.1% | 1.1% |
| HbA LoD | 0.1% | 0.7% |
| HbA LoQ | 2.3% | 2.2% |
| HbA2 LoD | 0.1% | 0.2% |
| HbA2 LoQ | 1.5% | 1.5% |
| HbS LoD | 0.1% | 0.3% |
| HbS LoQ | 1.0% | 0.9% |
| HbC LoD | 0.1% | 0.3% |
| HbC LoQ | 1.0% | 1.7% |
| HbD-LA LoD | 0.1% | 0.1% |
| HbD-LA LoQ | 1.5% | 1.4% |
| HbE LoD | 0.1% | 0.6% |
| HbE LoQ | 1.5% | 2.7% |
2. Sample Size and Data Provenance (Test Set):
- Correlation (Method Comparison): A total of 780 unique patient samples were collected and analyzed. The data provenance is described as being collected and analyzed at three (3) professional external laboratory sites. It is implicit that these were retrospective real-world samples, as they are referred to as "patient samples" used for method comparison against an existing device. The country of origin is not explicitly stated, but given the FDA submission, it is likely the US.
- Precision (Single Site): The sample size for each analyte was 80 data points, generated by a 20x2x2 study design over 20 days, with two runs per day and two replicates per run. These were "samples of varying concentrations" and not explicitly patient samples.
- Precision (Multisite): The sample size for each analyte was 75 data points (3x5x5 study design across three external sites, over five days with five replicates per day). These were "precision samples."
- Limits of Detection: 60 determinations of low-level samples for each hemoglobin type. These were "human whole blood samples" with varying levels of hemoglobins.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
This device is an in-vitro diagnostic (IVD) instrument for quantitative and qualitative analysis of hemoglobin species. The ground truth for such devices is typically established by well-characterized reference methods or by comparison to a legally marketed predicate device. In this submission, the primary method for establishing the device's performance is:
- Correlation (Method Comparison): Comparison against the Bio-Rad Variant II ß-thalassemia, which serves as the "ground truth" or reference for establishing substantial equivalence. No human experts are described as establishing ground truth for the test set, as the ground truth is the measurement from the predicate device.
4. Adjudication Method for the Test Set:
Not applicable. The study design involves direct comparison of quantitative measurements from two analytical instruments (device under review vs. predicate device), and precision of the device itself. There is no subjective interpretation requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is an in-vitro diagnostic device that provides quantitative and qualitative measurements, not an image-based diagnostic system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not relevant.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
Yes, the entire study focuses on the standalone performance of the "Premier Resolution System" as an automated HPLC system. There is no human-in-the-loop component described for its routine operation or for the performance studies presented. The device performs the analysis and provides results independently.
7. Type of Ground Truth Used:
The ground truth for the device's performance is established mainly through:
- Comparison to a legally marketed predicate device: The Bio-Rad Variant II ß-thalassemia, for method comparison (correlation).
- Internal consistency and statistical measures: For precision (repeatability, within-laboratory, reproducibility) and limits of detection/quantitation. This relies on the inherent analytical capabilities and controls of the new device itself.
8. Sample Size for the Training Set:
The document does not explicitly describe a "training set" in the context of machine learning or AI models. This device is an automated HPLC system, where performance is based on chemical separation principles, not a learning algorithm that requires a separate training phase with labeled data in the AI sense. Its "training" or development would involve chemical and engineering optimization.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this device. The development of an HPLC system involves instrument design, reagent formulation, and software development, which are validated through analytical performance studies like those presented (precision, linearity, method comparison, etc.).
Ask a specific question about this device
(94 days)
The Premier HpSA Flex enzyme immunoasay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post- therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.
