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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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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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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:

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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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 defects may be surgically created osseous defects created by traumatic injury to the bone. 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. OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation. OSTEOREVIVE™ is resorbed and replaced with bone during the healing process. OSTEOREVIVE™ must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

OSTEOREVIVE™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. OSTEOREVIVE™ consists of a powder component and a liquid component (modified saline solution) that are mixed at the time of surgery. The powder components include ß-tricalcium phosphate, magnesium oxide, monopotassium phosphate, and monosodium phosphate. The mixing liquid is saline with monosodium phosphate. After mixing and setting OSTEOREVIVE™ is a non-porous solid material. OSTEOREVIVE™ is provided sterile to the end user in 5 cc, 10 cc, and 15 cc sizes.

The provided text is a 510(k) summary for the OSTEOREVIVE™ bone void filler and does not contain information about an AI/ML-driven medical device requiring the specified acceptance criteria and study details.

The document describes a resorbable calcium salt bone void filler device and its substantial equivalence to predicate devices, referencing performance testing related to chemical composition, physical properties, sterilization, shelf life, biocompatibility, bacterial endotoxin testing, drillability, and animal testing in a rabbit posterolateral spine fusion model. There is no mention of an AI/ML component, human readers, or any typical acceptance criteria associated with AI/ML device performance (e.g., sensitivity, specificity, AUC).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria, as the provided text does not relate to an AI/ML device.

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The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The Mixing and Delivery System is used to mix graft material such that it can be delivered to the patient. The system is comprised of the mixing/delivery syringe and auxiliary components including a threaded spindle with nut, open bore luer cap, pusher and cannulae which provide alternative methods of delivery for the mixed material.

This document describes the 510(k) premarket notification for the "Mixing and Delivery System" by Bone Solutions, Inc. The document is a review of the device for substantial equivalence to legally marketed predicate devices. It does not provide detailed information about clinical studies or specific acceptance criteria for AI/ML device performance.

Based on the provided text, here is an analysis of the requested information:

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

The document does not explicitly state numerical "acceptance criteria" in the context of device performance as one might expect for an AI/ML algorithm. Instead, it lists non-clinical performance testing conducted to demonstrate that the device performs as intended and met all specified criteria.

Note: The phrase "met all specified criteria" indicates that the device performed acceptably against these tests, implying these were the "acceptance criteria" for these particular tests. The document does not provide specific quantitative thresholds for these criteria.

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

This document pertains to a medical device (a mixing and delivery system for bone graft material), not an AI/ML diagnostic or prognostic algorithm. Therefore, the concepts of "test set," "sample size," and "data provenance" in the context of image data or patient data are not applicable here. The testing mentioned is engineering/performance testing of the physical device.

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 an AI/ML device requiring expert ground truth for a test set.

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

Not applicable. This is not an AI/ML device involving expert adjudication for a test set.

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

Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.

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)

Not applicable. The ground truth for the performance tests (Liquid and Air Leak Testing, Separation from Axial Load Testing, Disconnection Torsional Testing, Sterility Validation Testing and Packaging Validation Testing) would be based on established engineering standards and specifications, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. This is not an AI/ML algorithm that requires a training set or ground truth for training.

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The Bone Solutions Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The Bone Solutions Mixing and Delivery System is commercially available disposable medical piston syringe (syringe barrel with female luer, plunger) to facilitate mixing and a funnel to facilitate filling of the syringe barrel. The system with a 14 mL syringe barrel and will be provided empty.

This document is a 510(k) premarket notification for the "Bone Solutions Mixing and Delivery System." This notice is for a Class II medical device, specifically a piston syringe. The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate.

The provided text focuses on the substantial equivalence of the Bone Solutions Mixing and Delivery System to an existing device rather than presenting a study with specific acceptance criteria and performance metrics for a standalone device. In the context of a 510(k) for a device like a piston syringe, "acceptance criteria" and "device performance" are typically demonstrated through comparisons to a predicate device and verification of basic functional requirements, material safety, and sterility, rather than clinical efficacy studies with numerical targets.

Based on the provided text, here's an analysis of the information related to acceptance criteria and the "study" (in this case, the substantial equivalence justification):

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics like a clinical trial report would. Instead, it relies on demonstrating substantial equivalence to a predicate device.

The core "acceptance criteria" for this 510(k) is that the Bone Solutions Mixing and Delivery System is substantially equivalent to the ETEX Mixing and Delivery System (K141245) in terms of:

• Design
• Manufacturing materials
• Intended use
• Principles of operation
• Technical characteristics
• Safety and effectiveness (i.e., it raises no new issues of safety or effectiveness compared to the predicate).

