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MagnetOs MIS is intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the extremities, pelvis, intervertebral disc space and posterolateral spine, MagnetOs MIS may be used standalone or with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs MIS must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

MagnetOs MIS resorbs and is replaced with bone during the healing process.

MagnetOs MIS includes a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs MIS graft material is a mixture of ceramic granules premixed with a synthetic polymeric binder that provides cohesion between the granules. The ceramic portion of MagnetOs MIS consists of 65–75% tri-calcium phosphate (TCP – Ca3(PO4)2) and 25–35% hydroxyapatite (HA – Ca10(PO4)6(OH)2) granules.

While the polymeric binder is rapidly resorbed after implantation, the granules of MagnetOs MIS guide the three-dimensional regeneration of bone in the defect site into which it is implanted. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling.

MagnetOs MIS graft material is provided in a 5cc pre-filled cartridge, packed together with a delivery system kit in a ready-to-use format. The MagnetOs MIS delivery system allows users to apply the bone graft into the defect. MagnetOs MIS is gamma-sterilized and sterile packaged for single use only.

Based on the provided FDA 510(k) clearance letter for MagnetOs MIS, the device is a bone void filler, which is a Class II medical device. The information details the device's characteristics and its substantial equivalence to predicate devices, primarily based on design, materials, and existing data from previously cleared products.

However, the provided document does not contain any information about acceptance criteria and a study that proves the device meets those criteria, specifically regarding AI/ML performance, diagnostic accuracy, or human reader improvement. The document focuses on the physical and material properties of the bone void filler and its delivery system, along with regulatory compliance related to device classification and manufacturing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them in the context of AI/ML performance, ground truth, expert adjudication, or MRMC studies. The document explicitly states: "No additional animal performance or clinical data was provided to support substantial equivalence for the proposed indications. Instead, animal and clinical data from previous clearances of the additional predicate devices were leveraged to support the current submission, as recommended in the FDA's Class II Special Controls Guidance document for Resorbable Calcium Salt Bone Void Filler Devices."

This indicates that the clearance was based on demonstrating the new device's material and design equivalence to already cleared devices, rather than new clinical or AI performance studies for this specific submission.

If you have a different document or would like to provide more context about an AI/ML component related to a similar device, please do so, and I would be happy to analyze it.

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MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the extremities, pelvis, intervertebral disc space and posterolateral spine, MagnetOs Easypack Putty may be used standalone or with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.

MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Easypack Putty consists of 65-75% Tri-Calcium Phosphate (TCP - Ca3(PO4)2) and 25-35% Hydroxyapatite (HA - Caro(PO4)6 (OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. The granules are covered with submicron-sized features and are premixed with a synthetic binder. New bone will be deposited on the surface of the implant. The implant resorbs and is replaced by bone during the natural process of bone remodeling.

MagnetOs Easypack Putty is a ready-for-use product. Pressure applied by manipulation allows the shaping of the devices to conform to the contours of bony defects. MagnetOs Easypack Putty is gammasterilized, comes in several sizes in block form and is sterile packaged for single use only.

The provided document is a 510(k) summary for a medical device called "MagnetOs Easypack Putty." It details the device's characteristics, indications for use, and a demonstration of its substantial equivalence to predicate devices. However, the document does not contain information regarding software or AI components, nor does it specify detailed "acceptance criteria" in the typical sense of a pass/fail threshold for an AI model's performance metrics (e.g., AUC > 0.90, Sensitivity > 95%). Instead, it discusses the device's physical properties, biocompatibility, and clinical performance related to its function as a bone void filler.

Therefore, I cannot extract the specific information requested in questions 1-9 as they pertain to AI/software acceptance criteria and performance studies. The document describes a traditional medical device (a bone void filler) where "performance" relates to its ability to resorb and promote bone healing, not to the diagnostic accuracy of an AI algorithm.

The closest analogue to "acceptance criteria" in this document is demonstrating substantial equivalence to predicates through:

• Bench testing data: analytical characterization, chemical composition, physical properties.
• Biocompatibility testing: LAL test, pyrogenicity study, sterilization.
• Clinical/Animal performance data: fusion-based imaging assessment (for interbody fusion), animal performance data for other uses.

