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When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Coment, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Kyphon™ Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arrsing from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

When used in conjunction with CD Horizon™ Fenestrated Screws, Kyphon™ Xpede™ Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with CD Horizon™ Fenestrated Screws, Medtronic HV-R™ Fenestrated Screw Cement is intended to restore the integrity of the spinal column, even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Medronic HV-R™ Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) bone cement (Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion. These implants may also serve as traditional pedicle screws when used without bone cement in patients with non-compromised bone quality. CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobalt-chromiummolybdenum allov.

Kyphon™ Xpede™ Bone Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is designed for delivery in a highly viscous state. Kyphon™ Xpede™ Bone Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene copolymer, barium sulfate and benzoyl peroxide. The liquid contains methylmethacrylate (monomer), hydroquinone and N, N dimethyl-p-toluidine.

Medtronic HV-RTM Fenestrated Screw Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is designed for delivery in a highly viscous state. Medtronic HV-RTM Fenestrated Screw Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate, and benzovl peroxide. The liguid contains methylmethacrylate (monomer), hydroquinone and N. N dimethyl-p-toluidine.

This FDA 510(k) summary does not contain any information regarding clinical performance studies, AI algorithms, or human-in-the-loop performance.

The document is a premarket notification for medical devices (bone cement and fenestrated screws), not an AI/ML-driven diagnostic device. The application focuses on demonstrating substantial equivalence to previously cleared predicate devices based on technological characteristics and existing performance data for those predicates.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, as these types of studies were not conducted or reported in this submission for these specific medical devices.

The document explicitly states:

"Medtronic believes that testing is not warranted for the subject devices as they do not present a new worst case when compared to the predicate devices. All existing predicate data previously provided in the predicate 510(k)s are still applicable."

This indicates that the submission relies on the performance data of the predicate devices rather than new performance studies for the subject devices themselves.

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When used without cement, the CD HORIZON™ Fenestrated Screws (with or without SEXTANT™ or LONGITUDE™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with Medtronic HV-R™ Fenestrated Screw Bone Cement or Kyphon™ XPEDE™ Bone Cement, the CD HORIZON™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON™ Fenestrated Screws augmented with either Medtronic HV-R™ Fenestrated Screw Bone Cement or Kyphon™ XPEDE™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

KYPHON™ Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

When used in conjunction with CD HORIZON™ Fenestrated Screws, KYPHON™ Xpede™ bone cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON™ Fenestrated Screws augmented with KYPHON™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Kyphon Xpede™ Bone Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. Kyphon Xpede™ Bone Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.

Medtronic HV-RTM Fenestrated Screw Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. Medtronic HV-RTM Fenestrated Screw Cement is provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer. barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.

The CD HORIZON™ Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON™ LEGACY™ and CD HORIZON™ SOLERA™ implants contained in the CD HORIZON™ Spinal System. The CD HORIZON™ Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON™ Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These implants may also serve as traditional pedicle screws when used without bone cement. These screws are provided non-sterile.

The provided text describes specific medical devices (KYPHON™ Xpede™ Bone Cement, CD HORIZON™ Fenestrated Screw Set) and their regulatory clearance (K171938). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than describing a study with acceptance criteria to prove device performance in a clinical setting in the way an AI/ML device would be evaluated for diagnostic accuracy.

Therefore, the requested information (acceptance criteria, study details for proving device meets criteria, sample sizes, expert involvement, MRMC study, standalone performance, ground truth types and establishment methods) is not applicable to this document.

This document refers to biocompatibility and mechanical testing for physical devices (bone cement and screws), which are evaluated against industry standards and by comparison to predicate devices, not through performance metrics like sensitivity, specificity, or AUC as one would expect for an AI/ML device.

Here's how the requested points relate to the provided text:

1. A table of acceptance criteria and the reported device performance: This document doesn't present acceptance criteria and device performance in the context of diagnostic accuracy or clinical outcomes for an AI/ML device. Instead, it describes:

   • Biocompatibility: The materials of the CD HORIZON™ Fenestrated Screws (titanium alloy, titanium, cobalt-chromium-molybdenum alloy) have a long clinical history of safe and effective use, so no additional biocompatibility testing was required. The Xpede™ Bone Cement is identical to the predicate and uses equivalent implant materials, sterilization methods, and bacterial endotoxin testing (20 EU/ml pyrogen limit).
   • Mechanical Testing:
     • Axial Pull Out Testing (ASTM F543-07): CD HORIZON™ Fenestrated Screws augmented with the subject Kyphon Xepede™ Bone Cement were compared to those augmented with Medtronic HV-R™ Fenestrated Screw Cement. Result: Pull-out strength of the screws was equivalent.
     • Flow Rate Analysis: Compared Kyphon Xpede™ Bone Cement to Medtronic HV-R™ Fenestrated Screw Cement regarding injection and flow characteristics using fluoroscopic imaging. Result: Flow rates of the subject and predicate cements were substantially equivalent.

