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Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). Fortitude Vue is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Fortitude Vue is intended to be used with bone graft.

Fortitude Vue is a hollow device intended for use as a spinal intervertebral body fixation orthosis.

The provided text describes the Fortitude™ Vue Vertebral Body Replacement Device. Here's a breakdown of the requested information based on the text:

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

The document does not specify quantitative acceptance criteria. Instead, it states:

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

• Sample size for test set: Not applicable. The document states, "Clinical data and conclusions were not needed for this device." The non-clinical testing results demonstrating substantial equivalence do not quantify a "test set" in the context of clinical or performance data from a specific number of devices.
• Data provenance: Not applicable for clinical data. For non-clinical (laboratory and bench testing), the provenance is not specified, but it would have been conducted as part of the manufacturer's development and testing processes.

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, as clinical data and a test set requiring expert ground truth were not part of the submission. The "ground truth" for substantial equivalence was based on engineering analysis and comparative mechanical testing to the predicate device.

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

Not applicable, as a clinical test set requiring adjudication was not used.

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

Not applicable. This device is a spinal implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are not relevant.

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

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

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

Not applicable for a clinical ground truth. The "ground truth" for the device's performance was its demonstrated equivalency in laboratory and bench testing against the predicate device, Fortitude™ Titanium (K031914).

8. The sample size for the training set

Not applicable, as there is no "training set" in the context of this device. The device is a physical implant, not an artificial intelligence model.

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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To provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures.

The Harmony Port System includes the Harmony Port, which provides surgical exposure during minimally invasive procedures, along with accessory instruments designed to facilitate the use of the Port and rigidly fix the system during use.

The provided 510(k) notification summary for the Harmony™ Port System does not contain specific acceptance criteria or a study that proves the device meets such criteria. Instead, it indicates that the device's substantial equivalence to a predicate device was established through non-clinical testing.

Here's a breakdown of the information that is present and what is missing based on your requested categories:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: "The results of non-clinical testing and evaluation demonstrate that the device is safe and effective." No specific performance metrics (e.g., accuracy, precision, duration of use) are provided.

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

• This information is not provided. The summary only mentions "non-clinical testing," which typically refers to bench testing, mechanical testing, or simulations, rather than human 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 information is not applicable and not provided, as the testing was non-clinical and did not involve human-derived data that would require expert ground truthing.

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

• This information is not applicable and not provided, as the testing was non-clinical.

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

• This information is not applicable. The device is a surgical retractor, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted or referenced.

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

• This information is not applicable. The device is a physical surgical tool, not an algorithm.

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

• This information is not applicable. For non-clinical device testing, ground truth typically refers to engineering specifications, physical measurements, or established mechanical properties, rather than clinical outcomes or pathology. The document does not detail the specific "ground truth" or reference standards used for the non-clinical tests.

8. The sample size for the training set

• This information is not applicable. The device is a physical product, not a machine learning model.

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

• This information is not applicable. The device is a physical product, not a machine learning model.

Summary of Device and Evidence:

The Harmony™ Port System is a surgical retractor intended "to provide a self-locking mechanism to hold the edges of a wound open and allow for surgical exposure during general use and neurosurgical procedures."

The basis for its 510(k) clearance (K050706) is its substantial equivalence to a predicate device, The Bright Medical Dilation Retractor System (K992898). The submission states that the Harmony Port System "has the same intended use, is manufactured from similar materials using similar processes, and is similar in design when compared to the predicate device."

The only performance data mentioned is: "The results of non-clinical testing and evaluation demonstrate that the device is safe and effective." This statement indicates that bench or mechanical tests were performed to confirm the device's functionality and safety, consistent with its classification as a Class II surgical retractor. However, no specific details about these tests, the acceptance criteria, or the reported performance metrics are provided in the excerpt.

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The Spinous Process Plate is intended for fixation to adjacent spinous processes (L1-L5) as an adjunct to anterior interbody fusion and bone graft. The indications for the spinous process plate include spinal trauma, degenerative spondylolisthesis and degenerative disc disease. The spinous process plate should only be used in the presence of a vertebral body replacement device such as the Spinal Concepts, Inc. InFix® System.

The Tandem system consists of spinous process plates and interconnecting male and female grommets. The implants are used in combination with a vertebral body replacement device such as the Spinal Concepts, Inc. InFix System. The plates feature a slim profile, several rows of spikes, and holes on each end with a spherical seat for grommet attachment. The spikes around the plate holes resist plate rotation after implantation, while a row of spikes over the intraspinous ligament aids in fixation to any optional bone graft.

