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The Easy Pain Supreme Self-Monitoring Blood Glucose System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.

The Easy Pain Supreme Self-Monitoring Blood Glucose System consists of the Easy Pain Supreme meter, Easy Pain Supreme Glucose Test Strips, Auto-Lancet Device, Check Strip, Code Card, and Control Solution.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not explicitly state formal "acceptance criteria" in a separate section. Instead, the performance characteristics are presented as findings from analytical and comparison studies. The implicit acceptance criteria are that the device's performance should be comparable to or within acceptable limits relative to the predicate device and established analytical standards. Below is a summary of the key performance metrics reported:

2. Sample Size Used for the Test Set and Data Provenance:

• Analytical Performance (Precision/Reproducibility):
  • Within-Run Precision: 5 different glucose concentration levels were tested. Each sample was measured 5 times. The table indicates "No. of Assay" as 200 for each level, suggesting that for each level, a concentration was prepared, and then multiple aliquots were tested (possibly 5 tests on each of 40 separate preparations or 40 tests on each of 5 preparations, or a combination).
  • Day-to-Day Precision: 3 control solutions (Low, Normal, High) were measured twice a day for a month. The "No. of Assay" is 400 for each control solution, indicating a substantial number of measurements over time.
  • Data provenance: Not explicitly stated, but implies laboratory-controlled experiments.
• Linearity/Assay Reportable Range:
  • A total of 210 tests were performed using 5 meters across seven glucose ranges. The regression analysis (N=630) suggests that each test might have involved multiple data points contributing to the regression calculation, or that 'N' refers to the total number of individual measurements collected across all meters and ranges.
  • Data provenance: Not explicitly stated, but implies laboratory-controlled experiments.
• Method Comparison with Predicate Device:
  • Sample Size: 202 subjects with diabetes.
  • Data Provenance: The study involved human subjects, implying prospective clinical data collection for this comparison. The statement "derived from a three independent capillary data versus YSI plasma data" suggests data was collected from patients, likely in a clinical setting. Country of origin not specified.

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

• No information provided about "experts" to establish ground truth in the traditional sense.
• For the analytical and method comparison studies, the "ground truth" was established by:
  • Carefully prepared glucose solutions with known concentrations (for precision and linearity).
  • The YSI 2300 Analyzer a recognized laboratory reference method, served as the ground truth for the method comparison study. The qualifications of the operators of the YSI 2300 Analyzer are not specified, but it's presumed to be a standard laboratory procedure with qualified personnel.

4. Adjudication Method for the Test Set:

• Not applicable / not mentioned. Since this device is a quantitative blood glucose measuring system, ground truth (reference values) are obtained through precise laboratory methods (YSI 2300 Analyzer, known glucose concentrations) rather than expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a self-monitoring blood glucose system, not an AI-powered diagnostic imaging tool that would typically involve human "readers" or MRMC studies. Its function is to provide a numerical measurement, not an interpretation of complex data.

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

• Yes, in essence, this is a standalone device. The performance characteristics (precision, linearity, method comparison) are evaluating the device's direct measurement capabilities. While it's used by individuals with diabetes (human-in-the-loop for using the device), the "performance" described relates solely to the accuracy and reliability of the device's output, independent of human interpretation beyond simply reading the displayed number. The YSI 2300 comparison directly assesses the algorithm/system's ability to match a reference.

7. The Type of Ground Truth Used:

• Analytical Ground Truth:
  • Known glucose concentrations for precision and linearity studies (i.e., preparing solutions with specific, verifiable glucose levels).
  • YSI 2300 Analyzer results for the method comparison study. The YSI 2300 is considered a laboratory reference method.

8. The Sample Size for the Training Set:

• Not applicable or Not explicitly stated as a separate "training set". This type of medical device (blood glucose meter) typically undergoes rigorous analytical testing and clinical comparison, but the internal algorithms (e.g., for converting electrochemical signal to glucose concentration) are often developed, calibrated, and validated through extensive in-house data and engineering processes rather than a distinct "training set" in the machine learning sense for submission. The provided summary focuses on validation data.

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

• Not applicable or Not explicitly detailed. As mentioned above, the development and calibration of the device's internal algorithms would likely use established chemical principles and controlled experiments with known glucose concentrations, similar to how the analytical ground truth was established for the performance studies. However, the exact process for "training" or calibrating the device during its development phase is not outlined in this 510(k) summary.

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The 32mm Epsilon Metasul Acetabular Insert and Metasul Femoral Head are intended for use in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., . avascular necrosis, osteoarthritis, and inflammatory joint disease (JJD), e.g., rheumatoid arthritis:
• those patients with failed previous surgery where pain, deformity, or dysfunction . persists:
• . revision of previously failed hip arthroplasty.