Since the request specifically asks about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device, and this document describes a physical medical device, I must state that the requested information is not available in the provided text.

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MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty may be used standalone or mixed with autograft. When used in intervertebral body fusion procedures, MagnetOs Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Putty resorbs and is replaced with bone during the healing process.

MagnetOs Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Putty consists of 65-75% Tri-Calcium Phosphate (TCP - Cas(PO4)2) and 25-35% Hydroxyapatite (HA - Ca10(PO4)6 (OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. The surface of the granules in MagnetOs Putty is covered with needle-shaped features that are submicron in size. The granules are premixed with a synthetic polymeric binder. The biocompatible polymeric binder is composed of Poly L (Lactic Acid) (PLA) and Poly(Ethylene Glycol) (PEG) in a triblock polymer PLA-PEG-PLA; which consists of 10-20% PLA and 80-90% PEG.

The fast-resorbing polymeric binder in the subject device is designed to improve handling properties, as well as reduce the risk of granules migration. While the polymeric binder is rapidly resorbed after implantation, the granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted.

When placed next to viable host bone, new bone will be deposited on the surface of the implant. The implant resorbs and is replaced by bone during the natural process of bone remodeling.

MagnetOs Putty is a ready-for-use product. Pressure applied by manipulation allows the shaping of the devices to conform to the contours of bony defects. MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is sterile packaged for single use only.

MagnetOs Putty is MRI (Magnetic Resonance Imaging) Safe.

This document is a 510(k) summary for the MagnetOs Putty, a medical device intended to fill bony voids or gaps. The submission aims to expand its indications for use to include intervertebral disc space in conjunction with an intervertebral body fusion device.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes performance testing but does not explicitly list quantitative acceptance criteria for many of the tests, nor does it provide specific numerical results or performance metrics in a structured table. Instead, it states that the device "met the acceptance criteria" or "passed" certain tests.

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

The document refers to "non-clinical testing data, supplemented with clinical data" from a prior clearance (K230736). However, no specific sample sizes for test sets are mentioned for any of the individual tests (biocompatibility, endotoxins, pyrogenicity, sterilization, shelf-life, or in-vitro studies).

• Data Provenance: The document generally refers to "non-clinical testing data" and "animal functional studies," and "in-vitro studies." It also mentions "clinical data" but doesn't specify if this refers to human clinical trials or other types of clinical observations. No explicit mention of country of origin or whether the studies were retrospective or prospective is provided.

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

This information is not provided in a way that directly answers the question. The document describes various scientific and engineering tests (e.g., LAL test, rabbit study, ISO standards) rather than expert-driven clinical ground truth for a test set. Establishing "ground truth" in this context would typically involve expert interpretation of medical images or patient outcomes, which is not detailed here for a specific test set.

4. Adjudication Method for the Test Set:

This is not applicable or mentioned in the provided text. The performance section describes laboratory and animal studies, not analyses requiring expert adjudication of a test set in the way one would for diagnostic imaging algorithms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a bone void filler, not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

This is not applicable. The device is a physical medical implant, not an algorithm.

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

For the non-clinical and animal functional studies, the "ground truth" is established by direct observation of biological responses, chemical properties, and physical characteristics based on established scientific protocols and standards (e.g., bone-like apatite layer formation, successful sterilization, absence of pyrogenicity in rabbits).

For the "clinical data" mentioned as supplementary, the specific type of ground truth is not detailed in this summary. It might refer to surgical outcomes, imaging results, or patient follow-up, but the document does not elaborate.

8. The sample size for the training set:

This is not applicable. The MagnetOs Putty is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable. As it's not an AI/ML algorithm, there is no training set or associated ground truth establishment process.

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MagnetOs Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

When used in posterolateral spine, extremities and pelvis, MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. When used in intervertebral body fusion procedures, MagnetOs Granules must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler and hydrated with blood. MagnetOs Granules may also be mixed with autograft.

MagnetOs Granules resorbs and is replaced with bone during the healing process.

