Search Results

The FOCUS Interbody System is intended to be used as a lumbar intervertebral fusion device at one or two adjacent levels from L2 to S1. This system should be limited to skeletally mature patients who have had six months of non-operative care for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. In addition, the FOCUS Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The FOCUS Interbody System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures such as the OrthoCircle Spine Pedicle Screw System.

The FOCUS Interbody System includes interbody fusion devices for lumbar implantation. The FOCUS-T and FOCUS-TO implants are designed as structural columns to provide surgical stabilization of the lumbar spine. Each interbody has a central cavity to be packed with bone graft material and inferior/superior teeth to resist expulsion. Lateral windows provide for radiographic visualization on most implant sizes. The implants are available with and without the XCELLerate surface coating and in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. The implants are supplied sterile.

The provided text describes the 510(k) premarket notification for the "FOCUS Interbody System," a lumbar intervertebral fusion device. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing rather than performance in a study involving human subjects or AI-assisted interpretation of medical images. As such, many of the requested elements for an AI/device study (such as MRMC studies, ground truth establishment for image data, or AI-specific acceptance criteria) are not applicable to this specific device submission.

The "study" in this context refers to the performance data obtained from mechanical testing of the device itself, proving its structural integrity and functional characteristics are substantially equivalent to predicates.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that "The mechanical test results demonstrate that the FOCUS Interbody System performance is substantially equivalent to the predicate devices." Specific numerical thresholds for acceptance criteria and the exact numerical results for the device are not provided in this summary, but are implicitly deemed acceptable by the FDA's clearance.

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

• Sample Size: The document refers to "worst case FOCUS Interbody System implant" undergoing testing. This implies a limited, focused sample size for mechanical testing. The exact number of units tested is not specified but is typical for benchtop mechanical validation rather than clinical study sample sizes.
• Data Provenance: The data is generated from laboratory mechanical testing of the device prototypes. This is not patient data; therefore, concepts like country of origin or retrospective/prospective do not apply.

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

• Not Applicable. For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F2077, ASTM F2267) and the physical properties of the materials and design. There are no "experts" establishing ground truth in the sense of medical image interpretation. Engineers and test technicians perform the testing and interpret results against the standards.

4. Adjudication Method for the Test Set:

• Not Applicable. This is mechanical engineering testing against defined standards, not an observational study requiring adjudication of expert opinions.

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

• No. This device is a physical medical implant. MRMC studies are relevant for devices that assist in diagnostic interpretation (e.g., AI for radiology). This is not such a device.

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

• Not Applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

• Engineering Standards and Material Properties: The "ground truth" for the performance of the FOCUS Interbody System is established by recognized ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices (F2077 for static/dynamic axial compression and F2267 for subsidence), as well as the known properties of the materials used (Ti6Al4V ELI titanium alloy, titanium powder, calcium phosphate).

8. The Sample Size for the Training Set:

• Not Applicable. This device did not involve machine learning or a "training set."

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

• Not Applicable. As there was no training set, this question is irrelevant to this device.

In summary, the provided document details the regulatory clearance of a physical medical device based on its mechanical performance demonstrating substantial equivalence to existing devices, adhering to established engineering standards. It does not involve AI, image analysis, or clinical performance studies with human subjects in the contexts typically associated with the acceptance criteria questions.

Ask a specific question about this device

Focus HD 35 Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.

Focus HD 35 Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 35cm×43cm.

The sensor plate of Focus HD 35 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus HD 35 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.

SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

The provided text is a 510(k) summary for the iRay Technology Taicang Ltd. Focus HD 35 Detector. This document primarily focuses on establishing substantial equivalence to a predicate device (Mars1417X Wireless Digital Flat Panel Detector, K210316) rather than directly presenting a study proving that the device meets specific acceptance criteria related to a diagnostic task or clinical performance.

Medical device 510(k) clearances typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering and performance testing. They do not usually involve clinical trials or studies like those required for novel AI/diagnostic devices that predict diagnoses or outcomes.

Therefore, many of the requested points regarding acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, and training set information are not applicable or not explicitly detailed in this type of submission.

Here's a breakdown of what can be gleaned from the text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the technical specifications and safety standards required for substantial equivalence, rather than diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). The comparison is primarily against the predicate device's specifications.

