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The Riverpoint Medical IDEAL Ziploop is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

The Riverpoint Medical IDEAL Ziploop adjustable button loop is comprised of an ultrahigh molecular weight polyethylene (UHMWPE) loop combined with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate or as a single titanium (Ti-6Al-4V ELI per ASTM F136) plate. Additional non-absorbable sutures consisting of UHMWPE looped through the titanium plate to aide in assembly of the device and passing the plate through the intended void. The UHMWPE is available undyed (white), dyed blue, or dyed black. A titanium (Ti-6Al-4V ELI per ASTM F136) plate or button is affixed to the loop during the procedure for configurations where the button is not pre-attached to the loop. For models that come with a pre-attached titanium plate, the procedure is the same except the titanium plate is passed through the void. In both configurations, additional sutures are used to pass the loop and titanium plate (if pre-attached) parallel through the bone tunnel and secure into place.

The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The classification for the IDEAL Ziploop is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.

The provided document is a 510(k) premarket notification for a medical device called the IDEAL Ziploop. This type of regulatory submission in the United States focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific (quantitative) acceptance criteria through novel clinical studies.

Therefore, the document does not contain the information requested regarding acceptance criteria for device performance, the study design (test set sample size, data provenance, expert consensus details, adjudication methods, MRMC studies, standalone performance), or training set details typically found in submissions for novel AI/ML-based medical devices or devices requiring de novo clearance with specific performance targets.

Instead, the document highlights:

• Substantial Equivalence: The primary method of demonstrating safety and effectiveness is by showing the IDEAL Ziploop is substantially equivalent to a predicate device (Riverpoint Medical OrthoButton AL K171060 and K230212).
• Performance Data (Non-Clinical): Performance data is primarily non-clinical, focusing on:
  • Suture requirements (USP tensile strength)
  • Sterilization adoption validation
  • Biocompatibility testing (ISO10993-1:2018)
  • Product packaging validation (ISO 11607-1:2006)
  • Usability engineering validation with simulated use in cadaveric models (EN62366: 2015)
  • LAL and rabbit pyrogenicity testing
  • Non-clinical mechanical testing: Specifically, cyclic testing to verify fixation strength was performed as compared to the predicate device.
• Conclusion: The device "performed comparably to the predicate device and the validations performed demonstrated that the IDEAL Ziploop met all requirements for its intended use."

In summary, this document is a 510(k) for a hardware medical device (a bone fixation fastener), not an AI/ML-driven device or one requiring extensive clinical performance studies against defined acceptance criteria. Therefore, the specific details requested about acceptance criteria, test set, expert involvement, MRMC studies, and training set information (which are common for AI/ML device submissions) are not present.

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Ideal® locking plate system is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.

Ideal® locking plate system contains locking plates with various specifications, cortical and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery.

The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The cortical and locking screws are made of Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

The provided document is a 510(k) premarket notification for a medical device called the "Ideal® Locking Plate System." It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical (bench) testing.

However, the document does not contain information about a study that would involve acceptance criteria related to device performance in a clinical setting, such as a study with human readers, AI assistance, or the establishment of ground truth by medical experts.

Therefore, many of the requested items cannot be extracted from this document as they are not applicable to the type of submission described. This is a submission for a metallic bone fixation appliance, and the evidence provided focuses on mechanical and material properties through bench testing, not clinical performance metrics typically associated with AI-driven or diagnostic devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

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

• Sample Size: Not specified in the document for any of the bench tests.
• Data Provenance: The tests were conducted to demonstrate compliance with ASTM standards, which are international standards. The device manufacturer is Jiangsu Ideal Medical Science & Technology Co., Ltd. in China. The specific location where the bench tests were performed is not mentioned within the text, but it can be inferred that they were part of the submission process from a Chinese manufacturer. The tests are non-clinical, so "retrospective or prospective" does not apply in the clinical sense.

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)

• Not applicable. This submission relies on engineering bench tests, not clinical evaluation requiring expert ground truth for interpretation of images or other clinical data.

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

• Not applicable. Adjudication methods are relevant for clinical studies, especially those involving human interpretation of data. This submission is based on physical and mechanical testing against recognized 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. This device is a metallic bone fixation system, not a diagnostic or AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.

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

• Not applicable. This device does not involve algorithms or AI. It is a physical implant.