The Epsilon Metasul 32mm Acetabular Insert is a hemispherically shaped design, composed of an outer component manufactured from polyethylene (UHMWPE) (in compliance with ASTM F648) which is thermo-mechanically bonded to a wrought hotforged CoCr alloy metallic inlay (in compliance with ISO 5832-12). The Epsilon Metasul Acetabular Insert is designed for use only with a Metasul femoral head component, as a metal-on-metal system. The body's natural synovial fluid lubricates the metal surfaces. The Epsilon Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes designed to mate with Converge® Acetabular Shells, sizes 53mm to 81mm (in 2mm increments).

The Epsilon Metasul 32mm Insert has what is commonly referred to as a "polysandwich" design. The inner diameter, which forms the bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and thermomechanically bonded into the polyethylene liner, which is then locked into the Converge acetabular shell via the proven snap mechanism. On the hooded inserts, the face of the polyethylene outer diameter incorporates a 20° overhang of polyethylene extending superiorly from the midpoint of the insert face. This hood feature is designed to provide additional resistance to subluxation and instability.

The 32mm Metasul® Modular Femoral Head is manufactured from Protasul-21WF (wrought forged CoCrMo, in compliance with ISO 5832-12). The design incorporates a 12/14 Morse-type female taper and a beveled face that allows for easier reduction of the hip intraoperatively. This femoral head component is offered in both a standard and an eccentric version, and is designed specifically to articulate with Centerpulse Orthopedics acetabular inserts having a Metasul® Inlav.

The provided 510(k) Premarket Notification for the 32mm Epsilon Metasul Acetabular Insert and 32mm Metasul Femoral Head does not contain acceptance criteria or study results in the format requested.

This document is a regulatory submission for a medical device that demonstrates substantial equivalence to predicate devices. It focuses on device description, intended use, and comparison to existing products, rather than presenting a performance study with specific acceptance criteria and results.

Here's why the requested information is not available in the provided text:

• Type of Submission: This is a 510(k) premarket notification. For many Class II and Class III devices (like this one, which is Class III), substantial equivalence can be demonstrated through design comparisons, materials, and indications for use, without requiring extensive clinical performance studies to define acceptance criteria or measure performance against them in the same way an AI/software device would.
• Device Type: The device is a total hip replacement system component (metal-on-metal hip prosthesis). Its "performance" isn't measured by metrics like sensitivity, specificity, or object detection rates. Instead, performance is related to mechanical properties, biocompatibility, and clinical outcomes that are generally assessed through long-term follow-up and post-market surveillance.
• Content Focus: The document emphasizes:
  • Predicate Devices: Identifying similar devices already on the market.
  • Device Description: Detailed explanation of materials, design, and dimensions.
  • Intended Use: Specifying the patient conditions it's designed to treat.
  • Basis of Substantial Equivalence: Arguing that it's "substantially equivalent" to predicate devices based on design features, materials, and indications for use.

Therefore, I cannot populate the requested table and answer the following questions based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

In summary, the provided document is a regulatory submission for a physical medical device (hip implant components) focused on substantial equivalence, not a performance study for, for example, an AI algorithm that would typically have the requested performance metrics and study design details.

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The Epsilon™ Durasul® Constrained Acetabular Liner is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.

This device consists of two components: a liner and a ring, which will be assembled and attached to one of the corresponding Centerpulse Orthopedics Inc. acetabular shells. The liner mates with previously-cleared Centerpulse Orthopedics Inc. acetabular shell components via a snap lock mechanism. The metallic reinforcing ring provides added femoral head constraint once assembled. The fixation method of the acetabular components is porous cementless with supplemental screws, and the fixation method of the femoral components is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component. At the time of surgery, the constrained liner and ring will be assembled to the corresponding acetabular shell and femoral head.

This 510(k) summary (K030923) is for a medical device (Epsilon™ Durasul® Constrained Acetabular Liner), not an AI/ML device. Therefore, the concepts of acceptance criteria related to device performance in terms of AI/ML metrics (like accuracy, sensitivity, specificity, AUC) and the study designs typically used to prove them (like standalone studies, MRMC studies, or training/test sets with ground truth established by experts) are not applicable.

This submission is for a physical orthopedic implant. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering performance tests and design comparisons demonstrating substantial equivalence to predicate devices, rather than the performance of an AI algorithm.

However, based on the provided text, I can extract information relevant to the device's regulatory acceptance, which is based on demonstrating substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the information that is applicable from your request, interpreted for a physical medical device:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format as one might expect for an AI/ML device. Instead, the "acceptance criteria" for this physical implant are implicitly met by demonstrating "substantial equivalence" to predicate devices. This equivalence is established through various performance tests, design comparisons, and functional analyses.

