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The Osteotomy Truss System (OTS) is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:

• Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• . Opening wedge of Medial Cuneiform or Cotton osteotomies
• Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
• Metatarsal/Cuneiform osteotomies
• . Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
• . Hindfoot osteotomies
  The device is intended for use with supplemental fixation.
  The Osteotomy Truss System is not intended for use in the spine.

The Osteotomy Truss System (OTS) consists of five implant designs in a variety of footprints and implant height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixation.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.

This document is a 510(k) premarket notification decision letter from the FDA for the Osteotomy Truss System (OTS) by 4WEB Medical, Inc. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the typical format of a clinical study report.

Instead, it relies on non-clinical performance testing to demonstrate substantial equivalence to a previously cleared predicate device. This is common for Class II medical devices seeking 510(k) clearance, where a new clinical study is not usually required if substantial equivalence can be shown through other means.

Therefore, the specific information requested in your prompt regarding acceptance criteria, sample sizes for test/training sets, expert involvement, MRMC studies, or ground truth types derived from human data is not present in this FDA clearance letter.

However, I can extract the information provided about the performance standards the device was tested against (which, in this context, serve as the "acceptance criteria" for demonstrating substantial equivalence through non-clinical means) and the "study" (non-clinical testing) that proves the device meets these.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable in the context of clinical studies. The testing described is non-clinical (mechanical and MRI compatibility). The specific number of devices or test specimens used for each non-clinical test (e.g., number of implants for static compression) is not stated in this document.
• Data Provenance: Not applicable in the sense of country of origin for human data. These are results from laboratory/engineering bench testing.

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

• Not applicable. This document describes non-clinical engineering and laboratory testing, not human expert-driven ground truth assessment.

4. Adjudication method

• Not applicable. Adjudication relates to resolving discrepancies in human expert assessments, which is not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. An MRMC study is a clinical study involving human readers and cases, which was not performed for this 510(k) submission.

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

• Not applicable. This device is a physical orthopedic implant, not a software algorithm.

7. The type of ground truth used

• Engineering Standards and Measurements: The "ground truth" for the non-clinical tests is based on the specifications and parameters defined by the ASTM standards themselves, along with established engineering principles. For example, for static compression, the ground truth is the measured force required to cause deformation or failure, compared against a predefined standard or the predicate device's performance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML algorithm that requires a training set.

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

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

Summary of what the document does communicate:

The clearance for the Osteotomy Truss System (OTS) is based on non-clinical performance testing demonstrating that the updated device does not introduce a new worst-case scenario compared to its predicate device (K220463) and is substantially equivalent. The tests performed align with recognized ASTM standards for orthopedic implants and MRI compatibility. This approach is typical for devices seeking 510(k) clearance that are similar in technology and intended use to existing cleared devices, where extensive new clinical data is not deemed necessary by the FDA.

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The Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device is a stand-alone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at one or two contiguous disc levels. Each interbody fusion device is intended to be used with three titanium alloy screws or anchors which accompany the implant. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g. posterior fixation). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. ASTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the lumbosacral spine and are placed via an anterior approach at the L2 to S1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). When using the ASTS-SA Interbody with fixation anchors, the device must be used with supplemental fixation.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws or anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

This looks like a 510(k) summary for a medical device called the "Anterior Spine Truss System - Stand Alone (ASTS-SA)". Unfortunately, this document does not provide the type of information you're asking for regarding acceptance criteria for a device performance study in the context of AI/ML.

Here's why and what's missing:

• Device Type: The ASTS-SA is an interbody fusion device, which is a physical implant used in spinal surgery. It's not an AI/ML-based diagnostic or therapeutic device. Therefore, performance studies for this device focus on mechanical properties, biocompatibility, and clinical outcomes related to fusion, not AI model performance metrics like sensitivity, specificity, AUC, etc.
• Performance Standards: The document lists performance standards such as ASTM F2077 (for mechanical testing) and ASTM F2267 (for subsidence testing), and expulsion testing. These are physical hardware tests, not software performance tests.
• No AI/ML Component: There is no mention of any artificial intelligence or machine learning component in the "Description," "Technological Characteristics," or "Performance Standards" sections.

Therefore, I cannot extract the requested information about acceptance criteria and AI model performance studies (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, training set details) because this document pertains to a physical medical implant, not an AI/ML-driven device.

The questions you are asking are highly relevant to AI/ML device submissions to regulatory bodies like the FDA, but they do not apply to this specific medical device summary.