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

• Ground Truth: The "ground truth" for the bench tests would be the specifications and performance requirements defined by the ASTM standards (ASTM F 382-99 and ASTM F 543-07). The device's performance is compared directly against these established engineering criteria, not against biological or clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This submission evaluates a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As above, no training set or AI model is involved.

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The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or alternative sites (palm, forearm, upper arm, calf, and thigh). The system is intended to be used by a single patient and should not be shared.

The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should only be done during steady state times when blood glucose is not changing rapidly.

The IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112 are for use with the IDEAL LIFE GlucoManager™ to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips, palm, forearm, upper arm, calf, and thigh.

The IDEAL LIFE Control Solution, Model GCS-0104 is intended for use with IDEAL LIFE GlucoManager™ and IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112. The control solution can be used to check that the qlucose meter and test strips are working properly and that the measurement is accurate.

The IDEAL LIFE GlucoManager™ can wirelessly communicate with a communication gateway such as the IDEAL LIFE Pod™ or the IDEAL LIFE Gateway Application™. The IDEAL LIFE Gateway Application receives data wirelessly from IDEAL LIFE devices to transmit over the Internet from the user's mobile device. The Gateway Application is intended to aid people at home and health care professionals to review and evaluate historical blood glucose results, to support effective health care management.

The IDEAL LIFE Gateway Application™ makes no interpretation, evaluation, medical iudgment or recommendations for treatment. This device is not intended as a substitute for medical care.

The IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, Model GMM0002 consists of a blood glucose meter, single use test strips and control solution. The new device IDEAL LIFE Gluco-Manager™, Model GMM0002 is based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device. The IDEAL LIFE Gluco-Manager™ can be used alone to measure your blood glucose. If the user would like to transmit blood glucose information for display on a personal computer, the IDEAL LIFE Gluco-Manager™ can wirelessly communicate with a communication gateway (the optional IDEAL LIFE Pod™) or by using the Gateway Application, a mobile medical application.

The IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, Model GMM0002, demonstrates its performance through compliance with ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. While the document asserts compliance with this standard, it does not explicitly state specific acceptance criteria values or detailed performance results in the provided text.

Therefore, I cannot directly complete Table 1 with specific acceptance criteria and reported device performance values from the provided text. The document refers to the ISO standard as the basis for performance.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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The Ideal™ Intramedullary Nail System is intended to provide temporary fracture fixation and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delayed union).

The Ideal™ Intramedullary Nail System is intended to provide temporary fracture and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delayed union). It consists of intramedullary nail. locking screw and end cap. The Intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. The locking screw passes through the holes at the proximal and distal sections of intramedullary nail for preventing rotation and axial compression. The end cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads. All implants of intramedullary nail system are manufactured from Ti-6A1-4V allov that meets the requirements of ASTM F-136. The materials are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

The provided text describes a 510(k) summary for the Ideal™ Intramedullary Nail System, a medical device intended for temporary fracture fixation and stabilization of the tibia. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size (number of nails or screws) used for each of the non-clinical tests.
• Data Provenance: The tests were conducted by the manufacturer, Jiangsu Ideal Medical Science & Technology Co., Ltd., which is based in China. The data would therefore be considered prospective non-clinical test data.

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

• Not Applicable. This is a non-clinical bench testing study, not a clinical study involving human or animal subjects that would require expert-established ground truth for a test set. The "ground truth" here is adherence to specified ASTM standards.

4. Adjudication method for the test set:

• Not Applicable. As a non-clinical bench testing study, there is no need for an adjudication method as would be used in a clinical trial to resolve discrepancies in expert interpretation. The performance is objectively measured against predefined 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:

• No. This document pertains to a physical medical implant (an intramedullary nail system), not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

• No. This is not an AI algorithm. The tests performed are standalone in the sense that they assess the physical properties of the device itself (mechanical strength, resistance to forces) without human-in-the-loop interaction in the testing process. However, this question typically refers to the performance of an AI algorithm operating independently, which is not applicable here.

7. The type of ground truth used:

• The ground truth for this device's performance is based on established engineering standards and specifications, specifically ASTM (American Society for Testing and Materials) standards. The device's performance is compared against the requirements outlined in ASTM F1264-03 (Reapproved 2007) for intramedullary fixation devices and ASTM F 543-07 for metallic medical bone screws.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. As this device does not utilize a training set, the establishment of ground truth for such a set is not relevant.

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IDEAL IQ is a software option intended for use on GE MR systems. IDEAL IQ is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities.

