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NEOTIS Plate is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

The NEOTIS plate is designed for medial approach High Tibial Osteotomy stabilization. Anatomically shaped, thin and short, the NEOTIS plate enables minimally invasive surgery. The changes brought by the NEOTIS plate are as follows (vs. OTIS-C Plus plate):

• The proximal temporary screw is replaced with a pin that offers a simpler and faster placement of the plate. The area of the cortical bone drilled through the process is also reduced.
• The distal temporary screw is replaced with an AO screw in order to maintain compression. The compression will be maintained by the 4 permanent 6.5 mm screws (OTIS screws).

The provided documentation describes a traditional 510(k) submission for the NEOTIS Plate and Screws, a medical device for bone fixation. Here's a breakdown of the acceptance criteria and the study information as extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions a "cadaver study" but does not provide details on the number of cadavers or specimens used.
• Data Provenance: The cadaver study is implied to be laboratory-based (non-clinical performance testing). The document does not specify the country of origin for the cadaver data, nor does it explicitly state if it was retrospective or prospective, though "non-clinical performance testing" typically implies prospective experimental testing.

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

• The documentation does not provide information about experts establishing ground truth for the cadaver study. The study appears to be a mechanical performance test rather than one requiring clinical interpretation by experts to establish ground truth.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The study described is a non-clinical performance test, not a study involving human interpretation with adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The device is hardware (plate and screws), not an AI algorithm or diagnostic tool that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, this is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• For the cadaver study, the "ground truth" was the level of compression induced by the device during placement. This is a direct physical measurement/observation in a controlled experimental setting, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. The device is not an AI/ML algorithm.

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When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, Aspect Systems.

When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from the L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, or Streamline MIS Systems.

When used as a vertebral body replacement (VBR) device (C-Plus, Rotate. Bullet-Tip, T-Plus, Contact, CrossFuse, CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Quantum Spinal Fixation System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the VBR device is intended to be used with bone graft.

The Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System consists of a variety of different footprints and heights which enable the surgeon to choose the implant best suited to an individual's pathology and anatomical condition. Supplemental anterior and/or posterior fixation is intended for use with the device to ensure stability of the spine and adequate compression of the implant. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique. The components are manufactured from a radiolucent polymer (PEEK Optima®) in order to allow radiographic imaging inside the implant to evaluate fusion status. The purpose of this submission is a line extension to add an additional design to the currently available C-Plus implants. The subject implants are for Cervical Intervertebral Body Fusion only. Class I (exempt) orthopedic manual surgical instruments are also available.

The provided text describes a 510(k) Summary for an Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical trials or AI/algorithm performance studies. Therefore, many of the requested elements regarding acceptance criteria, study design, ground truth, and AI performance are not applicable to the information provided.

Here's an analysis based on the available text:

Acceptance Criteria and Device Performance

The device demonstrates substantial equivalence through pre-clinical mechanical testing. The acceptance criteria are implicitly met by demonstrating that the mechanical strength of the subject device is substantially equivalent to a legally marketed predicate device and sufficient for its intended use.

• Static torsion strength in accordance with ASTM F2077.
• Static subsidence strength per ASTM F2267.
• Static expulsion strength per Draft Standard Z8423Z.
• Overall mechanical strength sufficient for intended use and substantially equivalent to a predicate device. | - "Mechanical testing showed that the mechanical strength of the subject system is substantially equivalent to a legally marketed predicate and sufficient for the intended use."
• Specific numerical results from these tests are not provided in the summary but were performed.
• "Any differences [between subject and predicate devices] were not considered significant based on mechanical bench testing." |

Study Details (Not Applicable for this 510(k) Summary)

