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MAIA is intended for taking digital images of a human retina without the use of a mydriatic agent.

MAIA is intended for taking digital images of a human retina without the use of a mydriatic agent.

The device works with a dedicated software application, operates as a standalone unit, integrates a multitouch display, a push-button and is provided with an external power supply.

MAIA operates in non-mydriatic conditions, i.e. without the need of pharmacological dilation and is intended for prescription use only

The key functional elements of the device are:

• the device base,
• the device optical head,
• the headrest,
• the chinrest,
• the multi-touch display,
• the embedded software,
• patient push-button,
• the power supply and its power cable.

The device acquires confocal retinal images illuminating the retina of the patient's eye, with visible light for imaging purposes and with infrared light for imaging purposes, focusing and retinal tracking.

A specific feature of MAIA is the pupil tracking. The patient's pupils are illuminated and viewed by a different optical system; two cameras track the pupil's movements and allow for automatic alignment of the optical head with the eye position.

From an imaging point of view, an important characteristic of MAIA is that it is a confocal instrument: this means that the illumination of the retina is focused on the same plane of the acquisition (same focus). Compared to traditional imaging, where the entire specimen is flooded evenly in light, a confocal illumination system is able to focus the illuminating light on the same focus plane (conjugate plane) of the acquisition optics.

Another important characteristic of MAIA is the use of white light to illuminate the retina.

The result of the combination of confocal imaging and white light obtained in MAIA is the acquisition of sharp, detailed, naturally colored retinal images.

This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review.

For this application, the product has also functions that are not subject to FDA premarket review; FDA assesses those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.

The "other function" of the device is the automatic perimetry (Product Code HPT, 510(K) Exempt), that allows the measurement of retinal threshold sensitivity and the analysis of fixation.

This function consists in projecting light stimuli at different intensities together with a uniform light background; the device records the pressures of the pushbutton by the tested patient when he detects such stimuli, as in Standard Automated Perimetry test.

With its retinal tracking, for all the duration of the exam, MAIA acquires infrared images of the retina and detects its movement, to correct the position for the stimuli, reducing the positioning error that might occur if the patient has poor fixation stability.

The provided text describes the Centervue Spa MAIA (AHMACME001) device, which is an ophthalmoscope intended for taking digital images of a human retina. The 510(k) submission (K243504) seeks to demonstrate substantial equivalence to the predicate device COMPASS (K150320).

However, the provided document explicitly states: "No clinical tests were needed." and "Based on the non-clinical tests (i.e. bench tests), MAIA is safe and performs as intended when used according to its indications for use and in accordance with its labeling. It performs as well as the legally marketed predicate device COMPASS (K150320)." This means that the submission does not contain a study proving the device meets acceptance criteria related to a clinical study involving human performance (e.g., MRMC studies, standalone algorithm performance, expert ground truth).

The acceptance criteria described pertain to design and manufacturing equivalence, and bench testing, rather than clinical performance for a diagnostic device. Since no clinical study was conducted or provided in this submission, it is impossible to populate most of the requested fields regarding performance, sample sizes, expert ground truth, adjudication, or MRMC studies.

Here's how to address the request based only on the provided information, acknowledging the absence of a clinical study:

Acceptance Criteria and Device Performance (Based on Non-Clinical Tests)

Since no clinical studies were performed to establish performance metrics against human-defined acceptance criteria (e.g., sensitivity, specificity, accuracy), the "acceptance criteria" here refer to the successful completion of various engineering and safety tests demonstrating equivalence to the predicate device.

Study Details (None for Clinical Performance)

1. Sample size used for the test set and the data provenance: Not applicable. No clinical test set. The submission relies on "non-clinical tests (i.e. bench tests)" and equivalence to the predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth for performance evaluation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No MRMC study was performed. The device is for "taking digital images," not providing AI assistance for diagnosis.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for performance metrics like sensitivity/specificity for a diagnostic outcome. The device's primary function described is image acquisition, a standalone function that was validated via bench testing and comparison to the predicate's technology.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The ground truth for the "technical performance" and "safety" of the device (such as image resolution, field of view, and electrical safety) would be established by engineering specifications, calibration standards, and regulatory safety standards.
7. The sample size for the training set: Not applicable. No machine learning training set mentioned or implied for a diagnostic algorithm. The device, an ophthalmoscope, acquires images. While it has components like pupil tracking and automatic alignment, these are presented as inherent functions validated through engineering tests, not trained AI models.
8. How the ground truth for the training set was established: Not applicable. No training set for a diagnostic algorithm.

