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Found 15 results
510(k) Data Aggregation
(150 days)
Mg OSTEOINJECT™
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.
Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process.
Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOREVIVE™
Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.
Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOCRETE™
Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.
Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETE™ must be used with morselized autograft and/or allograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
This submission includes three (3) devices with separate trade names bundled into the single 510(k) application. The purpose of this application is to expand the indications to include specific language for use in pediatric patients > 6 years old. The subject devices are a magnesium-based synthetic bone void filler that is moldable, drillable, resorbable, adhesive/cohesive, radiopaque, and osteoconductive. The subject devices consist of a powder component (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction occurs to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.
N/A
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(70 days)
Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine. When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETE™ must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft and or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
The subject devices are a magnesium-based synthetic bone void filler that is moldable, drillable, resorbable, adhesive, radiopaque, and osteoconductive. The subject devices consist of a powder component (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction occurs to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.
The provided text is a 510(k) Premarket Notification from the FDA regarding two bone void filler devices, Mg OSTEOREVIVE™ and Mg OSTEOCRETE™. This document primarily outlines the administrative information, device classification, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
The document states: "No clinical data were included in this submission." and focuses on non-clinical testing data leveraged from a previous submission (K234013) to demonstrate substantial equivalence, including chemical composition, physical properties, sterilization, shelf life, and biocompatibility.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and reported device performance (for AI/ML performance).
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
This document pertains to the clearance of a medical device (bone void fillers) based on demonstrating substantial equivalence to existing predicate devices through non-clinical data, not on the performance evaluation of an AI/ML component.
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(48 days)
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.
Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process.
Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be tysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.
Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.
Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETETM must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
The subject devices are a magnesium-based synthetic bone void filler that is moldable, injectable, drillable, adhesive/cohesive, radiopaque, and osteoconductive. The subject devices comprises a powder component (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.
The provided text is a Medical Device 510(k) Premarket Notification from the FDA. It does not describe acceptance criteria or a study that proves the device meets those criteria. Instead, it is a notification letter and a "510(k) Summary" which highlights the device's intended use, classification, comparison to predicate devices, and performance data summary.
Specifically, the "PERFORMANCE DATA" section states: "No clinical data were included in this submission." This indicates that there was no clinical study performed to demonstrate the device meets acceptance criteria in a human clinical setting. The submission primarily relies on non-clinical testing and leveraging data from previously cleared predicate and reference devices to demonstrate substantial equivalence.
Therefore, I cannot provide the requested information from the given text because the information regarding acceptance criteria and a study to prove the device meets these criteria (especially in a clinical context with human subjects/data) is explicitly stated as not included in this submission.
The document discusses:
- Non-clinical testing data referenced from other K numbers (K212991, K071004) for aspects like chemical composition, physical properties, sterilization, shelf life, biocompatibility, drillability, and use as an adjunct to hardware fixation.
- Bacterial endotoxin testing (LAL test) meeting a specified limit, again demonstrating a non-clinical performance aspect.
- Comparison to predicate devices to establish substantial equivalence.
It does not describe:
- Acceptance criteria for clinical performance (e.g., success rates in healing, pain reduction, etc.).
- A clinical study with human subjects, patient data, ground truth establishment by experts, or MRMC studies.
Without such information in the provided text, I cannot generate the table or answer the specific questions about clinical study design and results.
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(235 days)
The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
· Acute traumatic fracture of the femoral head or neck;
· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
The iNSitu Total Hip System femoral stems are intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.
The subject device Mg-PSZ Ceramic Femoral Head is manufactured from Zirconia Mg-PSZ ceramic material, which is the same material that comprises the predicate BioPro Ziralloy modular ceramic head. The subject device Mg-PSZ Ceramic Femoral Heads, including all sizes and offsets, have the same or similar design features and indications for use as the primary predicate device (Biolox Delta ceramic femoral head). The NextStep Arthropedix Mg-PSZ Ceramic Femoral Heads are packaged and sterilized using identical processes as the primary predicate device Biolox Delta femoral heads.
The provided text does not contain information about an AI/ML-driven medical device, its acceptance criteria, or a study proving that an AI/ML device meets these criteria. Instead, it is an FDA 510(k) clearance letter for a Mg-PSZ Ceramic Femoral Head, a physical medical device used in hip replacements.
Therefore, I cannot extract the information required for an AI/ML device, such as:
- Acceptance criteria and reported device performance (for an AI/ML device): The document reports on mechanical performance of a physical hip implant (static burst strength, fatigue testing, disassembly testing), not performance metrics for an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
- Sample size for test set and data provenance: Not applicable to a physical implant's mechanical testing.
