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The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or the IDS system. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in male and in females; hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries and androgenital syndromes.

The IDS-iSYS Free Testosterone assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:

• MP3: Magnetic particles coated with Streptavidin in a phosphate Pluronic buffer with sodium azide (NaN3) as preservative (

The provided document describes the analytical performance of the IDS-iSYS Free Testosterone assay but does not detail a device performance study with acceptance criteria in the typical format of a clinical trial for an AI/ML medical device. Instead, it focuses on the analytical characteristics of the in vitro diagnostic device, comparing it to a predicate device and demonstrating its performance through various laboratory tests.

Here's an attempt to structure the information based on your request, with the understanding that not all requested points are directly applicable to this type of IVD submission:

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic device like the IDS-iSYS Free Testosterone, "acceptance criteria" and "reported device performance" are typically defined by analytical performance characteristics, such as sensitivity, precision, linearity, and interference. The document presents these values but does not explicitly state pre-defined acceptance criteria for each measurement that would be found in a clinical study protocol. However, we can infer performance targets based on the data presented and common medical device standards (e.g., CLSI guidelines).

*   Males: 129 (21-39 yrs), 138 (40-59 yrs), 42 (>=60 yrs)
The provenance of these subjects is not stated, but they are described as "apparently healthy adults and children."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this document. The "ground truth" for an IVD device like this is typically established by reference methods or gravimetric preparation of calibrators/controls, not by human expert opinion as would be the case for image-based AI/ML diagnostics. The values are quantitative measurements of a biochemical marker.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in studies where human readers interpret data (like medical images) and their agreement, or lack thereof, needs to be resolved. For an IVD, the "ground truth" is a measured concentration, and the accuracy is assessed against reference standards or established methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study assesses how human readers' performance changes with and without AI assistance. This device is an in vitro diagnostic assay, directly measuring a biomarker without human interpretation in the workflow described.

6. Standalone (Algorithm Only) Performance

The performance data presented throughout the document (LoB, LoD, LoQ, precision, linearity, cross-reactivity, interference, method comparison, matrix comparison) is the standalone performance of the IDS-iSYS Free Testosterone assay. This device is a fully automated assay system, and its performance is evaluated independent of human interpretive steps.

7. Type of Ground Truth Used

The ground truth for the analytical studies is generally based on:

• Known concentrations: For LoB, LoD, LoQ, linearity, cross-reactivity, and interference, samples are prepared with known or target concentrations of free testosterone and potential interfering substances.
• Comparative methods: For method comparison, a "commercially available quantitative free testosterone ELISA" serves as the comparative method against which the IDS-iSYS Free Testosterone is measured.
• Reference Intervals: For expected values, "95% reference interval for apparently healthy adults and children" was calculated using a non-parametric method, likely referring to the distribution of measurements in that population.

8. Sample Size for the Training Set

This information is not provided and is typically not applicable in the same way it would be for an AI/ML device. For an IVD assay, "training" involves the development and optimization of the assay reagents, protocols, and calibration, rather than training a machine learning model on a distinct dataset. The "training set" for an IVD refers to the samples used to develop and refine the assay's performance characteristics and establish its calibration curve, which is distinct from the analytical validation samples.

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

This information is not explicitly provided in the document. For an IVD, the "ground truth" for developing a training set (i.e., for calibration) typically involves:

• Gravimetric preparation: Precisely weighing and dissolving a known amount of the analyte (free testosterone) in a suitable matrix to create primary calibrators with accurate, traceable concentrations.
• Reference methods: Using highly accurate and validated reference methods (e.g., LC-MS/MS, though not specified here) to assign values to calibrators or control materials.
• Standardization: Following established industry and regulatory standards (e.g., CLSI guidelines) for calibrator preparation and value assignment to ensure accuracy and traceability.

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The iSyncBrain-C is to be used by qualified medical or qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG) in patients aged 4.5 to 81 years.

iSyncBrain-C is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG). EEG signals can be measured by various EEG equipment, and the measured EEG data is saved in EDF files. iSyncBrain-C can upload, and analyze these EDF files, and personal information or results are automatically stored in AWS (Amazon Web Serve). The analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g., Delta, Theta, Alpha, Alpha2, Beta2, Beta3, Gamma) and frequency information from the EEG. These analysis results are displayed in statistical tables and topographical brain maps of absolute and relative power, power ratio, ICA components, power spectrum, occipital alpha peak, source ROI power(sLORETA) & connectivity(iCoh). All EEG devices has its own frequency characteristics which should be included for any data comparisons coming from different devices. iSyncBrain-C has an EEG amplifier matching module where frequency spectra are adjusted with calibration table between database amplifier and recording amplifier. In all over 33,000 measures are derived for comparison against carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution. Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the subject and an appropriate sex/aqematched reference group in the form of z-scores.

