Search Results

Ask a specific question about this device

The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonumion or revision surgery.

The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System consists of anatomically contoured, lowprofile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking Extremity Plating System (EPS) screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. Screws lengths are offered in 10-40mm for the 2.7mm diameter plate screws and in 10 – 60mm in 3.5mm and 4.0mm diameter plate screws. All components (implants and the associated instruments) are provided sterile and for single use only.

The provided document does not describe an AI/ML device or software. It pertains to the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System, which is a metallic bone fixation appliance used for surgical fusion in the foot.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable and cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and engineering analysis for a physical medical implant.

Ask a specific question about this device

The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.

The GEO Bone Screw System consists of sterile, stand-alone headed and headless, cannulated and solid, threaded bone screws, washers, and instrumentation. Bone screws are available in a variety of diameters and lengths including partially and fully threaded designs to accommodate application in varying bone sizes (for the Jones Fracture / 5th metatarsal procedures only the 4.0mm-6.5mm diameter screws are appropriate). Optional washers are available and sized to correspond with bone screws. K-wires and general, manual orthopedic instrumentation is provided and intended to facilitate implantation. Instrumentation includes wire quide handles. AO drive handles, drill bits, taps, depth gauges, countersinks, tissue protectors, hexalobe driver tips and screw diameter templates. GEO implants are comprised of titanium alloy. All implants are provided for single use only and sterilized by exposure to gamma irradiation.

The provided text does NOT contain information regarding the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria for an AI/ML medical device.

The document is a 510(k) premarket notification for a physical medical device called the "GEO Bone Screw System." It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device (K161904).

Therefore, I cannot provide the requested information. The document explicitly states:

"No additional performance testing was required. The GEO Bone Screw System components have been subjected to design controls and previously tested to appropriate device-specific standards to support substantial equivalence, and validation to standards necessary to demonstrate the functionality of the device system."

This indicates that no new studies were conducted to prove this specific submission of the device met acceptance criteria, but rather it relies on prior testing of its predicate device and general design controls.

Ask a specific question about this device

The GEO 1st MTP Joint Arthrodesis Plating System is indicated for use in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonunion or revision surgery.

The GEO 188 MTP Joint Arthrodesis Plating System consists of anatomically contoured, low- profile plates in a variety of configurations of length, left and right versions, and degrees of dorsiflexion and abduction. The plates accept both fixed angle locking screws and non-locking screws. Fixed angle cortical locking screws are available in diameters of 2.7mm and 3.5. Non-locking cortical screws are available in 2.7mm, 3.5mm and 4.0mm; and non-locking cancellous screws in 4.0mm. All screws are offered in lengths of 10-40mm. The system also includes associated instrumentation consisting of plate tacks, quide-wire, drill bit, drill bit, drill guides (locking and non-locking), AO driver tip, reamers, depth gauge, non-locking drill guide handle, AO driver handle, and templates for plate and reamer sizing. All GEO 1ª MTP Joint Arthrodesis Plating System components (implants and instruments) are provided sterile and for single use only.

This document is a 510(k) premarket notification for a medical device called the "GEO 1st MTP Joint Arthrodesis Plating System." As such, it describes a mechanical device for internal fixation of bones, not a software algorithm or AI-powered diagnostic tool. Therefore, the questions related to AI/algorithm performance, such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training sets, are not applicable to the content provided.

The performance data section for this type of device focuses on physical and mechanical testing to ensure its safety and effectiveness when used for bone fixation.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document highlights compliance with these standards and concludes substantial equivalence, implying the device met the performance requirements outlined in these standards. Specific numerical results or pass/fail thresholds against explicit acceptance criteria are not detailed in this summary document.

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

Not applicable for this type of mechanical device testing. The testing would involve physical samples of the plates and screws, not patient data.

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

Not applicable. Ground truth for a mechanical device is established through physical and mechanical testing against recognized standards.

4. Adjudication method for the test set

Not applicable. Mechanical testing is typically objectively measured against established engineering standards.

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, as this is a mechanical bone fixation device, not an AI or diagnostic imaging device.

