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Vitoss BA Injectable is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss BA Injectable bone graft substitute is a synthetic resorbable porous bone void filler for the repair of bony defects made from a combination of beta tricalcium phosphate and bioactive glass in a carrier of porcine gelatin and sodium carboxymethyl cellulose. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.

Vitoss BA Injectable is provided prepackaged in a syringe. At the time of use a specified volume of hydration fluid is combined with the dry component of the device. Mixing is facilitated by a syringe to syringe mixing system. The resulting material can be administered to the treatment site by injection through a cannula or by manual application. After injection or insertion into the defect site new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vitoss Bioactive (BA) Injectable device, formatted to address your questions.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for novel acceptance criteria. Therefore, some information you're asking for (like multi-reader multi-case studies, detailed ground truth establishment for a training set, or effect sizes for human readers with AI assistance) is not applicable or detailed in this type of regulatory submission because the device is a bone void filler, not an AI diagnostic tool.

Device: Vitoss Bioactive (BA) Injectable
Device Type: Resorbable Calcium Salt Bone Void Filler

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that a "risk analysis was performed to demonstrate that Vitoss BA Injectable is substantially equivalent to its predicate devices." The acceptance criteria are broadly defined by the "predefined acceptance criteria" being met for several types of testing. The performance is summarized as demonstrating substantial equivalence to the predicate devices.

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

• Sample Size: Not explicitly stated for each test in terms of number of subjects, samples, or tests performed. The document broadly refers to "comparative animal performance testing in a rabbit model" but does not give the number of rabbits or the specific endpoints measured.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified. Animal performance testing would be prospective in nature. In-vitro testing is laboratory-based.

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

Given this is a medical device for bone void filling, and not an AI diagnostic system evaluating images, the concept of "experts establishing ground truth for a test set" in the context of human interpretation (like radiologists for an imaging AI) does not directly apply here.

The "ground truth" for this device would be established through:

• In-vitro testing standards: Laboratory tests demonstrating material properties, bioactivity, permeability, etc.
• Animal model outcomes: Histological analysis, imaging, and mechanical testing of bone formation and resorption in the rabbit model, interpreted by researchers/pathologists specializing in bone healing.

The number and specific qualifications of the experts or analysts who conducted these evaluations are not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and the types of tests described. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in human-AI diagnostic studies, where there's potential for inter-reader variability in interpreting complex data. Performance testing for a bone void filler involves objective measurements (e.g., mechanical properties, biological response under controlled conditions).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks (e.g., radiology interpretation). This device is a bone void filler, not a diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

This question is not applicable. The device is a physical medical implant, not an algorithm. Its performance is inherent to its physical and biological properties.

7. The Type of Ground Truth Used

The "ground truth" in this context is established through a combination of:

• Objective Laboratory Measurements: For physical properties (permeability, extrusion, packaging, sterilization).
• Biological Response in Animal Models: For comparative animal performance (e.g., histological evidence of bone ingrowth, resorption, and integration). This would involve standard pathological evaluation techniques.
• In-Vitro Bioactivity Assays: Chemical and structural analysis demonstrating calcium phosphate growth.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set." The testing described (animal studies, in-vitro tests) is for validation of the device's performance against predefined criteria and comparison to predicate devices, not for training a model.

9. How the Ground Truth for the Training Set Was Established

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

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The Hydroset XT Mixing and Delivery System is intended to be used for the delivery of Hydroset XT to an orthopedic surgical site.

HydroSet XT is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, posterolateral spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet XT is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

HydroSet XT cured in-situ provides an open void/gap filler that can augment provisional hardware (e.g. k-wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support medium and is not intended to provide structural support during the healing process.

HydroSet XT is a self-setting calcium phosphate cement. The device includes a pre-filled liquid syringe and a pre-filled powder syringe utilized for mixing and delivery of the cement. The device also includes the necessary components to prepare and deliver the cement (syringe cap, luer adapter, luer cap, threaded plunger, and cannula). After preparation, the cement may be delivered by traditional plunger advancement or by rotating the threaded plunger to deliver the cement.

The provided text describes a 510(k) premarket notification for a medical device called "HydroSet XT". This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria and performance data for an AI/ML device. Therefore, the requested information elements related to AI model evaluation (like sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, MRMC studies, standalone performance) are not applicable or available in this document.

