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Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

In the posterolateral spine and intervertebral disc space, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender. When used in intervertebral body fusion procedures, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.

The anorqanic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine Achilles tendon.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

This is a 510(k) premarket notification for a medical device called "Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix". The document confirms FDA clearance and discusses the device's indications for use and substantial equivalence to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the traditional sense of a performance study with defined metrics for the device itself.

The document focuses on establishing substantial equivalence to predicate devices. This means that the FDA has determined the new device is as safe and effective as a legally marketed device that does not require premarket approval.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• No "AI" or "Algorithm": This is a bone graft matrix, a physical medical device. It's not a software device or an AI-powered system, so concepts like "AI assistance," "human-in-the-loop," "ground truth," "training set," "test set," "experts," or "adjudication methods" are not applicable.
• Focus on Substantial Equivalence: The "study" mentioned is not a performance study against acceptance criteria for an AI or software device. Instead, it refers to the comparison of the subject device to predicate devices to demonstrate substantial equivalence.

However, I can extract the relevant information regarding the "study" (in the context of demonstrating substantial equivalence) and the "performance" as described:

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

Since this is not a software/AI device with performance metrics like sensitivity, specificity, or accuracy, a traditional acceptance criteria table is not present. The "performance" is primarily described by its material composition and functional characteristics, and its equivalence to predicate devices.

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

Not applicable. This is not a study assessing performance of a diagnostic or AI device using a test set of data. The "testing" refers to non-clinical assessments, material characterization, and comparison to predicate devices, not data-driven performance metrics against a "test 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)

Not applicable. This is not a study requiring expert-established ground truth for a test set.

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 document is not about AI assistance or human reader performance.

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

Not applicable.

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

Not applicable. The "ground truth" for this device's safety and effectiveness is established by its demonstrated equivalence in material, design, and performance characteristics to previously cleared predicate devices through non-clinical testing (e.g., material testing, sterilization validation, biocompatibility) and the absence of new safety/effectiveness concerns.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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Mineral Collagen Composite Bioactive Extra Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

For spine application Mineral Collagen Composite Bioactive Extra Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.

Mineral Collagen Composite Bioactive Extra Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteroconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.

The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material of all organic components from bovine bone. The anorganic bone mineral meets ASTM F1581 standard specifications for the composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meeting ASTM F1538 standard specifications for malantation. The purified type I collagen is derived from bovine Achilles tendon.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

The provided 510(k) summary for the "Mineral Collagen Composite Bioactive Extra Moldable" device indicates that no new acceptance criteria or specific studies proving the device meets these criteria were conducted for this submission (K231942).

Instead, the submission relies on the substantial equivalence to predicate devices (K221735 and K182074) and states that the performance data, including sterilization, pyrogenicity, biocompatibility, and animal testing results, remain the same as those previously submitted for the predicate devices. No new clinical studies were required.

Therefore, many of the requested details about acceptance criteria and study particulars for this specific submission are not explicitly provided because the device's performance is asserted to be equivalent to previously cleared devices, and thus relies on their past demonstrations of meeting acceptance criteria.

However, based on the information provided, we can infer some details:

1. Table of Acceptance Criteria and Reported Device Performance:

Since new performance criteria are not explicitly stated for this submission, the "acceptance criteria" here refer to the standards that the predicate devices met, which are then carried over to the current device due to substantial equivalence.

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

• Sample Size for Test Set: Not applicable for this submission as no new testing was conducted to establish acceptance criteria for K231942. The "test set" and corresponding sample sizes would have been part of the predicate device submissions (K221735 and K182074). The document states, "In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device and remains the same as that submitted for the primary predicate device (K221735) and the secondary predicate device (K182074)."
• Data Provenance: Not specified for this submission, as it relies on previous submissions. It's not stated whether the original predicate studies were retrospective or prospective, or their country of origin.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable as no new specific ground truth establishment for a test set was detailed for this submission.

4. Adjudication Method for the Test Set:

• Not applicable as no new specific test set and adjudication method were detailed for this submission.

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

• No, an MRMC comparative effectiveness study was NOT done. The device is a "Resorbable Calcium Salt Bone Void Filler Device," which is a physical implant, not an AI or imaging diagnostic device that would typically involve human reader studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

• No, a standalone performance study was NOT done. This is not an algorithmic or AI device.