IDEAL IQ is an acquisition and reconstruction technique that simultaneously obtains independent images of hydrogen nuclei that resonate at different frequencies to provide separation of water and triglyceride fat. IDEAL IQ generates images of separated water and triglyceride fat, relative triglyceride fat fraction map, and tissue transverse magnetization relaxation. In the liver, the relative triglyceride fat fraction map is quantitative; it reflects the proton density (number of protons per unit volume) of triglyceride fat, divided by the sum of the proton density of triglyceride fat and the proton density of water, on a voxel-by-voxel basis.

When interpreted by a trained physician, these images provide information that can aid in diagnosis.

IDEAL IQ is a software application offered as an option for GE MR scanners. The IDEAL IQ imaging technique (IDEAL: Iterative Decomposition of water and fat with Echo Asymmetry and Least-squares estimation) is a triglyceride fat and water separation technique that acquires multiple images of the anatomy at separate echo times to calculate the phase differences and determine triglyceride fat and water content per pixel. It exploits the resonance frequency differences between triglyceride fat and water, measured as phase differences in multiple echoes, to resolve triglyceride fat and water. It provides reliable and uniform water-fat separation in the presence of B0 field inhomogeneity and improves the accuracy of water-fat separation by estimating and correcting for T2* decay between echoes and by more accurately modeling triglyceride fat's spectral profile as multiple peaks rather than a single peak. It produces images showing the separated water and triglyceride fat signals, and the tissue transverse magnetization relaxation. Finally, IDEAL IO processes decomposed water and triglyceride fat images to generate a relative triglyceride fat-fraction map. Such a representation of a proton density triglyceride fat fraction is intrinsically insensitive to B1 and coil-sensitivity heterogeneity. The IDEAL IO method uses a low flip angle excitation to reduce any TI bias in the relative triglyceride fat fraction map images caused by differences in the TI of triglyceride fat and water. With the confounding effects of T2*, multiple spectral peaks of triglyceride fat, and T1 differences reduced, the images from IDEAL IQ reflect the spatial distribution of relative concentration of triglyceride fat in a voxel.

The provided text describes the "IDEAL IQ Software Option" for GE MR scanners. However, the document does not contain a table of acceptance criteria or a detailed study that explicitly proves the device meets specific performance criteria through a clinical trial with reported outcomes against predefined metrics.

The submission focuses on establishing substantial equivalence to a predicate device (IDEAL Software Option, K072998) and outlining non-clinical tests for safety and internal quality assurance.

Here's an attempt to answer your questions based on the available information, noting where information is not present:

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

Not provided in the document. The submission states: "Clinical image comparisons demonstrate that the IDEAL IQ software option maintains the same imaging performance results as the predicate software option IDEAL." This implies the acceptance criterion was "maintaining the same performance as the predicate device," but no specific metrics or reported performance values are given.

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

Not explicitly provided. The document mentions "several in vivo human studies showing correlation to MR Spectroscopy" for quantification in the liver. It also refers to "clinical image comparisons." However, no specific sample sizes for these studies or their data provenance (e.g., country of origin, retrospective/prospective) are detailed.

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

Not explicitly provided. The document mentions "When interpreted by a trained physician, these images provide information that can aid in diagnosis." This implies expert interpretation, but the number or qualifications of these experts are not specified for any studies mentioned.

4. Adjudication method for the test set

Not provided.

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 described for this device. The IDEAL IQ is described as a software option for acquisition and reconstruction to generate specific image types (separated water and fat images, fat-fraction maps). It is not presented as an AI-powered diagnostic aid that improves human reader performance. Its purpose is to provide quantitative information (e.g., relative triglyceride fat-fraction map) that aids diagnosis.

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

Yes, the device has standalone performance. The IDEAL IQ software itself generates the separated water and fat images, the relative triglyceride fat-fraction map, and tissue transverse magnetization relaxation maps. The "quantification in the liver" is shown through "correlation to MR Spectroscopy," suggesting a direct comparison of the algorithm's output (fat-fraction map) to a reference standard (MR Spectroscopy). The key output, the "relative triglyceride fat-fraction map," is inherently quantitative, reflecting the proton density of triglyceride fat per voxel.

7. The type of ground truth used

For quantification in the liver (fat-fraction map), the ground truth used was MR Spectroscopy.

For the general "clinical image comparisons" to demonstrate "same imaging performance results as the predicate software option IDEAL," the nature of the ground truth is not specified but would likely involve expert visual assessment and comparison for image quality and diagnostic utility, though this is inferred.