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

This information is not applicable and not provided. For a physical device, "test set" would refer to the number of devices or components subjected to mechanical and material testing. The summary does not specify the number of units tested, the country of origin of the materials, or if the testing was retrospective or prospective.

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 is not applicable as there is no "ground truth" in the AI/ML sense for this type of device submission. The device's safety and effectiveness are established through engineering testing and comparison to existing, cleared devices, not through expert consensus on diagnostic interpretations.

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

Not applicable. This concept relates to expert review and consensus for AI/ML ground truth establishment.

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. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This is a physical orthopedic implant.

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

Not applicable. "Standalone performance" refers to an AI algorithm's performance without human interaction. This is a physical medical device.

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

Not applicable. The "ground truth" for this device's acceptance is its ability to meet engineering specifications and demonstrate comparable performance/safety to its predicates, often through established material and mechanical testing standards and clinical literature supporting the predicate technology.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical device in the AI/ML sense.

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

Not applicable.

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The EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

The Micropace EPS320 Cardiac Stimulator (Clinical Stimulator) is an external programmable computerised diagnostic cardiac stimulator. It is used in specialised hospital electrophysiological diagnostic laboratories by specialist cardiologists to electrically stimulate the heart to initiate and terminate tachyarrhythmias and allow measurement of refractory and conduction properties of the heart by third party equipment. The EPS320 system consists of a Stimulus Generator Unit (SGU) comprising of a manufactured metal instrument case and a standard IBM clone type Personal Computer (PC), the two interconnected by a serial data connection. The device has two independent fully programmable and isolated constant current pulse generator channels intended for temporary programmacro and locativa third party transvenous intracardiac electrodes. The pacing stimulus is output via a Stimulus Connection Box and may typically be routed to the intravenous pacing electrodes via third party electronic switching equipment. During normal operation of the EPS320, custom software on the PC provides keyboard input device and a graphical user interface which the operator uses to control the stimulation process in real time. The custom PC software interprets the user instructions and sends specific real-time commands to the I he ousehi I O software and and to control its function and generate appropriate pacing stimulus pulses. The two isolated outputs can deliver stimulus pulse widths from 0.5ms to 10ms, adjustable in 0.5 to 1ms steps with current amplitudes adjustable from 0.1mA to 25mA in steps of 0.1mA. Current delivery is limited within the specified range by a maximum available output voltage of 26V. The EPS320 is not a life support device and may be used only in the presence of a backup cardiac THE LE SES IS .In case of failure of mains power supply, malfunction of the PC or its software, or loss of the data link, the SGU can operate independently of the PC in the Manual Backup mode, powered by an internal backup battery. This operational mode can provides regular pacing stimuli at intervals and pulse current amplitudes programmable from and displayed on the SGU's front panel. It may be used to briefly support a bradycardic patient until temporary external pacing is established using an approved temporary pacemaker. A secondary electrically self-contained Emergency Fixed Pace approved willing the front of the SGU may be used for the same purpose in case of loss of normal SGU function.

The provided text describes the Micropace Model EPS320 Clinical Stimulator and seeks 510(k) clearance based on its substantial equivalence to the predicate device, the DCI Model EP-2 Clinical Stimulator. The document primarily focuses on technical specifications and functional comparisons rather than a study demonstrating performance against specific acceptance criteria in a clinical setting.

Here's an analysis based on the provided input:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical thresholds. Instead, it aims to demonstrate that the EPS320 is substantially equivalent to the predicate device (DCI Model EP-2) and is as safe and effective. The "acceptance criteria" are implicitly met if the FDA agrees that the EPS320's specifications and functionality are comparable or improved, and its differences do not raise new questions of safety or effectiveness.

The "reported device performance" is presented through a direct comparison with the predicate device's specifications in Tables 5-1 and 5-2.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

Breakdown of Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • The submission does not describe a specific "test set" or a formal clinical study with a defined sample size to prove the device meets acceptance criteria in a quantitative manner.
   • The provided information states that the EPS320 is an "expert-designed product, based upon the electrophysiological expertise of the cardiologist Managing Director and on extensive post market experience with an earlier EPS220 model in service in eight (8) Australian hospitals since 1995." It also mentions that "The current and earlier EPS320 models have been in clinical use in more than 40 clinical centres predominantly in Australia, Europe and India, as well as in Turkey, Vietnam and China for up to 4 years without significant adverse effects." This "post-market experience" serves as informal evidence of performance and safety rather than a structured clinical test set.
   • Data Provenance: Australia, Europe, India, Turkey, Vietnam, and China.
   • Retrospective/Prospective: The "post-market experience" suggests a retrospective review of observational data from clinical use, not a prospective study designed to evaluate the EPS320 against specific endpoints.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Since there's no formal "test set" or ground truth establishment process described for a specific study, this information is not directly applicable.
   • However, the device design itself is based on "electrophysiological expertise of the cardiologist Managing Director." This individual serves as a key "expert" influencing the device's design and functionality. The submission does not detail specific qualifications of this Managing Director beyond "cardiologist."

