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The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 1.00 diopter (D) or less of astigmatism.

Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical disinfection system only.

The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).

The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280mm -315nm), and >70% in the UVA range (316nm - 380nm).

The Oualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is manufactured in a spherical design configuration.

This document is a 510(k) Premarket Notification for a medical device, specifically a soft contact lens. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove a new level of performance or an AI's diagnostic capabilities. Therefore, many of the requested elements for an AI-based diagnostic device evaluation (like MRMC studies, expert consensus for ground truth establishment, training set details) are not relevant or present in this type of submission.

However, I can extract the relevant acceptance criteria and performance data provided for this specific type of device (a contact lens) which are typically focused on non-clinical and clinical safety and basic effectiveness parameters.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for many non-clinical tests are qualitative (e.g., "non-toxic," "no irritation") and are met by complying with relevant ISO standards. For quantitative metrics like Dk, water content, and refractive index, the device's measured values are compared to the predicate's known values to establish substantial equivalence.

2. Sample Size and Data Provenance

• Test Set Sample Size: 75 subjects were enrolled in the clinical study. 50 subjects wore the test lenses (Qualis) and 25 subjects wore the control lenses (Acuvue Vita). 73 of the 75 enrolled subjects completed the study.
• Data Provenance: Not explicitly stated regarding country of origin, but typical for FDA submissions, the clinical study would be conducted in a manner compliant with Good Clinical Practice (GCP) guidelines, often with a global reach or in the US. The study was "open-label, multi-center, randomized concurrent-control." It was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• This submission is for a contact lens, not an AI diagnostic device. Therefore, the concept of "ground truth" derived from expert consensus on diagnostic images is not applicable here. The "ground truth" for the clinical study would refer to the observed clinical outcomes (biomicroscopy findings, symptoms, vision safety measures) as assessed by the participating clinicians. The qualifications of these clinicians are not specified in the summary but would typically be licensed optometrists or ophthalmologists experienced in fitting and evaluating contact lenses.

4. Adjudication Method for the Test Set

• Not applicable in the context of a contact lens clinical trial, which primarily gathers objective and subjective clinical measurements directly, rather than judgments that require adjudication for a "ground truth."

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic imaging devices to assess the impact of AI assistance on human reader performance. This submission is for a contact lens.

6. Standalone (Algorithm only) Performance

• No, standalone performance (i.e., algorithm only without human-in-the-loop performance) was not done. This is not an AI device.

7. Type of Ground Truth Used

• The "ground truth" for the clinical study in this context is based on clinical observations, measurements, and patient-reported symptoms as assessed by Eye Care Professionals during the 91-day follow-up. This includes biomicroscopy findings, assessment of symptoms, and vision safety measures. Non-clinical "ground truth" is based on bench testing and laboratory analyses against established scientific methods and standards (e.g., ISO standards for biocompatibility).

8. Sample Size for the Training Set

• Not applicable. This is not an AI device that requires a training set in the machine learning sense. The "training" for such a device is its manufacturing process and quality control.

9. How Ground Truth for the Training Set Was Established

• Not applicable as this is not an AI device.

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The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

The Qualisys Clinical System (QCS) is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

In order to achieve this, the QCS utilizes data captured from image sensors (motion capture cameras) to triangulate the 3D-position of one or several reflective markers attached to the patient. This is done by two or more cameras calibrated to provide overlapping field of views from multiple angles. QCS produce data with 3 degrees of freedom for each marker, i.e. positional information. Rotational information (e.g. of a limb) may be retrieved from the relative orientation of three or more markers.

The tracking cameras may record images and identify the position of the markers with a high spatial and temporal resolution to generate high performance motion capture of the markers.

The markers are usually attached directly to the skin. The markers are specially designed to reflect the IR-light flashed from the tracking cameras.

In addition, subsystems may be added to record data in synchronization with the tracking cameras to facilitate the analysis, or for pure documentation purposes. The additional subsystems may be any one of, or a combination of: 1) Ordinary video, 2) EMG data and 3) Force plate data.

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

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., accuracy, precision) that the Qualisys Clinical System (QCS) must meet for regulatory purposes. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device (SMART-D [K131660]) through technical and functional comparisons, along with performance data from non-clinical tests.