8. The sample size for the training set

The document describes IDEAL IQ as a software option for image acquisition and reconstruction that exploits physical phenomena (resonance frequency differences between fat and water). It is not a machine learning or AI algorithm that typically has a "training set" in the conventional sense. Therefore, a training set size is not applicable or provided.

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

As there is no traditional "training set" for this type of image reconstruction algorithm, this question is not applicable. The algorithm's principles are based on established physics and signal processing.

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The IDEAL LIFE Pod™ receives data wirelessly from IDEAL LIFE devices to transmit over the Internet or common telephone lines from the user's home. The Pod is an optional accessory to IDEAL LIFE devices, including the GlucoManager™, the BP-Manager™ and/or the Body Manager™. The Pod is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.

The IDEAL LIFE Pod makes no interpretation, evaluation, medical judgment or recommendations for treatment. This device is not intended as a substitute for medical care.

The IDEAL LIFE Pod is a simple, user-friendly wireless modem accessory that wirelessly receives data from IDEAL LIFE devices and transmits the data to the IDEAL LIFE website. The IDEAL LIFE database is updated securely with the user's information, which is available for review via secure Internet access. Using the Pod, an individual can more easily view and track their blood pressure, blood glucose, and/or body weight information.

The provided text describes a 510(k) submission for the IDEAL LIFE Pod™ Model ILP 0001, which is an accessory designed to wirelessly transmit data from other IDEAL LIFE devices (like GlucoManager™, BP-Manager™, and Body Manager™) to a website for review.

Crucially, this submission does not include a study with acceptance criteria and a detailed description of device performance in a clinical or analytical setting. The IDEAL LIFE Pod is a data transmission device, not a diagnostic or therapeutic device that directly measures physiological parameters. Its function is to transmit data, and the provided document focuses on demonstrating substantial equivalence to predicate devices based on software, hardware, and user experience, rather than performance against a specific clinical metric.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample size for test set, expert involvement, adjudication method, MCMC study, standalone performance, type of ground truth, training set details) cannot be extracted from the given text because such information is not present or relevant to the device's function as described.

The document states:

• "Differences with the new Pod have been demonstrated not to affect safety or effectiveness of the device, using software design controls, V&V testing, and user testing of the device."
• "Hardware, software, and the manufacturing processes are the same as the predicate Pod. Software controls and validation and verification testing have demonstrated that the software changes do not affect device performance."
• "Since the Pod is a wireless device, the radiofrequency interference and emissions have been tested and the Pod complies with appropriate FCC Standards."
• "User testing and historical experience with the Pod have demonstrated that the Pod can be used in the intended setting."

This indicates that the "study" was primarily focused on software validation and verification (V&V), hardware testing (specifically RF interference and emissions), and user testing/historical experience to confirm that the updated version of the Pod maintains its intended function and safety without introducing new risks compared to its predicate. There is no mention of performance metrics like accuracy, sensitivity, or specificity, which would typically be associated with diagnostic devices.

Summary of available information:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of clinical or analytical performance metrics. The implied criteria revolve around maintaining software and hardware functionality, compliance with FCC standards, and user-friendliness, equivalent to the predicate device.
   • Reported Device Performance: The text states, "Software controls and validation and verification testing have demonstrated that the software changes do not affect device performance." Also, "radiofrequency interference and emissions have been tested and the Pod complies with appropriate FCC Standards." And "User testing and historical experience with the Pod have demonstrated that the Pod can be used in the intended setting." No quantitative performance metrics (e.g., accuracy, reliability of data transmission rate, error rates) are provided.

2. Sample size used for the test set and the data provenance: Not mentioned. The testing described (software V&V, FCC compliance, user testing) does not detail sample sizes. Data provenance is not specified beyond "user testing and historical experience."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned. The device transmits data rather than making a diagnosis or measurement that would require expert ground truth.

4. Adjudication method for the test set: Not applicable or mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This type of study is for diagnostic devices where human readers interpret results.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is an "algorithm only" in the sense that its function is data transmission. The "testing" mentioned is its standalone functionality and compliance, but not in the context of diagnostic performance.

7. The type of ground truth used: Not applicable. The device's function doesn't involve generating data that requires a ground truth in a clinical sense. The "ground truth" for its operation would be successful data transmission and proper function.