The provided text describes a pre-clinical bench testing study focusing on mechanical strength, not clinical performance, AI/algorithm performance, or human reader effectiveness. Therefore, the following items are not relevant to this submission:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices undergoing mechanical testing, not a dataset of medical images or patient records. The provenance is internal lab testing.
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 mechanical testing is established by physical measurement against ASTM standards, not expert clinical interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is a medical device (implant) submission, not an AI/imaging software submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device (implant) submission, not an AI/imaging software submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the mechanical performance testing is established by ASTM standards and measurements of physical properties like compression, torsion, subsidence, and expulsion.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study conducted was a pre-clinical mechanical bench testing of the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System. This involved performing various tests to assess the device's static compression, static torsion, static subsidence, and static expulsion characteristics. The results of these tests were compared against established ASTM standards (F2077, F2267) and a draft standard (Z8423Z), as well as against a legally marketed predicate device. The conclusion was that the device's mechanical strength is substantially equivalent to the predicate and sufficient for its intended use.

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OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies

The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTIS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The design of the self-tapping OTIS-C Plus screws (unmodified) allows easy and reliable one step locking, without counter-nut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.

This 510(k) submission describes a medical device, not a diagnostic AI/ML device. Therefore, the questions related to AI/ML specific performance criteria, ground truth, and expert evaluation are not applicable.

Here's an analysis of the provided text in the context of device acceptance criteria and study information:

Device Acceptance Criteria and Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The criteria are implicitly derived from the established safety and effectiveness of the predicate.

Study Description:

1. Sample size used for the test set and the data provenance: Not explicitly stated as this is a non-clinical, mechanical testing study. The "test set" would refer to the physical samples of the OTIS-C Plus device and its components used for the performance testing. The provenance of the data is from SCIENCE FOR BIOMATERIALS, a French company. The study is prospective in the sense that the testing was performed on the newly designed modified device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical engineering study, not an imaging or diagnostic study requiring expert interpretation for ground truth. The "ground truth" is established by the physical laws and engineering principles governing the materials and their interactions.
3. Adjudication method for the test set: Not applicable. This refers to consensus methods for expert opinions, which is not relevant for mechanical testing.
4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device or a diagnostic device involving human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used: For the mechanical performance tests (fretting corrosion, torsional yield strength, etc.), the "ground truth" is the established scientific and engineering principles for material properties and device performance under specified conditions, as measured by standard laboratory tests. For the Finite Element Method (FEM) analysis, the "ground truth" or reference for comparison is the mechanical behavior and fretting corrosion of the predicate device (K100604).
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

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OTIS-C Plus is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial Opening wedge osteotomies.

The OTIS-C Plus plate is designed for the stabilization of High Tibial Osteotomy with a medial approach. Anatomically shaped, thin and short, the OTTS-C Plus plate enables mini-invasive surgery. Its locking system provides immediate compression of the graft as well as stable fixation, thus allowing early weight-bearing. The selftapping OTIS-C Plus screws allows easy and reliable one step locking, without counternut, in a simple and concise approach. With its range of twelve screws lengths, fixation can be either mono or bi-cortical, upon the choice of the surgeon.

The provided document is a 510(k) summary for a medical device (OTIS-C Plus) and does not contain information about a study with acceptance criteria often seen for AI/ML-driven devices. Instead, it describes non-clinical performance testing for a traditional metallic bone fixation appliance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information, ground truth types) are not applicable to the information provided in this document excerpt.

However, I can extract the relevant information regarding the performance claims and the type of testing performed.

1. Table of acceptance criteria and the reported device performance

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 for the non-clinical performance testing. The "test set" in this context refers to the samples of the device components (plates and screws) used for mechanical and corrosion testing, not a clinical data set.

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 is not applicable. The ground truth for mechanical testing is derived from engineering standards and physical measurements, not expert consensus.

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

This is not applicable. Adjudication methods are typically used for clinical study data, not for non-clinical mechanical testing.

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 is not applicable. This document describes a traditional medical device (bone plate and screws), not an AI/ML-driven diagnostic or assistive technology.

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

This is not applicable. This describes a physical medical device.

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

For the non-clinical performance testing, the "ground truth" (or reference standard) would be established by engineering standards, material properties, and validated testing methodologies (e.g., ISO, ASTM standards for material testing) to measure the mechanical properties of the device components.

8. The sample size for the training set

This is not applicable. This document describes a traditional medical device, not an AI/ML system requiring a training set.

