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CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), CAPRI Static and Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths, and heights to match the patient's anatomy. Static (titanium) and expandable (titanium and cobalt chrome) cervical cages are available and are implanted via an anterior approach. The cervical implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001 and ASTM 136) and Cobalt Chrome (per ASTM F1537). The purpose of this Traditional 510(k) submission is to introduce a new 12x14mm cervical expandable footprint size to the previously cleared CAPRI Corpectomy Cage System.

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

The provided text describes the 510(k) premarket notification for the K2M, Inc. CAPRI Corpectomy Cage System. This submission introduces a new 12x14mm cervical expandable footprint size to an already cleared system. As such, the study focuses on demonstrating the substantial equivalence of this new footprint to the predicate device, rather than proving a new device's performance against specific clinical acceptance criteria for effectiveness or safety in a clinical trial setting. The studies conducted are mechanical tests to ensure the new footprint maintains the same structural integrity and performance characteristics as the predicate.

Here's the information extracted from the provided text, addressing your points:

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

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for each test, but it lists the mechanical tests performed to demonstrate substantial equivalence to the predicate device. The performance is implied to be "met" if the device demonstrates substantial equivalence.

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

The document does not specify sample sizes (number of devices tested) for the mechanical tests. It also does not mention data provenance in terms of country of origin or whether a retrospective/prospective study was conducted, as these were benchtop mechanical tests, not clinical studies involving 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 to the type of study described. The study involves mechanical testing against ASTM standards and comparison to a predicate device, not expert-based ground truth establishment as would be seen in diagnostic imaging or clinical effectiveness studies.

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

This is not applicable as the study involves mechanical testing against defined standards, not human evaluation requiring 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. The device is a spinal implant, not an AI-assisted diagnostic tool.

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

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

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

For mechanical testing, the "ground truth" is typically defined by adherence to established engineering standards (e.g., ASTM F2077-18, ASTM F2267-04 R18) and meeting performance characteristics comparable to the predicate device. There is no expert consensus, pathology, or outcomes data used as ground truth for this type of submission.

8. The sample size for the training set

This is not applicable. There is no training set mentioned, as this is a submission for a medical implant, not a machine learning algorithm.

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

Not applicable, as there is no training set.

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SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), SANTORINI cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the Santorini Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA

CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1). CAPRI Static cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the CAPRI Static cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA

The SANTORINI and CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid and adjustable cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001) and Cobalt Chrome (per ASTM F1537). The SANTORINI implants are made from PEEK OPTIMA LT1 (ASTM F2026) and tantalum (ASTM 560), with some components containing CP titanium (ASTM F67). The purpose of this submission is to expand the indications to include the cervical spine.

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

This document is an FDA 510(k) clearance letter for the SANTORINI and CAPRI Corpectomy Cage Systems. It primarily deals with the substantial equivalence of medical devices, not the performance of an AI/algorithm-based device. Therefore, the detailed information about acceptance criteria, study methodologies, expert ground truth establishment, MRMC studies, or training sets for AI models is not present in this document.

The document discusses the substantial equivalence of the SANTORINI and CAPRI Corpectomy Cage Systems to legally marketed predicate devices, focusing on:

• Device description
• Intended use
• Technological comparison
• Non-clinical performance evaluation via in vitro testing (static/dynamic compression and torsion, subsidence)
• Clinical evaluation via literature review.

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/algorithm-based devices, and this document pertains to physical surgical implants, I cannot extract the requested information as it is not relevant to this type of medical device clearance.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to biomechanical testing and clinical literature review for the physical cage systems, not performance metrics of an AI model.

Therefore, I am unable to populate the table and answer the specific questions related to AI/algorithm performance.

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The CAPRI Corpectomy Cage Systems is a vertebral body replacement device intended for use in the thoracolumbar spine (T) to L5) to replace collapsed, or unstable vertebral bodies due to tumor or trauma (i.e. fracture). The CAPRI Corpectomy Cage Systems is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.