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

Not applicable, as this is a mechanical bone fixation device, not an algorithm.

7. The type of ground truth used

For a mechanical device, the "ground truth" is typically defined by the established performance requirements and specifications outlined in the referenced ASTM standards (ASTM F382-17-17 and ASTM F543-17). These standards detail specific tests (e.g., bending strength, fatigue, pull-out strength for screws) and criteria that the device must meet.

8. The sample size for the training set

Not applicable, as this is a mechanical bone fixation device, not an AI or machine learning model that requires a training set.

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

Not applicable.

Ask a specific question about this device

The GEO Bone Screw System is indicated for bone fractures, arthrodesis, osteochondritis, and tendon reattachment.

The GEO Bone Screw System implants include cannulated and solid, low-profile headed and headless, partial and fully threaded bone screws in a variety of diameters and lengths. Optional washers, correspondingly sized to each bone screw, are available as well as k-wires and general orthopedic instruments. GEO implants are comprised of titanium alloy. The GEO Bone Screw System is provided sterile by exposure to gamma irradiation.

This document is a 510(k) premarket notification for a medical device called the "GEO Bone Screw System." It does not contain information about an AI/ML powered device or study results related to AI/ML. Therefore, I cannot extract the requested information about acceptance criteria and study data for an AI/ML device.

The provided text describes a bone screw system, its indications for use, and a comparison to predicate devices, focusing on technical characteristics and mechanical performance (torsional strength, pullout strength, pyrogenicity). It explicitly states: "No clinical performance data were needed to support substantial equivalence." This means it relied on engineering analysis and comparison to existing devices, not clinical trials or AI/ML performance evaluations.

Ask a specific question about this device

The Geodesic EEG System 400 Series™ (GES 400) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.

The Geodesic EEG System™ 400 Series (GES 400) is a digital electroencephalograph system (EEG). Each system consists of an amplifier, central processing unit, software, electrodes, and components of a standard personal computer (monitor, keyboard, and mouse). The GES 400 Series consists of 3 models (GES 400, GES 405, and GES 410), each of which has a slightly different amplifier. The amplifiers are very similar and all are called Net Amps ". They vary in connectors used to attach the electrodes and in the A/D chips, which support different maximum sampling rates. The other parts of the GES 400 Series are identical and consist of an isolation transformer, a power supply, Net Station software, proprietary EEG electrodes, and data acquisition computer. Optional accessories include a cart that holds the components of the system, interface cable, and articulated arm. The GES 400 Series also accepts third party DIN 42802 electrodes and an SpO22 electrode.

This 510(k) premarket notification for the Geodesic EEG System 400 Series (GES 400) primarily focuses on demonstrating substantial equivalence to its predicate device, the Geodesic EEG System 300 (GES 300), rather than outlining specific acceptance criteria or performing a clinical study to prove the device meets them in the conventional sense of a diagnostic or therapeutic AI/ML device.

The "acceptance criteria" here are implicitly related to the performance characteristics of an EEG system and demonstrating that the new device is as safe and effective as the predicate.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" for the GES 400 series in terms of diagnostic accuracy, sensitivity, or specificity. Instead, the performance is demonstrated through a comparison of technical specifications against a legally marketed predicate device (GES 300). The underlying acceptance criteria are that the new device's technical specifications are comparable or improved without raising new questions of safety or effectiveness.

Study Information

The provided document describes a premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies in the same way a novel diagnostic or therapeutic device might.

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

   • Test Set Sample Size: Not applicable. The submission states, "No animal or clinical testing was submitted." The device's performance is established through technical specification comparison and compliance with electrical safety and EMC standards, not a clinical test set with patient data.
   • Data Provenance: Not applicable. The assessment is based on engineering specifications and bench testing for electrical safety and electromagnetic interference.

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

   • Not applicable as no clinical test set requiring expert ground truth was used.

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

   • Not applicable as no clinical test set requiring adjudication was used.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. The device is an electroencephalograph, not a diagnostic AI intended to assist human readers in interpreting images or data.