However, I can extract the relevant information regarding the non-clinical performance testing conducted for the HydroSet XT device, which serves as the "study" proving the device meets certain acceptance criteria.

Acceptance Criteria and Device Performance (Non-Clinical Testing)

The document does not explicitly state numerical acceptance criteria for "Working Time" or "Compression Setting Time." Instead, it indicates that "Performance testing was completed for HydroSet XT to determine its suitability for use," and "The following tests were performed to evaluate the performance of HydroSetXT." The conclusion states that the device "demonstrated substantial equivalence" based on this performance testing, implying that the results met the criteria for suitability and equivalence.

Therefore, the table will reflect the tests performed and the implied "acceptance" through the substantial equivalence claim, rather than specific numerical criteria and results.

Detailed Information about the "Study" (Non-Clinical Performance Testing):

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

   • Sample Size: Not specified in the provided document for each test.
   • Data Provenance: Not specified, but generally, such testing is conducted in a laboratory setting by the manufacturer. It is non-clinical, not patient-derived data.

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

   • Not applicable. This device is a bone void filler, and the described tests are physical/chemical performance evaluations, not diagnostic assessments requiring clinician ground truth.

3. Adjudication method for the test set:

   • Not applicable. The tests performed are objective measurements of physical properties (e.g., working time, setting time, endotoxin levels), not subjective assessments requiring adjudication.

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:

   • Not applicable. This document is for a medical device (bone void filler) and does not involve AI or human reader interpretation.

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

   • Not applicable. This is not an AI/ML device.

6. The type of ground truth used:

   • For the non-clinical performance tests (Working Time, Compression Setting Time): The "ground truth" is established by standard laboratory testing methodologies and specifications for these physical/chemical properties.
   • For Bacterial Endotoxin Testing (BET): The "ground truth" is a Pass/Fail criterion based on the specified endotoxin limit (, Ph. Eur. 8.0 2.6.14).

7. The sample size for the training set:

   • Not applicable. The described testing is not for an AI/ML algorithm that requires a training set.

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

   • Not applicable. There is no AI/ML training set.

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Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BiModal Foam Strip is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Vitoss BiModal Foam Strip is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during process.

Vitoss BiModal Foam Strip is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 to 1000 um.

Vitoss BiModal Foam Strip guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss BiModal Foam Strip is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

This document is a 510(k) Summary for the Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip. It describes the device, its intended use, and demonstrates its substantial equivalence to predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The "Summary of the Performance Data" section lists various verification tests but does not provide quantitative acceptance criteria or detailed results of those tests.

Therefore, much of the requested information cannot be extracted from this document alone.

Here's what can be extracted and what cannot:

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

Note: The document states "the predefined acceptance criteria was met" for each, but does not specify what those criteria were (e.g., " Wettability > X %," "Porosity within Y-Z range"). It also does not provide the quantitative results (e.g., "Wettability = 95%").

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

This information is not provided in the document. The document refers to "risk analysis" and "design verifications and validations" but does not detail the methodology, sample sizes, or data provenance for these tests.

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 the document. The document refers to "verifications" and "validations" but does not mention expert involvement in establishing ground truth. This is likely a submission for a medical device that does not involve imaging or diagnostic accuracy studies where expert ground truth is typically assigned.

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

This information is not provided in the document.

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 information is not applicable/provided in the document. This device is a bone graft substitute, not an AI diagnostic tool.

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

This information is not applicable/provided in the document. This device is a physical bone graft substitute, not an algorithm.

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

The "ground truth" for this type of device would generally be established through various engineering, biocompatibility, and animal (if applicable) studies that confirm the device materials and performance meet established standards and benchmarks. The document mentions "Design Validation," "Biocompatibility," "Wettability," "Porosity," and "Bioactivity Verification." These would each have their own associated methods for establishing "truth" or meeting specifications, often through laboratory testing, not human consensus on diagnostic images. The specific type of "ground truth" used for each verification is not detailed in this summary.

8. The sample size for the training set:

This information is not applicable/provided in the document. As a physical medical device, there is no "training set" in the context of machine learning.

