Search Results
Found 6 results
510(k) Data Aggregation
(139 days)
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The CASCADIA hyperlordotic lateral lumbar implants (≥22°), are intended for levels L2-L5 and are to be used with CAYMAN United plates in addition to posterior supplemental fixation. The CASCADIA non-hyperlordotic lateral lumbar implants may optionally be used with CAYMAN United plates, in addition to supplemental spinal fixation systems.
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
The CASCADIA implants consist of hollow tube structures additively manufactured from titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional lumbar implant sizes into the system. Also CAYMAN United plates and screws provide additional integrated fixation, once attached to the CASCADIA Interbodies.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar spine.
The provided document is a 510(k) summary for the CASCADIA Interbody System, which is a medical device (intervertebral fusion device). It focuses on demonstrating substantial equivalence to predicate devices, primarily through technological comparison and non-clinical performance evaluation (mechanical testing). This type of submission does not involve a study proving the device meets acceptance criteria related to AI performance, human reader improvement with AI assistance, or standalone algorithm performance, as it is an orthopedic implant, not an AI/software device.
Therefore, the requested information regarding AI-specific criteria, such as acceptance criteria for AI performance, sample sizes for test sets for AI, expert adjudication of AI ground truth, MRMC studies, standalone AI performance, and AI training set details, cannot be extracted from this document, because it pertains to an entirely different type of medical device assessment.
The document discusses:
- Device Description: Hollow tube structures additively manufactured from titanium alloy, available in various sizes.
- Function: Provides support and stabilization of the lumbar spine as an intervertebral body fusion device.
- Indications for Use: For patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar or cervical spine, used with autograft and/or allogenic bone graft as an adjunct to fusion, and with supplemental spinal fixation systems.
- Technological Comparison to Predicates: The design features, materials, and sizes are substantially the same as predicate systems.
- Non-Clinical Performance Evaluation: Tested for static torsion, static compression, dynamic compression (ASTM F2077), subsidence (ASTM F2267), and expulsion. Also, bacterial endotoxin testing (BET) was performed for pyrogenicity.
- Conclusion: No significant differences from currently marketed systems that would adversely affect use; substantially equivalent in design, function, material, and intended use.
In summary, the provided text describes the regulatory filing for a physical medical implant, not a software-driven AI device. As such, the requested details about AI performance and human augmentation are not applicable to this document.
Ask a specific question about this device
(164 days)
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. The hyperlordotic CASCADIA lumbar implants (i.e., ≥ 20°) should be used with anterior supplemental fixation (e.g., an anterior lumbar plate).
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
The implants consist of hollow tube structures additively manufactured from titanium allov. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional lumbar implant sizes into the system.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the context of device performance metrics such as accuracy, sensitivity, specificity, AUC, human reader improvement, or FROC analysis.
The document is a 510(k) premarket notification from the FDA for the Cascadia Interbody System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing detailed acceptance criteria and performance study results for a new or significantly re-engineered AI/imaging device.
Here's what the document does mention in relation to performance and comparison:
- Non-Clinical Performance Evaluation:
- It states that "The worst case implants for the Cascadia Interbody System were previously tested and performed equally to or better than the predicate devices in static compression, dynamic compression (ASTM F2077), subsidence (ASTM F2267) and expulsion."
- It also mentions "Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of <20EU/Device."
This information pertains to mechanical and biological safety performance, not the kind of AI/algorithm performance you've asked about (e.g., accuracy, sensitivity, human reader improvement, etc.).
Therefore, I cannot populate the table or provide details about the specific aspects of AI/imaging device evaluation you've requested as that information is not present in the provided text.
Ask a specific question about this device
(41 days)
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
The implants consist of hollow tube structures additively manufactured from titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional implant sizes into the system.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
The provided document is a 510(k) summary for the K2M Cascadia Interbody System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies as one might find for a novel drug or a high-risk AI-powered diagnostic.