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The Centervue MAIA is intended for:
• measuring macular sensitivity,
• measuring fixation stability and the locus of fixation,
• providing infrared retinal imaging, and
• aiding visual rehabilitation.
It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

A previous version of the CenterVue MAIA, a device for macular integrity assessment, has been cleared by FDA under K133758 on 23 April 2014. The present submission relates to a revised version of the MAIA device in which the only difference between the subject device and the MAIA device cleared under K133758 is in the software, where a new function called "Fixation Training" (FT) has been introduced to aid visual rehabilitation of patients with unstable fixation. The FT is independent from the functions available in the device cleared under K133758 and it does not interfere or modify the original functions in any way. No other design changes are being introduced by this revision to the MAIA device.
The FT is intended for visual rehabilitation, to help Vision Rehabilitation Specialists train patients with unstable fixation to improve their fixation stability.
A FT session consists of asking the patient to move his/her gaze according to the trainer's instructions and to an audible signal, so to attempt fixation of the internal visual target using a specific retinal area, which is identified by the trainer ahead of the training session. The center of such area is called Fixation Training Target (FTT).
During the FT session, the MAIA retinal tracker continuously determines the position of the fixation point and provides an audible feedback to the patient in the form of pulses of a certain repetition frequency. The number of pulses / sec (i.e. the repetition frequency) is inversely proportional to the distance between the patient's fixation point at that time and the FTT; when such distance falls below one degree, the sound becomes continuous. Optionally, before starting the FT session, operators are able to replace the continuous sound with an MP3 audio file.
The MAIA device interacts with the patient by directing illumination into the patient's eye. The chin-rest and head-rest are the only parts of the device that contact the patient. The chin-rest includes a patient proximity sensor and is motorized for height adjustment. The biocompatibility of the patient-contacting materials, which are the same as used in the previous version of the subject device (K133758) has been established.
The MAIA device operates as a 'stand-alone' device and does not need to interface with other medical devices.

Here's an analysis of the provided text regarding the MAIA device, focusing on acceptance criteria and study details:

The document is a 510(k) premarket notification for the CenterVue MAIA device, which is an ophthalmoscope and perimeter. The submission is for a revised version of a previously cleared device (K133758), with the only change being the introduction of a new "Fixation Training" (FT) software function.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results for the new Fixation Training (FT) software function. Instead, it relies on demonstrating that the new software does not alter the safety or effectiveness of the previously cleared device and meets relevant software and risk management standards.

However, the comparison table (Table 1) provides performance specifications for various features of the MAIA device and its predicates. While not "acceptance criteria" in the sense of a numerical pass/fail for the specific new feature, these are the performance characteristics being maintained or compared.

Here's a table based on the provided predicate comparison, focusing on relevant aspects mentioned:

The crucial "study" for the new FT function is its compliance with software development and risk management standards, rather than a clinical performance study with numerical criteria. The document states: "the Fixation Training software meets the requirements of: ISO 62304: 2006, ISO 14971: 2007." This is the primary demonstration of its acceptability.

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

The document does not describe a specific clinical test set with a sample size for the new Fixation Training (FT) software. The submission focuses on the software's compliance with standards and its technological similarity to a feature in a secondary predicate device (Nidek MP1).

The core of the submission is that the FT function is independent, does not interfere with existing functions, and no other design changes were made. Therefore, the detailed studies for the underlying hardware and existing functions (macular sensitivity, fixation stability measurement, retinal imaging) from the K133758 clearance are implicitly reused.

There is no mention of country of origin for new data or whether any hidden data was retrospective or prospective, as no new clinical data is presented for the FT feature.

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

Not Applicable. Since no new clinical test set is described for the FT function, there is no mention of experts establishing a ground truth for such a set. The acceptance of the FT function hinges on its compliance with international software and risk management standards and its functionality being similar to an existing predicate device.

4. Adjudication Method for the Test Set

Not Applicable. No new clinical test set requiring adjudication is described for the FT function.

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

No. The document does not describe an MRMC comparative effectiveness study for the new Fixation Training (FT) software. The submission is centered on substantial equivalence to predicate devices and software standard compliance, not on demonstrating improved human reader performance with or without AI assistance. The FT function itself is for patient rehabilitation, not for aiding human readers in diagnosis.

