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510(k) Data Aggregation
(83 days)
The RTVue with Software 5.0 is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.
The RTVue is a computer controlled ophthalmic imaging and measurement system that employs optical coherence tomography to image and measure the posterior segment of the eye. The device is currently cleared for in vivo imaging and measurement of the various retinal layers (K062552). Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disk structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC, the outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE. The current submission, RTVue with Software 5.0, is for minor software modifications, such as such as scan name changes, scan length limits, marking and labeling conventions, and improved data acquisition/archiving speeds.
The provided document (K100861) is a 510(k) summary for a software modification (RTVue with Software 5.0) to an existing device (RTVue). The submission is a Special 510(k), which indicates that it's for minor changes that don't raise new questions of safety or effectiveness. As such, it relies on substantial equivalence to the predicate device and does not typically contain acceptance criteria or detailed study results for device performance validation in the way a traditional 510(k) for a novel device would.
Therefore, much of the requested information cannot be extracted from this specific document. The document explicitly states: "The RTVue with Software 5.0 is a modification to RTVue. ... The minor differences in the RTVue with Software 5.0 do not raise any new questions of safety or effectiveness. Thus, the RTVue with Software 5.0 is substantially equivalent to its predicate devices." This implies that the performance characteristics and acceptance criteria were established and met by the predicate device (RTVue).
Here's a breakdown based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided special 510(k) summary. For a special 510(k), the focus is on demonstrating that the modification does not alter the fundamental safety and effectiveness profile already established for the predicate device. Therefore, new acceptance criteria or performance studies are generally not required to be submitted in the summary.
2. Sample size used for the test set and the data provenance
This information is not present in the provided special 510(k) summary. Given that it's a special 510(k) for minor software modifications, new clinical or performance studies with test sets are not typically conducted or summarized if the change is non-impactful to clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present in the provided special 510(k) summary.
4. Adjudication method for the test set
This information is not present in the provided special 510(k) summary.
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 present in the provided special 510(k) summary. The device description does not indicate AI functionality or reader assistance, focusing on imaging and measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided special 510(k) summary. The device is described as an "optical coherence tomography system" involving "in vivo imaging and measurement," implying it's a diagnostic tool where a human interprets the output. There is no mention of an algorithm acting as a standalone diagnostic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided special 510(k) summary.
8. The sample size for the training set
This information is not present in the provided special 510(k) summary. The document does not describe the use of machine learning or algorithms that would require a "training set" in the conventional sense of AI.
9. How the ground truth for the training set was established
This information is not present in the provided special 510(k) summary.
Conclusion regarding the Special 510(k) (K100861):
This document describes a Special 510(k) submission for minor software modifications to an existing device. Such submissions typically don't include new performance data or acceptance criteria because the changes are considered not to affect the fundamental safety and effectiveness already established by the predicate device. Therefore, a detailed study proving the device meets acceptance criteria, with specific metrics, sample sizes, expert qualifications, and ground truth methodologies, is not part of this type of submission summary. To find such information, one would need to consult the 510(k) summaries for the predicate devices (K062552 and K071250) which established the initial performance and safety characteristics.
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(21 days)
R&D XERet Control is a tri-level, assayed Hematology control designed to monitor values on Sysmex® hematology analyzers. For in vitro Diagnostic Use Only
The R&D Systems XERet Hematology Control is an in vitro diagnostic reagent composed of human and porcine cells in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.
The provided text describes the acceptance criteria and the study for the R&D XERet Hematology Control. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within range over the life of the product | Passed this criterion. |
| Substantial equivalence in performance, precision, and stability to the predicate device | Demonstrated substantial equivalence in these aspects. |
| Closed vial expiration dating | Established at 85 days when stored at 2 - 8° C. |
| Open vial expiration dating | Established at 15 days when stored at 2 - 8° C and handled per instructions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Laboratory testing of 3 validation lots" was performed.