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The 4WEB Medical Ankle Truss System (ATS) is for use as an accessory to the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk for loss of limb. The ATS is not intended for standalone use.

The anatomical landmarks necessary for the design and creation of ATS devices that are patient matched must be present and identifiable on appropriate radiography scans. The ATS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The 4WEB Medical Ankle Truss System (ATS) is a permanently implanted device intended to provide mechanical support as an accessory to a tibiotalocalcaneal nail intended to fuse the tibiotalocalcaneal joint in a salvage procedure following a failed ankle arthrodesis or a failed ankle arthroplasty for patients at risk for loss of limb. ATS devices are titanium alloy (Ti6Al4V) structures in spherical or cuboidal configurations. The ATS device has an open architecture truss designed to provide structural support with open space throughout the implant to allow fusion. ATS devices are intended for use with the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal (TTC) fusion system.

The provided FDA 510(k) summary (K230088) for the Ankle Truss System (ATS) does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device conformance. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical and limited clinical performance evaluations.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

Device: Ankle Truss System (ATS) (K230088)

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state specific acceptance criteria in a quantitative or tabular format for the device's performance. It mentions "Effectiveness endpoints included fusion, pain, and functional outcomes for the subject and control treatments" in the clinical evaluation section, but it does not provide target values or thresholds for these. Similarly, for non-clinical testing, it lists the types of tests performed (ASTM F2077, ASTM F1264, Corrosion, Wear) but doesn't detail the acceptance criteria or the reported device performance against those criteria.

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

• Sample Size: The document mentions a "retrospective, single arm, multi-center evaluation of the ATS device" but does not specify the sample size (number of patients enrolled or number of ATS devices evaluated) in this clinical study.
• Data Provenance: The study was a "retrospective, single arm, multi-center evaluation." The country of origin is not specified, but given the FDA submission, it's highly probable the centers are within the United States.

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 study design does not appear to involve expert-driven ground truth establishment in the way typically seen for diagnostic AI or imaging devices. The "effectiveness endpoints" (fusion, pain, functional outcomes) and "safety outcomes" (adverse events, SSSI rates) would typically be gathered from patient records, imaging reports, and clinical assessments, rather than a panel of experts specifically establishing a "ground truth" for each case in the test set.

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

This information is not provided and is generally not applicable to the type of clinical evaluation described for an implantable device assessing outcomes like fusion, pain, and functional improvement. Adjudication methods like 2+1 or 3+1 are more common in studies evaluating reader performance for diagnostic tasks where ground truth might be ambiguous or require expert consensus.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The ATS is an implantable device, not an AI diagnostic tool.
• Effect Size: Therefore, effect size related to human reader improvement with AI assistance is not applicable and not provided.

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

• Standalone Performance: No, a standalone performance evaluation of an algorithm was not performed. The ATS is a physical implantable device, not an AI algorithm.

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

For the clinical evaluation, the "ground truth" or primary data used to assess effectiveness and safety were likely derived from:

• Outcomes Data: "fusion, pain, and functional outcomes" derived from patient follow-up, clinical assessments, and potentially imaging (to assess fusion).
• Adverse Event Data: "device and procedure related adverse events and rates of subsequent secondary surgical intervention (SSSI)" derived from patient medical records.

8. The sample size for the training set

This is not applicable as the ATS is a physical implant, not a machine learning model that requires a training set in the conventional sense. The "design and creation of ATS devices that are patient matched" suggests that individual devices might be tailored, but this is a design process, not an AI training process.

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

This is not applicable for the same reasons as #8.

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The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate. supplemental fixation must be used.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of heights, footprints, and lordotic angles. The CSTS Integrated Plates come in multiple heights to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the Integrated Plates into adjacent vertebral bodies for bony fixation. The Integrated Plates have a rotating locking tab to prevent back-out of the screws.

The provided text is a 510(k) summary for a medical device (Cervical Spine Truss System - CSTS). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical performance testing (mechanical and material testing, and finite element analysis).

It's crucial to understand that 510(k) submissions for devices like the CSTS (intervertebral body fusion devices) typically do not involve clinical studies with human participants in the same way that software-as-a-medical-device (SaMD) or drug trials do. Therefore, the concepts of "acceptance criteria for device performance studies," "sample sizes for test sets (in a clinical context)," "expert adjudication of ground truth," "MRMC studies," "standalone algorithms," and "training sets for AI models" as described in your prompt, are not applicable to this type of regulatory submission or the information contained within this document.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing that verifies the mechanical integrity and safety of the implant.