Here's an analysis of the provided text regarding the iSyncBrain-C device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the iSyncBrain-C as a software program for post-hoc statistical analysis of human EEG. The performance data section primarily discusses software validation in accordance with FDA guidance, rather than specific diagnostic performance metrics like sensitivity or specificity. The substantial equivalence argument is based on functional and technical similarity to a predicate device (qEEG-Pro), not on meeting specific quantitative clinical performance thresholds.

Therefore, the "acceptance criteria" appear to be focused on software functionality and safety, and substantial equivalence to a predicate device in terms of features and intended use. Specific quantitative performance metrics for disease detection or classification are not explicitly stated as acceptance criteria in this document.

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

The document does not explicitly state a test set specifically for evaluating the performance of the iSyncBrain-C algorithm against a clinical ground truth. The "Performance Data" section primarily refers to "software validation" against Software Design Specifications.

However, the document mentions statistics regarding the normative database used by the device for comparison:

• Sample size for Normative Database (used for comparison during analysis):

  • Eyes closed: 1289 samples
  • Eyes Open: 1288 samples

• Data Provenance: Not explicitly stated (e.g., country of origin). The document mentions "carefully constructed and statistically controlled age-regressed, normative database," but details about its collection (retrospective/prospective) and origin are absent.

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

This information is not provided in the document. The document refers to software validation and substantial equivalence claims, not a clinical study where experts establish ground truth for a test set. The normative database used for comparison is mentioned, but how its "ground truth" (i.e., "normal" characteristics) was established, or by whom, is not detailed.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a clinical test set requiring expert adjudication in the context of performance evaluation for the iSyncBrain-C algorithm itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided document. The device is described as a "software program for the post-hoc statistical analysis of the human electroencephalogram (EEG)" and its primary evaluation was software validation and substantial equivalence. There is no information about human readers' performance with and without AI assistance.

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

A standalone performance study of the algorithm's diagnostic accuracy (e.g., identifying specific EEG abnormalities or conditions) is not explicitly described in the provided text. The "Performance Data" section focuses on software validation against design specifications and claims of substantial equivalence based on functionality. While it performs analyses independently, the document does not present data from a study measuring its standalone clinical diagnostic performance against a ground truth.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the software validation, the ground truth appears to be the Software Design Specifications (SDS). The device was tested to ensure it met these specifications.

For the normative database against which individual patient EEGs are compared, the "ground truth" is implied to be a statistically controlled dataset representing "normal" age-regressed EEG patterns. However, the specific method used to establish this "normalcy" (e.g., expert review of all samples, lack of clinical symptoms/diagnoses) is not detailed. It's not a ground truth for a diagnostic task for the iSyncBrain-C itself, but rather a reference.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the iSyncBrain-C algorithm. This suggests that if machine learning is involved in the analytical processes (beyond statistical comparisons to a normative database), the training data details are not provided. The reference to the "normative database" with 1289 (eyes closed) and 1288 (eyes open) samples is a reference database for comparison, not necessarily a training set for the algorithm's core functions.

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

Since a "training set" is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided.

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The iSyncWave is intended for prescription use in a health care facility to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.

iSyncWave™ is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWave™ measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWave™ App. The data is displayed and recorded via the iSyncWave™ App. iSyncWave™ uses dry electrode technology, which doesn't require a preparation process(e.g., applyinq conductive gel), to obtain high quality EEG signals. Before measuring the EEG, you can check the impedance of each electrode under the impedance check screen in the iSyncWave™ app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution. This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWave™ app.

The iSyncWave is an electroencephalograph (EEG) device intended for prescription use in healthcare facilities to acquire, transmit, display, and store EEG and optional auxiliary signals for adults and children (excluding newborns). The primary study proving the device meets its acceptance criteria is a non-clinical bench test comparison to a predicate device, the WR19 System by Zeto Inc. (K172735).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the iSyncWave are primarily demonstrated through a substantial equivalence comparison to its predicate device, the WR19 System (K172735), and compliance with various international standards for medical electrical equipment. The "reported device performance" entries below reflect how the iSyncWave either matches or is deemed equivalent to the predicate, or meets the technical requirements of the standards.