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

• Sample size used for the test set: Not applicable for a typical 510(k) submission based on technical equivalence. The "test set" here refers to the actual physical device and its components undergoing engineering and safety tests, not a dataset for diagnostic performance evaluation.
• Data provenance: Not applicable. The data is from engineering and safety tests conducted on the physical device and from a comparison of specifications with the predicate. There is no mention of country of origin for clinical or image data, as such data is not the primary basis for this type of submission. The tests were likely conducted by the manufacturer or accredited labs.

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

• Not Applicable. This device is an X-ray detector, a hardware component. Its clearance is based on technical specifications, safety, and performance as an imaging capture device, not on its ability to produce a specific diagnosis from images or generate ground truth. There is no "ground truth" in the diagnostic sense being established for a test set of images within this submission.

4. Adjudication method for the test set

• Not Applicable. As no clinical diagnostic performance study with images and ground truth is described, there's no 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

• No. This is not an AI-powered diagnostic device. It's a digital X-ray detector. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported here.

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

• No. This is a hardware device (X-ray detector), not an algorithm.

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

• Not Applicable. For this hardware device submission, "ground truth" relates to physical measurements and compliance with engineering standards (e.g., spatial resolution, DQE, electrical safety standards). There is no clinical ground truth (pathology, expert consensus on images, etc.) associated with this submission.

8. The sample size for the training set

• Not Applicable. This is a hardware device; no "training set" in the context of machine learning or AI is mentioned or relevant to its clearance.

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

• Not Applicable. As no training set is mentioned, no ground truth for it was established.

Summary of the Study (as described in the 510(k) submission):

The "study" referenced in the document is primarily a technical assessment and comparison to establish substantial equivalence with a legally marketed predicate device (K210316, Mars1417X Wireless Digital Flat Panel Detector).

• Methodology:

  • Side-by-side comparison of technical specifications: The document provides tables comparing parameters like intended use, indications for use, physical dimensions, imaging characteristics (spatial resolution, MTF, DQE), environmental operating conditions, and interfaces between the proposed device and the predicate device.
  • Non-clinical testing: This included:
    • Electrical safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2 standards.
    • Biological Evaluation: Materials contacting operators' or patient's skin evaluated with ISO 10993-1.
    • Functional performance testing: The document implies that areas with minor differences (e.g., power consumption, local load capacity, operating temperature range, atmospheric pressure range) were still considered substantially equivalent following non-clinical studies. The improved spatial resolution (5.0 lp/mm vs. Min. 4.3 lp/mm) was presented as a positive difference.

• Conclusion: The manufacturer concluded that the Focus HD 35 Detector is substantially equivalent to the predicate device regarding safety and effectiveness, based on the non-clinical studies and comparison of technical characteristics. The main identified differences (DC input port, power consumption, local load, operating temperature range, storage/transportation atmospheric pressure) were implicitly determined not to raise new questions of safety or effectiveness.

Ask a specific question about this device

Focus HD 43 Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.

Focus HD 43 Detector is a kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 42.67cm×42.67cm. The sensor plate of Focus HD 43 Detector is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus HD 43 Detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software. SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.

The provided text is a 510(k) summary for the iRay Technology Taicang Ltd. Focus HD 43 Detector. It states that the device is substantially equivalent to a predicate device (Mars1717X Wireless Digital Flat Panel Detector, K210314).

Crucially, the document does NOT contain information about a study proving the device meets acceptance criteria derived from a performance study with human readers or AI algorithms. Instead, it focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technical specifications with a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in performance claims for AI/CADe devices or new clinical functionalities. The information given indicates a different pathway to market clearance for this type of device (a digital X-ray detector).

However, I can extract the information provided about the device's technical specifications and the comparison to its predicate, which implicitly serves as the "acceptance criteria" for demonstrating substantial equivalence for this type of hardware device.

Here's an attempt to structure the available information relevant to the prompt, acknowledging the absence of a "study" in the typical sense of AI/clinical performance, and focusing on the technical equivalence:

Acceptance Criteria and Study for Focus HD 43 Detector (Based on Substantial Equivalence to Predicate Device)

The "acceptance criteria" for the Focus HD 43 Detector are primarily its substantial equivalence in performance characteristics to the legally marketed predicate device, the Mars1717X Wireless Digital Flat Panel Detector (K210314). The "study" proving this equivalence is a series of non-clinical tests and direct comparison of specifications.