7. Type of Ground Truth Used:

• Not explicitly defined for this submission in the context of a new test set. For the predicate devices, the "ground truth" for demonstrating performance would likely involve histopathology (for bone ingrowth and resorption in animal studies), material characterization data (for biocompatibility and physical properties), and microbiological testing (for sterility).

8. Sample Size for the Training Set:

• Not applicable as this is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable as this is a physical medical device, not a machine learning model.

In summary, this 510(k) relies entirely on the demonstration of substantial equivalence to previously cleared predicate devices, asserting that the change (improved moldability) does not alter the fundamental performance as previously established. Therefore, no new primary studies to define and meet acceptance criteria were conducted or reported in this specific submission.

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Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

For spine applications, Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.

The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine Achilles tendon.

The product is available in various sizes and is provided sterile, non-pvrogenic, and for single use only.

The provided text is a 510(k) summary for the Mineral Collagen Composite Bioactive Moldable device. This document describes a medical device seeking regulatory clearance, not an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing (biocompatibility, sterilization, pyrogen, packaging, shelf life, and animal studies). Clinical studies were explicitly not required for this determination.

Here's an attempt to answer the questions based on the provided document, highlighting where the requested information is not applicable:

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

The document does not specify quantitative acceptance criteria in a table format for performance. Instead, it relies on demonstrating that the device performs substantially equivalently to its predicate and reference devices, particularly for the expanded indications for use.

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

• Animal Study: The document mentions "a rabbit femoral condyle critical-sized defect model." It does not specify the number of rabbits or exact sample size used for this study.
• Data Provenance: The studies mentioned (biocompatibility, sterilization, pyrogen, packaging, shelf life) were completed under the original submission (K182074). The animal study appears to be part of the current submission, likely conducted for the expanded indications. The country of origin and whether the data was retrospective or prospective is not specified, but animal studies are typically prospective.

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

This information is not applicable as this is not an AI/ML device requiring human expert annotation for ground truth. Ground truth for a bone void filler would typically be established through histological analysis of tissue regeneration in the animal model. The document does not specify who conducted such analyses or their qualifications.

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

Not applicable for this type of device and study.

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 not an AI/ML device that assists human readers.

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

Not applicable. This is not an AI/ML algorithm.

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

For the animal study, the "ground truth" for assessing device performance would primarily be based on pathology/histology of bone regeneration and integration within the rabbit femoral condyle defects, comparing the test device to the reference device. The document states "The results demonstrate performance substantially equivalent to the reference device with regards to the expansion of the indications for use," implying such an assessment was made.

8. The sample size for the training set

Not applicable. This 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.

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Mine 2.1 is a portable medical diagnostic-purpose X-ray generator that can be hand-held. The device uses an adjustable tube voltage and a fixed tube current for producing diagnostic x-ray images of extremities for both adults and pediatrics. It is intended to be used by a qualified and trained clinician on all patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

Mine 2.1, a portable X-ray generator, is radiation medical equipment that can only be used by professional radiologists. It controls and marks X-ray dose within the range of X-ray exposure limited by hardware. Also, it uses the algorithm of X-ray output for processing and control. This portable X-ray generator requires equipment for X-ray imaging in order to generate X-ray images. Small in size, this product is convenient to carry with, and suitable for being moved around. The main body can be compatibly used with a stand. When attached to a stand, it is easy to adjust positioning for medical imaging. MINE ALNU is programmed to be inoperable when the SSD is less than 40cm to the irradiation target.

The VL53L1X, a laser-ranging sensor, the fastest miniature Time-of-Flight (ToF) sensor on the market with accurate ranging up to 4 m and fast ranging frequency up to 50Hz. VL53L1X contains a laser emitter and corresponding drive circuitry. The laser output is designed to remain within Class 1 laser safety limits under all reasonably foreseeable conditions including single faults in compliance with IEC 60825-1: 2014.

The x-ray detectors, a necessary part of a complete imaging system, are not part of the current submission. The device is not intended to be used with a mechanical grid.

The provided text is a 510(k) summary for the MINE ALNU X-ray generator. It focuses on demonstrating substantial equivalence to a predicate device (Remex KA6) based on technical characteristics and adherence to safety standards. The document does not describe a study involving a comparison of an AI algorithm's performance against human readers, nor does it detail a standalone AI algorithm's performance.

