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InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.

The InFill® Interbody Fusion Device product family consists of radiolucent implantable devices manufactured from PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced and contains tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® Interbody Fusion Device is provided sterile.

The provided text describes a 510(k) premarket notification for a medical device called the "InFill® Interbody Fusion Device." This submission aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, and as such, it does not involve a study to prove the device meets acceptance criteria in the typical sense of a clinical trial or AI/software validation.

Instead, the "acceptance criteria" here are based on the device's technological characteristics and mechanical performance data meeting established industry standards (ASTM) and being comparable to legally marketed predicate devices.

Let's break down the information requested in your prompt based on the provided document:

1. Table of acceptance criteria and the reported device performance

There isn't a direct "acceptance criteria" table with numerical performance targets in the context of an AI/software validation study. Instead, the acceptance is based on the device meeting established ASTM standards and being substantially equivalent to predicates.

Note: The document explicitly states, "the minor differences do not raise any new issues of safety and effectiveness" and "The overall technology characteristics and mechanical performance data lead to the conclusion that the InFill® Interbody Fusion Device is substantially equivalent to the predicate device." This is the ultimate "acceptance" for a 510(k).

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

• Sample Size for Test Set: Not applicable in the context of a clinical study with patients. The "test set" here refers to the physical devices undergoing mechanical testing. The document states "The InFill® V2 Lateral Device (worst case device) has been tested..." This implies a sample size of physical devices tested to ASTM standards. The exact number of physical devices tested for each mechanical test is not specified in this summary, but these are typically small sample sizes for engineering verification (e.g., n=5 or n=10 devices per test).
• Data Provenance: The data comes from non-clinical mechanical testing performed on the physical device. The location of the testing is not specified but would typically be an accredited testing lab. This is a form of prospective testing of the manufactured devices, not retrospective clinical data.

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

• Not applicable. This is a mechanical device submission, not an AI or diagnostic imaging device requiring expert ground truth for interpretation of images or patient data. The "ground truth" for mechanical testing is established by the ASTM standards themselves and the objective measurements of the device's physical properties under various loads.

4. Adjudication method for the test set

• Not applicable. There is no human interpretation or adjudication involved in the mechanical testing of physical properties. The results are quantitative measurements against defined standards.

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 an implantable interbody fusion device, not an AI or software-as-a-medical-device (SaMD) for diagnostic assistance. Therefore, no MRMC study or AI-assisted human reader performance was conducted or reported.

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

• Not applicable. This is a physical, implantable medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this submission is established by validated ASTM international standards for the mechanical testing of intervertebral body fusion devices (e.g., F2077, F2267). These standards define the acceptable range of mechanical performance for these types of implants. The comparison is also made against the mechanical performance of predicate devices already on the market.

8. The sample size for the training set

• Not applicable. There is no training set as this is not an AI/machine learning device.

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

• Not applicable. As there is no training set, there is no ground truth established for one.

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InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients.
InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

The InFill® V2 Lateral is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient.

The InFill® V2 Lateral is provided sterile, for single use only.

The provided text describes a 510(k) premarket notification for an intervertebral body fusion device and does not contain information about the acceptance criteria and study proving device performance in the context of an AI/ML powered medical device. The document pertains to a physical medical implant (InFill® Interbody Fusion Device) and its substantial equivalence to a predicate device based on material, design, and mechanical testing (Finite Element Analysis).

Therefore, I cannot extract the information required for the provided questions as they are specific to AI/ML device performance studies, which are not present in this document.

The document discusses:

• Device Name: InFill® Interbody Fusion Devices
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral body fusion device
• Regulatory Class: Class II
• Product Code: MAX
• Predicate Device: InFill® Interbody Fusion Device (K151184)
• Device Description: Radiolucent implantable device manufactured from PEEK and tantalum, available in various sizes.
• Indications for Use: Intervertebral body fusion of the spine in skeletally mature patients (L2 to S1), used with autogenous bone graft and supplemental internal spinal fixation systems, for degenerative disc disease (DDD) with up to Grade I spondylolisthesis.
• Technical Characteristics: Comparison showing minor changes in lengths, widths, and marker diameter compared to the predicate device, but similar shape, surface features, bone graft support, primary material, surgical approach, and surface geometry.
• Performance Data: A Finite Element Analysis (FEA) was performed to assess the new device. It evaluated axial compression, static subsidence, and fatigue failure. The analysis concluded that the new device (InFill® V2 Lateral) showed lower principal stresses compared to the predicate and met specified criteria, demonstrating substantial equivalence without raising new safety or performance questions.