- Data Provenance: Not explicitly stated, but based on the manufacturer's location (Minneapolis, MN, USA) and the submission to the FDA, it's highly likely the data is from the USA and is prospective as it's part of a validation study for a new product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The "ground truth" for a hematology control typically refers to the expected range of values for given parameters, which are often established through rigorous internal testing and statistical analysis by the manufacturer, rather than by external expert consensus in the same way, for example, a diagnostic image might be.
4. Adjudication Method for the Test Set
- This information is not explicitly stated. Given the nature of a hematology control (monitoring quantitative values), adjudication by multiple experts in the traditional sense (e.g., 2+1, 3+1) is typically not applicable. The performance is assessed against predefined statistical ranges and comparisons to a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation is involved, such as medical imaging. The R&D XERet Hematology Control is an in vitro diagnostic reagent used to monitor automated hematology analyzers, not directly interpreted by human readers in the same context as an MRMC study.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, performance evaluation was done for the device itself. The device is a "control" for an analyzer, so its "standalone" performance relates to its ability to maintain stable and accurate assay values over time (stability, precision) and perform comparably to its predicate. The text states: "Laboratory testing of 3 validation lots has shown the R&D XERet Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device."
7. The Type of Ground Truth Used
- The ground truth for a hematology control is established by determining its assayed values and expected ranges for the measured parameters (RBC, RET%, RET#, IRF). This is typically done through a process of:
- Manufacturer's internal testing: Extensive testing of multiple lots to establish mean values and standard deviations for each parameter.
- Comparison to a predicate device: The study explicitly mentions "substantial equivalence... to the predicate device," implying the predicate's established performance serves as a reference point for acceptable ranges.
- Statistical analysis: To define the "range" within which the control should perform.
- Therefore, the ground truth is primarily based on established reference values/ranges derived from the manufacturer's testing and comparison to a legally marketed predicate device.
8. The Sample Size for the Training Set
- The document does not provide information regarding a training set. Hematology controls are manufactured to specific specifications and then
validated; they are not "trained" in the typical machine learning sense. The "3 validation lots" are part of the testing/validation phase.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not applicable or mentioned for this device, a method for establishing its ground truth is also not provided.
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(168 days)
Model R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.
R72 X-Ray Collimator: External cover in abs plastic Single-layer, square field radiological collimator. Focus/mounting flange plane distance is 70mm. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator, a lead cone situated near the x-ray anode reduces the off-focus radiation. Its light weight and compact size allow easy positioning and make it ideal for portable units. A table on the front panel allows the operator to read field dimensions set with the knobs.
Here's a breakdown of the acceptance criteria and study information for the Ralco Model R72 X-Ray Collimator, based on the provided 510(k) summary:
This device (Ralco Model R72 X-Ray Collimator) is not an AI-powered device, therefore, many of the requested sections (sample sizes for test/training sets, expert details, MRMC studies, standalone performance) are not applicable as they relate to studies typically performed for AI/ML medical devices. The submission focuses on demonstrating substantial equivalence to a predicate device through bench and user testing.
Acceptance Criteria and Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K946320) | Reported Device Performance (Ralco Model R72 K030487) |
|---|---|---|
| Intended Use | As a collimator on Model for operation on stationary units with fixed or rotating anode x-ray tube. Maximum radiation protection 150 kVp. Manual shutter control. Electronic timer for the activation of the light field. Plastic ABS covers. | As a collimator on Model for installation on portable and mobile units with fixed anode x-ray tubes. Maximum radiation protection 125 kVp. Two knobs on either side of the unit provide for the manual control of shutters. Electronic timer for the activation of the light-field simulating the x-ray field. (Note: Intended Use for R72 is specifically for portable/mobile units). |
| Physical Characteristics: Size | 207mm H x 196mm W x 237mm D. | 123 mm H x 168 mm W x 200 mm D |
| Physical Characteristics: Weight | 9.5 kg | 3.6 kg |
| Electrical: Energy Source | 24 V 100w (lamp) | SAME (24 V 100w lamp) |
| Electrical: Timer | 30 sec for light field projection lamp | SAME (30 sec for light field projection lamp) |
| Radiation Protection: kVp | 150 kVp max | 125 kVp max (Note: Lower than predicate device, consistent with intended use for portable/mobile units with fixed anode tubes). |
| Standards & Safety: Performance Standard | 21 CFR 1020.30 | SAME (21 CFR 1020.30) |
| Standards & Safety: Electrical safety | UL 2601, IEC 60601-1 | SAME (UL 2601, IEC 60601-1) |
| Additional Specifications (from Device Description) | (Implicit in predicate: standard features for manual collimator, specific to stationary units, potentially with rotating anodes) | External adjustment of mirror angulation; High luminosity (quartz iodide lamp 100W 24V); Timer limiting projection lamp exposure to 30 seconds (adjustable); Radiation protection up to 125 kVp 4mA; Minimum inherent filtration 2mm aluminum equivalent; Continuous film coverage from 0x0 cm to 35x35 cm ±1% FFD at an FFD of 70cm. Warning: Not to be used with rotating anode X-ray tubes. |
Study Proving Device Meets Acceptance Criteria
The study described is a comparison to a legally marketed predicate device (Ralco Model R302, K946320) to demonstrate substantial equivalence. The device is an X-Ray Collimator, a hardware component, not an AI/ML device.