Here's how to address your prompt based only on the provided text, while clarifying the differences:

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

The document does not explicitly state numerical "acceptance criteria" for the mechanical tests in a tabular format, nor does it provide specific numerical "reported device performance" values. Instead, it states that the tests were completed "per the following standards" (ASTM F2077, ASTM F2119, ASTM F2182, ASTM F2213, ASTM F2051, and "accepted industry standard" for Expulsion Testing) and that the results "show that the strength of the CSTS interbody and CSTS Interbody with an Integrated Plate is sufficient for its use and is substantially equivalent to legally marketed predicate devices."

Table: Non-Clinical Performance Testing and Outcomes

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

• Sample Size for Test Set: Not specified in terms of number of surgical cases or patient data, as this is not a clinical study. For mechanical testing, "sample size" refers to the number of physical devices or components tested, which is not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data. The "data" refers to results from laboratory mechanical and MR compatibility testing, and finite element analysis.

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

• This concept is not applicable as the "ground truth" for a mechanical device like this is established by adherence to engineering standards and validated models, not by expert consensus on clinical images or outcomes.

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

• This concept is not applicable 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

• An MRMC study is not applicable as this is not an AI/imaging device.

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

• This concept is not applicable as this is not an AI/software device.

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

• The "ground truth" (or verification of performance) for this device relies on:
  • Adherence to established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion device mechanical testing and MR compatibility.
  • Validated Finite Element Analysis (FEA), which is a computational method used to predict how a product reacts to real-world forces, heat, vibration, etc.
  • Demonstration of substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics (indications for use, materials, function, sizes) and performance testing.

8. The sample size for the training set

• This concept is not applicable as this is not an AI/machine learning device.

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

• This concept is not applicable as this is not an AI/machine learning device.

In summary: The provided document is a regulatory submission for a physical medical implant. Its "acceptance criteria" and "proof" relate to meeting established engineering and material standards, and demonstrating substantial equivalence to similar devices already on the market, rather than clinical efficacy studies involving human participants or AI performance metrics.

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The Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws or fixation anchors which accompany the device. DDD is defined as discogenic back pain with deqeneration of the disc confirmed by patient history and radiographic studies. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. When using the CTST-SA interbody with fixation anchors, the device must be used with supplemental fixation.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws or fixation anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device called "Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device."

While it lists performance standards (ASTM F2077, ASTM F-04.25.02.02, ASTM F2267) that performance testing was completed per, it does not describe:

• Specific acceptance criteria values.
• The results of the tests against those criteria.
• Details about a study involving, for example, a test set, ground truth, expert readers, or effect sizes of human performance improvement with AI.

The document primarily focuses on the regulatory aspects of the device's clearance, including its indications for use, device description, predicate devices, and a conclusion of substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device must be used with supplement fixation.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy.

The provided text describes a medical device, the Cervical Spine Truss System (CSTS) Interbody Fusion Device, and its 510(k) premarket notification to the FDA. This submission is for an updated version of an already cleared device, intended to introduce design changes to the interbody devices.

However, the document focuses on mechanical performance testing using engineering standards (like ASTM F2077, F2267-04, F2119, F2182, F2213, F2052) to demonstrate the device's strength and substantial equivalence to predicate devices. It does not present any clinical study data or involve acceptance criteria related to a device's diagnostic or therapeutic performance in the context of human-machine interaction or AI performance.

Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them (such as human reader improvement with AI assistance, expert consensus for ground truth, sample sizes for training/test sets for an algorithm, etc.) are not applicable to this document.

The document primarily demonstrates the structural and material integrity of the medical implant through non-clinical testing.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, the acceptance criteria are not in the form of specific performance metrics for an AI/diagnostic device, but rather compliance with established engineering standards for interbody fusion devices.

2. Sample size used for the test set and the data provenance: Not applicable. This involves mechanical testing of physical devices or simulations, not a test set of data like in an AI/diagnostic study. The "test set" here refers to the physical devices manufactured for testing. Data provenance is not relevant in the context of mechanical engineering tests on manufactured components.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for mechanical properties is established by the rigorous application of testing standards and physical measurements, not by human experts adjudicating images or clinical data.

4. Adjudication method for the test set: Not applicable for mechanical or simulation 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 is a physical medical device, not an AI-assisted 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.