None of the questions about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are applicable to the information provided in this document, as it is not about an AI/ML medical device.

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InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® interbody fusion device is provided sterile, for single use only.

The provided document is a 510(k) premarket notification from the FDA for the 'InFill® Interbody Fusion Devices'. It primarily discusses the substantial equivalence of the device to existing predicate devices, focusing on technical characteristics and intended use. The document does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific performance criteria in the way a clinical trial or a detailed performance study for an AI/CADe device would.

Instead, the "Performance Data" section specifically states: "An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions."

This means:

• The study performed was a Finite Element Analysis (FEA), a computational modeling technique, not a human reader study or a standalone algorithm performance study with a test set and ground truth.
• The purpose of the FEA was to compare the newly introduced sizes of the InFill device with the existing product family and predicate devices from a mechanical standpoint.
• The "acceptance criteria" referred to are the unspecified "specified criteria" related to mechanical performance, which the FEA demonstrated the device met. The document does not explicitly list these criteria or their values.
• There's no mention of sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or adjudication methods, as these concepts are not applicable to the type of study (FEA) described.
• No MRMC or standalone performance study in the context of an AI/CADe device was conducted or reported.

Therefore, I cannot populate the table or answer most of your specific questions because the provided document does not contain the type of AI/CADe performance study results you are asking for.

However, I can extract the relevant information regarding the "Performance Data" section.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study was a Finite Element Analysis (FEA), a computational simulation, not a study utilizing a "test set" of patient 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. No ground truth was established by experts for this FEA study.

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, 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. The study was a Finite Element Analysis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The study was a Finite Element Analysis.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The FEA used computational models and simulations, not ground truth derived from clinical data.

8. The sample size for the training set
Not applicable. The study was a Finite Element Analysis.

9. How the ground truth for the training set was established
Not applicable. The study was a Finite Element Analysis.

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InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® interbody fusion device is provided sterile, for single use only.

This is a 510(k) premarket notification for a medical device, the InFill® Interbody Fusion Devices. The primary goal of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This type of submission does not typically involve clinical trials or studies to establish novel performance criteria or the effectiveness of a new technology. Instead, it relies on demonstrating that the new device is as safe and effective as a previously cleared device.

Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth for a new clinical study proving the device meets acceptance criteria is largely not applicable in the context of this 510(k) submission.

Here's an breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are based on demonstrating substantial equivalence to the predicate device (InFill® Interbody Fusion Device, K133721). The device performance is primarily assessed through a Finite Element Analysis (FEA), not a clinical study with performance metrics like sensitivity, specificity, or accuracy.

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

• Test Set Sample Size: Not applicable in the context of a clinical performance test. The "test set" here would refer to the designs analyzed in the FEA.
• Data Provenance: The analysis was a Finite Element Analysis (FEA), a computational simulation. It is not based on patient data from a specific country or retrospective/prospective collection.

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

• Not applicable. Ground truth, in a clinical sense, is not established for an FEA. Instead, the FEA relies on engineering principles, material properties, and design specifications.

4. Adjudication method for the test set:

• Not applicable. This concept applies to human reader studies or clinical trials, not FEA.

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. MRMC studies are not performed for interbody fusion devices in a 510(k) submission.

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

• Not applicable. This is not an algorithmic device. The "standalone performance" was the FEA, demonstrating mechanical equivalence.

7. The type of ground truth used:

• For the FEA, the "ground truth" would be the fundamental laws of physics and material science, along with validated computational models and established engineering criteria for spinal implants. There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in this context. The FEA aims to prove mechanical equivalence.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a 510(k) submission for this type of device using FEA.

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

• Not applicable, as there is no training set.

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The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.

The modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannulated applicator tip and accessories for mixing bone graft materials and filling of the system. The modified InFill™ Graft Delivery System is provided sterile, for single use only.

The provided text describes a 510(k) premarket notification for a medical device called the InFill™ Graft Delivery System. This document focuses on demonstrating that the modified device is substantially equivalent to a previously cleared predicate device (K121476), rather than presenting a study to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study against predefined metrics.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from the provided text, as the submission relies on demonstrating equivalence through technical characteristics and a series of engineering tests.

Here's an attempt to extract relevant information and address the questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with specific thresholds. Instead, it refers to "all specified criteria" being met for various engineering tests. The "reported device performance" is that the device "met all specified criteria and did not raise new safety or performance questions."