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

   • The device itself is a data acquisition system. While it contains software (Net Station 4.5), it does not perform automated diagnoses or interpretations in a "standalone" AI sense. Its primary function is to measure and record electrical brain activity for interpretation by a human clinician. Performance assessment was based on technical specifications and adherence to relevant standards for an electroencephalograph.

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

   • Not applicable. Performance is validated through technical specification equivalence to a predicate device and compliance with electrical safety and EMC standards (UL 60601-1, IEC 60601-1-2, IEC 60601-2-26, CAN/CSA 601.1-M90, and CAN/CSA 60601-2-26). Software verification and validation (EN 62304 and EN 62366) were also conducted.

7. The sample size for the training set:

   • Not applicable. This device is an EEG system for data acquisition, not a machine learning model that requires a training set in the AI sense.

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

   • Not applicable. No training set for an AI/ML model was used.

Ask a specific question about this device

The Geo is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lbs (30 kg). The Geo mask system delivers airflow noninvasively to a user from the integrated CPAP device. The Geo system is intended for single-patient re-use in the home environment and while traveling.

The Geo is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lbs (30 kg). The Geo mask system delivers airflow noninvasively to a user from the integrated CPAP device. The Geo system is intended for single-patient re-use in the home environment and while traveling.

The provided text describes a Special 510(k) submission for the ResMed Geo device, which is a non-continuous ventilator (IPPB) intended for the treatment of obstructive sleep apnea (OSA). The submission is for a device modification, and it states that the modified device has similarities to the previously cleared Tasman device in terms of intended use, operating principle, technologies, and manufacturing process.

The document indicates that design and verification activities were performed on the modified device, and these tests confirmed the product met predetermined acceptance criteria.

Here's an breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Note: The document states that the tests met the acceptance criteria, but it does not explicitly list the specific numerical/quantitative acceptance criteria themselves (e.g., "pressure stability must be within +/- X units"). It only lists the parameters that were evaluated.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Design and Verification activities" and "All tests," but does not provide details on the number of units or patients included in these tests.
• Data Provenance: Not explicitly stated. The document indicates the submitter is ResMed, with an official contact in San Diego, CA, USA. However, it does not specify the country of origin for the data generated from the testing. The study appears to be prospective in nature, as it describes "Design and Verification activities were performed on the modified device."

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

This information is not provided in the document. The tests performed (pressure stability, jitter, swings, ISO 17510-1 pressure performance, functional dead space) are primarily engineering and performance-based, rather than relying on human expert assessment for "ground truth" in clinical interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The nature of the tests described (device performance metrics) does not typically involve an adjudication method in the way clinical diagnostic studies do.

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

An MRMC study is not mentioned and is not relevant to the type of device performance testing described. This is a ventilation device, and the focus of the submission is on engineering performance compared to a predicate device, not on diagnostic accuracy with human readers.

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

This information is not applicable/provided. The Geo device is a physical medical device (a ventilator), not an AI algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant here. The "standalone" performance in this context would refer to the device's inherent performance characteristics, which are implicitly what the "pressure stability, jitter, swings, ISO 17510-1 pressure performance and functional dead space tests" measured.

7. Type of Ground Truth Used

The "ground truth" for the tests performed was based on engineering specifications and established performance standards (specifically ISO 17510-1 for pressure performance) and comparison against the "previously cleared device using common protocols."

8. Sample Size for the Training Set

This is not applicable as the Geo device is a hardware product, not an AI algorithm that requires a "training set."

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

This is not applicable as the Geo device is a hardware product, not an AI algorithm that requires a "training set."

Ask a specific question about this device

GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens indicated for daily wear to correction of refractive ametropia (myopia and hyperopia) in aphakit and/or not rol ually weat to contection of Formative astigmative astigmatism up to 0.50 dioplers aphakic persons with non discussu eyos the ons is available clear or colored and may be used to enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lens for frequent wear, with cleaning, disinfecting, and scheduled replacement. (see Wearing Schedule).

GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens

This document is a 510(k) premarket notification approval letter for a contact lens. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is primarily administrative correspondence from the FDA to the device manufacturer, confirming substantial equivalence to a legally marketed predicate device.