Instead, the "performance testing" described in the document refers to engineering and safety performance of the X-ray generator itself, not an AI or diagnostic algorithm's accuracy. The "acceptance criteria" mentioned relate to electrical safety, electromagnetic compatibility, radiation leakage, and image quality of the X-ray generation hardware, not the diagnostic accuracy of an AI.

Therefore, many of the requested points regarding AI acceptance criteria, study design for AI evaluation, expert ground truth, MRMC studies, and training data are not applicable (N/A) to the content of this document.

Here's a breakdown based on the information provided:

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

The document discusses "acceptance criteria" in the context of the device's hardware performance and safety rather than an AI's diagnostic performance. The criteria are primarily related to compliance with various IEC standards and FDA's EPRC Performance Standard (21 CFR 1020.30 and 31).

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

The document describes non-clinical bench testing and compliance evaluations for the X-ray generator's hardware. It does not mention a "test set" in the context of diagnostic images or patient data for an AI algorithm.

• Test Set Sample Size: N/A (not an AI performance study with a test set of images)
• Data Provenance: N/A (no patient data or image data set discussed for AI evaluation)

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

N/A. This document is about the X-ray generator hardware, not an AI algorithm requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method for the test set

N/A.

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. The submission does not involve an AI diagnostic algorithm.

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

N/A. The device is an X-ray generator, not a standalone AI algorithm.

7. The type of ground truth used

N/A. Ground truth in the context of diagnostic accuracy is not discussed. The "ground truth" for this device's performance is adherence to established engineering and safety standards.

8. The sample size for the training set

N/A. There is no mention of an AI training set.

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

N/A.

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The MINE is intended to be used by trained dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

MINE, a portable dental X-ray system, operates on 11.1V DC supplied by a rechargeable LiPolymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger.

The portable X-ray system. MINE, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The operating principle of MINE starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)

This device contains a high frequency inverter that converts direct to alternating current, X-ray tube head, electrical protective devices, and other elements. The MINE produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

The provided text is a 510(k) summary for the medical device "MINE," an extra-oral x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device ("EXARO") rather than presenting a clinical study with detailed acceptance criteria and performance data for AI/human reader studies.

Therefore, the information requested in the prompt regarding acceptance criteria, study design for AI/human reader performance, sample sizes, expert qualifications, and ground truth establishment for such studies is not available in the provided text. The document explicitly mentions non-clinical testing and phantom images to demonstrate performance.

Here's a breakdown of what is available in relation to your prompt:

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

The document does not provide a table of acceptance criteria for a clinical performance study with defined metrics (e.g., sensitivity, specificity, AUC) for an AI or human reader outcome. Instead, it focuses on demonstrating compliance with safety and performance standards relevant to an X-ray device itself.

The "reported device performance" is primarily about the device's technical specifications and adherence to standards:

The document notes that "Phantom images were provided to demonstrate the overall performance of the device as part of a complete intraoral x-ray imaging chain." This suggests a technical performance evaluation, not a clinical efficacy study involving diagnostic accuracy.

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

• Not applicable / not provided. The document describes a technical device and its compliance with performance standards, primarily through non-clinical testing and phantom images. There is no mention of a "test set" for a clinical study involving diagnostic accuracy.

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

• Not applicable / not provided. As there is no clinical test set described, there's no information on experts establishing ground truth for diagnostic purposes.

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

• Not applicable / 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:

• Not applicable / not provided. This device is an X-ray source, not an AI-powered diagnostic tool. The submission is for a traditional medical device, demonstrating substantial equivalence to another X-ray device based on technical specifications and safety standards.

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

• Not applicable / not provided.

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

• Not applicable / not provided. The device's performance was assessed through phantom images and compliance with electrical/radiation safety standards, not clinical ground truth.

8. The sample size for the training set:

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

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

• Not applicable / not provided.

In summary: The provided document is a 510(k) summary for an X-ray device, focusing on its technical specifications, safety, and substantial equivalence to a predicate device. It does not contain information about acceptance criteria or study results for AI performance, human reader studies, or associated ground truth establishment, as it's not relevant to the type of device being cleared.

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Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender.

The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.