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

The provided document does not specify a separate "test set" in terms of patient data for evaluating diagnostic performance. The studies cited are primarily non-clinical bench tests focused on verifying compliance with various electrical, safety, software, and biocompatibility standards. The data provenance is related to these engineering and safety tests, not patient data from a specific country or whether it was retrospective/prospective.

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

This information is not provided in the document. The regulatory submission focuses on engineering and safety compliance, and substantial equivalence to a predicate device, rather than a clinical performance study requiring expert ground truth assessment for a diagnostic task.

4. Adjudication Method for the Test Set

This information is not applicable as there is no described clinical test set involving patient data and multiple expert readings for 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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being performed or any assessment of human reader improvement with or without AI assistance. The device functions as an EEG acquisition and display system; the document does not describe AI-driven interpretation or assistance in EEG reading for diagnostic purposes.

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

There is no mention of a standalone algorithm performance study. The device is described as an EEG acquisition and display system, not one that performs automated diagnostic interpretation.

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

The ground truth used for the non-clinical bench tests would be the established technical specifications and performance limits defined by the international standards (e.g., IEC 60601-1 for basic safety, IEC 80601-2-26 for electroencephalographs performance), and the technical characteristics of the predicate device. This is not a clinical "ground truth" derived from patient outcomes or expert reads.

8. The Sample Size for the Training Set

This information is not provided as the submission describes a medical device for acquiring and displaying physiological signals (EEG), not a machine learning or AI algorithm that requires a training set of data.

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

This information is not applicable as there is no described training set for a machine learning or AI algorithm.

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The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget's disease.

The IDS-iSYS Ostase® BAP assay consists of one reagent cartridge and one set of calibrators (CAL A & CAL B).

The reagent cartridge contains multiple reagents:

• MPM1 (Magnetic particles coated with streptavidin in a phosphate buffer with sodium azide as preservative);
• Ab-BIOT Monoclonal anti-BAP labelled with biotin, in buffer containing horse serum with bovine and mouse proteins and sodium azide as a preservative (

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "IDS-iSYS Ostase® BAP." This document is primarily concerned with demonstrating the substantial equivalence of the new device to a predicate device, rather than focusing on the acceptance criteria and study proving performance for an AI/ML-based medical device.

Therefore, the requested information regarding AI/ML-specific acceptance criteria and validation studies (like sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document because it describes an in vitro diagnostic (IVD) test for quantitative determination of bone-specific alkaline phosphatase, not an AI/ML-driven imaging or diagnostic algorithm.

However, I can extract the relevant performance characteristics that are analogous to "acceptance criteria" for this type of IVD device and the study data proving it meets those.

Device Description

The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget's disease.

1. Table of Acceptance Criteria (Performance Characteristics) and Reported Device Performance

For an in vitro diagnostic device, "acceptance criteria" are typically defined by various analytical performance characteristics that demonstrate the device's accuracy, precision, and reliability for its intended use. While explicit acceptance ranges are not always presented as a separate "criteria" table in a 510(k), the studies conducted implicitly aim to demonstrate performance within acceptable ranges for IVDs. The comparison to the predicate device and adherence to CLSI guidelines are key for demonstrating substantial equivalence.

Here's a table summarizing the analytical performance characteristics and the reported device performance, which serve as the "proof" that the device meets the implied acceptance criteria for an IVD:

• Predicate Within Run: 2.6% to 6.5% (7.4 to 79.5 μg/L)
• Predicate Between Run: 2% to 6.4% (8.4 to 81.1 µg/L) | Repeatability (Within Run):
  From 1.7% to 2.8% in the concentration range 6.2 to 59.8 µg/L (N=80 data points for each sample, for one representative lot).
  From 1.7% to 2.8% for combined 3 lots across samples 1-10 (6.2-59.8 μg/L).
  Within Laboratory (Between Run/Total Precision):
  From 3.0% to 7.6% in the concentration range 6.2 to 59.8 µg/L (N=80 data points for each sample, for one representative lot).
  From 3.0% to 7.2% for combined 3 lots across samples 1-10 (6.2-59.8 μg/L).
  Overall, shows robust precision comparable or improved relative to the predicate. |
  | Linearity / Reportable Range | The assay should demonstrate linearity across its claimed measuring range. Expected a high correlation coefficient (R²) close to 1.0.
• Predicate Range: 0.7 – 90 µg/L. | Linear Range: 0.9 to 78.5 µg/L.
  Measuring (Reportable) Range: 3 to 70 µg/L.
  Regression: Observed = 0.98 x (Expected) - 0.9 ng/mL.
  Regression coefficient R²: 1.00.
  The high R² demonstrates excellent linearity across the range. |
  | Detection Limits (LoB, LoD, LoQ) | Low values for LoB (Limit of Blank), LoD (Limit of Detection), and LoQ (Limit of Quantitation) are desirable to demonstrate the ability to detect very low concentrations of the analyte.
• Predicate: LoD 0.7 µg/L. Other values N/A. | LoB (Limit of Blank): 0.3 µg/L
  LoD (Limit of Detection): 0.4 µg/L
  LoQ (Limit of Quantitation): 0.5 µg/L
  Demonstrates improved or comparable sensitivity to the predicate. |
  | Analytical Specificity (Interference) | Bias due to common interfering substances should be non-significant, typically defined as