7. The type of ground truth used: For the mechanical properties, the "ground truth" is derived from the physical laws governing material science and mechanics, validated through standardized testing methods (e.g., ASTM standards) and finite element analysis.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of validating a mechanical implant through performance testing. Finite element analysis (FEA) models are "trained" or developed based on material properties and engineering principles, but not in the same sense as an AI algorithm.

9. How the ground truth for the training set was established: Not applicable. See point 8.

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The HTS is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the HTS can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.

This document is a 510(k) summary for the Hammertoe Truss System (HTS). It indicates that the purpose of the submission is to update the HTS implant offering to include two smaller sizes. The document outlines the device description, indications for use, and a comparison to predicate devices, focusing on the mechanical properties and MRI compatibility.

Here's an analysis based on your request, keeping in mind that the document mainly focuses on mechanical performance and equivalence to a predicate device, rather than a clinical study with patients or human readers.

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)

This submission describes engineering performance testing and simulation analysis, not a clinical study on a test set of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" in a clinical context are not applicable. The testing was done on physical device prototypes or through computer-simulated models.

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

This is not applicable as the submission reports on mechanical and MRI compatibility testing of a physical device, not a diagnostic or AI-driven system requiring expert review of medical images.

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

This is not applicable. Adjudication methods are relevant for studies involving human interpretation of data, typically in clinical trials or diagnostic accuracy studies.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the safety and effectiveness of a physical implantable device based on mechanical and MRI compatibility testing, demonstrating substantial equivalence to a predicate device. It does not involve AI or human readers.

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. This submission is for a physical medical device (implant).

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

The "ground truth" for this type of submission is based on engineering standards and established test methods (e.g., ASTM standards) for evaluating the mechanical properties and MRI compatibility of medical implants. The "truth" is whether the device physically performs in accordance with these validated standards and demonstrates similar characteristics to the predicate device.

8. The sample size for the training set

This is not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set. The "training" for such devices involves design, manufacturing, and extensive bench testing.

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

This is not applicable for the reasons mentioned in point 8.

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The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:

• · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
• · Opening wedge of Medial Cuneiform or Cotton osteotomies
• · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
• · Metatarsal/Cuneiform osteotomies
• · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
• · Hindfoot osteotomies
  The device is intended for use with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.

The Osteotomy Truss System (OTS) consists of three implant designs in a variety of footprints and opening wedge height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixations.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.

This 510(k) premarket notification describes a design update to an existing device, the Osteotomy Truss System (OTS). The submission focuses on demonstrating substantial equivalence to the predicate devices through non-clinical performance testing. Therefore, it does not involve clinical studies or in-depth performance metrics typically associated with AI/ML devices.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission relies on non-clinical performance testing (in vitro/bench testing and computational modeling). The document does not specify a "test set" in the context of patient data or clinical imaging. The tests were performed on the device itself and its components. Therefore, information regarding human data provenance (country of origin, retrospective/prospective) is not applicable.

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

Not applicable. The ground truth for the non-clinical performance testing is established by the specifications defined in the referenced ASTM standards and engineering principles for finite element analysis.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a submission for a medical device (implant) and not an AI/ML-driven diagnostic or assistive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study in the context of an algorithm or AI was not conducted. The device itself is the subject of the testing.

7. Type of Ground Truth Used

The ground truth used for this submission is based on:

• Established engineering standards: ASTM standards for mechanical testing and MR compatibility.
• Computational modeling results: Finite element analysis, which provides simulated performance data.
• Predicate device characteristics: The substantially equivalent performance to previously cleared predicate devices serves as the benchmark.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device or a study involving machine learning.

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

Not applicable, as there is no training set involved.

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The Cervical Spine Truss System Plating Solution (CSTS-PS) is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1.

The Cervical Spine Truss System Plating Solution (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Cervical Spine Truss System Plating Solution (CSTS-PS) is comprised of cervical plates and screws. The cervical plates have a rotating locking tab for each double screw position to prevent back-out of the screw. The plates are available in 1-level, 3-level, 4-level, and 5-level configurations. Each plate is available in multiple lengths to accommodate varying patient anatomy. The screws are available in two diameters and various lengths. All CSTS-PS plates and screws are made from Ti6Al4V alloy.

The provided text describes the Cervical Spine Truss System Plating Solution (CSTS-PS), a medical device intended for anterior interbody screw fixation of the cervical spine. It focuses on demonstrating the device's substantial equivalence to predicate devices, particularly regarding its mechanical performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, 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 study described is focused on the mechanical performance of the device, not a clinical study involving patients or human data.