1. Table of Acceptance Criteria and Reported Device Performance

For a device like an X-ray detector, acceptance criteria are generally based on meeting or exceeding the technical specifications of a predicate device, along with demonstrating safety and electromagnetic compatibility. The following table showcases the comparison provided in the 510(k) summary:

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

• Test Set Sample Size: Not applicable in the context of a clinical test set with patient data for performance evaluation. The "tests" were non-clinical engineering and safety tests.
• Data Provenance: The 510(k) summary explicitly states that "Non-clinical studies have been performed," and "All test results are meet the standard requirements." The testing was conducted by the manufacturer, iRay Technology Taicang Ltd. (China). The data refers to engineering and safety performance data, not patient-specific clinical data.

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

• Not applicable. Ground truth as typically defined for clinical/AI performance studies (e.g., expert radiological reads, pathology) was not established for this device's premarket clearance, as it's a hardware device demonstrating substantial equivalence through non-clinical testing.

4. Adjudication Method for the Test Set

• Not applicable. There was no human "adjudication" of images for clinical ground truth. Non-clinical tests typically adhere to defined protocols and measurement standards.

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

• No. An MRMC study is relevant for assessing human reader performance, often with and without AI assistance, or comparing different imaging modalities/interpretations. This 510(k) is for a digital X-ray detector hardware, not an AI or CADe device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This is not an algorithmic device in the sense of AI/CADe. Its performance is demonstrated through its physical characteristics and image acquisition capabilities, which are then used by human readers and integrated into existing DR systems.

7. Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering specifications, safety standards compliance (e.g., IEC/ES 60601-1, IEC 60601-1-2, ISO 10993-1), and direct comparison to the technical characteristics of a legally marketed predicate device. There is no clinical or pathological "ground truth" derived from patient outcomes involved in this specific premarket notification.

8. Sample Size for the Training Set

• Not applicable. This device is a hardware component (digital flat panel detector) and does not involve AI or machine learning that requires a "training set" of data.

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

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

Ask a specific question about this device

Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Focus DAILIES and DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.

The Focus DAILIES and DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.

The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high molecular weight PVA (for Focus DAILIES lenses) and/or ultra-high molecular weight PVA (for Dailies AquaComfort Plus lenses) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.

Focus DAILIES and DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foilblister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).

The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.

The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (DAILIES AquaComfort Plus products) and/or 0.85 ml (Focus DAILIES products) phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. For DAILIES AquaComfort Plus lenses the package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.

The provided text does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered medical device.

Instead, it is a 510(k) summary for contact lenses (Focus DAILIES and DAILIES AquaComfort Plus) which outlines a modification to an alternate foil lidding material for their primary packaging. The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for traditional medical devices under the 510(k) pathway, not AI/ML performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details relevant to an AI/ML device from this document.

Here's why and what information is missing:

• No AI/ML Component: The device described is a soft contact lens, a physical medical device. There is no mention of any AI or machine learning component, software, or algorithm in its functionality or development.
• No Performance Metrics for AI: Consequently, there are no AI/ML-specific performance metrics like sensitivity, specificity, AUC, F1-score, etc., nor any acceptance criteria for these.
• No Study Design for AI Validation: The "Performance Data" section discusses:
  • Non-clinical Testing: Stability, biocompatibility, and process validation, referencing ISO standards relevant to material safety and manufacturing for contact lenses. These are not AI/ML validation studies.
  • Clinical Testing: States that clinical testing was not required for this specific modification (changing packaging material), which further confirms the absence of AI/ML validation studies.
• No Mention of Ground Truth, Training Data, Experts: Since there's no AI, there's no need for ground truth establishment, training data, or expert adjudication as would be required for an AI/ML device.
• No MRMC Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable here.

In summary, the provided document is not about an AI/ML medical device and therefore does not contain the information you requested.

Ask a specific question about this device

Focus 43C and TRIMAX 43C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.