3. Adjudication Method for the Test Set:

   • Not applicable, as no formal test set and ground truth establishment with adjudication is described.

4. 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 cardiac stimulator, not an AI-driven diagnostic imaging device that uses multi-reader studies.

5. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. The EPS320 is a medical device that requires human operation by specialist cardiologists to apply electrical stimulation. It is not an autonomous algorithm.

6. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

   • No formal ground truth for a test set is described. The closest equivalent to "ground truth" for the device's design and effectiveness claims comes from:
     • Expert experience: "electrophysiological expertise of the cardiologist Managing Director."
     • Clinical outcomes/safety data: "4 years of post-market surveillance of the EPS320" and "clinical use in more than 40 clinical centres... for up to 4 years without significant adverse effects." This implicitly refers to positive clinical outcomes and lack of adverse events as evidence of safety and effectiveness in real-world scenarios.
     • Comparison to predicate: The EP-2's established safety and effectiveness serve as the baseline "ground truth" for the EPS320's substantial equivalence claim.

7. The Sample Size for the Training Set:

   • Not applicable. This submission does not describe an AI or machine learning algorithm that requires a "training set." The extensive clinical use of "current and earlier EPS320 models" in "more than 40 clinical centres" acts more as an extended real-world validation of the device's design and safety.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set described for an AI/ML algorithm.

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The DTU-215 Programmable Electrophysiology Stimulator with the EPStim Electrophysiology Stimulator Control Program is indicated for patients that are candidates for electrophysiology studies for the diagnosis, and the planning of treatment of supraventricular and other miscellaneous arrhythmias.

The EPstim is intended for assisting a physician in performing an electrophysiology study by providing automated control of the DTU-215 Programmable Stimulator. The system provides for compilation, storage and rapid execution of a customized series of stimulator outputs and provides for automated detection of capture during cardiac electrophysiological testing.

The DTU-215 Programmable Stimulator is intended for use in the electrophysiology laboratory setting under the direction of qualified personnel trained to administer electrophysiological procedures.

EPStim Software and Bloom DTU Electrophysiology Program Stimulator

I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the EPStim Software and Bloom DTU Electrophysiology Program Stimulator.

While it states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its "Indications for Use," it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes.
6. Details about standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on the regulatory clearance process and the intended use of the device, rather than the specifics of its performance validation testing.

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The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Epstein-Barr Early Antigen (EBV-EA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to the early antigen complex of the Epstein-Barr Virus in human serum. The test detects IgG antibodies to both the diffuse (D) and restricted (R) components of the EBV early antigen complex. The EBV-EA IFA Test Kit should be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen (EBNA), and heterophile antibody) as an aid in the diagnosis of infectious mononucleosis (IM).

The Epstein-Barr Virus Early Antigen (EBV-EA) IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to EBV-EA in human serum.

Here's an analysis of the acceptance criteria and study details for the Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Epstein-Barr Virus Early Antigen (EBV-EA) IgG Antibody, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds for sensitivity and specificity in the provided text. Instead, the study reports the device's performance relative to a commercially available predicate EBV-EA IFA. The implication is that comparable performance to the predicate device would be a key acceptance criterion.

Table 1: Relative Sensitivity and Specificity of the Stellar EBV-EA IFA Kit Relative to Alternate IFA

Note on Acceptance Criteria: The document explicitly states: "Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease." This highlights that the acceptance criteria are based on agreement with a predicate device, not on direct clinical truth or diagnostic accuracy.

Study Details

2. Sample size used for the test set and the data provenance

• Test Set Sample Size for Relative Sensitivity and Specificity: 75 samples (43 positive, 32 negative by the alternate IFA).
• Test Set Sample Size for Titer Agreement: 25 positive sera.
• Test Set Sample Size for Reproducibility: 180 (3 positive sera with various titers, 1 negative sera, each assayed 5 times on 3 different assays at 3 different sites).
• Test Set Sample Size for Specificity (Cross-reactivity): At least 9 samples (CMV+, VZV+, HSV 1&2+, HHV 6+, HHV 8+; note multiple HSV 1&2+ and HHV 6+ samples are listed).
• Data Provenance: The samples were selected from frozen retrospective sera tested at a commercial clinical laboratory. The document doesn't explicitly state the country of origin, but given the applicant's address (Columbia, MD 21046, USA), it's highly probable the data is from the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for the primary relative sensitivity and specificity study was established by the results of a commercially available EBV-EA IFA (the "Alternate IFA"). There is no mention of human experts directly establishing the ground truth for this comparison.