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

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests.
The data provenance is from engineering tests conducted on the device itself, likely at the manufacturer's facility. It is not clinical data and therefore not retrospective or prospective in the human study sense, nor does it have a country of origin in that context.

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

This question is not applicable. The "ground truth" here is determined by engineering specifications and objective measurements against those specifications. There are no human experts establishing ground truth in the context of diagnostic performance or clinical outcomes.

4. Adjudication Method for the Test Set

This question is not applicable as there is no human adjudication for these engineering tests. Test results would be compared directly against predefined engineering specifications.

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

This question is not applicable. The device is a "Graft Delivery System" (a medical piston syringe with accessories) for delivering bone graft material. It is a mechanical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this context is based on engineering specifications and measurable physical properties of the device established through standard testing methodologies (e.g., volume measurement, force measurement, leak detection). It is not expert consensus, pathology, or outcomes data, as those apply to clinical or diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product, not an algorithm that requires a training set. The "training" for such a device would refer to the developmental and design iterations leading to the final product which is not detailed here.

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

This question is not applicable for the reasons stated above.

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The InFill® cervical interbody fusion device is intervertebral body fusion of the spine in skeletally mature patients. The InFill® cervical interbody fusion device is designed for use with autogenous bone grafi to facilitate fusion. InFill® is intended for use at one level in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with this device. The InFill® cervical interbody fusion device is intended to be used with supplemental internal fixation systems that are cleared by the FDA for use in the cervical spine.

The InFill® Cervical Interbody Fusion device are radiolucent implantable devices manufactured from PEEK Optima LT1 and tantalum ASTM F560 (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient.

The InFill® Cervical Interbody Fusion device is provided sterile, for single use only.

This is an intervertebral body fusion device, and the information provided details its substantial equivalence to predicate devices, rather than a clinical study with AI or human readers. Therefore, many of the requested categories are not applicable.

Here's the breakdown of the available information:

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

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

Not applicable. The provided text describes mechanical performance testing of a physical device, not a study involving human subjects or data provenance in the clinical sense.

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 refers to engineering specifications and performance limits for mechanical testing, not clinical diagnoses by experts.

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

Not applicable. Adjudication methods are relevant for clinical studies with subjective interpretations, not for objective mechanical performance tests.

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 for surgical implantation, not an AI-powered diagnostic tool.

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

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

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

The ground truth for the mechanical performance tests would implicitly be the pre-defined engineering standards and performance specifications for intervertebral body fusion devices, as established by relevant regulatory bodies (e.g., FDA guidance documents, ASTM standards).

8. The sample size for the training set

Not applicable. There is no training set as this is not a machine learning model.

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

Not applicable. There is no training set.

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InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are radiolucent implantable devices manufactured from PEEK and tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are provided sterile, for single use only.

Here's a breakdown of the acceptance criteria and study information for the InFill® Interbody Fusion Devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not contain information regarding the sample size used for the test set (if applicable to the type of testing performed, i.e., clinical trials) or the data provenance (country of origin, retrospective/prospective). The performance data cited refers to mechanical testing, not clinical studies with patients.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The submission describes a device for intervertebral body fusion, and the testing outlined is primarily mechanical. There is no mention of establishing ground truth by expert consensus related to clinical outcomes or imaging interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. The data presented is from mechanical performance testing, not studies requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/CAD systems that assist human readers in interpreting medical images. The device in question is an implantable medical device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI system was not done. The device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be the physical measurements and observations of the device's performance against established ASTM (American Society for Testing and Materials) standards. These standards define the acceptable range or thresholds for properties like compression strength, subsidence, and expulsion resistance.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this device is a physical implant and not an AI/machine learning model.

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

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

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InFill™ TLIF Oblique is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ TLIF Oblique is designed for use with autogenous bone graft to facilitate fusion. InFill™ TLIF Oblique is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ TLIF Oblique is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The InFill™ TLIF Oblique is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill™ TLIF Oblique is provided sterile, for single use only.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of clinical data. The performance data is based on material and mechanical testing, not a clinical study involving patients. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided.

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

Not applicable. The "test set" here refers to physical and mechanical testing of the device, not a human-interpreted dataset. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable, as no human-interpreted test set requiring adjudication was used.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on substantial equivalence through technical and mechanical performance data, not a clinical comparison of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an intervertebral body fusion device (an implant), not an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the performance data, the ground truth is established by validated mechanical testing standards (ASTM F2077, ASTM F2267) and engineering specifications for the material properties and design characteristics of the device and its predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a medical implant device, not an AI or imaging device that requires a training set.

