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The Wiltrom Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6AI-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided non-sterile, and the implants are for single use only.

This document is a 510(k) Premarket Notification for a Wiltrom Spinal Fixation System. The provided text focuses on demonstrating the substantial equivalence of the subject device to a predicate device, primarily by showing that the proposed changes (updated surgical instruments) do not affect the safety and effectiveness of the spinal fixation system's core implants.

Therefore, the information you are asking for regarding acceptance criteria and a study proving device performance (like an AI/ML medical device where performance metrics are key) is not present in this document. This document is for a mechanical medical device, and its "performance data" refers to mechanical testing according to established ASTM standards, not clinical performance or diagnostic accuracy.

Here's why your request cannot be fulfilled by this document:

• Type of Device: This is a Class II Thoracolumbosacral Pedicle Screw System (a mechanical implant), not a diagnostic device, imaging AI, or therapeutic software.
• Approval Process: 510(k) clearance for this type of device relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, often through design comparison, material testing, and mechanical performance testing to established standards (like ASTM F1717-15, as mentioned).
• Nature of "Performance Data": For this device, "performance data" means the results of mechanical tests (static torsion, axial compression bending) to ensure the device can withstand physiological loads, not accuracy, sensitivity, or specificity as would be relevant for an AI/ML device.

Therefore, the sections below cannot be populated from the provided text, as the information is not relevant to this type of medical device submission.

Acceptance Criteria and Study for Wiltrom Spinal Fixation System (Based on provided text)

Based on the provided 510(k) summary for the Wiltrom Spinal Fixation System, the device is a mechanical implant (Thoracolumbosacral Pedicle Screw System). The "study that proves the device meets the acceptance criteria" for such a device primarily involves demonstrating substantial equivalence to an existing predicate device, backed by mechanical performance testing to established standards.

The concept of "acceptance criteria" and "study" as you've outlined involving human readers, AI assistance, ground truth establishment by experts, and specific clinical performance metrics (sensitivity, specificity, AUC) is typically applicable to diagnostic devices, particularly those incorporating AI/Machine Learning. It is not applicable to a mechanical spinal fixation system like the Wiltrom device based on the information provided in this 510(k) submission.

The "performance data" for this device, as stated in the document, refers to:

• Mechanical testing in accordance with ASTM F1717-15.
• Tests included: static torsion testing, static and dynamic axial compression bending testing.

The conclusion drawn from this testing is that "The performance of Wiltrom spinal implants in stabilizing the operative site and the mechanical safety was demonstrated, which is not affected by the proposed changes."

As such, I cannot provide the requested information in the format of AI/ML device performance. The provided document does not contain data on human reader studies, AI assistance, or expert ground truth adjudication for diagnostic purposes.

Specifically, for the points you asked for:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of diagnostic performance metrics. The acceptance criteria here would be meeting the mechanical performance requirements of ASTM F1717-15, which are not detailed in terms of specific force or displacement values in this summary.
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data for diagnostic evaluation. Mechanical testing typically uses a specific number of devices per test, as per ASTM standards, but these details are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for diagnostic ground truth. The "ground truth" for this device is its mechanical integrity and ability to stabilize the spine, demonstrated through in vitro mechanical testing to established engineering standards.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.

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Osteocera Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. Osteocera Resorbable Bone Substitute is indicated for use in the treatment of osseous defects created surgically or through traumatic injury. Following placement into the bony void, Osteocera Resorbable Bone Substitute resorbs and is replaced with bone during the healing process.

Osteocera Resorbable Bone Substitute is a bioceramic medical device that consists of over 95% beta-tricalcium phosphate (ß-TCP). Osteocera is a resorbable implant intended to fill bony voids or gaps that are caused by trauma or surgery and are not intrinsic to the skeletal stability. The interconnected porous structure of Osteocera provides a matrix for bone ingrowth. Osteocera Resorbable Bone Substitute is for single use only and is supplied sterile in sticks and granules with various sizes and package volumes.