Focus 43C Detector and TRIMAX 43C Detector (Hereinafter referred to as Focus 43C and TRIMAX 43C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models TRIMAX 43C and Focus 43C are totally same except for label and trademark. The sensor plate of Focus 43C and TRIMAX 43C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 43C and TRIMAX 43C detectors are to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.

The provided text describes a 510(k) premarket notification for the "Focus 43C Detector" and "TRIMAX 43C Detector". The submission focuses on demonstrating substantial equivalence to a predicate device, the "Wireless Digital Flat Panel Detector (Mars1717XF-CSI, K183713)".

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it compares the technical characteristics of the proposed device to the predicate device to demonstrate substantial equivalence. The performance metrics are generally presented as improvements or minor changes compared to the predicate.

The overarching "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The document asserts that the proposed devices meet this through direct comparison and noting improvements where applicable.

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

The document does not specify a distinct "test set" in the context of clinical images or patient data for evaluating the device's diagnostic performance. The evaluation is primarily focused on non-clinical performance testing and comparison of technical specifications to the predicate device.

• No specific sample size for a test set of images or patient data is mentioned.
• Data provenance (country of origin, retrospective/prospective) is not applicable or provided for such a test set.

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

This information is not applicable to the provided document. The submission does not describe a study involving expert readers establishing ground truth for a diagnostic test set. The evaluation is based on technical specifications and engineering testing.

4. Adjudication Method for the Test Set

This information is not applicable as no diagnostic test set or adjudication process is described in the provided text.

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

No MRMC comparative effectiveness study is mentioned. This device is a digital X-ray detector, not an AI-powered diagnostic tool, so such a study would not typically be performed or described in this type of submission.

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

This is not an AI algorithm. The device is a digital X-ray detector. Therefore, a standalone algorithm performance study is not applicable.

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

The concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not relevant to this submission, as it focuses on the technical performance specifications of the X-ray detector rather than its diagnostic accuracy in interpreting images. The "ground truth" for the device's performance characteristics (e.g., spatial resolution, MTF, DQE) would be established through physical measurements and standardized test phantoms according to industry standards.

8. The Sample Size for the Training Set

No training set is mentioned as this device is an X-ray detector, not an AI model requiring a training set.

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

Not applicable, as no training set is mentioned or relevant for this device.

Summary of Device Performance Demonstration:

The submission demonstrates substantial equivalence primarily through:

• Comparison of Technical Specifications: A detailed table comprehensively compares various technical characteristics, showing that the proposed device is either similar to or improved upon the predicate device (e.g., higher image matrix size, smaller pixel pitch, better spatial resolution, MTF, and DQE).
• Non-Clinical Performance Testing:
  • Electrical Safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2, with results meeting standard requirements.
  • Biological Evaluation: Materials contacting skin evaluated per ISO 10993-1, with results assuring safety "the same as the predicate device."
  • Other Non-Clinical Considerations: These studies showed that non-clinical considerations mentioned in the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" are substantially equivalent to the predicate. This likely includes aspects like image quality, dose performance, and environmental testing.
• Clinical Consideration: The document explicitly states that "clinical consideration may not necessary for changes in the pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence." It also states, "There was no significant difference between the images of the Focus 43C/TRIMAX 43C and those of the predicate device." This implies that while no formal clinical study is presented, the technical improvements are not expected to negatively impact clinical performance, and the output images are comparable.

Ask a specific question about this device

Focus 35C and TRIMAX 35C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. There are no differences between the 2 models except the model name and trade mark.

Focus 35C Detector and TRIMAX 35C Detector (Hereinafter referred to as Focus 35C and TRIMAX 35C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 34.56cm×42.00cm. Two models TRIMAX 35C and Focus 35C are totally same except for label and trademark. The sensor plate of Focus 35C and TRIMAX 35C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics. consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 35C and TRIMAX 35C detectors are to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to use directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.

The provided text describes the 510(k) premarket notification for the iRay Technology Taicang Ltd. Focus 35C Detector and TRIMAX 35C Detector. This submission asserts substantial equivalence to a predicate device (Mars1417XF-CSI, K182551). For devices like X-ray detectors, acceptance criteria often revolve around physical performance specifications and safety, rather than diagnostic accuracy as would be the case for an AI diagnostic device. The study described focuses on demonstrating that the proposed devices meet these technical and safety standards, and are substantially equivalent to the predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided text does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might typically expect for a diagnostic AI device (e.g., Sensitivity, Specificity, AUC). Instead, it presents a comparison of technological characteristics between the proposed device (Focus 35C / TRIMAX 35C) and its predicate device (Wireless Digital Flat Panel Detector, Mars1417XF-CSI). The acceptance is implied by demonstrating that the proposed device performs at least as well as or better than the predicate for key technical specifications, and meets relevant industry standards.

