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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 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.

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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. In the posterolateral spine, MagnetOs Putty must be used with autograft as bone graft extender. In extremities and pelvis, MagnetOs Putty is used alone. These osseous defects may be surgically created of 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 and osteoconductive bone void filler for the repair of bony defects, containing 65-75% beta-Tri-Calcium Phosphate (TCP, Ca3(PO4)2) and 25-35% Hydroxyapatite (HA, Ca5(PO4)3OH) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.

MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is sterile packaged for single use only.

This is a premarket notification (510(k)) for a medical device (MagnetOs Putty), not an AI/ML powered device. Therefore, the information requested in terms of acceptance criteria, study details, ground truth, and training data is not directly applicable in the format typically used for AI/ML devices.

However, I can extract and present the relevant information from the provided document regarding the device's performance, testing, and basis for substantial equivalence to its predicate devices, as if this were a non-AI medical device submission.

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

The document does not explicitly state "acceptance criteria" in the quantitative terms typically found for AI/ML device performance. Instead, it demonstrates substantial equivalence based on a comparison to predicate devices, supported by various tests. The reported performance is that the device is "equivalent" to the 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)

• Animal Studies: The document mentions "a posterolateral spine fusion animal model" and "a critical sized femoral animal model." It does not specify the exact number of animals used in these studies, nor their country of origin. It is implied these were prospective studies as they were conducted to support the 510(k) submission.
• Bench Testing: No "sample size" in the conventional sense is stated for bench tests. These tests are performed on the device material itself.
• Data Provenance: Not explicitly stated for either animal studies or bench testing, but likely associated with the manufacturer (Kuros Biosciences B.V., Netherlands) or testing facilities they contracted.

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

This concept of "experts establishing ground truth" is not applicable in this context. The "ground truth" for the device's performance in animal models would be based on histological analysis, imaging, and biomechanical assessments conducted by animal study researchers and pathologists, whose qualifications are not detailed in this summary. For chemical and physical properties, the "ground truth" is derived from established analytical methods.

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

Not applicable. This concept is typically relevant for human reader studies or clinical trials involving subjective human assessment.

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

Not applicable. This is a medical device (bone void filler), not an AI/ML powered diagnostic or therapeutic aid. No human reader studies or AI assistance are involved.

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

Not applicable. This device is not an algorithm. Performance of the device itself was evaluated in bench and animal studies (standalone in terms of the device's function as a biological implant).

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

• Biocompatibility: Ground truth is established by adherence to recognized ISO standards (ISO 10993 series) and USP <151>, which define acceptable biological responses.
• Chemical/Physical Properties: Ground truth is established by validated analytical methods (XRD, FTIR, NMR, ICP/MS, SEM, SBF immersion, mercury intrusion porosimetry) and comparison to the known properties of the predicate devices.
• Animal Studies: Ground truth for performance (e.g., bone fusion, defect repair) would be based on pathological assessment (histology, imaging) and potentially functional outcomes in the animal models, as evaluated by veterinary surgeons and pathologists. The document states "demonstrated that the performance of the subject device was equivalent to that of the predicate," implying direct comparative assessment of these outcomes.

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. See point 8.

Ask a specific question about this device

MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. MagnetOs Putty must be used with autograft as a bone graft extender in the 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 resorbs and is replaced with bone during the healing process.

MagnetOs Putty is a synthetic, resorbable and osteoconductive bone void filler for the repair of bony defects, containing 65-75% Tri-Calcium Phosphate (TCP, Cas(PQ2)>) and 25-35% Hydroxyapatite (HA. Cag(PO2)3OH) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.

MagnetOs Putty is gamma-sterilized, comes in four sizes in block form and is sterile packaged for single use only.

The provided document is a 510(k) premarket notification for the MagnetOs Putty device. It details the device's substantial equivalence to existing predicate devices, focusing on non-clinical testing. However, it does NOT provide the acceptance criteria or a study that uses such criteria to prove the device meets them in the context of diagnostic accuracy or performance against specific metrics as would be expected for an AI/CADe device.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies for AI are not applicable to this document. The document describes a comparison to predicate devices, which is a different type of assessment than proving performance against defined acceptance criteria typically seen for diagnostic devices.

Here's the closest possible interpretation of the requested information based on the provided text:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that the device must achieve. Instead, it demonstrates "substantial equivalence" to predicate devices through various non-clinical tests. The "performance" is implicitly deemed acceptable if it is found to be equivalent to the 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)

The document mentions an "animal model" for the posterolateral spine fusion study. However, it does not specify the sample size (number of animals or cases) used for this test set, nor does it provide details on data provenance beyond acknowledging it was an "animal model." The studies are pre-clinical, meaning they are conducted in a laboratory setting or on animals, not human 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)

This information is not provided in the document. Given that the testing included an "animal model" and material characterization, the "ground truth" would likely be established by experimental measurements and observations by laboratory personnel or veterinary specialists, rather than clinical experts like radiologists.

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

This information is 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

No such MRMC comparative effectiveness study was described, as this device is a bone void filler, not an AI/diagnostic imaging device that would assist human readers.

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

This concept is not applicable to the MagnetOs Putty device, which is a physical implant, not an algorithm.

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

For the material characterization, the "ground truth" would be established by scientific measurement techniques (e.g., XRD, FTIR, SEM, ICP/MS, porosimetry) and comparison to known material properties of the predicate devices. For the animal study, the "ground truth" would be established by histological analysis, imaging, or other relevant assessment of bone healing and fusion in the animal model.

8. The sample size for the training set

The concept of a "training set" is not applicable as this is not an AI/machine learning device.

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

Not applicable.

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