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The IDS-iSYS Intact PTH+ assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

The IDS-iSYS Intact PTH" assay is based on chemiluminescence technology. 100 uL of patient sample is incubated with a biotinylated polyclonal anti-PTH (39-84) antibody and an acridinium labelled PTH (13-34) antibody. Streptavidin labelled magnetic particles are added prior to a second incubation step. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of Intact PTH in the original sample.

IDS-iSYS Intact PTH reagent kit consists of one (1) Immunoassay Cartridge, two (2) vials each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.

IDS-iSYS Intact PTHN Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. The IDS-iSYS Intact PTHN Cartridge contains the following ready to use reagents:

• · Magnetic particles coated with streptavidin in a phosphate buffer containing sodium azide as preservative (1% (w/w%).
• · Calibrator B: Two vials of lyophilized porcine serum matrix buffer containing high level PTH and sodium azide as preservative >1% (w/w%).

The submission is due to a new source of antibody for the assay.

This document describes the performance characteristics of the IDS-iSYS Intact PTHN assay, an in vitro diagnostic device for quantitative determination of intact PTH.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets but are implicitly defined by the reported performance and the comparison to the predicate device. The information below summarizes the performance characteristics provided, which in a regulatory context, demonstrate the device meets its intended use and is substantially equivalent to the predicate.

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The IDS iSYS 25 VilD assay is intended for the quantitative determination of total 25-hydroxyvitamin D (125(OH)D) in hyman serum or plasma on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

The IDS-iSYS 25 VitD Control Set is used for quality control of the IDS-iSYS 25 VitD assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS 25 VitDs reagent kit consists of one (1) Immunoassay Cartridge, one (1) vial each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.

IDS-iSYS 25 VitDS Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. IDS-iSYS 25 VitDS Cartridge contains the following ready to use reagents:

• Magnetic particles coated with streptavidin in a phosphate . buffer containing sodium azide.
• . Sodium hydroxide solution.
• . 25(OH)D labelled with an acridinium ester derivative, in buffer containing bovine serum albumin with sodium azide.
• . Anti-25(OH)D sheep polyclonal antibody labelled with an biotin, in buffer containing bovine, sheep and mouse proteins and sodium azide.
• . Assay buffer containing proprietary displacing compounds, methanol and sodium azide.

The IDS-iSYS 25 VitD® Calibrators are included in the reagent kit. The ready to use calibrators contains human serum buffer matrix with two defined concentrations of 25(OH)D and sodium azide as preservative (

The provided document describes the IDS-iSYS 25VitD8 assay, a device for the quantitative determination of total 25-hydroxyvitamin D [25(OH)D] in human serum or plasma. Below is an analysis of its acceptance criteria and the studies performed.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for all performance characteristics in a single, consolidated table. However, it presents performance data for various analytical characteristics, and in some cases, implicitly defines acceptable ranges or desired outcomes for these studies. For instance, in the specificity study, an acceptance criterion of "

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IDS-iSYS 17-OH Progesterone Control Set
The IDS-iSYS 17-OH Progesterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS 17-OH Progesterone on the IDS-iSYS Multi-Discipline Automated System.
Rx Only.

IDS-iSYS 17-OH Progesterone Calibration Verifiers
The IDS-iSYS 17-OH Progesterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS 17-OH Progesterone assay, when performed on the IDS-iSYS Multi Discipline Automated System.
Rx Only.