- Number of experts and qualifications for ground truth: Not applicable to engineering tests of a physical implant.
- Adjudication method for test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a physical device, not an AI assisting human readers.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Ground truth here refers to actual physical properties and performance under stress, measured in laboratories, not clinical diagnoses or outcomes for AI.
- Sample size for training set (for an AI/ML device): Not applicable, as there is no AI training. The "training" for this device would be its design and manufacturing process.
- How ground truth for training set was established: Not applicable.
The document discusses preclinical performance testing for the Mg-PSZ Ceramic Femoral Head to evaluate its strength and performance characteristics and demonstrate substantial equivalence to predicate devices. This involves:
- Testing per ISO7206-10 and ASTMF2345 for:
- Static Burst-Strength Testing
- Fatigue Testing
- Static Burst-Strength, Post-Fatigue Testing
- Disassembly testing per ISO7206-10 and ASTM F2009, and torque testing per ISO 7206-13 for:
- Static Pull-Off (Axial) Strength
- Static Torque-Off/Strength
- Material requirements per ASTM F2393.
- Bacterial endotoxin testing per FDA guidance and ANSI/AAMI ST72.
The conclusion is that based on "comparison of technological characteristics and performance testing," the device is substantially equivalent to predicate devices.
To provide the requested information, the input text would need to describe an AI/ML-powered medical device and a study evaluating its clinical or diagnostic performance.
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(57 days)
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOINJECT™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. The Mg OSTEOINJECT™ Kit contains powder (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The device is provided sterile to the end user for single-use only in two sizes, 3 cc and 5 cc.
The provided text describes the 510(k) premarket notification for the Mg OSTEOINJECT™ device. This is a medical device submission, and the content primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study or AI model evaluation.
Therefore, the information required to populate the requested table and answer the study-related questions (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) is not present in the provided document. The document explicitly states:
"No clinical data were included in this submission." (Page 4, under "PERFORMANCE DATA")
The performance data mentioned ("Non-clinical testing data... referenced from K212991") pertain to:
- Chemical composition
- Physical properties
- Sterilization
- Sterile barrier shelf life
- Product shelf life
- Biocompatibility
- Drillability
- LAL testing for bacterial endotoxins
These are all non-clinical tests assessing the physical characteristics, safety, and sterility of the device, and are not related to an AI model's performance on medical images or clinical outcomes.
Based on the provided text, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a bone void filler and not an AI/imaging device requiring performance metrics like sensitivity/specificity, there are no "acceptance criteria" in the traditional sense of an AI model's performance on a test set. The acceptance here is based on substantial equivalence to a predicate device.
The document highlights the following characteristics that demonstrate equivalence, acting as de-facto "performance" attributes:
| Feature / Comparison | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (as per submission) |
|---|---|---|
| Composition (Mineral Components) | Identical to K212991 Predicate | β-tricalcium phosphate (8%), Magnesium oxide (41%), Monopotassium phosphate (44%), Monosodium phosphate (3%) |
| Material Form (Before setting) | Powder and liquid components | Powder and liquid components |
| Post-mixing/setting Properties | Injectable, sets in surgical site, cohesive paste | Injectable, sets in surgical site, cohesive paste |
| Porosity/Granule Size (after setting) | Non-porous solid | Not applicable, non-porous solid |
| Scaffold/Binder | None | None |
| Radiopacity | Not explicitly stated as a criterion, but mentioned if relevant for clinical use | Mentioned as "radiopaque" in device description |
| Resorbability | Resorbed and replaced with bone during healing process | Resorbed and replaced with bone during healing process |
| Drillability | Demonstrated in predicate testing (referenced) | Demonstrated in predicate testing (referenced) |
| Adjunct to hardware fixation | Can be used as adjunct | Can be used as adjunct |
| Sterility | Provided sterile | Provided sterile |
| Sterilization Method | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use |
| Bacterial Endotoxin Limit | ≤ 20 EU/device (for implanted devices) | Met the limit acceptance criterion (≤ 20 EU/device) |
| Non-clinical performance | Met standards demonstrated by predicate | Chemical composition, physical properties, sterilization, sterile barrier shelf life, product shelf life, and biocompatibility demonstrated to be equivalent. |
2. Sample size used for the test set and the data provenance:
- Not applicable. No clinical test set data was included. The performance details are based on non-clinical testing and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical ground truth was established for this submission.
4. Adjudication method for the test set:
- Not applicable. No clinical test set was evaluated.
