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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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The Kuros TLIF Cage is intended for use in intervertebral body fusion of the Kuros TLIF cage is inserted via a posterior approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is to be used with supplemental posterior spinal fixation systems for use in the lumbar spine that are cleared by the FDA.

The Kuros TLIF cage is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

The Kuros TLIF Cage is an implant interbody fusion surgery and is used to restore intervertebral height and facilitate intervertebral body fusion in the spine. The Kuros TLIF Cage is inserted via a posterior (transforaminal) approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and should be used in combination with supplemental posterior spinal fixation systems, intended for use in the lumbar spine and cleared by the FDA.

The Kuros TLIF cage is a rigid spacer, manufactured from PEEK Optima LT1 per ASTM F2026 to maximize biocompatibility, durability, and robustness. The design includes tantalum markers for imaging and has a hollow geometry, allowing the cage to be packed with grafting material per the indications for use. The Kuros TLIF Cages are available in various lengths, and angle variants to accommodate patient anatomy, and are supplied with their specific instrumentation. The device is intended to be used by orthopedic surgeons or neurosurgeons working in a hospital who are trained to use these devices in the patient population specified in the indications for use. The implants are provided sterile to the hospital.

The provided text describes the Kuros TLIF Cage, an intervertebral body fusion device. It details the device's indications for use, description, and comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance metrics, or a study reporting on these metrics.

The document is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's what can be extracted from the document regarding the device and its evaluation, but it explicitly states "No clinical data has been presented." and therefore cannot fulfill most of the request:

Device Name: Kuros TLIF Cage
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX

Indications for Use:
The Kuros TLIF Cage is intended for use in intervertebral body fusion of one or two contiguous levels of the lumbar spine (L1 to S1). It is inserted via a posterior approach and designed for use with autograft and/or allograft (cancellous and/or corticocancellous bone graft) to facilitate fusion. It must be used with supplemental posterior spinal fixation systems cleared by the FDA.

It is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

Description of the Device:
The Kuros TLIF Cage is a rigid spacer made from PEEK Optima LT1 (ASTM F2026). It includes tantalum markers for imaging and has a hollow geometry to be packed with grafting material. It is available in various lengths and angle variants and is supplied with specific instrumentation. The implants are provided sterile.

Summary of Performance Data (as presented in the document):
The Kuros TLIF Cage conforms to the "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007."
Worst-case devices were subjected to mechanical testing, including:

• Static axial compression
• Dynamic axial compression
• Static compression shear
• Dynamic compression shear
• Subsidence testing (according to ASTM F2267)
• Expulsion testing (according to Endolab protocol)

Results: "Results demonstrate comparable (or better) mechanical properties to the predicate devices."

Crucially, the document explicitly states: "No clinical data has been presented."

Given this information, it is impossible to complete a table of acceptance criteria and reported device performance from this document for the requested metrics as clinical performance data is absent. The acceptance criteria here are related to mechanical properties in comparison to predicate devices, not clinical outcomes.

Therefore, for your specific request:

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

   • Acceptance Criteria (Mechanical): Conformity to "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007." and mechanical properties comparable to or better than predicate devices across tested parameters (static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion).
   • Reported Device Performance (Mechanical): The Kuros TLIF Cage demonstrated "comparable (or better) mechanical properties to the predicate devices" for the tested parameters.
   • Clinical Performance: Not reported in this document.

2. Sample size used for the test set and the data provenance: Not applicable for clinical data, as "No clinical data has been presented." For mechanical testing, specific sample sizes are not provided, only that "Worst case devices were subjected to mechanical testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as "No clinical data has been presented."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as "No clinical data has been presented."

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, as "No clinical data has been presented" and this device is a physical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the ground truth would be established by the ASTM standards (ASTM F2077, ASTM F2267) and the Endolab protocol. For clinical performance, no ground truth is discussed as no clinical data was presented.

8. The sample size for the training set: Not applicable, as this is a physical medical device and no clinical "training set" of data is mentioned.

9. How the ground truth for the training set was established: Not applicable for the same reasons as above.

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