The IDS-iSYS 17-OH Progesterone Control Set consists of Two sets of three vials, 1.0 mL each in liquid form. Human serum containing 17-OH Progesterone and sodium azide as a preservative (

The provided text describes the acceptance criteria and supporting studies for two in vitro diagnostic devices: the IDS-iSYS 17-OH Progesterone Control Set and the IDS-iSYS 17-OH Progesterone Calibration Verifiers.

1. Table of acceptance criteria and the reported device performance:

• Precision: CV ≤ 10% for low concentration, ≤ 8% for middle and high concentration | - Accelerated stability studies (CLSI guideline EP25-A) support a stability claim of 9 months when stored at 2-8°C.
• Real-time studies are ongoing. (No explicit statement if current readings meet the mean concentration and precision criteria for the 9-month claim, only that it "supports" it). |
  | Open Vial Stability | Percent recoveries within 10% of the reference material concentration. | Data supports the open vial stability claim of 49 days when stored at 2-8°C. (Implies the 10% recovery criterion was met). |
  | On-Board Stability | Compared to a reference material run at time 0. (Specific quantitative criteria not explicitly stated, assumes comparison ensures acceptable performance.) | The on-board stability data supports the claimed on-board stability of 4 hours. (Implies acceptable comparison results). |
  | Calibration Verifiers | | |
  | Value Assignment | Assigned target value defined as the mean of all runs for the IDS-iSYS 17-OH Progesterone assay and analyzer. | Expected values: Cal Ver 0: Undetectable, Cal Ver 1: 2.0 ng/mL, Cal Ver 2: 8.0 ng/mL, Cal Ver 3: 17.0 ng/mL. (Similar to control set, implies these were achieved.) |
  | Closed Vial Stability | - Mean concentration must be within QC ranges (as stated in Certificate of Analysis)
• Precision: CV ≤ 10% for low concentration, ≤ 8% for middle and high concentration | - Accelerated stability studies (CLSI guideline EP25-A) support a stability claim of 9 months when stored at 2-8°C.
• Real-time studies are ongoing. (No explicit statement if current readings meet the mean concentration and precision criteria for the 9-month claim, only that it "supports" it). |
  | On-Board Stability | Compared to a reference material run at time 0. (Specific quantitative criteria not explicitly stated, assumes comparison ensures acceptable performance.) | The on-board stability data supports the claimed on-board stability of 4 hours. (Implies acceptable comparison results). |

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

• IDS-iSYS 17-OH Progesterone Control Set - Value Assignment:
  • Sample Size: A minimum of 21 runs using cartridge batches (number of batches not specified) tested in triplicate on each of three IDS-iSYS Multi Discipline Automated Systems. Control solutions were prepared gravimetrically.
  • Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin. Given it's a device manufacturer's study to establish product characteristics, it's inherently prospective in nature.
• IDS-iSYS 17-OH Progesterone Control Set - Stability (All types):
  • Closed Vial (Real-time): Three lots of controls, tested in pentaplicate (5 replicates) at 2-month intervals for up to a minimum of 15 months. Each tested vial compared to reference material stored at -20°C.
  • Closed Vial (Accelerated): Performed according to CLSI guideline EP25-A.
  • Open Vial: Tested in duplicate at time points stated in the stability protocol (time points not detailed), against unopened vials.
  • On-Board: Three batches of controls, using three IDS-iSYS instruments. Tested at 0, 2, 4, 6, and 8 hours compared to a reference material at time 0.
  • Data Provenance: Same as above, likely prospective internal testing.
• IDS-iSYS 17-OH Progesterone Calibration Verifiers - Value Assignment:
  • Sample Size: Minimum of five runs for each cartridge batch (number of batches not specified) tested in triplicate on each of three IDS-iSYS Multi Discipline Automated Systems. Calibration Verifier solutions were prepared gravimetrically.
  • Data Provenance: Same as above, likely prospective internal testing.
• IDS-iSYS 17-OH Progesterone Calibration Verifiers - Stability (Closed Vial & On-Board):
  • Closed Vial (Real-time): Three lots of calibration verifiers, tested in pentaplicate (5 replicates) at 2-month intervals for up to a minimum of 15 months.
  • Closed Vial (Accelerated): Performed according to CLSI guideline EP25-A.
  • On-Board: Three batches of calibration verifiers, using three IDS-iSYS instruments. Tested at 0, 2, 4, 6, and 8 hours compared to a reference material at time 0.
  • Data Provenance: Same as above, likely prospective internal testing.

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 device is an in vitro diagnostic (IVD) quality control material and calibration verifier for automated systems, not an imaging AI device. The "ground truth" here refers to the reference values established for the control and calibration materials themselves, rather than diagnosis or interpretation by human experts.