For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid (titanium) and adjustable (titanium and cobalt chrome) cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001) and Cobalt Chrome (per ASTM F1537).

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

This document describes the CAPRI Corpectomy Cage System, a vertebral body replacement device. This summary focuses on its regulatory clearance and mechanical testing, not a study involving AI or human readers for diagnostic accuracy. Therefore, many of the requested categories (like sample size for test sets, expert qualifications, HRMC studies, etc.) are not applicable to the information provided.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device "performed equally to or better than these systems" (referring to predicate devices) in the mechanical tests. This implies that the predicate devices' performance served as the acceptance criteria benchmark. The specific quantitative acceptance values are not provided in this summary.

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

• Sample Size for Test Set: Not applicable in the context of a "test set" for an AI or diagnostic device. For the mechanical and biocompatibility testing, the sample size would refer to the number of physical devices or components tested. This detail is not provided in the summary.
• Data Provenance: Not applicable for the type of testing described (mechanical and biocompatibility testing of a physical device). The tests were conducted in a laboratory setting. There is no mention of patient data, clinical studies, or country of origin for such data.

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 mechanical and biocompatibility testing of a physical medical device, not a diagnostic device requiring expert consensus for ground truth.

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

• Not applicable. This document describes mechanical and biocompatibility testing of a physical medical device.

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

• No. This is not a study of AI or a diagnostic device, so an MRMC comparative effectiveness study was not performed.

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

• Not applicable. This document describes a physical medical device (corpectomy cage), not a software algorithm.

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

• For mechanical testing, the "ground truth" or reference standard would be the established performance characteristics and safety profiles of the predicate devices, along with the requirements of the ASTM standards (F2077, F2267). The device's performance was compared directly to these benchmarks.
• For biocompatibility testing (BET/LAL), the "ground truth" is compliance with the specified standard (ANSI/AAMI/ST72:2011), which sets limits for endotoxin levels to ensure safety.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not a machine learning model.

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

• Not applicable. No training set for an AI model is involved.

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The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The CAPRI Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.

For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid (titanium alloy) and adjustable (titanium alloy and cobalt chrome) cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium alloy (per ASTM F3001) and Cobalt Chrome (per ASTM F1537).

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

This document is a 510(k) summary for the CAPRI Corpectomy Cage System, a medical device for vertebral body replacement. It details the device's intended use, classification, technological comparison to predicate devices, and non-clinical performance evaluation. It does not contain information about clinical acceptance criteria or studies with human subjects.

Therefore, I cannot provide the requested information, which pertains to clinical acceptance criteria, device performance on a test set, expert involvement, or human reader effectiveness studies. The document only describes non-clinical mechanical testing.

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The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-LS) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (ie. Fracture). The CAPRI Corpectomy System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.

For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the inplanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The CAPRI Corpectomy Cage System is a hollow tube structure manufactured from Ti6Al4V ELI and Co-Cr-Mo. The cages are available in a variety of footprints, with adjustable heights and lordoses to match the patient's anatomy.

• Function: The system functions as a vertebral body replacement device to used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

This document is a 510(k) summary for the CAPRI Corpectomy Cage System, a medical device. The information provided outlines the device's characteristics and its comparison to predicate devices, focusing on demonstrating substantial equivalence rather than presenting an exhaustive study proving that the device meets specific acceptance criteria via a clinical trial setup.

Therefore, many of the requested categories related to clinical study design (sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of FDA submission.

Here's an analysis of the provided text based on your questions:

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

The document does not specify quantitative acceptance criteria in the form of specific thresholds (e.g., minimum tensile strength, maximum wear rate) that the device must meet for mechanical performance. Instead, it states that the device was compared to predicate devices and performed equally to or better than these systems.