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

The Fixation Training (FT) is a software feature that provides real-time feedback to the patient based on fixation point tracking. While the tracking itself is an algorithm, the FT functionality is described with the patient in the loop, acting on the audible feedback. The document states: "the MAIA retinal tracker continuously determines the position of the fixation point and provides an audible feedback to the patient." This is an algorithm-driven feature intended for use with a human (patient) in the loop (for visual rehabilitation). It is not a standalone diagnostic algorithm for interpretation by an expert.

7. The Type of Ground Truth Used

For the new Fixation Training (FT) software:

• Software Design/Functionality: The "ground truth" for accepting the FT feature is its compliance with ISO 62304: 2006 (Medical device software – Software life cycle processes) and ISO 14971: 2007 (Medical devices – Application of risk management to medical devices). This represents a ground truth that the software is developed safely and effectively according to recognized standards.
• Functional Equivalence: The comparison to the Nidek MP1 (PD2) for the visual rehabilitation/fixation training aspects also acts as a form of "ground truth" for functional equivalence, showing that similar technology is already marketed and cleared.

For the core device functions (macular sensitivity, fixation stability measurement, retinal imaging), the ground truth for their original clearance (K133758) would have been established through clinical data, expert consensus, and comparison to other cleared devices, but these details are not provided in this document as it's a submission for an updated feature, not the initial clearance.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. The document does not describe any machine learning or AI algorithm that would require a "training set" in the conventional sense for the new Fixation Training (FT) feature. The FT function appears to be based on deterministic algorithms for tracking and feedback, rather than a learned model.

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

Not Applicable / Not Provided. As no training set is described, there's no mention of how its ground truth was established.

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The Macular Integrity Assessment (MAIA™) is indicated for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

The MAIA™ is a confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection to obtain perimetric measurements, using "fundus perimetry" (also "microperimetry"). MAIA™ integrates in one device an automated perimeter and an ophthalmoscope, providing: - images of the central retina over a field of view of 36° x 36°, acquired under infrared . illumination; - recordings of eye movements obtained by "tracking" retinal details in the live retinal images and . providing a quantitative analysis of fixation characteristics; - measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in . the macula, obtained by recording a patient's subjective response (see / don't see) to a light stimulus projected at a certain location over the retina; - comparison of measured threshold sensitivity with a reference database obtained from normal . subjects, indicating whether measured thresholds are above or below certain percentiles. MAIA 100 works with no pupil dilation (non-mydriatic). MAIA™ integrates a computer for control and data processing and a touch-screen display and it is provided with a power cord and a push-button. MAIA™ works with a dedicated software application running on a custom Linux O.S.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MAIA™ device are not explicitly stated in terms of specific performance thresholds (e.g., "accuracy must be >X%"). Instead, the study focuses on demonstrating the precision (repeatability and reproducibility) of the device's measurements for macular sensitivity. The reported device performance is presented as standard deviations (SD) for both overall mean thresholds and individual grid point thresholds.

• estimate of the standard deviation among measurements taken on the same operator and device in the same testing session with repositioning.
  ** estimate of the standard deviation among measurements taken on the same subject using different operators and devices, including repeatability.

The study's conclusion states that "all testing deemed necessary was conducted on the MAIA™ to ensure that the device is safe and effective for its intended use," implying that these precision results met the internal acceptance benchmarks for demonstrating substantial equivalence.

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

The "test set" in this context refers to the subjects used in the precision study.

• Sample Size:
  • Normal Subjects: 12 subjects (each tested on one eye only).
  • Pathology Subjects: 12 subjects (each tested on one eye only).
  • Each subject/eye was tested 3 times within a session (3 repeated measures).
• Data Provenance: The subjects were enrolled at two different clinical sites. The document does not specify the country of origin of these clinical sites, but the company is based in Italy. The study appears to be prospective, as subjects were enrolled for the purpose of this precision study.