• Value Assignment: The "ground truth" (assigned target values) for both the control set and calibration verifiers is established by the mean of all runs from multiple tests on three IDS-iSYS Multi Discipline Automated Systems, using cartridge batches, and confirmed by immunologic analysis using the IDS-iSYS 17-OH Progesterone assay. The solutions themselves are prepared gravimetrically from intermediate stock solutions.
• There are no "experts" in the traditional sense (e.g., radiologists) involved in establishing the ground truth for this type of chemical/immunological assay. The ground truth relies on the precision and accuracy of the analytical methods and the instrument itself.

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

Not applicable. This is not a study involving human interpretation or subjective assessment of data that would require an adjudication method. The device's performance is determined by quantitative measurements and statistical analysis against predefined criteria.

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 an IVD quality control and calibration material, not an AI-powered diagnostic tool for human readers. No MRMC study was conducted or is relevant for this product.

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

Yes, the studies are inherently standalone as they evaluate the performance of the control and calibration materials on the IDS-iSYS Multi-Discipline Automated System. The system/assay performs the measurements without human intervention in the interpretation of the control/verifier results themselves beyond setting up the experiment and analyzing statistical compliance. The performance reported (e.g., mean concentration, CV, percent recovery) is that of the material as measured by the automated system.

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

The ground truth used is based on:

• Gravimetric preparation: For the initial stock solutions and preparation of control/calibration verifier samples.
• Immunologic analysis: Confirmation of concentrations using the IDS-iSYS 17-OH Progesterone assay itself.
• Statistical averaging: The mean of multiple runs on multiple instruments to establish the assigned target values, treated as the reference ground truth for quality control and calibration verification.
• Reference material comparison: For stability studies, comparison to a reference control material stored under optimal conditions (-20°C).

This is a form of analytical ground truth derived from established quantitative laboratory methods and statistical analysis rather than clinical consensus or pathological diagnosis.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set. The values and stability characteristics are determined through direct analytical testing, not model training.

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

Not applicable. As there is no training set for an AI/machine learning model, no ground truth needed to be established for it.

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iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy" Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

iSy Implant System implants are self-tapping, root form, tapered endosseous dental implants made of titanium. The implant has a smooth machined surface in the transgingival portion, and a Promote surface on the endosseous portion. The subject device implants are provided in two lengths (7.3 and 16 mm) and three diameters (3.8, 4.4 and 5.0 mm). The subject device includes four abutment types, gingiva former, temporary abutment, Locator® and Esthomic Abutment. Abutments are compatible with all three diameters (3.8, 4.4 and 5.0 mm). The Esthomic abutment is available with three design angulations (0°, 15°, 20°). iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) premarket notification clearance letter for the iSy® Implant System, which establishes its substantial equivalence to previously marketed devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

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The IDS-iSYS Aldosterone assay (IS-3300) is a device intended for use in clinical laboratories for the quantitative determination of Aldosterone in human EDTA plasma on the IDS-iSYS Multi-Discipline Automated System. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of Aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hyperaldosteronism, edematous states and other conditions of electrolyte balance.

The IDS-iSYS Aldosterone Control Set (IS-3330) is intended for use as assaved quality control samples to monitor the accuracy of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS Aldosterone Calibration Verifiers (IS-3335) are intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS Aldosterone assay is based on chemiluminescence technology. A biotinylated monoclonal anti-Aldosterone antibody is incubated with the sample, after an incubation step an Aldosterone acridinium conjugate is added and after a further incubation step streptavidin coated magnetic particles are added. Following a third incubation step the particles are "captured" using a magnet. After a washing step and addition of trigger reagents, the light emitted by the acridinium label is inversely proportional to the concentration of Aldosterone in the original sample.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the supporting study:

The provided document is a 510(k) Summary for the IDS-iSYS Aldosterone assay, control set, and calibration verifiers. It focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. The document details performance characteristics but does not explicitly state acceptance criteria in a pass/fail format typical of formal acceptance criteria documents. Instead, it reports performance values found during validation studies.

Here's the breakdown of the information you requested, based on what's available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit "acceptance criteria" are not listed in a single table. However, the performance characteristics are reported, and implicitly, these values are considered acceptable for demonstrating substantial equivalence. The table below compiles the reported performance data from the document.

Note: The document does not provide a column for "Acceptance Criteria" as a separate, pre-defined target. The "Reported Device Performance" is the outcome of the studies aiming to demonstrate acceptable performance.