MagnetOs Granules is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Granules consists of 65-75% tri-calcium phosphate (TCP - Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. MagnetOs Granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Granules is a ready-to-use product. MagnetOs Granules is provided in vials in a range of product volumes. MagnetOs Granules is gamma-sterilized and sterile packaged for single use only.

The total interconnecting porosity of MagnetOs Granules is 70 ± 15%. Pore diameters in the scaffold range from 0 to 1000 µm (1mm).

The provided document is a 510(k) summary for a medical device called MagnetOs Granules. It does not describe acceptance criteria for a diagnostic AI/ML device, nor does it contain a study that proves a device meets such criteria. Instead, it details the substantial equivalence of MagnetOs Granules to predicate devices for its intended use as a bone void filler.

Therefore, I cannot extract the information required to answer your query. The document mentions "non-clinical testing data," "animal testing," and a "clinical study" for MagnetOs Granules itself, but these are for demonstrating the safety and effectiveness of a bone void filler for orthopedic application, not for evaluating the performance of an AI/ML diagnostic tool against specific acceptance criteria like sensitivity, specificity, or AUC.

The information you've requested (acceptance criteria table, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and training set ground truth establishment) are typical for the evaluation of a diagnostic AI/ML algorithm. This document is related to a different type of medical device (a resorbable calcium salt bone void filler) and does not provide these details.

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MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. MagnetOs Putty may be used standalone or mixed with autograft. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty resorbs and is replaced with bone during the healing process.

MagnetOs Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Putty consists of 65-75% Tri-Calcium Phosphate (TCP - Ca3(PO4)2) and 25-35% Hydroxyapatite (HA - Ca10(PO4)6 (OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. The granules are covered with submicron-sized features and are premixed with a synthetic polymeric binder. The biocompatible polymeric binder is composed of Poly L (Lactic Acid) (PLA) and Poly(Ethylene Glycol) (PEG) in a triblock polymer PLA-PEG-PLA; which consists of 10-20% PLA and 80-90% PEG.

The fast-resorbing polymeric binder in the subject device is improve handling properties, as well as reduce the risk of granules migration. While the polymeric binder is rapidly resorbed after implantation, the granules in both devices guide the three-dimensional regeneration of bone in the defect site into which it is implanted.

When placed next to viable host bone, new bone will be deposited on the surface of the implant. The implant resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Putty is a ready-for-use product. Pressure applied by manipulation allows the shaping of the devices to conform to the contours of bony defects. MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is sterile packaged for single use only.

This 510(k) expands the device's indications for use in K181958 as an autograft extender only to also allow use of the device alone in posterolateral spine.

The furnished information primarily discusses the regulatory clearance (510(k)) of MagnetOs Putty and its substantial equivalence to predicate devices, rather than an AI/ML powered device. As such, it does not contain the specific details typically found in studies for AI/ML device performance and acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, as the provided document pertains to a medical device for bone void filling.

However, I can extract the general acceptance criteria Met by the device for its regulatory clearance as a medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

This information does not relate to AI/ML software. Therefore, the following points are not applicable and cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

MagnetOs Easypack Putty is intended to filly bony voids or gaps of the skeletal system. i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.

MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects, MagnetOs Easypack Putty consists of 65-75% tri-calcium phosphate (TCP - Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.

New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling.

MagnetOs Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects. MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single use only.

The provided document is a 510(k) Summary for a medical device (MagnetOs Easypack Putty) and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the context of software/AI performance.

This summary primarily focuses on demonstrating substantial equivalence to a predicate device for an expanded indication for use. It mentions general performance testing and supporting rationale, but it does not detail specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or the methodology of an AI/software performance study with a test set, ground truth, or expert involvement as requested in your prompt.

Therefore, I cannot provide the requested information based on the given text. The document describes a physical medical device (bone void filler) and its regulatory clearance process, not a software or AI-driven diagnostic or therapeutic device.

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MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When used in intervertebral body fusion procedures, MagnetOs Flex Matrix must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process.

MagnetOs Flex Matrix is a resorbable, osteoconductive bone void filler for the repair of bony defects. The product is biocompatible.