The reported device performance is described generally through the successful completion of software and hardware tests, and demonstration of metrological accuracy and reliability.

Table 1: Implicit Acceptance Criteria and Reported Device Performance

Study Information

The document describes non-clinical tests rather than a formal clinical study with human subjects for novel device performance claims. The primary "study" is a comparative analysis demonstrating substantial equivalence to a predicate device.

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

• Test Set Sample Size: Not explicitly stated as a number of patients/cases. The "test set" primarily refers to software and hardware testing.
• Data Provenance: Not specified for any dataset related to the performance data. It is focused on demonstrating substantial equivalence through technical and functional comparisons and non-clinical 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)

• Number of Experts: Not applicable. The ground truth for the non-clinical tests and metrological accuracy would be established by engineering standards, calibrated instruments, and scientific literature rather than expert human interpretation of medical data.
• Qualifications of Experts: N/A.

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

• Adjudication Method: Not applicable. This concept typically applies to studies where human readers are interpreting a test set and their discrepancies need to be resolved. The document focuses on technical verification and validation against specified requirements and predicate device characteristics.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a motion capture system, not an AI-assisted diagnostic tool that aids human readers in interpretation.

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

• Standalone Performance: Yes, the described "Non-clinical tests performed on the QCS include software and hardware tests" and "Metrological accuracy and reliability of the raw output of the system (three-dimensional position of reflective markers) has been verified and validated" indicate standalone performance evaluations of the system's components and overall output. The system quantifies and displays movement patterns.

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

• Type of Ground Truth:
  • For metrological accuracy, the ground truth is established by physical standards (e.g., "dimensions of the calibration devices supplied with the system are traceable to a national meter reference").
  • For software and hardware functioning, the ground truth is against predefined technical specifications and requirements.
  • For the relevance of gait assessments, it refers to a "Clinical Evaluation report," implying a review against established clinical understanding and literature on gait analysis.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. The document describes a medical device for motion capture, not a machine learning or artificial intelligence system that requires a "training set" in the conventional sense.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine learning model.

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The Qualis is intended for preparing motile human sperm for use in the treatment of infertile couples by intracytoplasmic sperm insertion (ICSI) fertilization.

The Qualis is a sterile, disposable, plastic laboratory dish that contains four chambers connected through micro-channels and is designed to be used in conjunction with commercially available culture medium to selectively separate motile spermatozoa (sperm) for non-motile spermatozoa and cellular debris.

The provided text describes the "Qualis" device, a sterile, disposable, plastic laboratory dish designed to separate motile spermatozoa from non-motile spermatozoa and cellular debris for use in intracytoplasmic sperm insertion (ICSI) fertilization. The document evaluates the device's substantial equivalence to a predicate device, the "Research Instruments Migration Sedimentation Chamber."

The acceptance criteria are not explicitly listed in a table format within the provided text. However, the functional and safety testing paragraph and the substantial equivalence discussion highlight key performance and safety aspects that were evaluated.

Here's an attempt to parse the acceptance criteria and performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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 states: "To verify that device design met its functional performance and safety requirements, representative sample of the device underwent testing including human sperm survival assay (HSSA) and human sperm motility/morphology."

• Sample Size: The exact sample size used for the test set (i.e., the number of Qualis devices tested, or the number of sperm samples used for testing each device) is not specified in the provided text. It mentions "representative sample of the device."
• Data Provenance: The provenance of the data (country of origin, retrospective or prospective) is not specified.

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)

The document does not mention the use of experts to establish ground truth for the test set in the context of the device's functional or safety testing. The evaluation primarily relies on laboratory assays (HSSA, motility/morphology) which typically have objective measures. The ground truth for these assays would generally be the predetermined laboratory standards or comparison to controls, rather than expert consensus on interpretation of complex data.

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

The document does not mention any adjudication method, as the tests described (HSSA, motility/morphology) are typically objective laboratory measurements rather than subjective assessments requiring multiple reviewers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the Qualis device is for sperm preparation in assisted reproduction, not an AI-assisted diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

This section is not applicable as the Qualis device is a physical laboratory instrument for sperm processing, not an algorithm or software. It is a standalone device in the sense that its functional performance and safety were evaluated independently.

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

The ground truth for the functional and safety testing appears to be based on objective laboratory measurements and established biological assays.