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

Not applicable, as no training set was used.

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The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.

The modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannula applicator tip and two caps. The device is provided sterile, for single use only.

The provided documents describe the InFill™ Graft Delivery System and its substantial equivalence to a predicate device. However, the documents do not contain information related to an AI device or an AI-driven study.

Therefore, I cannot answer the specific questions about acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI device.

The information provided only describes a traditional medical device (a piston syringe for bone graft delivery) and its regulatory clearance based on performance tests like:

• Simulated Use Testing
• Volume Verification
• Separation Force Testing
• Liquid Leak Testing
• Biocompatibility Testing

The document states: "The modified InFill™ Graft Delivery System met all specified criteria and did not raise new safety or performance questions." This implies that the acceptance criteria were defined for each of these tests, and the device successfully passed them. However, the specific quantitative acceptance criteria or the detailed reported performance values for each test are not provided in the given text.

In summary, this submission is for a conventional medical device and lacks the AI-specific information requested in the prompt.

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InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The InFill™ intervertebral body fusion device is a radiolucent implantable device The in in in - fine PEEK and tantalum (marker material). The implant is available in manatatored 110 11011 * 11011 * 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11

The InFill™ intervertebral body fusion device is provided sterile, for single use only.

The provided text is a 510(k) summary for the InFill™ Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device for a minor modification rather than presenting a novel device with extensive new performance data. Therefore, the information required for a detailed acceptance criteria and study description, especially for AI/ML devices, is largely absent.

Here's an analysis based on the provided text, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not specify quantified acceptance criteria (e.g., "tensile strength must be >X MPa" or "fatigue life >Y cycles"). Instead, it broadly states that "all specified criteria" were met, implying that the device was tested against established standards for intervertebral body fusion devices, and it performed comparably to the predicate device.

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

This information is not provided in the document.

• The document implies that "testing was performed on test units representative of finished devices," but states no specific sample sizes for mechanical, material, or other performance tests.
• The provenance of any data (e.g., country of origin, retrospective/prospective) is not mentioned.

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

This information is not applicable and not provided in the document.

• This device is a physical intervertebral body fusion device, not an AI/ML diagnostic or therapeutic device that would typically involve expert-established ground truth from a test set of medical images or patient data.
• The evaluation is focused on the device's physical and material properties, and its substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document.

• Similar to point 3, adjudication methods (like 2+1 or 3+1) are common in studies involving human interpretation or AI model performance on qualitative data. This device's evaluation does not involve such a process.

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

This information is not applicable and not provided in the document.

• MRMC studies are relevant for evaluating AI-assisted diagnostic tools. This submission is for a physical medical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided in the document.

• Standalone performance studies are for AI algorithms. This is an implant.

7. The Type of Ground Truth Used

This information is not applicable in the context of typical AI/ML ground truth (expert consensus, pathology, outcomes data).

• For this device, the "ground truth" for its performance would be engineering specifications, material properties, biomechanical test standards, and successful performance against those standards and comparison to the predicate device. The document generally states "met all specified criteria."

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document.

• There is no AI/ML algorithm involved in this device submission, therefore no "training set."

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

This information is not applicable and not provided in the document.

• As there is no training set for an AI/ML algorithm, this question is irrelevant to this submission.

Summary of the Study (Based on the document):

The study described is not a clinical trial or an AI/ML performance study. It is a design verification and validation process for a minor modification to an already cleared intervertebral body fusion device. The "study" aims to demonstrate substantial equivalence to the predicate device (InFill™ Intervertebral Body Fusion Device, K103729).

• Objective: To verify that the modified InFill™ Intervertebral Body Fusion Device performs as intended and introduces no new safety or performance concerns, making it substantially equivalent to the predicate device.
• Methodology: "Performance Data: All testing was performed on test units representative of finished devices." The document implies that this testing included evaluations of the device's material properties, mechanical strength, and other relevant characteristics for an intervertebral body fusion device, against predetermined engineering specifications and industry standards.
• Proof: The key "proof" of meeting acceptance criteria is the statement: "The modified InFill™ intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions." This, coupled with the assertion that "The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device," forms the basis for the FDA's determination of substantial equivalence.

In essence, the "study" is a comparison of the modified device's characteristics and performance to existing requirements and the predicate device, rather than a novel investigation with detailed clinical or AI performance metrics.

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