2. Sample sizes used for the test set and the data provenance: Not applicable. The testing described (biocompatibility, mechanical testing) refers to material and mechanical properties, not a clinical "test set" for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no diagnostic accuracy study requiring expert adjudication is described.

4. Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable. The "ground truth" here relates to established material properties and mechanical performance standards, not clinical diagnoses.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

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

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Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Kyphon® Xpede™ Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

The provided text is a 510(k) summary for a medical device, Kyphon® Xpede™ Bone Cement. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data to support substantial equivalence.

However, the questions posed (regarding acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment, specifically for an AI/ML powered device) are not applicable to the information provided in this document.

This document pertains to a Polymethylmethacrylate (PMMA) bone cement, which is a material used in surgical procedures. It is a traditional medical device, not an AI/ML powered diagnostic or assistive technology. The "acceptance criteria" and "study" described in the document relate to the physical and chemical properties of the bone cement, its biocompatibility, and its performance in cadaveric studies and clinical literature review to demonstrate safety and efficacy for its intended use, primarily by comparing it to already approved predicate devices.

Therefore, I cannot answer the questions as they are phrased because the information requested is for AI/ML device validation, which is not what this document describes.

To directly address the request, if we were to reinterpret the provided text in the context of "acceptance criteria" and "study" for this specific bone cement device, here's what could be extracted, noting that it will not fit the AI/ML framework:

Reinterpretation for a PMMA Bone Cement Device (Not AI/ML)

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

The document does not present quantitative acceptance criteria in a formal table or specific reported device performance metrics beyond qualitative statements about safety and efficacy. The study aims to show "substantial equivalence" to predicate devices, rather than meeting predefined numerical thresholds for a novel AI algorithm.

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

• Test set (Clinical Literature Review): 5 articles reviewed, covering clinical outcomes for 462 patients.
• Test set (Cadaver Study): The document states "A cadaver study... was completed." It does not specify the number of cadavers or specific test cases.
• Data Provenance: Not explicitly stated, but clinical literature typically includes studies from various global regions. The cadaver study would have been performed by the manufacturer or a contracted lab. It is retrospective for the literature review and prospective for the cadaver study within the context of this submission.

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

• Cadaver Study: "The procedure and imaging review was performed by trained physicians." The exact number and specific qualifications (e.g., years of experience, specialty) are not provided.
• Clinical Literature Review: Ground truth is established by the findings and conclusions of the published clinical studies themselves. The experts involved would be the authors and peer reviewers of those articles.

4. Adjudication method for the test set

• Cadaver Study: Not explicitly described. It's stated that "trained physicians" performed the review, but the method for resolving discrepancies or reaching consensus (if multiple physicians were involved per case) is not detailed.
• Clinical Literature Review: The 'adjudication' would be inherent in the peer-review process of the scientific literature and the interpretation by the device manufacturer's team.

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

• No, this is not an MRMC study. This type of study is specifically relevant to diagnostic imaging systems or AI tools where human readers interpret images with or without AI assistance. The studies performed here are a literature review of clinical outcomes and a cadaveric study of the bone cement's physical behavior (e.g., extravasation).

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

• Not applicable. This device is a physical material (bone cement), not an algorithm or software. "Standalone performance" in this context would refer to the in-vitro and in-vivo properties of the cement itself, which were evaluated through material testing and the cadaver study.

7. The type of ground truth used

• Clinical Literature Review: The "ground truth" is derived from the reported clinical outcomes in peer-reviewed publications. This is a form of outcomes data and expert clinical assessment as reported in those studies.
• Cadaver Study: The "ground truth" for extravasation was established by direct observation and imaging review by trained physicians during the physical testing in cadaveric models.

8. The sample size for the training set

• Not applicable. This device is a material, not an AI/ML model that requires a training set.

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

• Not applicable. (See point 8)

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Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Kyphon® Xpede™ Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

This document is a 510(k) premarket notification for a medical device (Kyphon® Xpede™ Bone Cement), and as such, it does not contain the type of detailed study information typically found in a clinical trial report or a performance study for AI/AI-assisted devices.

The document states that the subject device is "substantially equivalent" to a legally marketed predicate device (Kyphon® Xpede™ Bone Cement K102397 S.E. 2/28/2011). This means the manufacturer is asserting that the new device has the same fundamental scientific technology, equivalent implant materials, sterilization methods, and has not raised new issues of safety or effectiveness with its revised indications for use.

