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The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.

The intended environments are hospitals, institutions, sleep centers, sleep clinics.

The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.

The XactTrace Single Use Respiratory Effort Belt System subject device applies Respiratory Inductive Plethysmography (RIP) Sensor Belts to support respiratory effort signals used in the diagnosis of sleep disorders or sleep related respiratory disorders. The XactTrace Single Use Respiratory Effort Belt System subject device supports a measure of changes in inductance as a result of changes in abdominal, thorax circumference.

There are two variations of the XactTrace® Single Use Respiratory Effort Belt System:

1. XactTrace® Single Use Cut-to-Fit Respiratory Effort Belt System, and

2. XactTrace® Single Use Pre-Sized Respiratory Effort Belt System.

The XactTrace Single Use Cut-to-Fit Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Locks (belt connectors) with a cable that connects to a recording device. The system supports conversion of changes in inductance to a digital signal that provides both qualitative information of respiratory effort. The Sensor Belt of the XactTrace Single Use Cut-To-Fit Belt variation is cut by the medical professional to appropriate lengths to fit patient abdomen, thorax circumference.

The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Snap Sensors (Sensor Belt connectors) with a cable that connects to a recording device. The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation supports conversion of Sensor Belt changes in inductance to a signal that provides both qualitative and quantitative information of respiratory effort. XactTrace Single Use Pre-Sized Respiratory Effort belts are available in four sizes: Pediatric, Small, Medium and Large.

An optional Inductive Interface Cable (RIP Processor) is available to interface with PSG systems that accept the 1.5mm female touchproof connectors, and do not have internal RIP Sensor Belt technology.

Both variations of XactTrace Respiratory Effort Belts are interfaced with either an optional external Inductive Interface Cable or a RIP technology compatible Embla PSG system amplifier. Compatible Embla amplifiers are identified by keyhole connectors for Sensor Belt input.

Here's an analysis of the acceptance criteria and study detailed in the provided FDA 510(k) summary for the XactTrace Single Use Respiratory Effort Belt System:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of human subjects or clinical data. The performance testing described is primarily bench-level evaluations.

Therefore:

• Sample size: Not applicable in the traditional sense of a clinical test set. The tests involved components and systems.
• Data provenance: Not applicable in the context of country of origin or retrospective/prospective clinical data. The data originates from laboratory/bench testing.

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

Not applicable. The reported performance tests are engineering and bench performance evaluations, not clinical studies requiring expert interpretation of ground truth in patient data.

4. Adjudication Method for the Test Set

Not applicable, as this was not a clinical study involving human judgment that would require an adjudication method.

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 respiratory effort belt system, not an AI or imaging device that would typically be evaluated with MRMC studies or involve human readers in that capacity.

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

Not applicable. The XactTrace system is a sensor that produces electrical signals for physiological recording equipment; it does not include an "algorithm" in the sense of an AI or automated diagnostic tool that would have standalone performance.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering specifications and the performance of the predicate device. For example:

• Dimensional requirements: Standard engineering measurements and specifications.
• Compatibility: Functional verification against established interface standards and predicate device behavior.
• Resistance: Direct electrical measurements against expected values.
• Equivalence of breathing effort signal output: Direct comparison of the electrical signal output from the new device and the predicate device under controlled conditions (e.g., same displacement).
• EMC compliance: Adherence to the IEC 60601-1-2, 4th edition standard.

Essentially, the ground truth is derived from engineering specifications, direct measurements, and comparative performance to the legally marketed predicate device under controlled bench conditions.

8. The Sample Size for the Training Set

Not applicable. The device is a hardware sensor system and does not involve AI or machine learning that would require a "training set."

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

Not applicable, as there is no training set for this device.