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

This information is not applicable/provided in the document.

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The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. k-wires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

This document describes the regulatory submission for the "Imbibe Needle" and its substantial equivalence to a predicate device. It primarily focuses on the device's design and intended use, rather than a clinical study evaluating its performance against specific acceptance criteria in the context of an AI-powered device.

Therefore, many of the requested categories related to acceptance criteria, device performance, a study design (like sample size, ground truth, expert involvement, and MRMC studies) are not applicable or cannot be extracted from the provided text for this specific device. This is a medical device clearance, not an AI/software as a medical device (SaMD) submission.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable for this type of submission:

Acceptance Criteria and Device Performance

Since this is a submission for a physical medical device (a needle) and not an AI/software device, the concept of "acceptance criteria" and "device performance" as measured by metrics like sensitivity, specificity, or accuracy in a diagnostic context (which is typical for AI devices) does not directly apply here. Instead, the "performance" relates to its physical characteristics, safety, and functionality.

The document states: "Previous testing of the predicate device (i.e. mechanical, cadaveric testing and biocompatibility) has demonstrated that Imbibe Needle is safe and effective for its intended use." This indicates that the predicate device met certain performance criteria through those types of tests. The current submission's "performance data" is the assertion that the new device is the same as the predicate and therefore inherits its safety and effectiveness profile.

In summary, this document is a 510(k) summary for a physical medical device (Imbibe Needle) seeking substantial equivalence to a previously cleared predicate device. The primary "study" proving it meets criteria is the assertion that it is "the same device as the predicate" with only a packaging change, and thus inherits the safety and effectiveness demonstrated by the predicate through "mechanical, cadaveric testing and biocompatibility." The detailed aspects of an AI/SaMD performance study are not present.

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The Stryker KWIC Needle is a manual surgical instrument intended to be used in spine surgery to facilitate placement of guidewires. The device may also be used to aspirate autologous blood or bone marrow by use of a syringe. The blood or bone marrow may be combined with bone graft or bone void filler.

The Stryker KWIC Needle may be used as part of a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The KWIC Needle is indicated for use in spinal surgical procedures in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull or vertebra, can be identified relative to medical images.

The Stryker KWIC (K-wire Insertion Cannulated) Needle is a manually operated needle that is used to assist in the placement of guidewires (e.g. K-wires) and/or the aspiration of autologous blood or bone marrow for orthopedic surgery. The Stryker KWIC Needle is designed to interface with already-cleared Stryker navigation systems.

This device is to be manually calibrated and used with Stryker navigation systems. This device is intended to be used in spine applications to perform general manual functions within the orthopedic environment including the placement of guidewires (e.g. K-wires) or to draw bone marrow. Guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

Here's an analysis of the acceptance criteria and study information for the Stryker KWIC Needle based on the provided 510(k) summary:

This device is a manual surgical instrument and not a software-driven AI device. Therefore, many of the typical questions for AI devices regarding statistical metrics, ground truth, expert adjudication, MRMC studies, and standalone performance are not applicable. The performance data focuses on demonstrating mechanical and functional equivalence to predicate devices, as is common for physical medical instruments.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated with a numerical value. The study refers to "simulated cadaveric testing." It does not specify the number of cadavers or individual tests performed.
• Data Provenance: Not explicitly stated. Given the nature of a 510(k) submission for a physical device, the testing would have been conducted internally by the manufacturer or a contracted lab. The location (e.g., country of origin) of the cadaveric testing is not provided. The testing is retrospective in the sense that it's performed as part of the device development and submission process, not as a real-world, prospective clinical trial.

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

• Not Applicable. For a manual surgical instrument, the "ground truth" is typically established by the physical verification of its function (e.g., did the guidewire pass, did the system recognize the instrument). There is no mention of human experts interpreting data or images to establish ground truth in the way one would for an AI diagnostic device. The performance is assessed by direct observation of the device's mechanical and functional capabilities.

4. Adjudication method for the test set:

• Not Applicable. There is no mention of an adjudication process, as the performance tests are functional and objective (e.g., the needle either works with the navigation system or it doesn't; the guidewire either can be placed or it cannot).