Meridian Bioscience has modified its FDA-cleared PREMIER Platinum HpSA® PLUS assay (K182559), a qualitative, in vitro diagnostic test for the detection of Helicobacter pylori antigens present in unpreserved human stool specimens. This modification, to be marketed under new device trade name Premier HpSA® Flex upon FDA clearance, is the addition of a new specimen type claim to the intended use of the previously cleared device (K182559) whereby specimens may be preserved in Cary-Blair or Culture and Sensitivity (C&S) transport media.
The Premier HpSA Flex test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool specimens, either unpreserved in transport media. The test uilizes a plurality (mixture) of monoclonal anti-H. pylori capture antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.
Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text.
Acceptance Criteria and Device Performance
The core of this submission is about adding a new specimen type claim (preserved stool in Cary-Blair or C&S transport media) to an already FDA-cleared device. Therefore, the "acceptance criteria" revolve around demonstrating that the device performs equivalently with these new specimen types as it did with the original unpreserved stool and that the performance remains robust.
Here's a summary of the performance characteristics presented as implicit acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit by Study Design) | Reported Device Performance (Premier HpSA Flex with Preserved Stool) |
|---|---|
| Analytical Sensitivity (Limit of Detection - LoD): Demonstrate a specific LoD for H. pylori antigen in preserved stool. | LoD = 12 ng/ml in Cary-Blair or C&S transport media. (Previously established LoD for unpreserved stool was 4.66 ng/mL). Equivalence between Cary-Blair and C&S media at LoD and below LoD antigen concentrations was determined. |
| Precision/Reproducibility: Demonstrate consistent results across different laboratories, operators, and kit lots with preserved stool samples. | Overall agreement between assay result and expected result was 100.0% (95% CI: 98.9-100.0%). (Reproducibility with unpreserved stool was previously evaluated under K182559). |
| Specimen Storage Stability: Demonstrate stability of preserved stool specimens under various temperature and duration conditions. | Specimens stable up to 120 hours at 2-8°C or 19-27°C, or up to 14 days frozen (-20°C and/or -80°C). |
| Freeze/Thaw Stability: Demonstrate robustness of preserved stool specimens to multiple freeze/thaw cycles. | Stable for up to two (2) freeze/thaw cycles when stored frozen (≤ -20°C). |
| Analytical Specificity/Interference: Show no interference from common chemical and biological substances found in stool. | No interference observed for any of the evaluated substances (TUMS, Mylanta, Pepto-Bismol, Tagamet, Prilosec OTC, Barium Sulfate, Whole Blood, Leukocytes, Mucin, Hemoglobin, Stearic Acid, Palmitic Acid, NSAID, Ibuprofen) at their respective test concentrations. (Same substances previously evaluated for predicate). |
| Analytical Specificity/Cross-Reactivity: Show no cross-reactivity with common microorganisms or interference with H. pylori detection. | No cross-reactivity or microbial interference observed with any of the tested bacteria, fungi, and viral strains. (Same organisms previously evaluated for predicate). |
| Method Comparison (Clinical Performance with a Comparator Device): Achieve acceptable positive and negative percent agreement with an FDA-cleared comparator device using preserved stool. | Positive Agreement: 100.0% (49/49) [95% CI: 92.7% - 100.0%] Negative Agreement: 98.5% (131/133) [95% CI: 94.7% - 99.6%] |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Analytical Sensitivity (LoD): Not explicitly stated how many samples per lot were used in the LoD study, but it mentions "Three lots" and "positive results >= 95% of the time."
- Precision/Reproducibility: 360 samples (10 panels x 12 blinded samples x 3 laboratories). The samples were "contrived stool samples" with H. pylori antigen spiked in. Data provenance is implied to be domestic (USA) due to the submission context, and it's a prospective study looking at controlled, contrived samples.
- Preserved Specimen Storage Stability: Not explicitly stated how many samples were used, but the study was designed to validate stability claims.
- Freeze/Thaw Stability: Not explicitly stated how many samples were used.
- Analytical Specificity/Interference: Not explicitly stated how many samples were used, but testing was performed in the presence of various substances.