This document describes the Osteocera Resorbable Bone Substitute, a medical device. The information provided is for regulatory clearance (510(k) submission) and focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria in the context of a typical AI/ML medical device study.

Therefore, many of the requested elements for an AI/ML device study (like acceptance criteria for AI model performance, sample sizes for test sets, expert adjudication, MRMC studies, etc.) are not applicable or not explicitly stated in this document. The study described is an animal study to demonstrate safety and effectiveness for a bone substitute, not an AI model.

However, I can extract the relevant information from the provided text based on the nature of this device.

Device: Osteocera Resorbable Bone Substitute

Description of Use: Intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. Osteocera Resorbable Bone Substitute is indicated for use in the treatment of osseous defects created surgically or through traumatic injury. Following placement into the bony void, Osteocera Resorbable Bone Substitute resorbs and is replaced with bone during the healing process.

Summary of Study Type: Animal studies were conducted to demonstrate the safety and effectiveness of the Osteocera Resorbable Bone Substitute compared to a predicate device (Synthes (USA) chronOS (K043045)). These are non-clinical studies for a material-based device, not an AI/ML algorithm.

Here's a breakdown of the requested information, indicating what is N/A (Not Applicable) or Not Explicitly Stated for this type of device and study:

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

For a material-based device like this, "acceptance criteria" are generally tied to demonstrating equivalence in material properties and biological performance (resorption, bone ingrowth, safety) to a legally marketed predicate device. The performance data presented focuses on demonstrating this equivalence rather than meeting pre-defined quantitative metrics in a "true positive/false positive" sense as would be found in an AI/ML context.

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

• Test Set Sample Size:
  • Distal Femur Study (Extremities): 18 New Zealand white rabbits
  • Posterolateral Spine Study: 36 New Zealand white rabbits
• Data Provenance:
  • Country of Origin: Not specified, but likely where the animal studies were conducted.
  • Retrospective or Prospective: Prospective (controlled animal studies).

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

• Not Applicable. This is an animal study evaluating direct biological response to a material implant, not an AI model requiring human expert ground truth for interpretation of images or other data. "Ground truth" would be established via direct measurements (histology, histomorphometry, radiography).

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

• Not Applicable. As above, no human reader adjudication is involved in establishing the "truth" for direct biological and anatomical assessments in an animal study of an implant.

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-assisted device.

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

• Not Applicable. This is not an AI algorithm.

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

• For the animal studies, the "ground truth" was established through:
  • Radiographic analysis: Imaging assessments.
  • Histological analysis: Microscopic examination of tissue samples.
  • Histomorphometric analysis: Quantitative measurement of tissue structures from histological slides.
  • Manual palpation (for the posterolateral spine study, to assess fusion).
  • These methods directly assess the biological outcome (bone formation, resorption, fusion) after implant placement.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. This is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment process in that context.

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Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). The bone graft can be used as a bone filler for orthopedic surgery. It is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The composite material is gradually resorbed and replaced by bone tissues. Bicera® Resorbable Bone Substitute is supplied sterile in various shapes and sizes.

The provided text is a 510(k) summary for a medical device (Bicera® Resorbable Bone Substitute). It details the device's classification, intended use, and comparison to predicate devices, focusing on demonstrating substantial equivalence based on non-clinical testing.

However, the provided document does not contain any information regarding clinical studies, human subject data, or AI/ML-driven device performance evaluations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results (effect size of human readers with/without AI)
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document explicitly states that "Discussions of Non-Clinical Tests for Determination of Substantial Equivalence" were performed, including physical and chemical property evaluations, biocompatibility tests (in vitro and animal implantation studies), and pyrogen/endotoxin testing. It confirms that these non-clinical tests showed the device to be similar in effectiveness to predicate devices.