8. The sample size for the training set: Not applicable or mentioned, as this is not a machine learning-based diagnostic device.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the 510(k) summary for the IDEAL LIFE Pod™ ILP 0001 details its function as a data transmission accessory and demonstrates its substantial equivalence to predicate devices through software/hardware validation, FCC compliance, and user testing. It does not provide information related to clinical or diagnostic performance studies with specific acceptance criteria or detailed results, as those are not within the scope of this device's intended use.

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The IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

This system offers Bluetooth wireless communication function which is able to transfer historical data in the memory to other devices, such as PC or IDEAL LIFE POD™

IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The provided document is a 510(k) summary for the IDEAL LIFE Gluco-Manager™ GMM 0001 Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and concludes that it demonstrates satisfactory performance. However, it does not contain the detailed performance study results, acceptance criteria, or ground truth establishment methods that would be required to fully answer your questions.

Therefore, I cannot provide a complete answer based solely on the provided text. I can, however, extract the information that is present and highlight what is missing.

Here's a breakdown of what can and cannot be answered:

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

• Acceptance Criteria: Not explicitly stated in the provided text. Blood glucose monitoring systems typically have specific accuracy criteria (e.g., ISO 15197 standards), but these are not listed.
• Reported Device Performance: The document only states, "The studies demonstrated that the performance of this system meets its intended use" and "IDEAL LIFE Gluco-Manager ™ GMM 0001 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use." No quantitative performance data (e.g., accuracy, precision, bias, MARD) is provided.

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

• Sample Size: Not specified for any test set.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users."

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)

• Ground Truth Experts: The document states "clinical settings by healthcare professionals and lay users," but it does not specify how many healthcare professionals were involved or their qualifications for establishing ground truth, nor does it explicitly mention ground truth methods for lay user data. For blood glucose monitoring, ground truth is typically established by laboratory reference methods, not by expert consensus on visual inspection or interpretation.

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

• Adjudication Method: Not specified. This concept (e.g., 2+1, 3+1) is more relevant to human interpretation of images or other subjective data, not typically for objective measurements like blood glucose where a reference method serves as the 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

• MRMC Study: Not applicable or mentioned. This is a blood glucose monitoring system, not an AI-powered diagnostic imaging device that assists human readers.

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

• Standalone Performance: Yes, implicitly. The "Performance Studies" section refers to the system's performance, which measures the accuracy of the device itself (meter + test strips) against reference methods. While users operate the device, the core performance measured is the algorithm's ability to accurately quantify glucose from the provided sample. The document does not detail these studies.

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

• Type of Ground Truth: Not explicitly stated, but for blood glucose monitoring systems, the ground truth is overwhelmingly a highly accurate laboratory reference method (e.g., YSI analyzer, hexokinase method). The document mentions "in the laboratory," which implies such reference methods would have been used.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/not mentioned. This device is an electrochemical blood glucose meter, not a machine learning or AI algorithm that undergoes a "training" phase in the conventional sense with a distinct training set. Its "training" is in its design and calibration, which would be validated through the performance studies.

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

• Training Set Ground Truth Establishment: Not applicable, as there's no explicitly defined "training set" in the context of an AI/ML algorithm. Calibration and validation data would have been compared against laboratory reference methods.

In summary, the provided document serves as a high-level summary for regulatory submission, confirming the device's technical characteristics and intended use. It does not contain the detailed technical data or study methodologies needed to answer specific questions regarding acceptance criteria, performance metrics, sample sizes, or ground truth establishment in a quantitative manner. Such information would typically be found in the full 510(k) submission, not the public summary document.

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IDEAL is a software option intended for use on GE Signa MR systems. It is indicated for magnetic resonance imaging of the musculoskeletal, breast, abdominal, and neurological systems of the human body.

IDEAL is an acquisition and reconstruction method that simultaneously obtains independent images of nuclei that resonate at different frequencies. IDEAL provides uniform tissue separation, reduces chemical shift artifacts, and minimizes the effects of magnetic field inhomogeneities. The IDEAL method provides higher image quality relative to chemically selective fat saturation techniques and STIR. Specific tissue for separation may include water and fat.

When used with a GE Signa MR system, IDEAL is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the cervical-spine, joints, and extremities. The independent images produced from IDEAL may be added or subtracted for tissue delineation.

The images reflect the spatial distribution of nuclei exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, molecular environment, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The IDEAL Software Option is a software only product for use on GE Signa MR scanners.