Here's a table compiled from the "Technological Characteristic" section comparing the proposed device to the predicate device, which implicitly serves as the baseline for performance acceptance:

Study Proving Acceptance:

The study proving acceptance is primarily a non-clinical performance study and safety testing demonstrating that the proposed devices (Focus 35C and TRIMAX 35C) are substantially equivalent to the predicate device.

• Electrical Safety and EMC Testing: "Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements."
• Biological Evaluation: "The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device."
• Non-clinical Considerations: "The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1417XF-CSI, K182551)."
• Clinical Consideration: "There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device." This suggests an informal comparison of image quality, likely by engineers or qualified personnel during the non-clinical evaluation.

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

This information is not provided in the document. The studies were non-clinical performance and safety tests, not clinical studies involving patient data in the typical sense for evaluating diagnostic performance. The comparisons were primarily based on technical specifications and output image quality (likely using phantoms or test targets, rather than a "test set" of patient images with ground truth diagnoses).

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 information is not applicable and not provided. This device is an X-ray detector, not an AI diagnostic algorithm. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device submission. The "ground truth" for its technical performance would be the specifications and measurements from calibration and performance tests. The statement "There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device" implies an informal assessment of image quality, likely by qualified personnel (engineers, physicists, or potentially radiologists if consulted for image perception) rather than a formal expert consensus for a diagnostic task.

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

Not applicable and not provided. This is not a study requiring adjudication of diagnostic findings.

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 and not provided. This is an X-ray detector, not an AI-powered diagnostic tool, so no MRMC study or AI assistance evaluation was performed.

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

Not applicable and not provided. This is an X-ray detector, not an AI algorithm. Its performance is measured by its physical and technical capabilities to produce an image.

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

Not applicable in the typical sense. For this device, the "ground truth" for its performance evaluation comes from:

• Engineering specifications and measurements (e.g., spatial resolution, MTF, DQE).
• Compliance with international safety and electromagnetic compatibility standards (IEC/ES 60601-1, IEC 60601-1-2).
• Biocompatibility testing against a standard (ISO 10993-1).
• Comparison of image characteristics to the predicate device, likely using phantoms or standard test patterns.

8. The sample size for the training set

Not applicable and not provided. This is not an AI device that requires a training set.

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

Not applicable and not provided. This is not an AI device that requires a training set.

Ask a specific question about this device

The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. Environments of Use: Clinics, hospital and home environments Patient Population: Adult

The PM710 is a wearable electrotherapy device that is designed to alleviate chronic, acute and arthritic muscle leg pain. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient control on the main unit. The reusable, self-adhesive contouring pads allow for discreet and convenient placement on the pain locations below the knee. The device contains one main TENS unit which is rechargeable and can be attached to a single sized gel and a medium or large band (model number follow by "-M" / "-L") which helps to attach the device to the leg. The pad with attached TENS unit can then be applied to intact skin at the desired location below the knee for therapy and pain relief. Control of the PM710 TENS system is through the control buttons on the main unit and the intensity of the therapy is displayed by the Intensity Level Indicators during treatment. The PM710 will be packaged with an Instruction Manual which provides details on setting up the device for use, setting and controlling intensity levels, and troubleshooting. The system accessories include one charger, one AC adapter for the charger, and one pad holder and storage case.

Here's a summary of the acceptance criteria and study information for the Omron Focus TENS Therapy, Model PM710-M/-L, based on the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" against which a clinical study's performance metrics are directly compared. Instead, it demonstrates substantial equivalence through extensive non-clinical testing and comparison of technological characteristics with predicate and reference devices. The "performance data" provided refers exclusively to these non-clinical tests.

However, based on the comparison tables, we can infer some "performance criteria" that the device implicitly meets by matching or being within acceptable ranges of the predicate and reference devices.