MagnetOs Flex Matrix is a mixture of medical grade collagen and hydroxyapatite and Btricalcium phosphate ceramic (92.5-95.5 wt% MagnetOs Granules and 4.5-7.5 wt% collagen). The ceramic portion of MagnetOs Flex Matrix consists of 75-65% B-Tri-Calcium Phosphate and 25-35% Hydroxyapatite. The collagen is produced of highly purified bioresorbable bovine split skin and consists mainly of collagen type I. The components are mixed in a slurry and lyophilized, which results in a highly porous sponge matrix that provides cohesion between the MagnetOs Granules without inhibiting the granule surface structure.

MagnetOs Flex Matrix is a ready-to-use product. Upon hydration, the material is moldable and allows users to shape MagnetOs Flex Matrix to conform to the contours of bony defects. MagnetOs Flex Matrix is supplied as a ready-to-use strip, it is sterile packaged and gammasterilized for single patient use only.

The provided document is a 510(k) summary for a medical device called MagnetOs Flex Matrix. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving objective performance against predefined acceptance criteria for AI/ML devices. Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 about acceptance criteria, specific study details, and training set information typically associated with AI/ML device evaluations.

However, I can extract information related to performance testing that was conducted to support the substantial equivalence claim.

Performance Testing Summary (as described in the document):

The performance testing primarily aimed to demonstrate substantial equivalence to a predicate device, not necessarily to meet specific, quantifiable acceptance criteria in the manner an AI/ML device would.

• Animal Testing: Performed in a rabbit posterolateral fusion model to demonstrate substantial equivalence to a legally marketed predicate device.
• In-vitro Studies: Showed that MagnetOs Flex Matrix induced the growth of a bone-like apatite layer on the surface of the MagnetOs Granules component following exposure to simulated body fluid.
• Other Non-Clinical Testing: In support of a prior clearance (K213959), non-clinical testing data were submitted according to FDA guidance documents. These data covered:
  • Physical properties
  • Sterilization
  • Product shelf life
  • Biocompatibility

Missing Information (as per your request):

The document does not provide any of the following information, as it is not a study designed to demonstrate performance against specific acceptance criteria for an AI/ML device:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or effect size of human reader improvement with AI.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. In the posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate and used as an extender to autograft bone. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process.

MagnetOs Flex Matrix is a resorbable, osteoconductive bone void filler, intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine, In the posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate and used as an extender to autograft bone. The product is biocompatible.

MaqnetQs Flex Matrix is a mixture of medical grade collagen and hydroxyapatite and ß-tricalcium phosphate ceramic granules. The collagen is produced from highly purified bioresorbable bovine split skin and consists mainly of collagen type I. The ceramic portion of MagnetOs Flex Matrix consists of β-tricalcium phosphate and hydroxyapatite.

MagnetOs Granules has a porous trabecular structure that resembles the structure and interconnected porosity of human cancellous bone. The surface of MagnetOs Granules is covered with needle-shaped features that are submicron in size.

The collagen matrix has a fibrillar porous structure which allows for the exposure of MagnetOs Granules' surface structure without interfering with its mode of action. While the collagen sponge matrix is readly resorbed in the first 6 weeks after implantation, MagnetOs Granules guides the three-dimensional regeneration of bone in the defect into which it is implanted. New bone will be deposited on the surface of the graft when it is placed next to viable host bone. The graft will be resorbed and replaced by bone during the natural process of bone remodelling.

MagnetOs Flex Matrix is a ready-to-use product. Upon hydration, the material is moldable and allows users to shape MagnetOs Flex Matrix to conform to the contours of bony defects. MagnetOs Flex Matrix is gamma-sterilized, sterile packaged and ready for single patient use only.

The K213959 510(k) submission for MagnetOs Flex Matrix describes a resorbable calcium salt bone void filler. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and animal studies.