Therefore, I cannot extract the requested information based on the provided text.

Ask a specific question about this device

The Geodesic EEG Mobile 100 (GEM 100) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.

The Geodesic EEG Mobile 100 (GEM 100) is a digital electroencephalograph system (EEG). It consists of an amplifier, two adapters, central processing unit, software, electrodes, isolation transformer, and components of a standard personal computer (monitor, keyboard, and mouse). Integral components allow wireless communication.

The GEM 100 has 4 configurations. These are based on the type of EEG electrodes that will be used and the environment for use. The Neurotravel software is used to acquire, record, and archive the data from all 4 configurations. These configurations are:

• Ambulatory EEG only .
• Ambulatory EEG with conventional electrodes and physiological sensors ●
• Stationary (in-clinic) EEG only .
• Stationary (in-clinic) EEG with conventional electrodes and physiological sensors .

The GEM 100 EEG Amplifier is used with all configurations, but the other components vary depending on the requirements of the patient and physician. Accessories that can be used with the GEM 100 include: Sensor Kit for SpO2, LTM Net Support Kit, Video EEG, photic stimulator, TTL patient event switch, laser or inkjet printer, mobile cart, and ambulatory pouch.

The GEM 100 operates like other digital electroencephalographs. It can run on mains power or on battery power. Data can be recorded to a CompactFlash card or to the system computer. Data can be transmitted by USB connection or by Bluetooth or can be transferred from the Compact Flash card to the system computer.

This submission is for a medical device (Geodesic EEG Mobile 100), which measures and records the electrical activity of the brain. The provided text does not contain acceptance criteria for device performance, nor does it detail a study proving the device meets performance criteria. The submission focuses on substantial equivalence to a predicate device and non-clinical safety/electrical testing.

Here's a breakdown of what is and isn't present in the provided document, in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document describes the device, its intended use, and compares its features to a predicate device. It mentions "non-clinical testing" for safety and software verification/validation, but does not provide specific performance metrics or acceptance criteria for those tests.

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

Not applicable/Not available. The document explicitly states: "No clinical testing was submitted." Therefore, there is no test set of patient data, no sample size, and no data provenance information.

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

Not applicable/Not available. As no clinical testing was submitted, there was no need for experts to establish ground truth from patient data.

4. Adjudication Method for the Test Set

Not applicable/Not available. No clinical testing, thus no adjudication method for a test set.

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

Not available. The document states "No clinical testing was submitted," which means no MRMC study was conducted or provided in this submission. Therefore, there is no effect size of human reader improvement with or without AI assistance. (Note: This device is an EEG recording system, not an AI-driven diagnostic tool in the sense of image analysis, so an MRMC study comparing human reader performance on interpretations would likely be outside its scope anyway unless it involved an AI interpretation component, which is not indicated here).

6. Standalone (Algorithm Only) Performance Study

Not available. The device is an EEG recording system. Its primary function is data acquisition. While it contains software, the submission does not describe it as having a standalone "algorithm" for diagnostic interpretation or a study to evaluate its performance independently of human interpretation. "No clinical testing was submitted."

7. Type of Ground Truth Used

Not applicable/Not available. Since no clinical testing was submitted, no ground truth based on patient outcomes, pathology, or expert consensus was established for the purpose of validating the device's diagnostic performance. The device's "performance" in this submission is related to its electrical safety, software functionality, and ability to acquire EEG signals, which are assessed through engineering and non-clinical tests.

8. Sample Size for the Training Set

Not applicable/Not available. As no machine learning or AI algorithm development for diagnostic interpretation is described, there is no concept of a "training set" of patient data.

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

Not applicable/Not available. As there's no training set, there's no ground truth establishment for it.

Summary of what the document does indicate about testing:

The "Non-clinical Testing" section states:

• Extensive testing was conducted.
• The product passed general testing to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-26 (international standards for medical electrical equipment safety, essential performance, and electromagnetic compatibility for electroencephalographs).
• Additional testing verified long-term monitoring capabilities and use of an SpO2 sensor.
• Software verification and validation activities were successfully completed.