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Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA) , which is performed in microwells, at room temperature, and in three thirty minute incubations The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

Here's a breakdown of the acceptance criteria and study details for the SeraQuest HSV Type 2 Specific IgG device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size used for the test set and data provenance:

   • Precision Testing: 6 serum specimens (2 negative, 4 positive) and the SeraQuest Positive and Negative Controls. Each sample/control was assayed in triplicate, on three separate occasions, at three different laboratories (Quest International and two external independent laboratories). This results in a total of 27 data points per sample/control (3 triplicates * 3 occasions * 3 labs).
   • Specificity Testing:
     • HSV 1 IgG: 9 samples
     • CMV IgG: 11 samples
     • VZV EBNA IgG: 14 samples
     • VZV VCA IgG: 17 samples
     • VZV IgG: 21 samples
     • Measles IgG: 19 samples
     • Rubella IgG: 18 samples
     • Toxoplasma IgG: 6 samples
     • Syphilis IgG: 4 samples
     • Human Papilloma Virus: 7 samples
     • Chlamydia trachomitis: 8 samples
     • Neisseria gonorrhea: 7 samples
     • Provenance: Samples positive for various related pathogens/antibodies but negative for Type 2 HSV by another legally marketed device. Human Papilloma Virus, Chlamydia trachomitis, and Neisseria gonorrhea samples were from individual patients with confirmed sexually transmitted infections.
   • Interference Testing: Samples that were negative, weakly positive, and moderately positive for antibodies to Type 2 HSV were tested with and without the addition of elevated levels of specific interfering substances. (No specific number of samples provided for this test).
   • Comparison with Predicate Device:
     • Sexually Active Adults: 164 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from a clinical laboratory in the Southeastern United States.
     • Expectant Mothers: 242 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from clinical laboratories in the Northeastern and Southeastern United States. 82% from first trimester, 8% second, 10% third.
   • CDC Panel: 100 sera (30 HSV-2 IgG positive and 70 HSV-2 IgG negative samples). Provenance: Centers for Disease Control and Prevention (CDC) serum panel.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated for most studies.

   • For the cross-reactivity study, the samples were determined positive for various related pathogens "by other legally marketed devices" and confirmed negative for Type 2 HSV by a legally marketed device. This implies a standard diagnostic process, but no specific human experts or qualifications are mentioned for this initial determination.
   • For the comparative studies with the predicate device (Immunoblot), the ground truth was established by the predicate device itself. While the predicate device is a "legally marketed" test, it doesn't specify human expert interpretation or qualifications.
   • For the CDC Panel, the ground truth is "CDC consensus results" and the panel samples are described as "well characterized," implying established expert consensus or reference methods. No specific number of experts or their qualifications are detailed.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated. The ground truth seems to be established by reference methods or legally marketed devices rather than direct human adjudication of results in most cases. For the CDC panel, it's "CDC consensus results," which implies an agreed-upon truth, but the adjudication method isn't 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:

   • No MRMC comparative effectiveness study involving human readers or AI assistance was conducted or reported for this device. This is an IVD (In Vitro Diagnostic) assay, not an imaging AI device.

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

   • Yes, the performance characteristics (sensitivity, specificity, precision, etc.) of the SeraQuest HSV Type 2 Specific IgG assay were evaluated as a standalone device. Its results are compared to a predicate device (Immunoblot) or a "well characterized serum panel" (CDC panel). There is no "human-in-the-loop" component described for this specific device in the context of its performance evaluation.

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

   • Precision: Internal controls and reference samples.
   • Specificity: Samples characterized by other legally marketed devices (positive for related pathogens, negative for HSV-2) and confirmed sexually transmitted infections.
   • Interference: Artificially spiked samples.
   • Comparison Studies: A "commercial HSV 2 Immunoblot test" (predicate device) was used as the reference standard for both sexually active adults and expectant mothers. This is a type of reference test ground truth.
   • CDC Panel: "CDC consensus results" from a "well characterized serum panel." This implies expert consensus or a gold standard determination for each sample in the panel.

7. The sample size for the training set: Not applicable and not mentioned. This document describes the performance evaluation of a medical device (an ELISA assay), not a machine learning or AI model that requires a "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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The Nox T3 device is intended for ambulatory recording of physiological signals during sleep. The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3 application (Noxturnal). The Nox T3 system is indicated for use in patients greater than 2 years of age.

The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis.

The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home.

The Nox T3 system is used for patients suspected of suffering from Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD).

The Nox T3 is an ambulatory recording system. It includes a recording device, respiratory effort sensors, clip straps, filter tube connector and an USB cable for data download and the Nox T3 application (Noxturnal).

The Nox T3 device is a pocket size battery powered digital recorder that incorporates electronics to record and store up to three nights of physiological parameters. The Nox T3 device is worn on the patient's chest by snapping it to the thoracic respiratory effort sensor belt and securing its position with the clip straps. It has a display for status indication, signal integrity and preliminary results, and buttons for control.