It appears there might be a misunderstanding regarding the nature of the provided document. The text is a 510(k) summary for a medical device (Spinal Concepts, Inc. Tandem Spinous Process Plate System), which is a premarket notification to the FDA.

This document describes a mechanical surgical implant and its regulatory approval process, not an AI or software-based device that would typically have "acceptance criteria" and be "proven to meet the acceptance criteria" through clinical studies in the way you've outlined with terms like "test set," "ground truth," "MRMC," or "standalone performance."

For this type of device, "acceptance criteria" are generally related to its physical and functional properties, and "proof" comes from mechanical testing and demonstrating substantial equivalence to a predicate device.

Given this context, I cannot provide the information in the format requested as it's not applicable to this document. However, I can extract the relevant information pertaining to the device's assessment from the provided text:

Summary of Device Assessment from K040096: Spinal Concepts, Inc. Tandem Spinous Process Plate System

1. Acceptance Criteria and Reported Device Performance (as inferred for a mechanical device):

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

• Not applicable in the way specified. For this mechanical device, the "test set" would refer to physical prototypes or samples subjected to mechanical stress tests. The document does not specify the number of samples used in these tests.
• Data Provenance: The mechanical test data would be generated in a lab setting, likely by the manufacturer (Spinal Concepts, Inc.). The exact country of origin for the testing is not specified, but the manufacturer is based in Austin, TX, USA. The testing would be prospective in the sense that the device was tested to demonstrate its capabilities before widespread use.

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. The "ground truth" for a mechanical device like this is established through engineering principles, material science, and biomechanical standards, not expert consensus on images or clinical outcomes in the same way an AI device would be evaluated. The mechanical performance itself (e.g., load-bearing capacity, fatigue resistance) is the "ground truth" being measured.

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

• Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant to mechanical testing results. Mechanical test results are typically quantitative and objective measurements.

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 mechanical surgical implant, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

• Not applicable. This concept is for AI algorithms, not mechanical implants. The device itself (the implant) is the "standalone" product that undergoes testing.

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

• For mechanical devices, the "ground truth" or standard of comparison is typically based on established engineering standards, biomechanical principles, and the performance of predicate devices. The document states:
  • "Mechanical testing demonstrated that the Tandem System exhibits the functional requirements to support its use as a spinous process plate system under normal physiologic loads in the spine." This suggests mechanical properties (strength, stability) as the core "ground truth."
  • The FDA determined "substantial equivalence" to a "legally marketed predicate device" (Meurig-Williams Plate). The performance characteristics of the predicate device serve as a benchmark for "ground truth."

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a mechanical device undergoing mechanical testing or a 510(k) review for substantial equivalence. "Training set" refers to data used to train an AI algorithm.

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

• Not applicable. As there is no "training set" as defined for AI or statistical models, there is no ground truth established for it.

In summary, this document is for a traditional medical device, a surgical implant, and its regulatory clearance is based on mechanical performance and substantial equivalence, not the kind of AI/algorithm performance analysis detailed in your questions.

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Coda is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

Coda is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Coda is intended to be used with bone graft and supplemental fixation. Additionally, Coda is intended to be implanted in a paired configuration.

Coda is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136. The device consists of two opposing surfaces that make contact with the bony endplates of the vertebral bodies, and can be adjusted to provide from 0-11 degrees of fordosis.

Coda is available in two lengths and widths, and in various heights to provide the surgeon anatomic flexibility.

Coda is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

The provided text describes a 510(k) summary for a medical device called "Spinal Concepts Inc. Coda®," which is a vertebral body replacement device. This summary focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. It does not present information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which is typically what this type of request asks for.

The document is a traditional 510(k) submission for a physical implant, not a software device. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance metrics (such as sensitivity, specificity, AUC), sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training sets is not applicable to this submission.

The "Substantial Equivalence" section states: "Mechanical testing demonstrated that Coda® exhibits the functional requirements to support its use as vertebral body replacement under normal physiologic loads in the spine." This is the core 'study' and 'acceptance criteria' for this type of device, focusing on biomechanical performance rather than diagnostic accuracy or AI model performance.

In summary, none of the requested fields regarding acceptance criteria and studies for AI/ML devices can be extracted from the provided text because the document pertains to a physical, non-AI medical implant.

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Cadence and TraXis are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Cadence™ is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polvaryletheretherketone, ASTM F2026) and is offered in a tapered style of various sizes.