Therefore, many of the requested categories (acceptance criteria, study details, sample sizes, expert ground truth, MRMC, standalone performance, training set details) are not applicable (N/A) because the FDA's clearance is based on substantial equivalence to an existing device, rather than a de novo clinical performance study against specific acceptance criteria.

However, I can extract the relevant information regarding the device itself and the basis of the clearance.

Here's a breakdown based on your request, with N/A for information not present in a 510(k) substantial equivalence determination:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, there are no specific "acceptance criteria" defined in the way one would for a novel device's performance study against a predefined threshold. The "performance" is based on its similarity to the predicate device and the fact that its design features, materials, chemical composition, and manufacturing are equivalent.

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

• Sample Size for Test Set: N/A (No specific "test set" in the context of a de novo performance study is mentioned for this substantial equivalence). The evaluation is based on comparison to the predicate device.
• Data Provenance: N/A

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

• Number of Experts: N/A
• Qualifications of Experts: N/A

4. Adjudication method for the test set

• Adjudication Method: N/A

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, this is not an AI/AI-assisted device. It is bone cement.
• Effect Size: N/A

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

• Standalone Performance Study: No, this is not an AI/AI-assisted device. It is bone cement.

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

• Type of Ground Truth: N/A (The "ground truth" for this submission is the established safety and effectiveness of the predicate device).

8. The sample size for the training set

• Sample Size for Training Set: N/A (No "training set" in the context of an AI/ML model or a de novo performance study is mentioned).

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

• Ground Truth Establishment for Training Set: N/A

Summary of what the document does provide:

• Device Name: Kyphon® Xpede™ Bone Cement
• Regulation Number: 21 CFR 888.3027 (Polymethylmethacrylate (PMMA) bone cement)
• Regulatory Class: Class II
• Product Code: NDN
• Indications for Use: Treatment of pathological fractures of the vertebral body due to osteoporosis, cancer (multiple myeloma, metastatic lesions from breast/lung cancer, lymphoma), or benign lesions (hemangioma, giant cell tumor) using cementoplasty (kyphoplasty or vertebroplasty). Pathologic fracture may include a symptomatic vertebral body microfracture without obvious loss of vertebral body height.
• Predicate Device: Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011)
• Basis for Clearance: Substantial equivalence to the predicate device, stating that the subject device has the same fundamental scientific technology, equivalent implant materials, sterilization methods, design features, chemical composition, device performance, packaging, manufacturing, and that the revision/modification of the indications for use does not raise new issues of safety or effectiveness.

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KYPHON® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.

KYPHON® Xpede™ Bone Cement is provided as a two- component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl- methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

The provided 510(k) summary for Kyphon® Xpede™ Bone Cement does not contain information about acceptance criteria or a study proving its performance against such criteria for a clinical application using AI. This document is a premarket notification for a medical device (bone cement), and the testing described is primarily focused on bench testing and biocompatibility to demonstrate substantial equivalence to previously approved predicate devices, not clinical performance metrics measured in a study with a test set of data.

Therefore, many of the requested categories related to AI performance, ground truth, and human reader studies cannot be populated from this document.

However, I can extract the relevant information regarding the testing that was conducted to demonstrate substantial equivalence.

Here's the breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not define specific acceptance criteria values in a table format for the mechanical, physical, chemical, or handling tests. Instead, it states that "The results of this testing support the determination of substantial equivalence." This implies that the performance of the Kyphon® Xpede™ Bone Cement fell within acceptable ranges or was comparable to the predicate devices for these various tests.

What is reported is the type of testing conducted to support substantial equivalence:

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

• Sample Size: The document does not specify the exact sample sizes for each of the bench tests (mechanical, handling, physical, chemical, biocompatibility). These are typically laboratory tests performed on a certain number of material samples.
• Data Provenance: The tests are described as "Testing was conducted to verify the performance of Kyphon® Xpede™ Bone Cement for in vivo applications." This indicates laboratory-based testing, not clinical data from patients. The country of origin for the data is not explicitly stated but can be inferred to be from the manufacturer (Medtronic Spine LLC) or a contracted lab. This is a retrospective analysis of the material properties, not a prospective clinical study.

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

Not applicable. This is not a study involving human interpretation of data where expert ground truth is established. The "ground truth" for material properties is derived from standardized laboratory measurements.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation of data for 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

Not applicable. This is a submission for a bone cement, not an AI-powered diagnostic or assistive device.

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

Not applicable. This is a submission for a bone cement, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's evaluation is based on objective, standardized laboratory measurements of material properties (e.g., strength, viscosity, chemical composition, biocompatibility testing against established safety profiles). There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these types of tests for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

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

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