For the categorization of sera by serological status (Acute, Seropositive, Seronegative), the criteria were based on ELISA results for VCA IgM/IgG and EBNA. Again, this points to laboratory assay results, not human expert consensus, as the ground truth.

4. Adjudication method for the test set

No adjudication method involving multiple human readers is mentioned. The ground truth was determined by the results of established laboratory assays (the Alternate IFA and various EBV ELISAs).

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. This device is a diagnostic assay (IFA), not an AI-assisted interpretation tool for human readers.

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

Yes, the performance data presented is for the standalone device (the Stellar EBV-EA IFA kit). The "human-in-the-loop" equivalent for an IFA assay would typically be a lab technician reading the fluorescence under a microscope. The study design tests the performance of the kit itself in producing results compared to other similar kits.

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

The ground truth used was primarily the results from a commercially available predicate EBV-EA IFA kit or other serological assays (VCA IgG/IgM ELISA, EBNA ELISA, heterophile antibody assay), rather than expert consensus, pathology, or outcomes data. The study explicitly states there was no attempt to correlate assay results with disease presence or absence.

8. The sample size for the training set

The document does not provide information on a specific training set or its size. As this is a traditional in-vitro diagnostic (IVD) kit based on an established IFA methodology, it's unlikely to have a "training set" in the machine learning sense. The assay development would involve optimizing reagents and protocols during its design phase, but not typically a labeled dataset for algorithm training.

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

Since no training set for an algorithm is mentioned, the method for establishing its ground truth is not applicable/not provided.

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The EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured Radiographic & Fluoroscopic ("R/F") systems. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review, providing assistance to Radiologic Technologists in routine diagnostic examinations and special procedures in R/F. The EPS system may be used to acquire, display, record, archive, and disseminate digital R/F image data.

The Electronic PhotoSpot (EPS) is a 10 bit PC based multitasking acquisition/display system configured for use in R/F applications. This system is designed for use by a qualified Radiologic Technologist. More specifically, the EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured R/F systems. This system consists of independent and simultaneous acquisition of data, review, post processing of raw data and archive transfer functions. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review. The system has 10 bit, 1024 digital acquisition, display and storage capability and uses a Windows based operator interface on the Operator Console/Review Station. It includes the following major components (minimally): Pentium computers, Image monitor(s), Camera X-Ray Interface, MOD media for archival, Software program developed by Marquette Medical Systems to run in conjunction with Microsoft Windows NT. The EPS provides image acquisition, display, archival, and exchange media compliant with the DICOM 3.0 standard. Furthermore, the EPS allows connection to the medical facility's existing LAN network for data dissemination to support reviews, reports, and patient billing.

The provided text is a 510(k) summary for the Marquette Medical Systems' EPS (Electronic PhotoSpot) system. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not contain details about acceptance criteria, a specific study proving device performance, or the various aspects of a clinical study typically associated with new device validation.

The document focuses on establishing equivalence rather than presenting novel performance data. Therefore, I cannot extract the requested information from the provided text.

Here's why the information you requested is not present:

• Acceptance Criteria and Reported Device Performance: The document describes the system's capabilities (e.g., 10-bit, 1024 digital acquisition, display, and storage) and features (acquisition, display, archival, DICOM 3.0 compliance) but does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) against predefined acceptance criteria. The purpose of a 510(k) is often to show that a new device is "as safe and effective" as a predicate, rather than to prove new performance claims with a dedicated study against hard targets.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document does not describe any specific study conducted to validate the device's performance. There is no mention of a test set, training set, expert radiologists establishing ground truth, or any form of multi-reader, multi-case study. The FDA clearance is based on comparison to a predicate device, not on a new clinical performance study. The "Predicate Device" section confirms this, stating, "A comparison of device specifications and principles of operation indicates no new questions of safety or efficacy, or substantial risk are raised."

In summary, the provided 510(k) document is for a medical imaging system that handles acquisition, display, and archiving, and it establishes substantial equivalence to a predicate device. It does not contain the kind of clinical study data, acceptance criteria, or performance results that would typically be found in a submission for a device making novel diagnostic claims or requiring new clinical validation.

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