In summary, this document describes a traditional 510(k) submission based on non-clinical data, not a study evaluating an AI/ML device against specific performance criteria with human readers or clinical data.

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The Wiltrom Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided non-sterile, and the implants are for single use only.

This document is a 510(k) premarket notification for a medical device called the Wiltrom Spinal Fixation System. It focuses on establishing substantial equivalence to a predicate device, the Fortex Pedicle Screw System (K090224). The information provided is primarily related to mechanical testing for safety and effectiveness, rather than a clinical study evaluating diagnostic or prognostic performance based on specific acceptance criteria for AI or algorithmic output. Therefore, many of the requested sections about AI/algorithm performance and ground truth establishment cannot be directly answered from this document.

Here's a breakdown of what can be extracted and what cannot:

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

The document discusses mechanical testing criteria for the physical device, not for an AI or algorithm.

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

This information is for mechanical testing of the physical device, not an AI test set. The sample size would refer to the number of implants/constructs tested. The document states "mechanical testing including static torsion testing, static and dynamic axial compression bending testing were conducted," but does not specify the number of samples for each test or the provenance of the data in the context of clinical or image data.

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. Ground truth, in this context, would relate to the physical integrity and performance of the device under stress, measured through engineering standards, not expert evaluation of clinical data.

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

Not applicable. Adjudication methods are typically for clinical or imaging studies where expert consensus is needed. The testing here is mechanical.

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 a study involving human readers or AI assistance.

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

Not applicable. This document does not describe an AI 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 engineering standards themselves (e.g., ASTM F1717-15) and the objective measurements of force, deformation, and failure points taken during the tests.

8. The sample size for the training set

Not applicable. This document does not pertain to the development of an AI algorithm with a training set.

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

Not applicable. This document does not pertain to the development of an AI algorithm with a training set.

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Bicera™ Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera™ Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera™ Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Bicera™ Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (B-TCP). Bicera™ is a bone void filler for orthopedic surgery. It is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. This composite material is acretts resumity in vivo and is replaced by new bone. Bicera™ Resorbable Bone Substitute is supplied sterile in various shapes and sizes.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core of the "acceptance criteria" for Bifcera™ Resorbable Bone Substitute is demonstrating substantial equivalence to an existing predicate device, MBCPTM Bone Graft Substitute (K032268). This is achieved by comparing several technological characteristics and demonstrating similar performance in biological and in-vivo settings.

Table of Acceptance Criteria and Reported Device Performance:

Study Details

The provided document describes studies conducted to demonstrate substantial equivalence, primarily focusing on non-clinical tests.

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

   • Test Set (Animal Study): The document mentions a "long bone animal critical sized defect model." It does not specify the exact sample size (number of animals or defects) used in this model.
   • Data Provenance: The study was conducted by the submitter, Wiltrom Corporation (Taiwan). The provenance for the animal study is therefore prospective as it was specifically conducted for this submission.

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

   • The document does not specify the number of experts or their qualifications for establishing ground truth in the animal study. The evaluation likely involved veterinary pathologists or histologists specializing in bone healing, but this is not explicitly stated.

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

   • The document does not describe any adjudication method used for the animal study results. The evaluation of resorption and new bone formation would typically involve histological assessment, often by one or more trained pathologists, but formal adjudication is not mentioned.

4. 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, an MRMC comparative effectiveness study was not done. This device is a bone substitute material, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

   • No, this is not applicable. The device is a physical medical implant, not an algorithm.

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

   • For the animal study comparing resorption and new bone formation, the ground truth was based on histopathological evaluation (pathology) of the bone defect sites at multiple post-operative evaluations. This is a standard method for assessing bone graft performance in animal models.
   • For the biocompatibility tests (cytotoxicity, sensitization, etc.), the ground truth was established by standardized laboratory test methods (e.g., cell viability assays, skin irritation tests) which have defined endpoints for acceptability.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not a machine learning algorithm, so there is no "training set."

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

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

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