Here's the breakdown of the acceptance criteria and study details based on the provided text, with specific answers to your numbered points:

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

The provided text does not explicitly state quantitative acceptance criteria in a pass/fail format for specific performance metrics. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices in the following areas:

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

• Sample Size for Test Set: The text mentions "animals" were evaluated in the rabbit posterolateral spine fusion model but does not specify the exact number of animals used in the study for MagnetOs Flex Matrix. It states "Animals were evaluated after implantation...".
• Data Provenance: The animal study was conducted using a rabbit posterolateral spine fusion model. The country of origin for the study is not specified in the document, but it's an animal study for pre-clinical performance testing. It is inherently prospective in its design as it involves implanting the device and then evaluating outcomes over time.

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

The document does not mention the use of human experts to establish ground truth in the context of the animal study. The evaluation endpoints were objective measures such as:

• Manual palpation
• Range of motion flexibility testing
• Plain and high-resolution radiography
• Microcomputed tomography (micro-CT) imaging
• Undecalcified histologic evaluation
• Histomorphometric analysis

The grading according to ISO 10993-6 (Annex E) for decalcified paraffin histology sections would typically be performed by trained histologists/pathologists, but the number and specific qualifications of such individuals are not detailed.

4. Adjudication method for the test set

The document does not describe an adjudication method (like 2+1 or 3+1) for the test set. Given that the ground truth was established through objective measurements and standard histological grading, an adjudication process involving multiple human readers for a "ground truth" establishment in a subjective interpretation sense is not indicated.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (bone void filler), not an AI-based diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

This question is not applicable. The MagnetOs Flex Matrix is a physical medical device (bone void filler), not an algorithm or AI system.

7. The type of ground truth used

The ground truth for the animal study (performance test set) was established through a combination of:

• Objective physiological assessments: Manual palpation, range of motion flexibility.
• Imaging data: Plain and high-resolution radiography, micro-CT.
• Histological and histomorphometric analysis: Microscopic evaluation of tissue samples, including grading according to ISO 10993-6 (Annex E).
• Comparison to controls: Autograft (positive control) and primary predicate device (MASTERGRAFT® Strip).

This can be categorized as a combination of animal model outcomes data and expert histological/imaging interpretation (though the number of experts is not specified).

8. The sample size for the training set

This question is not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of demonstrating substantial equivalence for a bone void filler through animal studies and bench testing.

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

This question is not applicable for the same reason as point 8.

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MagnetOs Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis and posterolateral spine. MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Granules resorbs and is replaced with bone during the healing process.

MagnetOs Granules is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Granules consists of 65-75% tri-calcium phosphate (TCP -Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)c(OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. MagnetOs Granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Granules is a ready-to-use product. MagnetOs Granules is provided in vials in a range of product volumes. MagnetOs Granules is gamma-sterilized and sterile packaged for single use only.

The provided text details the 510(k) summary for MagnetOs Granules, but it does not contain the specific information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.

The document describes a bone void filler and its clinical evaluation (a randomized non-inferiority trial for posterolateral fusion), along with bench testing for material properties. This is a traditional medical device submission, not an AI/ML device.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text. The document does not discuss:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes used for a test set in an AI/ML context.
• Data provenance (e.g., country of origin, retrospective/prospective) for AI/ML data.
• Number of experts, their qualifications, or adjudication methods for ground truth in an AI/ML study.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI/ML.
• Standalone performance of an algorithm.
• Training set details for an AI/ML model.

The text focuses on the substantial equivalence of a physical bone void filler device to predicate devices based on material properties, manufacturing, and clinical performance in a human trial without AI assistance.

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MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. In the posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone graft extender. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the bony structure.

MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.

MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects.

MagnetOs Easypack Putty consists of 65–75% tri-calcium phosphate (TCP – Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.

New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling.

MagnetOs Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects.

MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single use only.

This document does not describe a study involving an AI/ML device, therefore, a description of acceptance criteria and the study that proves the device meets the acceptance criteria is not applicable. The provided text is a 510(k) summary for a medical device called "MagnetOs Easypack Putty," which is a resorbable calcium salt bone void filler. It details the device's characteristics, intended use, and demonstrates substantial equivalence to predicate devices through non-clinical testing and animal studies, not AI/ML performance.

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