The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine deep flexor Achilles tendon.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

The provided text is a 510(k) Summary for a medical device called "Mineral Collagen Composite Bioactive Moldable." It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets them.

Here's why and what's missing:

• Acceptance Criteria and Reported Device Performance: This document states that in vivo and in vitro testing was conducted to demonstrate substantial equivalence, and "The results of the animal study demonstrate performance substantially equivalent to the predicate device Vitoss BA and performance substantially equivalent to autograft when used as an autograft extender." However, it does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., bone formation percentage, fusion rates, mechanical strength) or provide tables comparing the device's performance against these criteria. It only makes a general statement of "substantially equivalent."

• Sample Size for Test Set and Data Provenance: The document mentions "posterolateral spine fusion rabbit model" for the in vivo study, but does not specify the sample size (number of rabbits or test articles) used in this test set. It also doesn't explicitly state the country of origin or whether the data was retrospective or prospective, though animal studies are typically prospective.

• Number of Experts and Qualifications for Ground Truth: This information is not present in the document. Ground truth for animal studies often involves histological analysis by veterinary pathologists, but this detail is missing.

• Adjudication Method: This information is not present in the document.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not mention an MRMC study. The study described is an animal in vivo study comparing the device to a predicate and autograft, not a human reader study.

• Standalone (Algorithm Only) Performance: This device is a physical bone graft matrix, not an algorithm. Therefore, a "standalone algorithm performance" assessment is not applicable.

• Type of Ground Truth Used: For the animal study, the ground truth would likely be based on histological analysis and potentially imaging (e.g., X-rays, micro-CT) assessed by experts (e.g., veterinary pathologists, radiologists). While not explicitly stated, this is standard for such studies.

• Sample Size for Training Set: Since this is a physical device and not an AI/ML algorithm, there is no "training set" in the context of an algorithm's development. The "training" for the device would be its manufacturing process.

• How Ground Truth for Training Set Was Established: As above, this concept is not applicable to a physical medical device.

In summary, while the document confirms that studies were conducted to support the device's substantial equivalence, it lacks the detailed breakdown of acceptance criteria, specific performance metrics, sample sizes, and expert involvement that your request specifies for AI/ML or diagnostic device evaluations. The information provided is typical for a 510(k) summary for a physical implantable device, focusing on material composition, biocompatibility, and in vivo performance relative to predicates.

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Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

Mineral Oil is used to cover medium during embryo, oocyte, and sperm culture in assisted reproduction technology (ART) and micro-manipulation procedures. Mineral Oil is recommended for use as an overlay for a small volume of medium to prevent evaporation stable osmolality and pH.

The material composition:

High Purity Paraffin Oil comes in two density types:

• Light type has a ratio between 0.8200 to 0.8400 g/mL (15°C) and a viscosity which is between 8.850 to 11.70mm²/s (37.78°C)
• Heavy type has a ratio between 0.8500 to 0.8700 g/mL (15°C) and a viscosity which is between 41.90 to 44.10mm²/s (37.78°C).

There are two types of products, Mineral Oil - Light and Mineral Oil - Heavy. Two different unit sizes (100mL and 50mL) are available for each type. Mineral oils are colorless, tasteless, clear oil fluids which do not produce fluorescence.

Both Mineral Oils (Heavy and Light) do not contact the ova or embryo during culture. Mineral Oil is filter sterilized and dispensed into sterile light-resistant glass bottles.

The provided text describes a 510(k) premarket notification for a medical device called "Mineral Oil" used in assisted reproductive technology. This is not the type of document that typically includes information about acceptance criteria and a study proving the device meets those criteria, as one would find for a software-based AI/ML medical device.

The document is a US FDA 510(k) clearance letter and summary for a physical product (Mineral Oil) which functions as a reproductive media supplement. It aims to demonstrate "substantial equivalence" to a predicate device rather than independently proving safety and efficacy through extensive clinical studies and AI performance metrics.

Therefore, many of the requested categories for acceptance criteria and study details for an AI/ML device are not applicable or cannot be extracted from this document. However, I can extract the "non-clinical performance data" which serves as the "acceptance criteria" and "device performance" for this specific product, as well as some details about its testing.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not available:

1. Table of Acceptance Criteria and Reported Device Performance & 7. The type of ground truth used:

The acceptance criteria for this non-AI/ML device are based on non-clinical performance tests designed to establish substantial equivalence concerning safety and effectiveness. The "ground truth" here is essentially the compliance with these established biological and chemical specifications.