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

The document does not describe the establishment of ground truth for the test set (the precision study participants) in terms of expert consensus for specific macular sensitivity measurements. Instead, for the pathology group, the "diagnosis of retinal pathology was made by a complete eye examination by an ophthalmologist, including dilated funduscopic examination and pertinent history." The number and specific qualifications (e.g., years of experience) of these ophthalmologists are not specified.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The study focuses on the device's precision in measuring macular sensitivity, rather than on a diagnostic performance where multiple expert opinions would need to be adjudicated.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done. The document does not mention human readers or AI assistance in the context of the MAIA™ device's operation or evaluation in this submission. The device itself is an automated perimeter and ophthalmoscope.

6. Standalone (Algorithm Only) Performance

The device itself is a standalone algorithm-based system for measuring macular sensitivity and fixation. The precision study evaluates the performance of this system independently. There is no "human-in-the-loop" component described that would alter or assist the device's primary measurements of macular sensitivity and fixation.

7. Type of Ground Truth Used

• For the Precision Study (Test Set):
  • For normal subjects, the implication is that they had no known retinal pathology.
  • For pathology subjects, the ground truth for their pathological status was established by "a complete eye examination by an ophthalmologist, including dilated funduscopic examination and pertinent history." The specific values of macular sensitivity measured by the MAIA™ are the output being evaluated for precision, not compared against an external "ground truth" measurement for sensitivity.
• For the Reference Database (Training Set - described in section 9): The ground truth for the reference database was established by measuring threshold sensitivity in subjects deemed "normal subjects" (see point 9).

8. Sample Size for the Training Set

The document mentions a "reference database" that serves as the equivalent of a training or reference set for the device's normative comparison.

• Sample Size: 494 eyes of 270 normal subjects.

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

The "ground truth" for the reference database (training set) was established by measuring threshold sensitivity data from:

• "Normal subjects": These subjects were enrolled at 4 different clinical sites.
• Age Range: 21-86 years (mean 43, std. dev. 15).
• Recruitment: Among the clinics' personnel and relatives of the clinics' regular patients.

The implication is that these subjects were screened and determined to be without ocular pathology affecting macular sensitivity, thus providing a "normal" baseline for comparison. The specific criteria for deeming a subject "normal" (e.g., visual acuity, fundus examination results) are not detailed beyond "normal subjects."

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The Biodata Testosterone Maia Kit is a radioimmunoassay for the quantitative determination of testosterone in human serum or plasma. The device is intended to be used for the diagnosis of elevated or depressed levels of testosterone. It is FOR IN VITRO DIAGNOSTIC USE ONLY.

Neoplasms of the testes and adrenal cortex and hyperthyroidism may result in elevated levels of testosterone in the male. Elevated testosterone levels are observed in females with endometrial carcinoma, hirsutism, neoplasms of the ovaries, and Cushing syndrome. Patients with hypogonadism of pituitary origin, anorchia, gonadel dysgenesis, Klinefelter syndrome, and pseudohermaphroditism have decreased testosterone levels.

The Biodata Testosterone Maia kit is based on the competitive binding principles of radioimmunoassay. Testosterone (unlabeled antigen) in samples, standards, or controls competes with testosterone labeled with radioactive 1251 ("testosterone - 1251") (labeled antigen) for a limited number of testosterone antibody sites. The amount of testosterone - 1251 bound by the antibody is inversely proportional to the amount of testosterone present in the sample, standard, or control. Testosterone Maia Separation Reagent (an antibody covalently bound to a magnetic particle capable of binding the testosterone antibody) is added to the reaction mixture to facilitate the separation of the bound and free fractions of labeled testosterone. The bound fraction of each standard, sample and control is sedimented in a magnetic separator. Each bound fraction is then counted in a gamma counter calibrated to detect 125].

The concentration of testosterone in the samples can be determined by comparing the relative percent binding of the standards with known concentrates of testosterone on the standard curve. The testosterone concentration in the sample is then compared to the reference range of testosterone concentrations established by each laboratory or the expected volumes listed in the package insert.

The provided text describes several studies related to the performance of the Biodata Testosterone Maia Kit, but it does not explicitly state pre-defined acceptance criteria for each study. Instead, it presents the results and concludes that the performance is "satisfactory," "high degree of precision," "acceptable," "no significant cross-reaction," or "does not significantly affect."

Therefore, I will create a table with the study type, the reported device performance, and then explain the details of each study as they relate to the requested information.

1. Table of Acceptance Criteria and Reported Device Performance

As no explicit "acceptance criteria" are stated in the document, the table will reflect the reported findings/conclusions for each performance study, indicating whether the device met the implied performance standards.

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