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Sample size used for the test set and the data provenance:
- Test Set: Not explicitly quantifiable in terms of "samples" or "data" as would be for an AI model. The testing involved "bench and user testing." The document does not provide the number of units tested or the specific conditions of "user testing."
- Data Provenance: Not specified, but implied to be from testing conducted by Ralco srl (Italy). The nature of "bench and user testing" suggests prospective testing rather than retrospective data analysis.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a hardware device submission, not an AI/ML device requiring expert ground truth for classification or interpretation. Testing would involve adherence to technical specifications and safety standards.
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Adjudication method for the test set:
- Not applicable for this type of submission. The evaluation is based on technical specifications and functional equivalence.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in image interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a passive hardware component, not an algorithm. Its function is to limit the X-ray beam, and its performance is inherent in its design and physical characteristics, not in an interpretive algorithm.
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The type of ground truth used:
- The "ground truth" for this device's performance would be derived from engineering specifications, direct measurements (bench testing), and compliance with recognized standards (e.g., 21 CFR 1020.30, UL 2601, IEC 60601-1). For functional aspects like timer accuracy or beam coverage, the ground truth would be the expected performance based on design and physical measurement.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set.
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(14 days)
R&D BODY FLUID Control is used to monitor total cell counts performed manually using a hemocytometer to validate the quantitation of red and white cells in patient body fluid samples.
This control is an assay control mixture for hemocytometer counts. R&D BODY FLUID Control is composed of WBCs and RBCs in a stabilizing medium. R&D BODY FLUID Control simulates cells and body fluids in morphology and count.
The provided text describes the 510(k) summary for the R&D Systems, Inc. BODY FLUID Control device. This device is a quality control mixture for hemocytometer counts, simulating cells and body fluids in morphology and count.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the life of the product. | "R&D BODY FLUID Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Demonstrated precision. | "R&D BODY FLUID Control has demonstrated precision as indicated by the small standard deviation and %CV's obtained during laboratory testing." |
| Expiration dating established. | "Expiration dating has been established at 14 weeks in customers hands (closed vial) and 30 days, or 14 entries (open vial) when stored at 2 - 8° C and handled according to instructions for use." |
| Substantial equivalence in performance, precision, and stability to the predicate device (Spinalscopics Control). | "Laboratory testing of 3 validation lots have shown R&D BODY FLUID Control to have substantial equivalence in performance, precision and stability to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Laboratory testing of 3 validation lots" were used for the study. The specific number of individual samples or measurements within each lot is not specified.
- Data Provenance: The study was conducted through "laboratory testing," implying an internal validation study. The country of origin and whether the data was retrospective or prospective are not explicitly stated. However, given it's a 510(k) submission from a US-based company (Minneapolis, MN), it's highly likely to be prospective laboratory testing conducted in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable / not provided for this device. The device is a quality control material, not a diagnostic device that interprets patient data. Its "ground truth" or reference values are inherent to the controlled composition of the product, verified through laboratory testing against established methods, rather than expert interpretation of images or patient cases.