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

The document does not specify exact sample sizes for each non-clinical performance test. It only states that tests were completed. Data provenance is not detailed beyond the manufacturer being "KITAZATO BioPharma Co., Ltd." in Japan. The tests are non-clinical (laboratory-based), not human data, so "retrospective or prospective" does not apply in the typical sense.

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

This is not applicable as the "ground truth" for these non-clinical tests is based on established laboratory standards (e.g., USP <71>, <271>), chemical specifications, and biological assay outcomes, rather than expert interpretation of medical images or patient data.

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

Not applicable for non-clinical laboratory tests.

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 for a physical medical device (mineral oil), not an AI/ML device.

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

Not applicable. This is a physical product, not an algorithm.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set. The "device" itself is the mineral oil which is manufactured according to specifications.

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

Not applicable. This is not an AI/ML device.

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MINERVA 58 ALLOY is indicated as a dental alloy for fabricating MOD inlays, crowns, bridges, precision milling bars and attachments, and partial dentures.

MINERVA 58 ALLOY is a high noble, gold-based dental alloy.

The provided document is a 510(k) summary for a dental alloy, MINERVA 58 ALLOY, and not an AI/ML device. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition and prior marketing history in Europe.

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Indicated clinical applications include use as repair of pulpal exposures.

Mineral Trioxide Aggregate (MTA) is a cement-like substance which seals off all pathways of communication between the root canal system and the external surface of the tooth. Indicated clinical applications include use as repair of pulpal exposures. The powder consists of fine hydrophilic particles which set in the presence of moisture. Hydration of the powder results in a colloidal gel which solidifies to a hard structure.

Mineral Trioxide Aggregate is biocompatible, and exhibits significantly better adaptation to dentinal walls than other materials. It possesses a high degree of sealability; the presence or absence of blood does not affect its sealing ability. Setting time after hydration and application is approximately three hours. In tests, its compressive strength at 21 days is about 70 Mpa. Use of MTA requires only the appropriate hydration of the powder to a viscous consistency. The mixture can then be placed over the exposure site and gently patted into place using a moistened cotton ball if necessary.

This document provides a summary for a 510(k) submission for a medical device, Mineral Trioxide Aggregate (MTA), a dental cement. It does NOT contain the details of an acceptance criteria study as typically understood in the context of an AI/ML or diagnostic device.

The information provided describes the device, its intended use, and states that it is substantially equivalent to other devices on the market. It highlights some performance characteristics like setting time and compressive strength, but these are descriptive properties of the material, not acceptance criteria from a formal study proving clinical effectiveness or diagnostic accuracy.

Therefore, most of the requested information cannot be extracted from this text. Here's a breakdown of what can and cannot be answered:

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

Missing Information/Not Applicable:
The document does not define specific, quantifiable acceptance criteria for clinical outcomes (e.g., success rate of pulpal exposure repair) or diagnostic performance (e.g., sensitivity, specificity, AUC), nor does it present data from a formal clinical study designed to meet such criteria. The "performance" values described are material properties from laboratory tests.

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

• Not provided. This document is a summary for a 510(k) submission, not a detailed study report. The "tests" mentioned (e.g., for compressive strength) are likely laboratory material tests, not clinical trials with a test set of patients.

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. There is no "test set" of patient data in the sense of a diagnostic or AI study mentioned. Ground truth as typically defined for such studies is not relevant here.

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

• Not applicable. See point 3.

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 dental material, not an AI/ML-driven diagnostic or assistive device for human readers.

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

• Not applicable. This is not an algorithm.

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

• Not applicable. The "ground truth" for a dental cement would be its measured physical and biological properties in laboratory and potentially animal studies, and then clinical outcomes in human trials. This document reports some physical properties ("compressive strength") from "tests" (implying lab measurements), but doesn't detail clinical ground truth or how it was established.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. See point 8.

In summary, this document fulfills the requirements of a 510(k) summary for a traditional medical device by describing its properties and claiming substantial equivalence. It does not provide the kind of detailed study information (especially concerning acceptance criteria for diagnostic performance, sample sizes, expert ground truth, or AI/ML study design) that would be expected for a submission involving software or AI.

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