To improve the separation between fat and water, the IDEAL technique acquires three measurements of IDEAL echoes to resolve fat, water and the magnetic field variations. The IDEAL processing produces four images from the IDEAL echoes: a water image, a fat image, a combined water plus fat image, and a combined water minus fat image. This process helps achieve uniform fat suppression and reduce chemical shift artifacts.

The provided text makes a general statement about the device's performance relative to predicate devices but does not include specific acceptance criteria or a study detailing numerical performance results.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that IDEAL provides "higher image quality relative to chemically selective fat saturation techniques and STIR" but does not quantify this improvement with specific metrics or acceptance criteria.

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

Not available in the provided text.

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

Not available in the provided text. The document states that images should be "interpreted by a trained physician," but this refers to the intended use of the device, not the validation process.

4. Adjudication Method for the Test Set

Not available in the provided text.

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

Not mentioned in the provided text.

6. Standalone Performance Study

Not mentioned in the provided text. The device is described as "IDEAL is a software option for use on GE Signa MR systems," indicating it functions as an integrated component, not a standalone algorithm in isolation.

7. Type of Ground Truth Used

Not available in the provided text.

8. Sample Size for the Training Set

Not available in the provided text.

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

Not available in the provided text.

Summary of the Study Discussed in the Document:

The provided document, K072998, is a 510(k) summary of safety and effectiveness for the IDEAL Software Option for GE Signa MR Scanners. It is focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance metrics from a specific clinical study with acceptance criteria.

The conclusion states: "This premarket notification submission demonstrates that the IDEAL software option is substantially equivalent to the analogous feature in the cleared GE 1.5T and 3.0T Signa HDx MR Systems because it has the same intended use and differences in methodology do not raise new questions of safety and efficacy."

This indicates that the "study" proving the device meets its "acceptance criteria" (which in this context is primarily substantial equivalence) is the comparison to the predicate device, K052293. The acceptance criterion appears to be that the IDEAL software option has the same intended use and its methodological differences do not raise new questions of safety and efficacy compared to the predicate. No specific performance numbers or detailed study methodology (like expert reads, sample sizes, or ground truth establishment) are provided in this regulatory summary.

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The IDEAL LIFE BP-MANAGER™ is a non-invasive blood pressure monitor intended for the measurement of systolic and diastolic blood pressure and heart rate (pulse rate) using the oscillometric technique.

The IDEAL LIFE BP-MANAGER™ should be used in adults (individuals aged 18 and older) in a non-clinical environment such as in the home. The IDEAL LIFE BPMANAGER ™ should not be used on infants or children. The end user of this device should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. This device makes no interpretation, evaluation, medical judgeners or recommendations for treatment. Clinical judgment and experience are required for interpretation of information. This device is not intended as a substitute for reedical care.

The IDEAL LIFE POD™ is an optional accessory to the IDEAL LIFE BPMANAGER TM and is a transmitter that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting. The IDEAL LIFE POD™ is an optional accessory designed to ssist in the management of user information. This device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check or interpret information transmitted. This device is not intepded as a substitute for medical care.

The IDEAL LIFE BP-MANAGER™ is a single unit software-controlled device with a blood pressure cuff, and operation is automatic. The IDEAL LIFE BP-MANAGFER™ can bc used alone without any other accessories. Blood pressure and heart rate results are displayed on the screen of the IDEAL LIFE BP-MANAGER™. Up to 70 blood pressure readings are stored in the blood pressure computer processor. The device is not intended for self-diagnosis of discase and it is expected that individuals using the IDEAL LIFE BP-MANAGER™ will consult with a physician for interpretation of results.

If an individual desires automated graphical presentation of their blood pressure and heart rate data, the IDEAL LIFE POD™ may be purchased separately and used with the IDEAL LIFE BP-MANAGER™ as an optional accessory. The IDEAL LIFE POD™ is not required for operation of the IDEAL LIFE BP-MANAGER™ . The IDEAL LIFE POD™ is a simple transmitter (i.e., a wireless router) that is intended to transmit data obtained by the IDEAL LIFE BP-MANAGER™ to the internet via common telephone lines from the user's home setting.

The provided text describes the IDEAL LIFE BP-MANAGER™ and IDEAL LIFE POD™ devices. However, it does not contain specific acceptance criteria or detailed results from a study that definitively proves the device meets such criteria in a quantitative manner as requested in the input format.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

The document states that the performance testing was conducted "in accordance with the guidance document entitled 'Non-Invasive Blood Pressure (NIBP) Monitor Guidance' dated March 10, 1997." This guidance document would contain the actual acceptance criteria (e.g., accuracy ranges for blood pressure measurements).