Therefore, many of the requested fields regarding acceptance criteria, study details, and ground truth establishment are not applicable in the context of this 510(k) submission. The FDA clearance for this device hinges on mechanical testing and comparison to existing devices, not performance against clinical endpoints.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as such, but inferred from testing regime) | Reported Device Performance |
|---|---|
| Static Compression: Performance equal to or better than predicate devices. | Performed equally to or better than predicate devices. |
| Dynamic Compression (ASTM F2077): Performance equal to or better than predicate devices. | Performed equally to or better than predicate devices. |
| Subsidence (ASTM F2267): Performance equal to or better than predicate devices. | Performed equally to or better than predicate devices. |
| Expulsion: Performance equal to or better than predicate devices. | Performed equally to or better than predicate devices. |
| Bacterial Endotoxin Limit (ANSI/AAMI ST72:2011): <20 EU/Device | Meets the Endotoxin limit of <20 EU/Device. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for individual mechanical tests. The testing was conducted on "worst case implants."
- Data Provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting, not with human or animal data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The "ground truth" for mechanical testing is the physical measurement of device performance against established ASTM standards and predicate device performance, not expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set
- Not Applicable. Mechanical tests are objective measurements, not subject to adjudication by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is an intervertebral body fusion system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to readers improving with AI is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used
- Mechanical Testing Standards and Predicate Device Performance: The "ground truth" is defined by the objective performance requirements set by ASTM standards (F2077, F2267) and the established performance characteristics of the predicate devices.
8. The sample size for the training set
- Not Applicable. This device is a physical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8)
Ask a specific question about this device
(93 days)
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
The subject Cascadia Interbody System is comprised of additively manufactured implants made of titanium allov (ASTM standards F3001 and F136). These devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to add cervical implants to the system and to expand the indications for use of the CASCADIA lumbar implants to include use as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical segments of the spine.
This document describes the Cascadia Interbody System, specifically focusing on its regulatory approval via a 510(k) submission (K160125). A 510(k) submission demonstrates substantial equivalence to legally marketed predicate devices, rather than proving that a device meets specific, pre-defined acceptance criteria through a study designed explicitly for that purpose with detailed performance metrics.
Therefore, the information requested about acceptance criteria and a study proving those criteria are met for an AI/ML device is not directly applicable to this submission for a medical implant. This document does not describe an AI/ML device or a study with performance metrics in terms of sensitivity, specificity, or reader improvement.
However, I can extract information related to the performance evaluation and comparative analysis that was performed for this device to gain FDA clearance.
Here's a breakdown of the relevant information from the provided text, structured as closely as possible to your request for clarity, but with the understanding that it's for a medical implant, not an AI/ML diagnostic system:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a medical implant, there aren't "acceptance criteria" in the sense of specific clinical performance metrics like sensitivity/specificity for an AI/ML algorithm. Instead, the "performance evaluation" described is non-clinical and aims to demonstrate the mechanical and structural equivalence to predicate devices. The "acceptance criteria" can be inferred as successfully passing these non-clinical tests, showing substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstand Static Torsion (Worst Case Components) | Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices. |
| Withstand Static Compression (Worst Case Components) | Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices. |
| Withstand Dynamic Compression (Worst Case Components) | Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices. |
| Withstand Dynamic Torsion (Worst Case Components) | Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices. |
| Withstand Static Compression Shear (ASTM F2077) (Worst Case Components) | Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices. |
| Withstand Dynamic Compression Shear (ASTM F2077) (Worst Case Components) | Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices. |
| Resist Subsidence (ASTM F2267) (Worst Case Components) | Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices. |
| Resist Expulsion (Worst Case Components) | Performance evaluations conducted. Proposed implants were found to be substantially the same as predicate devices. |
| Overall Conclusion | "There are no significant differences between the Cascadia Interbody System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." (This is the ultimate "acceptance" for a 510(k) submission). |
2. Sample Size for the Test Set and Data Provenance
This information is not applicable. The "test set" in this context refers to the samples used for non-clinical performance evaluations (mechanical testing), not a clinical trial with human data. The document does not specify the exact number of components or test specimens used for the evaluations, nor does it refer to data provenance in terms of country of origin or retrospective/prospective acquisition, as would be relevant for clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels or outcomes. For this medical implant, "ground truth" is established by engineering standards and mechanical test results, not by expert clinical review. The document does not mention the involvement of experts for establishing "ground truth" in the AI/ML sense.
4. Adjudication Method for the Test Set
This information is not applicable for a medical implant's non-clinical performance evaluation. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies among human readers or experts establishing ground truth for clinical data, which is not the type of evaluation described.