2. Sample Size for Test Set and Data Provenance

The submission explicitly states: "Clinical testing was not performed to support this 510(k) submission." Therefore, there is no "test set" in the context of clinical data, no sample size, and no data provenance for a clinical test set. The evaluation relies entirely on non-clinical (bench) testing and comparison to legally marketed predicate devices.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable, as no clinical test set was used to establish ground truth in this submission.

4. Adjudication Method for Test Set

Not applicable.

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

No MRMC comparative effectiveness study was done, as traditional clinical studies were not performed. The submission does not discuss human reader improvement with or without AI assistance as this is a TENS device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device, not an AI algorithm. Its performance is evaluated through its physical and electrical characteristics as a TENS unit.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on engineering specifications, adherence to international and national standards (e.g., IEC 60601 series), and the demonstrated performance of legally marketed predicate and reference TENS devices. The "truth" is that the device's electrical outputs and functional characteristics are safe and effective by being substantially equivalent to these established devices.

8. Sample Size for the Training Set

Not applicable, as no AI model or learning algorithm is described, and no clinical "training set" was used. The device is a TENS unit, not a machine learning system.

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

Not applicable, as there is no training set mentioned in the submission.

Ask a specific question about this device

Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.
Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
The lenses are to be prescribed for single-use Daily Disposable Wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single-use.
DAILIES TOTAL 1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism.
DAILIES TOTAL1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs as applicable:
Spherical lenses: Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1
Toric lenses: Focus DAILIES Toric and DAILIES AquaComfort Plus Toric
Multifocal lenses: Focus DAILIES Progressives, DAILIES AquaComfort Plus Multifocal and DAILIES Total1 Multifocal
The lens material of Focus DAILIES, DAILIES AquaComfort Plus and FreshLook One-Day products is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with Nformylmethyl acrylamide) and 69% water. For Focus DAILIES and DAILIES AquaComfort Plus products the lens material further contains non-functionalized PVA (high- and/or ultra-high molecular weight PVA) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint®) to make the lenses easier to see when handling. Additionally, lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue (CFR 74.3045) and phthalocyanine green (CFR 73.3124). FreshLook One-Day color contact lenses are printed with an intermittent coating containing the following pigments (either alone or in combination): iron oxides, titanium dioxide, Cu-phthalocyanine blue, chromium oxide and phthalocyanine green. All pigments are approved color additives for use in contact lenses.
DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. Delefilcon A soft contact lenses are surface coated with hydrophilic components. The lenses contain a color additive (copper phthalocyanine blue) to assist handling tint). In addition, lenses contain 1,2-Dimyristoyl-sn-glycero-3-phosphocholine which is considered a 'comfort agent' to improve lens wearing comfort by physical mode of action (water binding and lens lubricating effect).
Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 products are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).
The blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top. The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (for DAILIES AquaComfort Plus and DAILIES Total1) and/or approximately 0.85 ml (for Focus DAILIES and FreshLook One-Day) of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline of DAILIES AquaComfort Plus family lenses additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each (Focus DAILIES, DAILIES AquaComfort Plus, DAILIES Total1) and/or 10 lenses each (FreshLook One-Day), respectively.

This document is a 510(k) premarket notification for contact lenses, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include extensive de novo clinical studies with acceptance criteria for a novel AI device as would be seen for a new technology or an AI/ML diagnostic.

Therefore, the information required to answer the questions about acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone performance for an AI device is not present in this document.

Instead, this submission focuses on demonstrating substantial equivalence based on:

• Identical Indications for Use: The modified contact lenses have the same intended use as the predicate devices.
• Similar Technological Characteristics: The materials, manufacturing methods, lens designs, sterilization, and basic performance specifications (refractive index, light transmittance, oxygen permeability, elastic modulus) are either identical or very similar to the predicate devices.
• Non-clinical Performance Testing: Biocompatibility and stability testing were performed to show that the minor modifications (primarily to the primary packaging foil lidding supplier) do not negatively impact safety or performance.
• No Clinical Testing Required: Due to the high similarity and successful non-clinical testing, clinical testing was deemed unnecessary to establish substantial equivalence.

In summary, this document is for a medical device (contact lenses) and not an AI/ML-based device. Hence, the detailed criteria for AI device validation (like acceptance criteria for AI performance, MRMC studies, ground truth establishment, etc.) are entirely irrelevant and absent from this submission.