These describe safety and functional performance tests against recognized standards, not clinical performance metrics or diagnostic accuracy against a ground truth from patient data.

Ask a specific question about this device

GeoSource is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an idealized head model and an idealized MRI image.

GeoSource is an add-on software module to EGI's Net Station software and can only be used on EEG data generated by EGI hardware. It runs on a personal computer. It is used to approximate source localization of EEG signals and visualize those estimated locations. It uses the linear inverse methods LORETA, LAURA, and sLORETA and the sphere and Finite Difference forward head models.

Here's a summary of the acceptance criteria and study details for the GeoSource device, based on the provided 510(k) notification:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

The primary acceptance criterion for GeoSource was demonstrating substantial equivalence to predicate devices in terms of source localization accuracy. The study aimed to show that the GeoSource algorithms (LORETA, sLORETA, LAURA with FDM) provided similar source localization results to the predicate algorithm (LORETA with spherical head model).

Since this was a substantial equivalence submission, specific quantitative performance metrics and acceptance thresholds (e.g., sensitivity > X%, accuracy > Y%) are not explicitly stated in the provided text. The "reported device performance" is essentially the conclusion that the GeoSource algorithms were found to be substantially equivalent to the predicate device.

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

• Sample Size for Test Set: 20 epilepsy subjects.
• Data Provenance: Retrospective data analysis. Country of origin is not explicitly stated but implied to be from the University of Washington's Regional Epilepsy Center (USA).

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

• Number of Experts: Three.
• Qualifications of Experts: Experienced epileptologists from the University of Washington's Regional Epilepsy Center. Specific years of experience are not mentioned.

4. Adjudication method for the test set

The adjudication method involved each of the three experienced epileptologists reviewing the source localization results for each algorithm and summaries of the postoperative reports. They were then asked to rate whether each of the four algorithm solutions (GeoSource LORETA, sLORETA, LAURA with FDM, and predicate LORETA with spherical head model) were located within the resected brain regions. The text does not specify a specific consensus or majority voting method (e.g., 2+1, 3+1). It states "The results demonstrated...", implying a collective finding rather than individual expert opinions being the final ground truth.

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

• Was an MRMC comparative effectiveness study done? No, not in the typical sense of evaluating human reader performance with and without AI assistance. This study focused on the performance of the algorithms themselves by having experts evaluate the algorithm's outputs in relation to the ground truth. It did not directly measure how much human readers improved by using the GeoSource software.

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

• Was a standalone study done? Yes, in essence. The study's primary goal was to evaluate the GeoSource algorithms' source localization accuracy in a standalone manner, with expert epileptologists providing the "ground truth" assessment of whether the algorithm's output correlated with the resected region. The experts were evaluating the algorithms' predictions, not using the algorithm as assistance for their own interpretation.

7. The type of ground truth used

• Type of Ground Truth: A combination of clinical and outcome data:
  • Clinical Neurophysiologist review: Identification and averaging of spikes in EEG data.
  • Operative data: Descriptions of the resected zone from surgery.
  • Outcomes Data: Postoperative Engel 1 or 2 determination (indicating good seizure control after resection).
  • Expert Consensus/Evaluation: The decision of three experienced epileptologists on whether the source localization algorithm's output was within the resected brain regions, using all available clinical information (postoperative reports, resected zone descriptions) as context.

8. The sample size for the training set

The document does not provide information about a separate "training set" for the GeoSource algorithms. The mentioned clinical study was a retrospective data analysis of subjects who had previously undergone resection surgery, and this data was used to test the algorithms' performance, not to train them. Source localization algorithms like LORETA, sLORETA, and LAURA are typically model-based and do not require a separate "training set" in the same way machine learning models do.

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

As no specific training set is identified for the GeoSource algorithms, the question of how its ground truth was established is not applicable in the context of this 510(k) submission. These linear inverse methods are derived from mathematical and biophysical principles rather than being "trained" on a dataset with a predefined ground truth.

Ask a specific question about this device