• For "functional performance" in sperm separation, the ground truth would likely be the quantitative analysis of enriched motile sperm populations (e.g., count, motility percentage, morphology) compared to established benchmarks or predicate device performance.
• For "safety" (HSSA), the ground truth is the survival and viability of human sperm after exposure to the device, measured against controls and established safety limits for cell viability.

8. The sample size for the training set

This section is not applicable. The Qualis device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of its development and validation.

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

This section is not applicable for the same reason as above (no training set for a physical device).

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The Qualisys PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The Qualisys PSA Immunoassay is further indicated for the serial measurement of PSA as an aid in the prognosis and management of patients with prostate cancer.

The Qualisys PSA Immunoassay is a two-site chemiluminescense assay. 1st incubation: 15 minutes at room temperature. Specimen, control or calibrator [100 µL] and PSA Antibody Solution [100 µL] react to form a sandwich complex. 2nd incubation: 2 minutes at room temperature. Streptavidin-coated paramagnetic particle solution [25 µL] is added to the reaction mixture. After the 2-minute incubation, the sandwich complex is bound to the solid-phase via the interaction of biotin and streptavidin. Removal of unbound materials: The paramagnetic particles are washed four times with wash buffer [1.0 mL/wash] to remove unbound materials. Re-suspension of paramagnetic particles: Deionized (DI) water [25 uL] is added to re-suspend the washed paramagnetic particles. Substrate addition and detection: Chemiluminogenic substrate [50 uL] is added to the solid-phase bound complex and results in "glow" chemiluminescence, which is measured using a luminometer (photomultiplier). Emission of light is quantified for 1 second, and is expressed in relative light units (RLU). The amount of bound labeled antibody in RLU's is directly proportional to the concentration of PSA in the sample. Results are determined using cubic spline immunoassay curve fitting.

The Qualisys PSA Immunoassay is a device designed for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum, specifically for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a go/no-go fashion. Instead, it presents performance characteristics for the Qualisys PSA Immunoassay and compares them to the predicate device, Abbott IMx® PSA. For the purpose of this response, the performance characteristics of the Qualisys PSA are considered the reported device performance, and the comparison to the predicate implies that similar or improved performance is an acceptance benchmark for substantial equivalence.

Note: The specific PSA concentrations for the Qualisys precision targets differ from the predicate, making direct percentage comparison difficult without further context on the clinical relevance of those specific concentrations. However, the percentages themselves are in a similar range, indicating comparable precision.

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

• Method Comparison Study: The test set for the method comparison study consisted of n = 108 samples.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission, it's highly likely to be prospective study data collected to demonstrate device performance.

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

This device is an immunoassay for quantitative determination of PSA levels, not an imaging or interpretive device that requires expert review for ground truth. The "ground truth" for the test set in this context refers to the actual PSA concentrations in the samples, which were implicitly determined by the predicate device (Abbott IMx® PSA) that the Qualisys device is being compared against, or by a reference method. The document does not mention experts establishing ground truth in the way described for interpretive medical devices.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative immunoassay, there would be no subjective interpretation requiring an adjudication method. The method comparison involves comparing numerical results obtained by the test device against the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for interpretive tasks where multiple readers evaluate cases. This device is a quantitative immunoassay and does not involve human "readers" in the performance assessment in the context of an MRMC study.

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

Yes, the performance characteristics listed (precision, sensitivity, recovery, method comparison, interference, hook effect) are all standalone performance metrics of the Qualisys PSA Immunoassay device itself, independent of human interpretation or intervention beyond performing the assay procedure.

7. The Type of Ground Truth Used

The ground truth for the method comparison study was established by the Abbott IMx® PSA device. The predicate device's measurements served as the reference against which the Qualisys PSA Immunoassay's measurements were compared (y = 0.9955x + 0.5185, r² = 0.9747). For other performance characteristics like precision, sensitivity, and recovery, the "ground truth" refers to the known concentrations of analytes in control samples or spiked samples.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" or sample sizes used for training. Immunoassays are typically developed and validated rather than "trained" in the machine learning sense. The performance characteristics described are related to the analytical validation of the device.

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

Not applicable. As noted above, immunoassays typically undergo analytical validation rather than machine learning training. Therefore, a "training set" and its associated ground truth establishment method are not relevant in this context.

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