If this question was intended for an AI/ML-based medical device, the provided document does not contain the necessary information.

Ask a specific question about this device

The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1 to S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.

The FOCUS Pedicle Screw System is a spinal system used as an adjunct to fusion, to provide immobilization and stabilization of spinal segments in the non-cervical posterior spine (T1 to S1) of skeletally mature patients. The system consists in pedicle screws implanted into the bones, and capturing spinal rods. The system is stabilized by cross connectors. The device is implanted via a posterior approach.

This document is a 510(k) premarket notification for the "FOCUS Pedicle Screw System" and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The provided text pertains to a traditional medical device (a pedicle screw system for spinal fixation) and its substantial equivalence determination by the FDA. The evaluation of this device is based on non-clinical mechanical testing and comparison to predicate devices, not on AI/ML performance metrics.

Therefore, the requested information cannot be extracted from the provided input, as it describes a different type of device and regulatory review process.

Ask a specific question about this device

Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.

The lenses are to be prescribed for single-use Daily Disposable Wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single-use.

DAILIES TOTAL (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to approximately 1.50 diopters (D) of astigmatism.

DAILIES TOTAL 1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism .

The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs as applicable. The lens material of Focus DAILIES, DAILIES AquaComfort Plus, and FreshLook One-Day products is nelfilcon A. DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. The lenses are supplied sterile in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave.

This document is a 510(k) premarket notification for several types of soft contact lenses manufactured by Alcon Laboratories, Inc. The purpose of this submission is to demonstrate that the modified devices are substantially equivalent to their legally marketed predicate devices.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

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

The document does not explicitly present a table of acceptance criteria for specific performance metrics in the way one might expect for a new device claiming improved performance. Instead, it focuses on demonstrating that the modified devices maintain the same performance specifications as their predicate devices. The acceptance criterion implicitly seems to be "no negative impact on safety, efficacy, and performance compared to predicate devices, and consistency with established standards."

The "Performance Data" section lists the types of testing conducted to support substantial equivalence, rather than specific numerical acceptance criteria.

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

• Biocompatibility Testing: The document states "Test results from a series of in vivo biocompatibility evaluations" but does not specify the sample size for these tests. It indicates the tests were "conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards." Provenance information (country, retrospective/prospective) is not provided.
• Stability Testing: "Successful stability testing supports the labeled expiration date." No specific sample size, provenance, or detailed methodology is provided.
• Clinical Testing: No clinical testing was performed for the modified devices to establish substantial equivalence. Therefore, there is no sample set, provenance, or type of study to report for clinical trials. The assumption is that the clinical performance of the predicate devices is maintained due to the minor nature of the modification.

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 information is not applicable as the document describes a 510(k) submission for contact lenses, which does not involve "ground truth" derived from expert image interpretation or clinical diagnosis in the way an AI/CAD device would. The "ground truth" for contact lenses is established through well-defined physical, chemical, and biological testing methods against established standards.

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

This information is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are used in studies where human experts are tasked with independently assessing cases, and discrepancies need to be resolved. The testing described here (biocompatibility, stability, material characteristics) does not involve such human-expert adjudication processes.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for AI/CAD systems that assist human readers in tasks like image interpretation, which is not relevant to soft contact lenses.

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

No, a standalone algorithm performance study was not done. The device in question is a physical medical device (contact lens), not an algorithm or AI system.

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

For the specific tests mentioned:

• Biocompatibility: The "ground truth" is established by the results of standardized in vivo (e.g., animal models) and in vitro (e.g., cell cultures) tests based on ISO 10993 standards and measured against predefined toxicity and irritation thresholds.
• Stability: The "ground truth" is established by direct measurement of physical and chemical properties of the lenses over time under various conditions to ensure they meet specifications throughout their shelf-life.
• Technological Characteristics: The "ground truth" is established by direct measurement of physical properties (e.g., refractive index, water content, oxygen permeability, elastic modulus) using validated scientific methods, compared against the known values of the predicate devices and product specifications.

8. The sample size for the training set

This information is not applicable. The submission is for a physical medical device (contact lenses), not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for a contact lens product.

Ask a specific question about this device