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. This is a manual surgical instrument, not an AI or imaging device that involves human readers interpreting diagnostic results. Therefore, an MRMC study is not relevant or mentioned.

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

• No. This device is a physical instrument, not an algorithm. Its performance is always tied to human use (manual operation) and, in some cases, integration with other systems (Stryker Navigation System), which themselves are tools for human surgical guidance.

7. The type of ground truth used:

• For the functional testing (guidewire placement, navigation system compatibility): The ground truth is established by direct observation and successful completion of the intended physical function in a simulated environment (cadaveric testing).
• For the aspiration function: The ground truth is derived from demonstrated capability of the predicate device paired with material/constructive equivalence of the current device.

8. The sample size for the training set:

• Not Applicable. This is not an AI or machine learning device that requires a training set.

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

• Not Applicable. As there is no training set mentioned or implied for this physical device.

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The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.
The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

This document describes a 510(k) premarket notification for the Stryker Imbibe Needle, a manually operated surgical instrument. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria. Therefore, several requested fields related to a detailed performance study are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present explicit, quantifiable acceptance criteria with corresponding performance statistics. Instead, it relies on demonstrating "substantial equivalence" to a predicate device. The comparison points are primarily design features and intended uses, implying that if the new device shares these characteristics and performs similarly, it meets the "acceptance criteria" for substantial equivalence.

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

• Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of a performance study. The document mentions "Preclinical bench data supplied including mechanical and cadaveric testing." However, the exact number of devices tested, samples used in mechanical tests, or cadavers utilized is not provided.
• Data Provenance: The testing appears to be internal preclinical bench and cadaveric testing conducted by Orthovita, Inc. (now Stryker). The country of origin is not specified but implicitly within the US given the FDA submission. It is retrospective in the sense that the data was collected prior to the submission, but the tests were presumably prospective in their execution.

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

• Not Applicable (N/A): This type of information is pertinent to studies involving human interpretation (e.g., imaging studies, diagnostic tools). The described tests are mechanical and cadaveric, which do not typically involve experts establishing a "ground truth" through consensus or interpretation. The performance is assessed against engineering specifications or physical outcomes.

4. Adjudication Method for the Test Set:

• N/A: As explained above, this concept is not relevant to the type of preclinical bench and cadaveric testing described.

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:

• N/A: This submission is for a surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are not applicable.

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

• N/A: This submission is for a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

• For the mechanical testing, the "ground truth" would be established by engineering specifications, material properties, and expected mechanical responses (e.g., force, torque, fatigue limits).
• For the cadaveric testing, the "ground truth" would be the observed physical outcome and ability to perform the intended surgical actions (e.g., successful aspiration, accurate guidewire placement) in a simulated anatomical environment. This is typically assessed against established surgical techniques and anatomical knowledge.

8. The Sample Size for the Training Set:

• N/A: This concept is relevant for machine learning or AI models. This submission is for a physical medical device and therefore does not have a "training set" in that context. The development process would involve iterative design, prototyping, and testing, but not a formally defined "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established:

• N/A: As above, this concept is not applicable to the development and testing of a physical surgical instrument.

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Vitoss BA Bimodal Bioactive Bone Graft 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. Vitoss BA Bimodal is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Vitoss BA Bimodal Bioactive Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss BA Bimodal Bioactive Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um.

Vitoss BA Bimodal Bioactive Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss BA Bimodal Bioactive Bone Graft Substitute is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

The provided text describes the 510(k) summary for Vitoss™ BA Bimodal Bioactive Bone Graft Substitute, a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific performance acceptance criteria for a new type of device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria for clinical performance that would typically be seen in a de novo device study (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the performance demonstrated is against established standards for general medical grade materials and through comparative testing to a predicate device.

2. Sample Size and Data Provenance for Test Set (Clinical/Performance Data)

• The submission does not describe a standalone test set with human subject data used to evaluate specific clinical performance metrics. The performance data presented are primarily technical and material characterization tests.
• The "comparative testing" mentioned (wettability, fluid retention, etc.) was likely conducted in a laboratory setting on samples of the device and its predicate, not on a human test set. Therefore, there is no information on data provenance (country of origin, retrospective/prospective) in the context of a clinical test set.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Not applicable. The submission does not detail a study involving expert assessment of a test set for ground truth establishment. The ground truth for material properties is based on accepted scientific standards and laboratory measurements.