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

• Precision/Reproducibility:

  • Sample Size: Six EDTA plasma samples (9 "samples" were run over 20 days, generating 80 replicates per sample concentration).
  • Data Provenance: Not explicitly stated, but clinical laboratory setting is implied. The phrase "two sites using three analyzers" could suggest multi-center testing, potentially from different locations/countries, but this is not specified. The studies were performed for the manufacturer for regulatory submission.

• Linearity/Assay Reportable Range:

  • Sample Size: One high plasma sample diluted with a low sample to create 11 dilution samples. Run in quadruplicate.
  • Data Provenance: Not specified, likely internal laboratory data for the manufacturer.

• Detection Limit (LoB, LoD, LoQ):

  • Sample Size:
    • LoB (Lot 1): One zero-aldosterone plasma sample, 10 replicates for 5 days (total 50 replicates).
    • LoD/LoQ (Lot 1): 7 samples, 2 replicates per sample, once per day for 8 days.
    • LoB (Lot 2): One zero-aldosterone plasma sample, 6 replicates for 5 days (total 30 replicates).
    • LoD (Lot 2): 8 samples, 2 replicates per sample, once per day for 5 days.
    • LoQ (Lot 2): 7 samples, 2 replicates per sample, once per day for 5 days.
  • Data Provenance: Not specified, likely internal laboratory data for the manufacturer. Two different sites and two different analyzers were used.

• Analytical Specificity (Interference and Cross-Reactivity):

  • Sample Size:
    • Interference: Two base plasma samples ("Low" and "High" Aldosterone concentrations), spiked with various potential interferents. For each interferent, 26 replicates for blank and spiked samples were compared.
    • Cross-reactivity: Stock solutions of various compounds diluted serially to create 7-point standard curves for each substance.
  • Data Provenance: Not specified, likely internal laboratory data for the manufacturer.

• Method Comparison:

  • Sample Size: 161 samples (including 12 altered samples).
  • Data Provenance: Not specified, implied to be clinical or patient samples. Whether these were retrospective or prospective, or their country of origin, is not mentioned.

• Reference Range Study (Expected Values):

  • Sample Size: 228 Caucasian adult samples.
  • Data Provenance: Collected in the US, prospective (samples collected under specific conditions: 7-10 am after overnight fasting, upright/supine positions).

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

This type of information is generally NOT applicable to in vitro diagnostic (IVD) devices like the Aldosterone assay described. For IVD assays, "ground truth" is typically established by:

• Reference methods/predicate devices (e.g., Diasorin Liaison Aldosterone assay for method comparison).
• Gravimetric preparation of standards and calibrators for traceability.
• Defined sample characteristics (e.g., "zero aldosterone plasma," "high plasma sample").

There were no human experts assessing images or making diagnoses that would require adjudication.

4. Adjudication Method for the Test Set

Not applicable, as this is an IVD assay, not a device requiring human interpretation of results in a diagnostic context that would call for adjudication of different interpretations.

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 is an IVD assay for quantitative determination of a biomarker; there are no "human readers" interpreting results in the way an MRMC study would be designed for an imaging AI device.

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

Yes, the studies conducted (Precision, Linearity, LoD/LoQ, Analytical Specificity, Method Comparison) represent the standalone performance of the IDS-iSYS Aldosterone assay system. The device quantifies aldosterone in plasma samples directly, without human interpretation of results being a variable in its core analytical performance.

7. The Type of Ground Truth Used

The ground truth used for various studies includes:

• Reference materials: Aldosterone (≥95% HPLC; A9477Sigma-Aldrich) dissolved in Dioxane, with concentration calculated by UV quantitation using molar extinction coefficient (for calibrators and traceability).
• Predicate device results: The Diasorin Liaison Aldosterone assay (K130321) for method comparison.
• Spiked samples: For linearity, interference, and cross-reactivity studies, known concentrations of analyte or interferents were added to base samples to create "true" concentrations.
• Patient samples: For method comparison and reference range studies, patient samples were used. Their "truth" for method comparison was established by the predicate device. For reference ranges, the "truth" was the measured value distributed among a healthy population.

8. The Sample Size for the Training Set

The document describes performance studies (validation) but does not explicitly mention a "training set" in the context of machine learning. For an IVD assay, the development process involves reagent optimization, calibration curve fitting, etc., which conceptually use data, but this is not typically termed a "training set" like in AI/ML.