- Analytical Specificity/Cross-reactivity: Not explicitly stated how many samples were used, but each organism was tested with a true negative and a contrived low positive sample at specified concentrations.
- Method Comparison (Clinical Performance): 200 archived stool specimens were enrolled, of which 182 were evaluable and used for the comparison. Data provenance is of archived specimens from patients, suggesting retrospective data. The specific country of origin is not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an in-vitro diagnostic (IVD) for detecting antigens, not an imaging device requiring expert interpretation for ground truth.
- For the Precision/Reproducibility study, "expected assay result" was used as ground truth for contrived samples. This implies the ground truth was based on the known concentration of spiked antigen.
- For the Method Comparison study, the comparison was against an "FDA-cleared comparator device" and "Standard of Care (SoC) testing using an FDA-cleared commercial assay." The "ground truth" for clinical performance appears to be established by the results of these existing FDA-cleared methods. No human expert consensus was used to define the ground truth for individual samples.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No human adjudication method was mentioned or implied, as the device is an IVD detecting antigens, and ground truth was established either by known concentrations in contrived samples or by results from existing FDA-cleared assays.
-
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 MRMC comparative effectiveness study was conducted. This type of study is typically performed for AI-assisted diagnostic imaging devices where human interpretation directly impacts results. This device is an immunoassay (IVD).
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data provided (LoD, Reproducibility, Interference, Cross-reactivity, Method Comparison) represent the standalone performance of the Premier HpSA Flex assay. It's an automated or semi-automated EIA, not an algorithm requiring human interaction for its direct output.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For analytical performance studies (LoD, Precision, Interference, Cross-Reactivity), the ground truth was known concentrations of H. pylori antigen in contrived samples or known presence/absence of interfering/cross-reacting substances/organisms.
- For the method comparison (clinical performance), the ground truth was established by results from an FDA-cleared comparator device and Standard of Care (SoC) testing using an FDA-cleared commercial assay.
-
The sample size for the training set:
- This is a traditional in-vitro diagnostic device (immunoassay), not a machine learning/AI algorithm that requires a "training set" in the conventional sense. The device's components and parameters are developed through standard chemistry and assay development processes, not through iterative training on a dataset.
-
How the ground truth for the training set was established:
- As stated above, there is no "training set" for an immunoassay in the context of AI/ML. The "ground truth" for the development of the assay itself would align with standard analytical validation methods, ensuring the assay accurately detects the target analyte (H. pylori antigens) at various concentrations and in the presence of relevant interferents, against known standards.
Ask a specific question about this device
(1 days)
Premier's MultiMatch Universal Chameleon Restorative Composite is a nano-hybrid dental restorative intended for direct placement in all cavity classes in anterior teeth. Additional indications include repair of enamel defects, repair of provisionals, and repair of porcelain restorations, minor occlusal build-ups, and incisal abrasions.
Premier's MultiMatch Universal Chameleon Restorative Composite is a light-cured, radiopaque, resin-based nanohybrid restorative composite. It is formulated for direct placement in any type of anterior and posterior cavity form. It is intended to be used with a dental bonding agent and can be sculpted prior to curing. Once light cured, the composite can be easily finished and polished to achieve a highly esthetic and durable restoration. Available in three chameleon shades, MultiMatch can be dispensed via a unit-dose capsule or syringe to provide a restoration with an excellent visual color match to the surrounding dentition.
This document is a 510(k) Summary for Premier's MultiMatch Universal Chameleon Restorative Composite. It seeks to demonstrate substantial equivalence to a predicate device, SimpliShade (K162257).
The document does not describe a study involving an AI/Machine Learning algorithm for medical image analysis or similar diagnostic purposes where an "acceptance criteria" for algorithm performance would be relevant in the way outlined in the prompt. Instead, it describes a dental restorative material and its performance testing as compared to a predicate device.