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 bone void filler, not an AI diagnostic/imaging assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable. No clinical ground truth was established. Performance demonstration relies on non-clinical testing results and substantial equivalence to a predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning product.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this device.
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(145 days)
The MGB LAPBAG sterile retrieval bag for Endoscopic surgery is intended to be used for:
- -General surgery
- Abdominal surgery - .
- Gynecological surgery -
- Thoracic minimally invasive procedures. -
The Specimen Retrieval Bag is indicated for use in endoscopic procedures to allow tissues or debris to be removed from the abdominal cavity.
Not Found
I am sorry, but the provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to MGB Endoskopische Geräte GmbH Berlin regarding their MGB Disposable Retrieval Bag/LAPBAG. It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, study methodologies, or ground truth details.
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(30 days)
Total knee replacement is indicated for patients suffering from severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, or pseudogout. These devices are intended for cemented use only.
Stemmed tibial baseplate components are part of the MG II Total Knee System. They incorporate a central stem with available modular stem extensions. There are three versions of stemmed tibial baseplate components: Porous, PMMA Precoat, and Option (non-coated). They are available in the same size range, and are compatible with the same articular surface components, as the predicate device.
The provided document is a 510(k) summary for a medical device (MG II™ Total Knee System Stemmed Tibial Baseplate Components) and a clearance letter. This type of regulatory submission for orthopedic implants differs significantly from the type of information you'd find for AI/ML-based medical devices.
Therefore, the document does not contain any of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for an AI/ML algorithm.
Instead, it's a submission for a physical orthopedic implant and focuses on demonstrating substantial equivalence to a predicate device based on design modifications and non-clinical performance (mechanical testing).
Here's why the requested information isn't present:
- No AI/ML Component: The device is a knee prosthesis, not an AI/ML diagnostic or predictive tool.
- Regulatory Pathway: The 510(k) pathway for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, often through bench testing and comparison of materials, design, and intended use, rather than clinical efficacy studies involving human readers or AI performance metrics.
- "Performance Data (Nonclinical and/or Clinical)" Section: The document explicitly states:
- "Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device." This refers to mechanical or material testing, not AI performance.
- "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device." This confirms no clinical studies were performed, which would be essential for AI/ML device validation.
In summary, this document does not describe the acceptance criteria and study proving an AI/ML device meets those criteria because the device in question is a physical orthopedic implant, not an AI/ML system.
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(28 days)
The MGP 15 Dicom Theater device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The MGP 15 Dicom Theater is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners.
The MGP 15 Dicom Theater device is a digital image display system
The MGP 15 Dicom Theater consists of components to provide high resolution visualization of digital images.
This 510(k) premarket notification (K042942) for the Barco MGP 15 Dicom Theater is for a digital image display system. As such, it is not an AI/ML device and the concept of "acceptance criteria" and a "study proving the device meets the acceptance criteria" in the context of diagnostic performance metrics like sensitivity, specificity, or reader agreement is not applicable here.
This submission focuses on demonstrating substantial equivalence to a predicate device (Dicom Theater, K033153) for its function of displaying and viewing digital images for review by trained medical practitioners. The "acceptance criteria" for such a device would relate to technical specifications, image quality, and compliance with standards, rather than clinical performance metrics.
The provided documents do not contain information about:
- A table of acceptance criteria and reported device performance: This type of table is relevant for medical devices with diagnostic or AI/ML components where performance metrics like sensitivity, specificity, accuracy, etc., are measured against predefined targets. For a display system, performance would be characterized by technical specifications like resolution, brightness, contrast, color depth, viewing angles, and compliance with DICOM standards, none of which are detailed here.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, or how ground truth was established: These details are typically found in studies evaluating the diagnostic performance of a device, especially AI/ML systems. Since the MGP 15 Dicom Theater is a display system, these types of studies are not relevant to its regulatory clearance.
In summary, based on the provided text, the MGP 15 Dicom Theater is a display system, not an AI/ML diagnostic tool. Therefore, the questions posed regarding acceptance criteria validated by clinical performance studies are not applicable to this device and no such information is present in the 510(k) summary.
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(64 days)
The MGC DAU Control Set consists of unassayed controls intended for use in the validation of drug of abuse assays performed using human urine.
Each configuration of the MGC DAU Control Sets is prepared in a human wine matrix, with stabilizers and preservatives added. As is shown in the table below, the MGC DAU Control Set is offered in three configurations differing only in the concentration and number of analytes offered.