4. Adjudication Method for the Test Set
This information is not applicable / not provided. As mentioned above, the study focuses on the performance characteristics of a quality control product, not on interpreting patient results where adjudication by experts might be needed for ground truth establishment. The performance is assessed against predefined assay ranges and comparison to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable, as no such study was conducted. This type of study is relevant for diagnostic devices where human readers interpret cases with and without AI assistance. This device is a quality control material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in spirit, a standalone performance was done. The device itself is a control material, and its performance (precision, stability, assay range adherence) was evaluated independently. There isn't an "algorithm" in the typical sense for an AI device, but the performance of the control material (analogous to the "algorithm" in terms of its function) was assessed directly. The intended use is to "monitor total cell counts performed manually using a hemocytometer," so the control itself doesn't involve an automated human-in-the-loop scenario, but rather provides a standard for a manual process.
7. Type of Ground Truth Used
The "ground truth" for this control device is its predefined target values and established assay ranges, determined during its development and manufacturing, and validated through laboratory testing. The study verified that the device remained within these expected ranges and demonstrated precision, and confirmed its "substantial equivalence" to the established performance of the predicate device.
8. Sample Size for the Training Set
This information is not applicable / not provided. This device is a quality control material, not an AI or machine learning algorithm that requires a "training set" in the traditional sense. Its formulation and performance characteristics are established through chemical and biological manufacturing processes and analytical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided. As above, there is no "training set" for this type of device. The "ground truth" for the control's performance is established through manufacturing specifications, analytical methods, and comparison to an existing commercially available predicate device.
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(200 days)
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(67 days)
R&D Systems' Whole Blood Flow Control (WBFC) is a stabilized preparation of human peripheral leukocytes and erythrocytes to be used as a control in the complete immunophenotyping process which includes: antibody staining, RBC lysis, instrument set-up and instrument performance.
The product is an assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples. R&D Systems' Whole Blood Flow Control is composed of human leukocytes and erythrocytes in a stabilizing medium.
The provided text describes a medical device called "R&D Systems' Whole Blood Flow Control." However, it does not contain the specific information requested in the prompt regarding a study that proves the device meets acceptance criteria in the context of an AI-powered diagnostic device. The text describes a traditional laboratory control, not an AI device.
Therefore, I cannot fulfill the request for the following reasons based on the provided text:
- No AI-powered device: The product described is an "assay control mixture for flow cytometric determinations of leukocyte subsets," which is a laboratory reagent, not an AI diagnostic device.
- No acceptance criteria related to AI performance: The acceptance criteria mentioned ("remaining within the assay range over the life of the product" and "precision") are standard for laboratory controls and do not relate to metrics like sensitivity, specificity, AUC, or other performance indicators typical for AI diagnosis.
- No mention of experts, ground truth adjudication, or MRMC studies: These elements are specific to the evaluation of diagnostic algorithms involving human interpretation or AI interpretation, which are not applicable to the described device.
- No training or test set information: Since it's a lab control, there are no AI training or test sets.
Therefore, here is a summary of what can be extracted from the text regarding acceptance criteria and performance, as well as an explanation of why the other requested information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over life | WBFC passed this criterion. |
| Precision (small standard deviations, low CVs) | WBFC demonstrated precision as indicated by "small standard deviations and low CVs obtained during the testing." It also "exhibited similar reproducibility of performance" when compared to freshly drawn whole blood. The expiration dating was established as 28 days closed vial and 7 days open vial. |
Missing Information (and why it's missing from the provided text):
- Sample size used for the test set and the data provenance: Not applicable. The device is a control mixture, not an AI algorithm evaluated on a diagnostic test set. The "testing" referred to is performance lot-release testing, not a diagnostic trial.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic interpretations is not relevant to a laboratory control product.
- Adjudication method for the test set: Not applicable.
- 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 for AI-assisted diagnostic tools.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a laboratory control. The "truth" for a control is its known concentration/composition within the specified range.
- 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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