Therefore, the prompt asks for information that is not present or applicable to the provided document. The document focuses on:
- Device Description: A light-cured, radiopaque, resin-based nanohybrid restorative composite.
- Intended Use/Indications for Use: Direct placement in all cavity classes in anterior and posterior teeth, repair of enamel defects, provisionals, porcelain restorations, minor occlusal build-ups, core build-ups, and incisal abrasions.
- Technological Characteristics: Comparison of composition, curing mechanism, storage, etc., with a predicate device.
- Non-Clinical Performance Data: Mechanical strength (flexural strength, compressive strength), water sorption and solubility, depth of cure, light sensitivity, radiopacity, polymerization shrinkage, volumetric wear, and color stability, as well as biocompatibility testing.
Since this 510(k) is for a dental restorative material and not an AI-powered diagnostic device, there are no "acceptance criteria" related to AI performance metrics (like sensitivity, specificity, AUC), no "test set" of images, no "experts" establishing ground truth for AI, no "adjudication methods" for AI interpretations, no "MRMC studies," no "standalone algorithm performance," and no "training set" in the context of machine learning.
The "acceptance criteria" mentioned in the document relate to the physical and chemical properties of the composite material, tested against established ISO standards for dental materials, and comparison to the predicate device's performance.
To answer the prompt directly based on the provided text, it's necessary to state that the requested information (related to AI model acceptance criteria and study design) is not relevant to this specific premarket notification.
Ask a specific question about this device
(135 days)
The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The Premier Guard Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile. The proposed device is not made from natural rubber latex.
The provided text presents a 510(k) summary for a surgical face mask, focusing on non-clinical performance and biocompatibility testing. It does not describe a study involving an AI/software device or human readers. Therefore, I cannot extract the information required for questions pertaining to AI performance, human reader improvement with AI assistance, MRMC studies, or multi-expert ground truth establishment.
However, I can provide information based on the presented non-clinical performance testing of the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask.
Here's the information that can be extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | Pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% | ≥98% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥98% | ≥98% | Pass |
| Differential Pressure (Delta P) (EN 14683) | <6 mmH2O/cm² | <6 mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Pass |
| Biocompatibility Testing: | |||
| Cytotoxicity (ISO 10993-5) | Not explicitly stated as pass/fail, but implied by result. | Grade 0 | Pass |
| Sensitization (ISO 10993-10) | No sensitization reactions (implied) | No sensitization reactions were observed in test animals | Pass |
| Irritation (ISO 10993-10) | Primary Irritation score=0 (Negligible) (implied) | Primary Irritation score=0 (Negligible) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for each non-clinical test (e.g., how many masks were tested for particulate filtration). However, for Fluid Resistance, the acceptance criteria explicitly states "29 out of 32 pass at 160 mmHg," indicating a sample size of 32 units for that particular test.
Data Provenance: This is a medical device (surgical face mask), not an AI/software product. The tests were performed according to specified ASTM and EN standards, which are laboratory-based. The data provenance is these standardized tests, likely conducted in a controlled laboratory environment, not from patient populations or clinical sites. The document does not specify country of origin for the testing itself. The filing company is Premier Guard USA LLC, based in the US.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is for a physical medical device (surgical face mask), not an AI/software device requiring human expert ground truth for interpretation. The "ground truth" for the performance tests comes from the established protocols of the ASTM, EN, and CFR standards.
4. Adjudication Method for the Test Set
Not applicable. This is for a physical medical device; adjudication by multiple readers or experts is not relevant to the described non-clinical performance and biocompatibility testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is not an AI/software product.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests consists of:
- Established ASTM, EN, and CFR standards and their specified methodologies.
- Laboratory measurements and observations according to these standards (e.g., particle count, pressure differential, visual assessment of fluid penetration, biological responses in test animals).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device.
Ask a specific question about this device
(49 days)
The PREMIER Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.
The PREMIER Platinum HpSA® PLUS test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool. The test utilizes a plurality (mixture) of monoclonal antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically. No calculations are required and the visual color change makes the interpretation of results objective and simple.