The Nox T3 device records signals from five external sensors and three built-in sensors. The external sensors that can be used with the device are abdominal and thoracic respiratory effort sensors, oximeter (via wireless transmission), and two leads of the following: ECG, EMG, EEG or EOG. The built-in sensors include a pressure transducer allowing either recording of nasal pressure (via nasal cannula) or mask pressure and measuring of snoring, a three dimensional acceleration sensor for measure of patient's position and activity, and a microphone for true audio recording capabilities.

The Nox T3 device includes a class II Bluetooth transmitter/receiver to allow for wireless transmission of data from Nonin´s Model 4100 Patient Oximeter Module.

The Nox T3 application (Noxturnal) is used to configure the device for recording, and downloading, viewing and analyzing of recorded data on a PC.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Nox T3 device:

The document (510(k) summary) describes the Nox T3 as an ambulatory recording system for physiological signals during sleep. The primary goal of the "performance testing summary" is to demonstrate substantial equivalence to predicate devices, rather than establishing specific performance metrics against a predefined acceptance criterion. The key performance claims for this device focus on its ability to record reliable signals and the accuracy of its automated scoring software (Noxturnal) compared to manual scoring.

Here's the breakdown as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the comparisons "do not raise new questions of safety and effectiveness and demonstrate the same effectiveness and safety as that of the predicates." This implies that the 'acceptance criteria' are primarily based on demonstrating equivalence rather than achieving absolute performance thresholds.

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

• Sample Size for Automatic Scoring Comparison: 1057 Embla N7000 recordings.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the data consisted of "Embla N7000 recordings." Embla is a brand associated with sleep diagnostics, and both Medcare Flaga (the predicate's manufacturer) and Nox Medical are based in European countries (Medcare Flaga in the past was associated with Iceland, though it might have had broader presence; Nox Medical is in Iceland). Given the context of a 510(k) submission to the FDA, it's highly probable that the data was collected from clinical settings, likely retrospectively as they were "recordings which had all gone through the process of being manually scored."

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

• Number of Experts: Not explicitly stated as a specific number. The ground truth was established by "Sleep Technicians with RPSGT certification" and "then reviewed by a Physician." This suggests at least one technician and one physician per recording, but doesn't give an aggregate count of unique individuals.
• Qualifications of Experts:
  • Sleep Technicians: "RPSGT certification" (Registered Polysomnographic Technologist).
  • Physician: "reviewed by a Physician." (Specific specialization like a sleep physician is implied but not explicitly stated.)

4. Adjudication Method for the Test Set

• The method described is sequential: "manually scored by Sleep Technicians with RPSGT certification, and then reviewed by a Physician." This implies a form of hierarchical review, where the technician's scoring is the initial pass, followed by a physician's oversight. It is not explicitly stated if there was a consensus process (e.g., 2+1, 3+1) if the physician disagreed with the technician, or if the physician's review constituted the final ground truth.

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

• No, a MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not performed or reported in this summary. The study reported compared the device's standalone automatic scoring (Noxturnal application) against manual scoring by human experts. The study's focus was on the performance of the automated algorithm, not on improving human reader performance.

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

• Yes, a standalone performance evaluation of the algorithm was done. The "Analysis comparison was performed to validate the quality of the automatic scoring performed by the Noxturnal application compared to manual scoring of full PSG data." This directly assesses the algorithm's performance without a human in the loop during the scoring process.

7. The Type of Ground Truth Used

• The ground truth used was expert consensus/manual scoring. Specifically, "manual scoring of full PSG data" performed by "Sleep Technicians with RPSGT certification" and "then reviewed by a Physician."

8. The Sample Size for the Training Set

• The document does not specify a sample size for the training set. It only mentions the "recordings used consisted of 1057 Embla N7000 recordings" for the validation study. It is common for 510(k) summaries to omit details about training data, but its absence here means we cannot ascertain the training set size from this document.

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

• The document does not provide information on how the ground truth for the training set was established. Given the lack of detail on the training set itself, this information is not available in the provided text.

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VIVACAP HR is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Not Found

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental filling material called VIVACAP HR. This document grants market clearance based on substantial equivalence to a predicate device and details the intended use of the product.

Crucially, this document does not contain any information regarding clinical studies, acceptance criteria for device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

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

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