The "reported device performance" is essentially the assertion that these equivalences hold true, as stated in the following phrases:

• "The Bone Solutions Mixing and Delivery System is substantially equivalent to the predicate device, in which the basic features and intended uses are the same."
• "The identical mixing syringes, made of identical materials, have been provided to both manufacturers by the same qualified supplier, as verified in the design history file."
• "The lack of gradation markings on the BSI syringe does not change the performance or biocompatibility compared to the predicate."
• "Additions from the accessory tray are considered minor and do not raise questions concerning safety and effectiveness."

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

• Sample Size for Test Set: This type of information (e.g., number of units tested for specific material properties or functional aspects) is not detailed in the provided summary. The 510(k) summary focuses on the justification of equivalence rather than presenting raw test data. Information about specific mechanical or material tests would typically be found in the full 510(k) submission's supporting documentation (e.g., engineering reports, biocompatibility reports), which is not part of this summary.
• Data Provenance: Not specified in this summary. The "study" here is a regulatory comparison rather than a data-driven clinical or performance study with provenance like country of origin or retrospective/prospective design.

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 and not present in the document. The "ground truth" for a substantial equivalence determination in a 510(k) for a device like this is the established safety and effectiveness of the predicate device, and the new device's compliance with general controls and recognized standards. Expert panels for establishing "ground truth" in terms of diagnoses or outcomes are not part of this type of submission.

4. Adjudication method for the test set:

• Not applicable. There is no "test set" in the sense of a clinical or image-based diagnostic study requiring adjudication. The FDA's review process itself involves regulatory experts evaluating the submitted documentation for compliance and equivalency.

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/diagnostic imaging device, and therefore, an MRMC study is not relevant to this submission.

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

• Not applicable. This is not an algorithm-based device. It is a physical medical device (piston syringe).

7. The type of ground truth used:

• The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (ETEX Mixing and Delivery System, K141245). The submission asserts that the new device shares fundamental technological characteristics and intended use with this predicate, and thus is equally safe and effective.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."

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

• Not applicable, as there is no training set for this type of device.

In summary:

This document is a 510(k) summary for a relatively low-risk Class II device (piston syringe). The "study" presented is a demonstration of substantial equivalence to a predicate device, rather than a clinical trial or performance study with quantitative acceptance criteria and detailed test set sample sizes and ground truth establishment methods for diagnostic accuracy. The FDA's acceptance is based on the argument that the new device is fundamentally the same as a device already on the market, thereby implying it meets the same safety and effectiveness standards.

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Bone Solutions. Inc., OsteoCrete™ Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. OsteoCrete™ Bone Void Filler is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

OsteoCrete™ is an injectable, moldable, and biocompatible Bone Void Filler. The OsteoCrete™ Bone Void Filler Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.

The provided text describes the OsteoCrete™ Bone Void Filler and its 510(k) submission but does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding the test set, expert involvement, or statistical methods typically associated with AI/ML device evaluations.

The relevant section in the document states:

"OsteoCrete™ Bone Void Filler was subjected to performance testing Performance Data: (bench and animal) in accordance with the FDA Guidance Document, 'Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler; Guidance for Industry and FDA.' The testing confirmed substantial equivalence to the predicate device."

This indicates that the device underwent non-clinical performance testing (bench and animal studies) to demonstrate substantial equivalence to predicate devices, as per FDA guidance for this type of medical device (resorbable calcium salt bone void filler). These types of devices are not typically AI/ML-driven, and therefore, the information requested in your prompt regarding AI/ML study design (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions below with the provided text.

1. A 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)

Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission focusing on bench and animal testing for substantial equivalence, not a clinical study involving a test set of data with human-in-the-loop or standalone AI performance.

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. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission focusing on bench and animal testing for substantial equivalence, not a clinical study involving experts establishing ground truth for data for AI/ML validation.

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

Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission, not an AI/ML study requiring adjudication methods for a test set.

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

Not applicable. The provided text describes a non-AI/ML medical device (bone void filler) and its 510(k) submission. MRMC studies are specific to evaluating human reader performance with and without AI assistance, which is not relevant to this device.

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

Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). Standalone algorithm performance is relevant to AI/ML devices, not to this product.

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

Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). "Ground truth" in the context of AI/ML validation is not relevant here. The "performance data" mentioned refers to bench and animal testing results demonstrating physical and biological properties.

8. The sample size for the training set

Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). Training sets are relevant to AI/ML model development, not to this product.

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

Not applicable. The provided text describes a non-AI/ML medical device (bone void filler). Training set ground truth is relevant to AI/ML model development, not to this product.

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