In addition, the HpSA test permits assessment of established or novel anti-H. pylori treatment during and posttherapy to monitor for treatment effectiveness, relapse or eradication.
PREMIER Platinum HpSA PLUS (K053335), as the predicate device for this submission, was a modification of PREMIER Platinum HpSA (K983255, K980076) that provided increased signal strengths with positive test results and better discrimination between low positive and negative tests. This submission is for modifications to the antibodies used in the microwells and conjugate reagent.
The PREMIER Platinum HpSA PLUS assay is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool, intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy.
Here's the breakdown of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The modification being assessed is to the antibodies used in the microwells and conjugate reagent of the PREMIER Platinum HpSA® PLUS. The relevant performance characteristics for comparison are based on the predicate device.
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Modified Device) |
|---|---|---|
| Analytical Sensitivity (LoD) | ≥ 4.67 ng H. pylori protein/mL of stool | 4.66 ng H. pylori protein/mL of stool (meets) |
| Clinical Sensitivity (PPA) | 100% | 100% |
| Clinical Specificity (NPA) | 94.8% | 100% |
| Reproducibility | Not explicitly stated as a minimum, but implied to be high based on predicate acceptance | 100% (300/300) of results as expected |
| Cross-Reactivity | None of the listed organisms affected positive or negative test results | None of the listed organisms affected positive or negative test results |
| Interfering Substances | None of the listed substances interfered with positive or negative test results | None of the listed substances interfered with positive or negative test results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study: 159 archived, unpreserved stool samples.
- Data Provenance: The samples were from symptomatic patients but no country of origin is specified. The samples were "archived," indicating a retrospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The documentation does not provide details on the number or qualifications of experts used to establish the ground truth for this specific clinical study comparing the modified device to the predicate. The "ground truth" for this comparison was the result obtained from the predicate device itself.
4. Adjudication Method for the Test Set
Not applicable. The study involved a direct comparison of the modified device's results against the predicate device's results. There was no independent adjudication of individual cases against an external ground truth in the traditional sense, as the predicate served as the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic (EIA) test for detecting antigens, not an imaging or diagnostic aid that involves human readers interpreting results in a variable manner. The interpretation of results is visual or spectrophotometric, implying a more objective, less reader-dependent outcome.
6. Standalone Performance Study
Yes, a standalone performance of the modified device was effectively demonstrated by comparing its results against the predicate device on the same set of samples. The performance metrics (sensitivity, specificity, reproducibility, analytical sensitivity, cross-reactivity, interfering substances) are all measures of the algorithm's (or device's) standalone performance under specified conditions.
7. Type of Ground Truth Used
For the clinical study, the ground truth was established by the predicate device (PREMIER Platinum HpSA® PLUS K053335). The study aimed to demonstrate substantial equivalence by showing agreement between the modified device and the predicate. For analytical studies, the ground truth was based on controlled experimental conditions (e.g., known concentrations of H. pylori protein for LoD, known presence/absence of microorganisms for cross-reactivity, known interfering substances).
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size. The PREMIER Platinum HpSA PLUS is an enzyme immunoassay, implying a deterministic chemical reaction, not a machine learning algorithm that requires a separate training phase. The development of the device would involve optimization and internal testing, which might be analogous to model training, but these details are not provided in terms of sample size or methodology.
9. How the Ground Truth for the Training Set Was Established
As noted above, there's no mention of a traditional "training set" in the context of an EIA device. The "ground truth" during initial development and optimization would have been established through controlled experiments using known concentrations of H. pylori antigens and various other substances (cross-reactants, interferents) to characterize the assay's performance and specificity. This would involve laboratory standards and analytical methods to confirm the composition of samples.
Ask a specific question about this device
(134 days)
The Premier is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).