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. An MRMC study is relevant for evaluating the clinical utility of diagnostic devices, particularly AI/ML algorithms, by comparing human reader performance with and without AI assistance. The Cascadia Interbody System is an implant, not a diagnostic tool or an AI/ML system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This refers to the performance of an AI/ML algorithm in isolation. The Cascadia Interbody System is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For this medical implant, the "ground truth" for the non-clinical performance evaluations is engineering standards and mechanical test results (e.g., ASTM F2077, ASTM F2267). This demonstrates that the device meets intended mechanical properties and behaves similarly to predicate devices. It is not expert consensus, pathology, or outcomes data in the clinical diagnostic sense.
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train an AI/ML algorithm. The Cascadia Interbody System is a physical implant and does not involve an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
Ask a specific question about this device
(27 days)
The CASCADIA implants are indicated for use with autgenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use as either one level or two contiguous levels from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.
The implants consist of hollow tube structures additively manufactured from titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional implant sizes into the system.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cascadia Interbody System, addressing your specific questions.
Important Note: The provided document is an FDA 510(k) summary for a spinal interbody fusion device. These types of devices are primarily mechanical implants. The document does not describe an AI/software device or a study involving human readers or expert consensus for image interpretation. Therefore, many of your questions related to AI studies, ground truth establishment, reader performance, and training/test set sample sizes for AI models are not applicable to this physical medical device submission.
I will answer the questions based on the information available in the document, clarifying when a question is not applicable to this type of device.
Analysis of Cascadia Interbody System 510(k) Summary (K160547)
1. A table of acceptance criteria and the reported device performance
For mechanical implants, acceptance criteria are typically defined by engineering standards and performance benchmarks against predicate devices. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static compression | Performed equally to or better than predicate devices. |
| Dynamic compression | Performed equally to or better than predicate devices. |
| Static compression-shear | Performed equally to or better than predicate devices. |
| Dynamic compression-shear | Performed equally to or better than predicate devices. |
| Subsidence (ASTM F2267) | Performed equally to or better than predicate devices. |
| Expulsion | Performed equally to or better than predicate devices. |
| Biocompatibility: | Assumed to meet standards as the material (titanium alloy) and design are "substantially the same" as predicate. |
| Material Properties: | Titanium alloy; "substantially the same" as predicate systems. The implants are "additively manufactured." |
| Design/Function: | "Substantially the same" as predicate systems in design, function. |
| Indications for Use: | Matched predicate device indications, with additional implant sizes incorporated. |
Note: Specific numerical acceptance criteria (e.g., "must withstand X N of compression") are not provided in this summary, but are inherent in the referenced ASTM standards and predicate equivalence.
2. Sample sizes used for the test set and the data provenance
- Test Set (for performance evaluation): The document refers to "the worst case implants for the Cascadia Interbody System were previously tested." It does not specify the sample size (N) for these mechanical tests. It implies that only representative "worst-case" configurations were tested, and engineering rationales were used for other sizes.
- Data Provenance: The data provenance for mechanical testing is not explicitly mentioned (e.g., "conducted in a lab in USA"). It's internal company testing or testing done by a contracted lab. The data is inherent to the device's design and manufacturing process.
- Retrospective/Prospective: Not applicable to mechanical testing of physical device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical medical device, not an AI or diagnostic imaging device that requires expert ground truth for interpretation. Performance is assessed through engineering testing and comparison to established standards and predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a mechanical medical device study, not a study involving human reader interpretation or clinical 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 mechanical medical device. No human reader studies or AI assistance are involved in this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical medical device. There is no algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F2077, ASTM F2267) and benchmarking against predicate devices. Its functional safety and effectiveness are supported by demonstrating that it performs "equally to or better than" devices already on the market and that its materials and design are substantially equivalent.
8. The sample size for the training set
Not applicable. This is a mechanical medical device. There is no AI training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI training set.
Ask a specific question about this device
(177 days)
The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondvlolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intents who have had six months of non-operative treatment.
For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.
The subject submission describes the Cascadia Interbody System. The implants consist of hollow tube structures made of titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is for a line addition to the lumbar intervertebral body fusion devices previously cleared in the K2M Aleutian Intervertebral Body Fusion System, to include implants additively manufactured from titanium alloy.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the Cascadia Interbody System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than providing detailed performance data against specific acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.
Ask a specific question about this device
Page 1 of 1