The provided text is a 510(k) summary for a medical device called "MGC DAU Control Sets: Primary, Clinical and Select," which are drug mixture control materials. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one might for an AI/ML diagnostic device.
Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable (N/A) in this context, as this submission is for a quality control material and relies on demonstrating similar physical properties and intended use to a previously cleared device.
Here's a breakdown based on the provided text, indicating N/A where information is not present or relevant to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not present a formal table of quantitative acceptance criteria and corresponding reported performance data in the typical sense of a diagnostic or therapeutic device. Instead, it relies on a qualitative comparison of characteristics to a predicate device to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (MGC DAU Control Sets) |
|---|---|---|
| Intended Use | For use as unassayed control material with drugs of abuse assays. | The MGC DAU Control Set consists of unassayed controls intended for use in the validation of drug of abuse assays performed using human urine. (Substantially equivalent) |
| Analytes | Benzoylecgonine, EDDP, LSD, d-Methamphetamine, Methadone, Methaqualone, Opiates, Benzodiazepenes, Phencyclidine, Propoxyphene, Barbituates (as per predicate's list). | Primary Config: Benzoylecgonine, EDDP, d-Methamphetamine, Methadone, Methaqualone, Opiates, Benzodiazepenes, Phencyclidine, Propoxyphene, BarbituatesClinical Config: Benzoylecgonine, EDDP, d-Methamphetamine, Methadone, Opiates, Benzodiazepenes, Phencyclidine, Propoxyphene, BarbituatesSelect Config: 6-Acetylmorphine, Benzoylecgonine, LSD, MDMA, Benzodiazepenes(Variations exist, but presented as acceptable configurations for "stated intended use" via substantial equivalence). |
| Matrix | Urine | Urine (Substantially equivalent) |
| Control Form | Liquid | Liquid (Substantially equivalent) |
| Control Levels | Two: Low and High | Two: Low and High (Substantially equivalent) (Specific concentrations are provided for the subject device in a table, implying they were tested and found suitable for the stated purpose within the context of their intended use, which is validation of assays, not necessarily diagnostic accuracy performance). |
| Storage | 2°C to 8°C until expiration date | 2°C to 8°C until expiration date (Substantially equivalent) |
| Stability | Until expiration date noted on vial label | Until expiration date noted on vial label (Substantially equivalent) |
Note: The "acceptance criteria" here are implicitly met by demonstrating that the device characteristics are "substantially equivalent" to those of a legally marketed predicate device (Multi-Drug Control Set, K951135). The study in this context is the comparison itself, showing that "each configuration of the MGC DAU Control Set is substantially equivalent in form and function to the Multi-Drug Control Set (K951135) for its stated intended use."
2. Sample size used for the test set and the data provenance
This submission does not describe a traditional "test set" in the context of diagnostic accuracy or algorithm performance. The evaluation is a comparison of device characteristics and intended use to a predicate device. There are no "samples" of patient data or images. The "data provenance" is the manufacturer's internal characterization of their product and comparison to their previously cleared product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a quality control material submission, not an AI/ML diagnostic. There's no ground truth established by experts for a test set in this context. The "truth" is related to the chemical composition and stability of the control materials, which are characterized through laboratory methods by the manufacturer.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No adjudication method is applicable as there's no diagnostic test set with human interpretations requiring consensus.
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
N/A. This is a quality control product, not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an algorithm or an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like this, the "ground truth" for the control materials themselves would be their assigned target concentrations (expected values) and their stability characteristics, which are determined through highly controlled analytical chemistry methods and manufacturing processes, rather than expert consensus on clinical cases, pathology, or outcomes data. The submission relies on the established safety and effectiveness of a predicate device with similar "ground truth" generation.
8. The sample size for the training set
N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
N/A. This is not an AI/ML device.
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(203 days)
The MGD 2621P Medical Grayscale Display is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The MGD 2621P is a diagnostic display
The provided text is a 510(k) summary for the Barco MGD 2621P Medical Grayscale Display. This document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets these criteria.
The 510(k) summary focuses on general device information, intended use, and substantial equivalence to a predicate device (Barco MGD 221 2 Megapixel Diagnostic Display - K000293). It describes the device's technical characteristics as a high-resolution monitor with electronic capabilities for evaluating high-resolution medical images.
The letter from the FDA confirms market clearance based on substantial equivalence but does not delve into specific performance studies or acceptance criteria for the display itself. It mainly cites relevant regulations and guidelines for the manufacturer.
Therefore, I cannot provide the requested table or answer questions 1-9 based on the input text. The document is essentially a regulatory clearance notice, not a detailed performance study report.
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