• Sample Size for Test Set: The text does not explicitly state the number of devices or components tested for each mechanical test (static compression bending, dynamic compression bending, static torsion, screw push out). It only indicates that "4WEB has conducted" these tests. For these types of biomechanical tests, sample sizes are typically determined by established standards like ASTM F1717 and ASTM F543, which would specify the number of samples required.
• Data Provenance: The data is generated from in-vitro (benchtop) testing in a laboratory setting by the manufacturer, 4WEB Medical, Inc. It is not patient data, and therefore, concepts like "country of origin" or "retrospective/prospective" do not apply in the typical sense for clinical trials.

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

This question is not applicable in the context of this submission. The "ground truth" for mechanical performance tests is established by the specified ASTM standards (F1717, F543, F2503) and the FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway. These standards and guidelines dictate the testing methodologies and acceptance thresholds, which are developed through a consensus process involving engineers, scientists, and regulatory bodies. The compliance is against these pre-defined, objective criteria, not based on expert consensus on individual test outcomes in the same way clinical ground truth is established.

4. Adjudication Method for the Test Set:

Not applicable. Mechanical testing results are objectively measured against pre-defined numerical or qualitative criteria specified in the ASTM standards and FDA guidance. There is no human adjudication process involved in interpreting these mechanical test results beyond verifying that the measurements fall within the acceptable ranges.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation AI devices where human readers' performance is being evaluated with and without AI assistance. The CSTS-PS is a physical medical implant, and its evaluation revolves around its mechanical and material properties, not its interpretive capabilities.

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

Not applicable. The CSTS-PS is a surgical implant, not an algorithm or AI system. Its "performance" is assessed through its physical and mechanical properties in a standalone, benchtop testing environment.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is derived from established engineering standards and regulatory guidance. Specifically:

• ASTM F1717: Standard Test Methods for Static and Fatigue Testing of Spinal Implant Constructs in a Corpectomy Model.
• ASTM F543: Standard Specification for Metallic Medical Bone Screws.
• ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
• FDA Guidance Document, Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway (December 11, 2020): This document provides the specific acceptance criteria for the various mechanical tests.

These documents establish the objective performance benchmarks against which the device's mechanical integrity and MR compatibility are evaluated.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its development and testing are based on engineering principles and materials science, not machine learning.

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

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

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The Lateral Spine Truss System (LSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. All LSTS Interbody Fusion Devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Interbodies with 18° lordosis or greater must be used with the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) with integrated fixation. If using the 1-hole 4WEB LSTS-PS with integrated fixation, additional supplemental fixation is required (e.g. posterior fixation). These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.

The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

This document is a 510(k) summary for the 4WEB Lateral Spine Truss System (LSTS) Interbody Fusion Device. It focuses on the mechanical performance of the device rather than the performance of an AI/ML diagnostic algorithm. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance metrics are not directly applicable to this submission.

However, I can extract the information related to the device's performance testing based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Specific tests performed to demonstrate compliance:

• Axial screw pushout per ASTM F543
• Static axial compression per ASTM F2077
• Static compression shear per ASTM F2077
• Dynamic axial compression fatigue per ASTM F2077
• Dynamic compression shear fatigue per ASTM F2077
• Expulsion testing
• MR Conditional testing

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

This information is not applicable. The device is a surgical implant, and its performance is evaluated through mechanical testing and finite element analysis, not through a test set with 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)

This is not applicable. Ground truth for a physical device's mechanical properties is established through adherence to engineering standards (ASTM) and scientific principles, not expert consensus on patient data.

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

This is not applicable. Mechanical testing does not involve 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 is not applicable. This is a medical device (interbody fusion device), not an AI/ML diagnostic or assistive technology.

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

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

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

The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F543, ASTM F2077), which define the methods and criteria for evaluating mechanical properties like strength, fatigue, and expulsion. Finite element analysis (FEA) is also used to simulate mechanical behavior and establish "ground truth" in terms of predicted performance under various conditions, validated against established engineering principles.

8. The sample size for the training set

This is not applicable. The document discusses a physical medical device, not an AI/ML algorithm. Finite Element Analysis (FEA) is a computational method that doesn't involve a 'training set' in the machine learning sense.

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

This is not applicable. As stated above, this is about a physical device and not an AI/ML algorithm.

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