TraXisTM is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polyaryletheretherketone, ASTM F2026) and is offered in various lengths, widths and heights.

The provided text describes a 510(k) premarket notification for the Spinal Concepts, Inc. Cadence™ and TraXis™ vertebral body replacement devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study with acceptance criteria and a detailed study report. Therefore, many of the requested elements (like specific numerical acceptance criteria, sample sizes for test/training sets, expert qualifications, and MRMC studies) are not present in this document.

However, I can extract the relevant information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the document. The mechanical testing mentioned would have involved a sample size of devices, but this detail is not provided.
• Data Provenance: Not specified. The document states "Mechanical Testing," implying a laboratory study, but does not give details on the location or whether the data was retrospective or prospective.

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

• Not applicable/Not mentioned. The "study" mentioned is "Mechanical Testing," which evaluates the physical characteristics of the device, not a diagnostic or prognostic performance requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. Mechanical testing typically involves objective measurements, not adjudication of interpretations.

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

• No, a MRMC comparative effectiveness study was not done. The document describes mechanical testing of a medical device, not a study involving human readers and AI for clinical interpretation.

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

• Not applicable. This is a physical medical device, not an algorithm. The "mechanical testing" could be considered a form of standalone performance evaluation for the device itself.

7. Type of Ground Truth Used

• For the mechanical testing, the "ground truth" would be the engineering specifications and biomechanical requirements for a vertebral body replacement device, against which the device's performance (e.g., strength, durability under load) is measured. It is not an expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. See point 8.

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When intended for pedicle screw fixation from L1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.

As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

InSight constructs consist of bone screws, lock screws, connectors, swivels, and rods, which when assembled create a polyaxial range of motion. InSight only allows the placement of 5.5 mm titanium rods. InSight screws may be implanted in an open manner; or via cannulation, which allows a subset of procedures to be completed through a mini open procedure.

The provided text describes the "Spinal Concepts, Inc. InSight™ Pedicle Screw System" and details its indications for use and mechanical testing. However, it does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device.

The document is a 510(k) summary for a medical device (spinal pedicle screw system), which is a physical implant, not a software device. Therefore, the concepts you've asked about (AI/ML device performance, test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets) are not relevant to this type of submission and are not present in the text.

The text does mention "Mechanical testing data, including data collected in accordance with ASTM 1717 and ASTM 1798, was collected to verify that the design changes met established design requirements." These design requirements would serve as the "acceptance criteria" for this mechanical device, and the ASTM testing would be the "study" proving it. However, specific values for these criteria and reported performance are not detailed in this summary.

Therefore, I cannot provide the requested information based on the given input, as it pertains to a different type of medical device evaluation.

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When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The Spinal Concepts, Inc. Nex-Link Spinal Fixation System consists of a series of longitudinal members, anchors, and transverse connectors. The Nex-Link system is intended for fixation to, and stabilization of, the cervicothoracic spine.

Nex-Link implants are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F-136 or commercially pure titanium per ASTM-F-67.

The provided document is a 510(k) summary for the Spinal Concepts, Inc. Nex-Link Spinal Fixation System. It describes the device, its indications for use, and mentions that mechanical test data was provided to support the 510(k) notification. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in a way that aligns with the questions posed (e.g., related to AI/algorithm performance, ground truth, expert review, sample sizes for training/test sets).

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the questions related to a study proving the device meets those criteria, as the document does not contain this information. The document focuses on regulatory approval based on substantial equivalence to a predicate device and mechanical testing, not on clinical performance metrics as typically presented for AI/software devices.

The only relevant information from the prompt for the questions is that "Mechanical testing data, collected in accordance with ASTM F1717-01 and ASTM F1798-97, were provided to support this 510(k) notification." This indicates a type of testing, but not the specific data or criteria outcomes.

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The TraXis Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

The Spinal Concepts Inc. TraXis Cement Restrictor is a modified version of the Spinal Concepts Cadence Cement Restrictor (K022218 and K023647). Both are indicated for use as cement restrictors in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

TraXis is crafted from titanium alloy (ASTM F136) or PEEK OPTIMA™ (polyaryletheretherketone, ASTM F2026). As PEEK OPTIMA™ is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires (ASTM F560) that are press-fit into small holes in the implant.

TraXis is offered in various lengths, widths and heights. TraXis is intended for restriction of bone cement in the distal femoral canal.