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

This is not applicable. This document describes a traditional medical device, not an AI/ML system.

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This product is intended for dermatological use by physicians and healthcare professionals for the following:

• Removal of unwanted hair in all skin types (from 570- to 1200mm filter) .
• Treatment of vascular and benign pigmented lesions, cutaneous lessons including . warts, scars, striae and facial and leg veins (from 550 to 1200mm filter).
• Treatment of Acne (from 390 to 1200nm filter) .

The device is designed and manufactured to emit a high intensity pulsed light applied to the patient's skin. The light is emitted by a quick discharge of capacitors on a xenon flash lamp with a high energy. The lamp delivers a wavelength in the band of 390-1200nm. The three principal parts of this system are:

• The Principal Unit which contain all circuitry to control the device.
• The Handpiece contains circuitry to control the Lamp & Filter group.
• The Lamp & Filter group is a removable box that contains Xenon Flash Lamp and Filter mounted on to the handpiece.

The provided documents do not contain information about acceptance criteria, device performance, or any studies with sample sizes, expert ground truth, or adjudication methods.

The documents are primarily a 510(k) premarket notification summary and a clearance letter from the FDA for the EPI-C PLUS device. They describe the device, its intended use, and indicate that it has been found substantially equivalent to a predicate device.

Specifically, the information requested in the prompt, such as:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance study
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

is not present in the provided text. The FDA clearance is based on substantial equivalence to a predicate device, implying that the safety and effectiveness are considered comparable based on existing data or established principles, rather than new performance studies detailed in these specific documents.

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The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N₂O), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO-), nitrous oxide concentration (%N2O), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking.

The monitor consists of line-powered console (with optional back-up battery) which is placed outside the magnet boren, and appropriate electrodes, transducers, cables and tubes to allow the patient to be monitored during the examination. The console enclosure is a Faraday cage for the protection of sensitive electronic circuits.

The provided text describes the 510(k) summary for the MAGLIFE C/MAGLIFE C Plus patient monitor. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

The device is evaluated based on its ability to function without degradation in performance within an MRI environment and to not interfere with the MRI unit. The reported performance suggests it meets these criteria.

Since this is a 510(k) submission for a patient monitor and the studies are non-clinical tests, much of the requested information regarding clinical studies, ground truth, and expert evaluation is not applicable or explicitly stated in this document.

Here's an attempt to answer the remaining questions based on the provided text, indicating "Not Applicable" or "Not Stated" where the information is missing:

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 applicable as these were non-clinical engineering and bench tests, not patient data tests. The "sample" would be the device itself.
• Data Provenance: Not applicable. The tests were presumably conducted internally by SCHILLER MEDICAL or a contracted testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of Experts: Not applicable. Ground truth for these non-clinical tests would have been established by engineering standards and direct physical measurements/observations by testing personnel, not medical experts.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This refers to expert review of clinical cases. For non-clinical tests, compliance is typically determined by meeting predefined technical specifications or 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

• MRMC Study: No, an MRMC study was not done. This type of study involves human readers interpreting cases, often with AI assistance, which is not relevant for a patient monitor's non-clinical validation.
• Effect Size: Not applicable.

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

• Standalone Performance: While the "device" itself functions standalone in terms of its monitoring capabilities, the testing described is primarily about its physical and electromagnetic compatibility within an MRI environment, not an AI algorithm's standalone diagnostic performance. No "algorithm only" performance study in the context of AI is described.

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

• Type of Ground Truth: For the non-clinical tests described, the "ground truth" was established by engineering standards, physical laws, and direct measurement (e.g., whether the device moved, whether images showed visible differences, ability to function at a certain field strength). This is not equivalent to clinical ground truth derived from pathology or expert consensus.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a patient monitor, and there is no mention of an AI/machine learning component that would require a "training set" in the context of the 510(k) summary provided.

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

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

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Dried Rabbit Brain Thromboplastin with Calcium. For use in prothrombin time (PT) determinations and prothrombin time based assays.