However, the "Master curve" and "two-point calibration" system is mentioned. The "logistic parameters of the Master calibration curve" are generated using "data of 20 runs Internal Reference Calibrators" (p.9). This could be considered analogous to a training process for establishing the core measurement algorithm, but it's not a training set for an AI inference model.

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

If we consider the generation of the "Master calibration curve" as a "training" process:

• Ground Truth: The "Internal Reference Calibrators" referenced (p.9) would serve as the ground truth. These calibrators are traceable to gravimetrically prepared Aldosterone standards using high-purity Aldosterone and UV quantitation (p.9).
• Establishment Method: The "new kit calibrator sets are run as 'unknowns' in duplicate in at least 20 assays on one analyser" (p.9). "The data of 20 runs Internal Reference Calibrators are used to generate the logistic parameters of the Master calibration curve by using Prism software package" (p.9).

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The IDS-iSYS CTX-1 (CrossLaps ®) Calibration Verifiers is a device intended for the verification of the IDS-iSYS CTX-I (CrossLaps ®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer

The IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers consists of one set of four vials, 2.5 mL each in liquid form, containing horse serum with

The document is a 510(k) Summary for the IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers, a device intended for the verification of calibration of the IDS-iSYS CTX-I (CrossLaps®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Here's an analysis of the provided information to answer your request:

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

The document does not explicitly state "acceptance criteria" for the device's performance in a table format. Instead, it defines the "Target Range" for each Calibration Verifier level, derived from the mean ± 2 standard deviations during value assignment. This target range implicitly serves as the acceptance criteria for individual measurements when verifying calibration.

Note: The "Reported Device Performance" here is the target mean derived during the value assignment process, which aligns with the center of the acceptance range. The study ensures that the device can consistently achieve these target means and fall within the defined ranges.

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

The document describes the "value assignment" process, which functions as the primary method for establishing the performance characteristics and implicitly, the "test set" for the verifiers.

• Sample Size: "Each lot-specific value assignment was tested in five runs on at least three different IDS-iSYS analyzers in triplicate, for a total of 45 replicates." This refers to 45 individual measurements for each calibrator verifier (Cal. Ver. 0, 1, 2, 3).
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that Immunodiagnostic Systems Ltd is based in the United Kingdom, it's likely the studies were conducted there. The value assignment process described suggests a prospective study design for establishing lot-specific values.

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 to this type of device. The device is a "Quality control material (assayed and unassayed)" for an in vitro diagnostic assay. Its "ground truth" (target values) is established through rigorous analytical testing and standardization against in-house reference standards, not by human expert interpretation of signals or images.

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

Not applicable. As explained in point 3, the ground truth is established through analytical methods, not through expert 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 is not a study involving human readers or AI assistance. The device is a calibration verifier for an automated immunoassay.

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

This refers to the performance of the IDS-iSYS CTX-I assay on the IDS-iSYS Multi-Discipline Automated Analyzer when calibrated and verified using these verifiers. The "value assignment" study described is a standalone performance assessment of the verifiers themselves, demonstrating their ability to consistently produce expected concentration values within a statistically defined range. The objective of the verifiers is to ensure the assay's standalone performance is accurate.

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

The "ground truth" for the calibrator verifiers is their assigned concentration values, which are established through:

• Standardization against in-house reference standards (CTX-I in horse serum).
• Derivation from the mean of multiple replicates across multiple runs and instruments. The target ranges (e.g., 0.12 - 0.16 ng/mL for Cal. Ver. 1) are determined statistically (mean ± 2SD).

8. The sample size for the training set

This concept is not directly applicable to a calibration verifier in the same way it would be for an AI algorithm. The "training" here refers to the process of standardizing the manufacturing of the verifiers and establishing their lot-specific values. The "value assignment" study (45 replicates per verifier level) serves to establish these "ground truth" values and ranges.

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

For each lot, the "ground truth" (target mean values and ranges) was established through:

• Extensive testing: "Each lot-specific value assignment was tested in five runs on at least three different IDS-iSYS analyzers in triplicate," generating a substantial dataset for statistical analysis.
• Statistical analysis: The "assigned target value of each calibrator verifier was defined as the mean of all the runs for each calibrator verifier. The guideline target range is defined as the mean of all runs ± 2SD."
• Standardization: The IDS-iSYS CTX-I assay (for which these verifiers are used) is itself "standardized against in-house reference standards (CTX-I in horse serum)." This implies a chain of traceability to primary or secondary reference materials.

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