The purpose of this 510(k) is to make modifications to the previously cleared Premier Spinal System (K160320). The changes include modifications to the implants, surgical instruments, indications and labeling. The Premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, iliac screw, domino connector, lateral connector and hooks.
It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Allov for Surgical Implant Applications, which are widely used for surgical implants with wellknown biocompatibility.
The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
The provided text does not describe an AI medical device or a study proving its acceptance criteria. Instead, it is an FDA 510(k) clearance letter for a Premier Thoracolumbosacral pedicle screw system, which is a physical orthopedic device used in spinal surgeries.
Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth related to an AI device. The document focuses on regulatory clearance for a medical implant and mentions conformance to ASTM standards and ISO guidelines for sterilization, not AI performance metrics.
Ask a specific question about this device
(132 days)
Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.
Not Found
I am sorry, but the provided text from the FDA 510(k) premarket notification for the "Premier Sealant" does not contain any information about a medical device that uses artificial intelligence (AI) or machine learning.
The document is a standard FDA clearance letter for a dental pit and fissure sealant, which is a physical product, not a software-based diagnostic or assistive device that would involve acceptance criteria for AI performance.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- How ground truth for the training set was established.
This information is simply not present in the provided text as the device in question is a traditional dental material, not an AI-powered diagnostic tool.
Ask a specific question about this device
(56 days)
The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.
The premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, domino connector, lateral connector and hooks. It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
This document is a 510(k) summary for the "Premier" pedicle screw spinal system. It does not describe an AI/ML powered medical device or a study involving human readers or AI assistance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.
Therefore, the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.
The document indicates "No clinical study is included in this submission" (Page 6). The acceptance criteria and the study that proves the device meets them are based on non-clinical tests verifying design specifications and compliance with ASTM F 1717-13 as detailed in the "Non-Clinical Test Conclusion" section (Page 6).
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standards Met) | Reported Device Performance (Non-Clinical Test Results) |
|---|---|
| ASTM F 1717-13: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (including: Static compression bending test, Dynamic compression bending test, Static torsion test) | The non-clinical tests demonstrated that the proposed device complies with and met all design specifications based on ASTM F 1717-13. |
| Biocompatibility (Material: Titanium Alloy (Ti6Al4V) meeting ASTM F136-13) | Material used is widely known for biocompatibility and meets relevant standard. |
| Sterilization (Required SAL of 10^-6 via autoclave method) | Recommended sterilization method was validated per ISO 17665-1: 2006. |
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical mechanical testing, not a test set for an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on the performance according to established ASTM standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is for mechanical testing, not clinical data 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: No, an MRMC study was not done. The device is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: No, this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical tests, the "ground truth" is defined by the performance parameters and failure criteria established within the ASTM F 1717-13 standard. For material, it's compliance with ASTM F136-13. For sterilization, it's compliance with ISO 17665-1: 2006.
8. The sample size for the training set: Not applicable. There is no training set for this type of device (spinal implant).
9. How the ground truth for the training set was established: Not applicable. There is no training set.
Ask a specific question about this device
(132 days)
Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.
Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a 510(k) clearance letter from the FDA for a dental etching product, "Premier Etch," confirming its substantial equivalence to legally marketed predicate devices. The letter primarily addresses regulatory compliance and device classification.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.
Ask a specific question about this device
(119 days)
Premier Ceramic Primer is a prescription-only, one-step silane coupling agent intended for preparation of ceramic materials such as porcelain, ceramic, hybrid ceramic or composite resin and zirconia restorations designed to improve adhesion to resin materials prior to cementation or restoration. This primer does not require prior sandblasting or the use of an etchant.
Not Found
I am sorry, but the provided text only contains regulatory correspondence from the FDA regarding a 510(k) premarket notification for the "Premier Ceramic Primer." It discusses the device's classification, general controls, and indications for use.
However, the document does not contain any information about acceptance criteria, study design, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
Ask a specific question about this device
Page 1 of 4