The provided text for K031318, "Spinal Concepts, Inc. TraXis™ Cement Restrictor," does not include information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) summary for a medical device and primarily focuses on:

• Device description and its components.
• Indications for use.
• Identification of a predicate device (Spinal Concepts Inc. Cadence™ Cement Restrictor).
• A statement regarding mechanical tests: "No mechanical tests were performed to support this application."
• The FDA's decision regarding substantial equivalence and required labeling limitations.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies based on the provided text.

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The InFix System is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

InFix is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The InFix is intended to be used with bone graft.

InFix® is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136, and is available in various sizes and dimensions. The device is comprised of two opposing endplates supported by vertical members or "struts" that can be varied in height such that the surgeon can fix the vertebrae in a proper anatomical alignment and lordosis.

Each of the struts includes a load-sharing mechanism that allows a limited amount of strain across the fusion mass while supporting the load bearing surfaces. An Ultra High Molecular Weight Polyethylene (UHMWPE) end cap may be placed inside the device prior to packing of bone graft to effectively block the posterior opening in the device and contain the material inside.

Holes in the titanium endplates provide space for bone in-growth while angled spikes (teeth) penetrate the vertebral endplates and provide resistance to rotation and migration.

The provided text describes a 510(k) summary for a medical device called the "Spinal Concepts Inc. InFix® System". It does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/readership performance perspective.

The document is a premarket notification for a traditional medical device (a spinal implant) and focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. It does not involve any AI components, human reader performance evaluations, or diagnostic accuracy studies typically associated with the questions posed in the prompt.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training/testing data sets as these concepts are not relevant to the provided text.

The only "study" mentioned is mechanical testing to demonstrate substantial equivalence, which is a different type of evaluation.

Summary of available information related to performance criteria, even though it's not AI-related:

1. Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria (Implicit): The device (InFix® System) is designed to be "substantially equivalent" to predicate devices (Interpore Cross GEO™ Structure and Interpore Cross International Anterior Fixation Device (AFD)) based on mechanical performance. This implies that its mechanical properties must be comparable or superior to the predicate devices.
   • Reported Device Performance: "Mechanical testing demonstrates that InFix® is substantially equivalent to the Interpore Cross GEO™ Structure and Interpore Cross International Anterior Fixation Device (AFD) predicate devices."

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to the physical devices subjected to mechanical testing, not a dataset of images or clinical cases. The provenance of the data is that it was generated through mechanical testing, presumably in a lab setting by the device manufacturer, Spinal Concepts, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is typically established by engineering specifications and objective measurements, not clinical expert consensus.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not applicable as the device is a physical implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.

7. The type of ground truth used: For the mechanical testing, the ground truth would be quantitative measurements of material strength, load-bearing capacity, fatigue resistance, etc., against established industry standards and/or the performance of the predicate devices.

8. The sample size for the training set: Not applicable. "Training set" refers to data used to train an AI model.

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

In conclusion, the provided document is a regulatory submission for a physical medical implant, and the questions posed are primarily relevant to AI/diagnostic software. Therefore, most of the requested information is not present or applicable.

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The Fortitude Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

Fortitude, cleared as a cement restrictor via K021719, is currently crafted from titanium alloy (ASTM F136). The purpose of this special 510(k) is to obtain clearance to market a PEEK OPTIMA™ (polyaryletheretherketone, ASTM F2026) version of Fortitude. The modification does not change the intended use or the fundamental scientific technology of the device.

As PEEK OPTIMA™ is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires (ASTM F560) that are press fit into small holes in the implant.

Fortitude is a hollow device with texture on two opposing flat sides, and is offered in straight and tapered styles of various sizes. Fortitude is intended for restriction of bone cement in the distal femoral canal (see figure below).

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.

Instead, the document is a 510(k) summary for a Special 510(k) submission for the Spinal Concepts, Inc. Fortitude™ Cement Restrictor. This submission is for a modification of an already cleared device (K021719) to introduce a new material (PEEK OPTIMA™).

Key points from the document indicating why this information is missing:

• "No mechanical tests were performed to support this application." This explicitly states that performance tests, which would typically establish acceptance criteria and demonstrate performance, were not conducted for this specific 510(k) submission. The clearance relies on substantial equivalence to the predicate device and the new material's general properties and biocompatibility.
• The document primarily focuses on the device description, indications for use, and regulatory correspondence regarding the 510(k) clearance process.
• The FDA letter confirms substantial equivalence based on the provided information and imposes a specific warning about spinal indications, but does not refer to new performance data.

Therefore, I cannot populate the requested table or sections based on the provided text, as the necessary information regarding acceptance criteria and performance studies is not present.

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