However, the provided text does not explicitly list these acceptance criteria or the specific reported device performance values (e.g., mean difference and standard deviation of blood pressure readings compared to a reference standard). It only provides a general statement: "Results of these tests confirm the appropriate performance of both the IDEAL LIFE BP-MANAGER™ and the IDEAL LIFE POD™."

Therefore, a table cannot be fully constructed from the provided text.

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

The document mentions "performance testing in human volunteers" but does not specify the sample size for this test set. It also does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document states that performance testing included "performance testing in human volunteers." For a blood pressure monitor, the ground truth is typically established by trained medical professionals using a reference blood pressure measurement method (e.g., auscultation with a sphygmomanometer). However, the document does not specify the number of experts used or their qualifications.

4. Adjudication method for the test set:

The document does not mention any adjudication method for the test set.

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

This device is a blood pressure monitor and a data transmitter, not an AI-powered diagnostic tool requiring human interpretation of images or complex data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not mentioned.

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

The IDEAL LIFE BP-MANAGER™ is a standalone device for measuring blood pressure. The performance testing "in human volunteers" would inherently be a standalone performance evaluation of the algorithm's ability to measure blood pressure. However, the document does not explicitly label it as a "standalone" study in contrast to human-in-the-loop. The IDEAL LIFE POD™ is a data transmitter and doesn't have an "algorithm-only" performance in the sense of making medical judgments.

7. The type of ground truth used:

For the blood pressure measurements, the ground truth would typically be established by concurrent measurements using a validated reference method (e.g., auscultation by trained observers). While not explicitly stated as "ground truth," performance testing in human volunteers for a blood pressure monitor implies comparison against such a standard.

8. The sample size for the training set:

The document does not mention a training set or its sample size. Given the device's function as a blood pressure monitor, it's unlikely to have a "training set" in the context of machine learning. The device's calibration and algorithm development might have used a dataset, but it's not referred to as a "training set" in the provided text.

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

Since no training set is described, this information is not available.

In summary:

The provided document, a 510(k) summary, focuses on establishing substantial equivalence to predicate devices and generally stating that performance tests were conducted according to guidance. It lacks the specific quantitative details requested regarding acceptance criteria, sample sizes for testing, expert qualifications, or detailed study methodology. To obtain such information, one would typically need to refer to the full study reports that were submitted to the FDA, which are not included in this summary.

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The IDEAL® 1 ORTHODONTIC BAND CEMENT is indicated for bonding of orthodontic bands to natural and artificial tooth surfaces.

The IDEAL® 1 ORTHODONTIC BAND CEMENT is a light-cure two-part system: an orthodontic cement and a primer. A tooth conditioner is available if desired for the highest stress bonding cases. The cement is packaged in syringes. No mixing is necessary. The primer is packaged in unit dose, self-dispensing capsules.

The provided text is a 510(k) summary for the IDEAL® 1 ORTHODONTIC BAND CEMENT. It focuses on device description, intended use, and technological characteristics, asserting substantial equivalence to predicate devices based on component use and performance data. However, it does not include detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria. The document states: "We believe that the prior use of the components of the IDEAL® 1 ORTHODONTIC BAND CEMENT in legally marketed devices, the performance data provided, and the similarity of the prodicate to the new device support the safety and effectiveness of the IDEAL® 1 OILTHODONTIC BAND CEMENT for the intended uses." This implies that the 'performance data' was likely general characterization or referencing of the predicate device's performance, rather than a specific clinical study for this device detailed in the provided text.

Therefore, I cannot extract the requested information in the format provided because the document does not contain:

1. A table of specific acceptance criteria and reported device performance against them.
2. Details on sample sizes for test sets, data provenance, or the nature of any "performance data provided."
3. Information on experts, adjudication methods, or MRMC studies.
4. Details of a standalone algorithm performance study.
5. Clarification on the type of ground truth used.
6. Sample size or ground truth establishment for a training set.

The 510(k) summary primarily addresses the regulatory aspect of demonstrating substantial equivalence to a predicate device (Ideal® 1 Orthodontic Bracket Adhesive K033703) rather than presenting a detailed clinical or performance study for the IDEAL® 1 ORTHODONTIC BAND CEMENT.

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