Dade® Thromboplastin C Plus is a lyophilized preparation of dried rabbit brain with calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.

Here's a summary of the acceptance criteria and study details for the Dade® Thromboplastin C Plus, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Max. Error Criteria %CV" column in the precision study. The device performance (Total %CV) is compared against these maximum allowable values. For the method comparison studies, the "Coefficient of Correlation (r)" values suggest that a strong positive correlation (closer to 1) is desired, though a specific threshold for acceptance isn't explicitly stated. However, given the context of demonstrating substantial equivalence, values close to 1.0 are indicative of good performance.

• BCTTM/BCTTM: r = 0.951
• BCSTM/BCTTM: r = 0.935
• Sysmex® CA-1500/BCT: r = 0.965
• Sysmex® CA-6000/BCT: r = 0.943
• Sysmex® CA-500/BCT: r = 0.975 |
  | Precision Study (Derived Fibrinogen) | %CV should be ≤ Max. Error Criteria %CV (10%) | Control Plasma N (CPN): Total %CV = 5.4% (vs. 10% criteria)
  Control Plasma P (CPP): Total %CV = 1.1% (no criteria specified for this low-level control, but low is good)
  Normal Plasma Pool (NPP): Total %CV = 4.6% (vs. 10% criteria)
  Pathological Plasma Pool (PPP): Total %CV = 4.5% (vs. 10% criteria) |

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

• Test Set Sample Size: For the method comparison studies, the sample sizes ranged from 103 to 176 specimens, depending on the analyzer used. For the precision study, each control/plasma pool had 40 replicates (n=40).
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• This information is not applicable as the device is an in vitro diagnostic (IVD) for laboratory testing, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these studies would be the actual fibrinogen concentration or prothrombin time as measured by an established reference method (the predicate device, Multifibren™ U, in the comparison study).

4. Adjudication Method for the Test Set

• Not applicable. As an IVD, an adjudication method by human experts is not typically used for establishing ground truth for chemical/coagulation assays. Ground truth is based on the reference method's results.

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 an IVD for prothrombin time and fibrinogen determination, not an AI-assisted diagnostic tool for human readers.

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

• Yes, a standalone performance study was done. The studies presented (method comparison and precision studies) demonstrate the performance of the Dade® Thromboplastin C Plus reagent in conjunction with automated coagulation analyzers. These are essentially standalone performance evaluations of the reagent and analyzer system.

7. The Type of Ground Truth Used

• For Method Comparison Studies: The ground truth was essentially the measurements obtained using the predicate device, Multifibren™ U. The goal was to show strong correlation and agreement between the new device and the predicate.
• For Precision Studies: The ground truth for calculating variability (%CV) would be the true/reference value of the control plasmas, which are characterized for their expected fibrinogen levels.

8. The Sample Size for the Training Set

• Not applicable. The provided text describes performance validation studies for an IVD reagent. There is no indication of a machine learning model or "training set" in the context of this device's development or regulatory submission.

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

• Not applicable. (See point 8.)

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For the calibration of test systems for the measurement of HDL and LDL Cholesterol in human serum or plasma.

The Boehringer Mannheim c.f.a.s. - HDL/LDL-C plus calibrator consists of lyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol.

The provided text is a 510(k) Summary for a medical device, specifically a calibrator used in diagnostic tests for HDL and LDL cholesterol. This type of document is for regulatory clearance and does not typically include detailed study results, acceptance criteria, or performance metrics in the way a clinical study report would.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) Summary focuses on demonstrating "substantial equivalence" to a predicate device, not on presenting novel performance data from a clinical trial with acceptance criteria. It states:

• "The Boehringer Mannheim Direct LDL-Cholesterol test is substantially equivalent to other products in commercial distribution intended for similar use."
• "The intended use of this BM calibrator and the predicate devices is the same..."

For this type of device (a calibrator), the "performance" demonstrated for regulatory clearance would likely involve analytical studies confirming its accuracy, precision, and stability as a calibrator, ensuring it produces expected values when used with compatible test systems. However, these specific details are not present in the provided text.

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