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

This document describes non-clinical performance evaluation through mechanical testing, not a clinical study involving human or animal subjects. Therefore, the concept of "sample size for the test set" in a clinical sense, or data provenance (country of origin, retrospective/prospective clinical data), is not applicable here. Mechanical testing typically involves a specific number of device samples manufactured to specification. The document does not provide the exact number of devices tested for each mechanical evaluation.

Data provenance: Mechanical testing is typically conducted in a laboratory setting, likely in the US where the company is based, but this is not explicitly stated.

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. This is a mechanical evaluation of a physical device, not a study requiring expert clinical review to establish ground truth. "Ground truth" in this context would refer to the true mechanical properties, which are measured directly by engineering tests.

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

Not applicable. This concept relates to disagreement resolution in expert reviews for clinical or imaging studies, which is not relevant to mechanical 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 mechanical device evaluation, not an AI-assisted diagnostic or clinical assessment study.

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

Not applicable. This is a mechanical device evaluation.

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

The "ground truth" for the mechanical performance evaluation is the direct measurement of physical properties through standardized engineering tests (ASTM F2077) performed on the device samples. This is considered objective, empirical data.

8. The sample size for the training set

Not applicable. This document describes mechanical testing for a medical device's 510(k) submission, not a machine learning model's development.

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

Not applicable. This document does not describe the development or training of an algorithm or model.

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The CAPRI™ Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

The CAPRI Applicator is a specialized applicator that is temporarily inserted into the vagina or rectum to facilitate the application of radiation to the target site in the treatment of carcinoma. The CAPRI Applicator is provided sterile for single use and is disposable.

The provided text describes a 510(k) summary for the CAPRI™ Applicator, a brachytherapy applicator. This type of regulatory submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a standalone study with defined acceptance criteria and statistical analysis.

Based on the provided document, the following observations can be made regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria and reported device performance in the manner typically seen for algorithmic or diagnostic devices. Instead, it states:

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

The document does not mention a "test set" in the context of an AI/algorithmic device evaluation. The CAPRI™ Applicator is a physical medical device (brachytherapy applicator). Therefore, concepts like retrospective/prospective data, country of origin of data, and sample sizes for test sets are not applicable to the evidence presented for this device.

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

This information is not applicable to the CAPRI™ Applicator as it is a physical device, not an AI or diagnostic algorithm requiring expert-established ground truth from images or other data.

4. Adjudication Method:

This information is not applicable for the same reasons mentioned in point 3.

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

An MRMC study is relevant for evaluating the impact of AI on human reader performance (e.g., radiologists interpreting images). Since the CAPRI™ Applicator is a physical brachytherapy applicator and not an AI-powered diagnostic tool, an MRMC study was not conducted and is not relevant to its submission.

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

This type of study is relevant for AI algorithms. As the CAPRI™ Applicator is a physical device, a standalone algorithm performance study was not conducted and is not relevant.

7. Type of Ground Truth Used:

Ground truth, in the context of AI/diagnostic algorithms, refers to the definitive correct answer for a given case. For the CAPRI™ Applicator, the "ground truth" equivalent would be its manufacturing specifications, material properties, and functional performance, which are evaluated through verification and validation testing (e.g., mechanical, biocompatibility, sterilization, dimensional accuracy). The document states: "All necessary verification and validation testing has been performed for the CAPRI Applicator to assure substantial equivalence to the predicate devices."

8. Sample Size for the Training Set:

This information is not applicable as the CAPRI™ Applicator is a physical device, not an AI algorithm that undergoes training.

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

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

In summary:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the CAPRI™ Applicator to existing legally marketed predicate devices, rather than presenting a performance study with defined acceptance criteria and statistical results for an AI or diagnostic algorithm. The evidence presented relates to the physical and technical characteristics, intended use, and principle of operation being similar to the predicates, supported by "necessary verification and validation testing." The structure of the information requested (points 1-9) is primarily geared towards AI/algorithmic devices, which the CAPRI™ Applicator is not.

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