4. Adjudication Method (Test Set)

• Not applicable. No expert adjudication method is described as there is no human-evaluated test set for performance metrics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI devices, where the goal is to assess improvement in human reader performance with AI assistance. The Vitoss BA Bimodal device is a bone graft substitute, not a diagnostic AI tool.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a material implant, not an algorithm. Therefore, there is no "standalone performance" in the context of an AI algorithm. Its performance is inherent to its physical and chemical properties.

7. Type of Ground Truth Used (Test Set)

• For the material and technical performance, the "ground truth" is based on:
  • Accepted Industry Standards: ASTM F 1088-04a for beta-tricalcium phosphate.
  • Laboratory Measurements: Data from tests like wettability, fluid retention, SEM, XRD, FTIR, ICP, porosity, and dissolution.
  • Biocompatibility Standards: ISO 10993-1.

8. Sample Size for the Training Set

• Not applicable. As this is not an AI device, there is no concept of a "training set" in the machine learning sense. The device's properties are designed and manufactured based on established material science and engineering principles, not through a data-driven training process.

9. How Ground Truth for Training Set Was Established

• Not applicable, as there is no training set for an AI algorithm.

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ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.

ORTHOVITA PEEK SPACER is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an aid in spinal fixation. Machined from medical grade PEEK-OPTIMA®, the device is trapezoidal in shape with a hollow frame to accept autogenous bone graft. ORTHOVITA PEEK SPACER is available in a range of heights and geometries to accommodate individual pathologies and anatomical conditions.

This document describes an intervertebral body fusion device and its pre-clinical testing, not a study evaluating a device's performance against specific acceptance criteria for diagnostic output. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be found in the provided text.

Here is the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the acceptance criteria for all tests were met, but it does not quantitatively define what those criteria were. It refers to the ASTM standards but doesn't detail the specific pass/fail thresholds used.

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

The provided text describes pre-clinical bench testing, not a clinical study involving a test set of data. Therefore, this information is not applicable.

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

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not a diagnostic or AI-driven device requiring expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not a diagnostic or AI-driven device requiring ground truth adjudication.

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 information is not applicable as the document describes pre-clinical bench testing of a physical device, not a diagnostic or AI-driven device involving human readers or AI assistance.

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

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not an algorithm.

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

This information is not applicable. For this device, "ground truth" would be the engineering specifications and performance limits defined by the ASTM standards and the device's design, which were verified through physical testing.

8. The sample size for the training set

This information is not applicable as the document describes pre-clinical bench testing, not a machine learning study.

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

This information is not applicable as the document describes pre-clinical bench testing, not a machine learning study.

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FM-02 Bone Graft 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. FM-02 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

FM-02 Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

FM-02 Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um.

FM-02 Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When FM-02 Bone Graft Substitute is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

The provided document is a 510(k) summary for a medical device (FM-02 Bone Graft Substitute). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study demonstrating performance against specific acceptance criteria for AI or diagnostic imaging.

Therefore, the requested information elements related to AI/algorithm performance (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document.

However, I can describe the performance data provided in the document which supports the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a bone graft substitute, and its "performance" is assessed against physical and biological standards required for such materials, rather than diagnostic accuracy metrics. The acceptance criteria are essentially meeting the requirements of specific ASTM standards and demonstrating characteristics comparable to the predicate device.

• Wettability
• Fluid retention
• Wash away resistance
• Homogeneity
• Radiopacity
• Bioactivity
• SEM comparisons
  These tests demonstrated that FM-02 is "substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness." |
  | Physical/Chemical Characterization (vs. Predicate Device) | Evaluation of:
• XRD (X-ray diffraction)
• FTIR (Fourier-transform infrared spectroscopy)
• ICP (Inductively coupled plasma atomic emission spectroscopy)
• Porosity
  (These were evaluated for the predicate device, implying FM-02 shared similar characteristics or was evaluated against these established parameters for comparison.) |

Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical performance testing to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance. The study described focuses on characterizing the material and comparing its properties to a legally marketed predicate device and to established material standards.

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

• Sample Size for Test Set: Not applicable in the context of a bone graft substitute material characterization study. The "test set" would refer to samples of the FM-02 material itself, tested in laboratory settings. The number of samples per test (e.g., how many specimens for wettability) is not specified.
• Data Provenance: Not specified in terms of country of origin. This would be laboratory testing conducted by Orthovita, Inc. or a contracted lab. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission.

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 refer to the true physical/chemical properties of the material, which are determined by objective laboratory measurements and adherence to scientific standards (e.g., ASTM, ISO). Expert consensus is not relevant for establishing the "truth" of these material properties.

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

Not applicable. This is not a study requiring expert adjudication of results, but rather objective laboratory testing.

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

Not applicable. This device is a bone graft substitute, not an AI or diagnostic imaging device.

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

Not applicable. This device is a bone graft substitute, not an AI or diagnostic imaging device.

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

The "ground truth" for the performance data presented is based on objective laboratory measurements against established standards (ASTM F 1088-04a, ISO 10993-1) and comparison of physical/chemical properties to a predicate device. This involves analytical chemistry techniques (XRD, FTIR, ICP), microscopy (SEM), and various physical property tests (wettability, fluid retention, etc.).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

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

Not applicable. This is not an AI/machine learning study.

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VITOMATRIX is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

• Augmentation or reconstructive treatment of the alveolar ridge.
• Filling of infrabony periodontal defects.
• Filling of defects after root resection, apicoectomy, and cystectomy.
• Filling of extraction sockets to enhance preservation of the alveolar ridge.
• Elevation of the maxillary sinus floor.
• Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

VITOMATRIX is a resorbable bone grafting material composed of β-Tricalcium Phosphate intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile and available in .2 1mm and 1-2mm morsel sizes.
VITOMATRIX guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When VITOMATRIX is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

This is a 510(k) summary for VITOMATRIX, a resorbable bone grafting material. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices. However, it does not fit the typical format for describing acceptance criteria and study results for an AI/ML powered device. The information provided pertains to a traditional medical device (bone graft material), not a software or AI-powered system that would have performance metrics like sensitivity, specificity, accuracy, or AUC.

Therefore, many of the requested fields are not applicable to the provided input. I will extract the information that is present and note when specific requested information is not available in the document.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in the format typically used for AI/ML devices (e.g., target sensitivity, specificity). Instead, it mentions that the device "satisfies the requirements of ASTM F 1088-04a, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation" and that "Data supplied demonstrates that VITOMATRIX is substantially equivalent to the predicate devices and any differences do not raise new questions of safety and effectiveness."

The "performance" described is in terms of physical, chemical, and biological properties, as well as resorption rates and bone healing, rather than diagnostic accuracy.

Since this is not an AI/ML device, the following points regarding AI/ML device studies are largely Not Applicable (N/A) based on the provided text.

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

• Sample Size:
  • Animal Performance Testing: Adult mongrel dogs (number of animals not specified). Bilateral rabbit tibial defect model (number of rabbits not specified).
  • Data Provenance: N/A (animal studies, not human patient data with country of origin). The studies appear to be prospective animal studies.

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)

• N/A. Ground truth for animal studies would typically be based on histological analysis, imaging, and gross observations by veterinary pathologists and researchers, rather than human expert interpretation of diagnostic images in the context of an AI/ML device. The document does not specify the number or qualifications of such experts.

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

• N/A. This concept is relevant for reconciling discrepancies in human expert labeling for AI/ML ground truth. For animal studies evaluating material performance, evaluation methods would follow standard veterinary and pathology protocols. The document does not describe an adjudication method for ground truth in this context.

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

• N/A. This is a material science and biocompatibility study, not an AI-assisted diagnostic study involving human readers.

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

• N/A. This question refers to an AI algorithm's standalone performance. VITOMATRIX is a physical device, not an algorithm.

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

• Pathology/Histology/In-vivo observation: For the animal studies, the "ground truth" would be established through histological examination of the tissue, bone growth, and material resorption, alongside macroscopic observation and potentially imaging (e.g., radiography) to assess bone healing and material integration.

8. The sample size for the training set

• N/A. This device does not involve a "training set" in the context of AI/ML.

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

• N/A. This device does not involve a "training set" in the context of AI/ML.

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