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BEE Cervical Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cervical Cages are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

The BEE Cervical Cage is an intervertebral body fusion device for treatment of cervical disc degeneration and/or cervical instability utilizing the anterior cervical discectomy and fusion surgical technique. The tapered nose design provides ease of insertion while the convex superior and flat inferior surfaces replicate the patient's vertebral anatomical architecture for maximum surface contact. The cranial and caudal surfaces have a honeycomb geometry that accepts packing of bone graft to help facilitate bony integration. The device consists of implants available in various sizes and configurations to be accommodate for varying patient anatomy. The BEE Cervical Cages are fabricated using a Direct Metal Printing (DMP) via additive manufacturing (AM) process using Ti-6Al-4V ELI powder.

The provided text describes the regulatory clearance (K231371) for the BEE Cervical Cage, a medical device used for intervertebral body fusion. It outlines the device's indications for use, its technical specifications, and the rationale for its substantial equivalence to previously cleared devices.

Here's the breakdown of the requested information:

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

The document primarily focuses on mechanical performance testing for the device. The reported performance is that the devices met the predefined acceptance criteria for each test. Specific numerical results are not provided in this regulatory summary.

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

The document does not specify the sample sizes (number of devices) used for each mechanical test. The "test set" in this context refers to the physical devices subjected to mechanical testing, not a dataset for an AI algorithm. The provenance of the data is from performance testing conducted by NGMedical GmbH. It is a retrospective evaluation of a device, where the testing is performed to demonstrate substantial equivalence to previously cleared devices.

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

This question is not applicable to the provided document. The "ground truth" for this device is established through mechanical engineering standards (ASTM standards) and a comparison to predicate devices, not through expert human interpretation of data like in an AI/imaging study.

4. Adjudication method for the test set

This question is not applicable. Mechanical testing against industry standards (ASTM) does not involve adjudication methods like those used for expert consensus in medical image interpretation. The outcome is determined by whether the device meets the specified mechanical thresholds.

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 physical intervertebral fusion cage, not an AI or imaging diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this device's clearance.

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

This is not applicable. The device is a physical medical implant, not an AI algorithm.

7. The type of ground truth used

The ground truth used for this device is based on established mechanical engineering standards (ASTM) and a comparison to the performance of predicate devices. The device's safety and effectiveness are inferred by its ability to meet these standards and demonstrate substantial equivalence in design and performance to devices already cleared for market.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a physical medical device. The device's design is based on engineering principles and previous successful designs, not on machine learning training data.

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

This is not applicable as there is no training set for this type of device.

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NGM WAVE® PLIF cages are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The subject NGM WAVE PLIF Cage is a lumbar interbody fusion device. The NGM WAVE Cage is manufactured from PEEK-Optima™ Natural LT1 and tantalum (pins) per ASTM F560. The NGM WAVE Cage is an expandable interbody fusion device for treatment of lumbar disc degeneration utilizing the posterior lateral approach. NGM WAVE Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The cranial and caudal side of the implant is rough to provide increased stability and to help prevent movement of the device.

It is not allowed to use NGM WAVE implants in contact with components of other manufacturers with the exception of autograft or allograft materials.

WAVE PLIF Cage is intended for single use only and is provided sterile, using gamma irradiation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NGM WAVE PLIF Cage:

This document is a 510(k) summary for a medical device cleared by the FDA. It does not describe an AI device or a study involving human readers or AI performance metrics like sensitivity/specificity. Instead, it concerns the mechanical and biological performance of an intervertebral body fusion device. Therefore, several points in your requested output format (like MRMC studies, AI effect size, ground truth for training/test sets as typically applied to AI, etc.) are not applicable here.

However, I can extract the relevant information regarding the device's performance testing and acceptance criteria as provided.

Acceptance Criteria and Device Performance for NGM WAVE PLIF Cage

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but standard for bench testing of medical devices.
• Data Provenance: The tests are "non-clinical bench performance testing," meaning they were conducted in a laboratory setting. The manufacturer is NGMedical GmbH, located in Nonnweiler, Germany.

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

• Not Applicable. This is a physical medical device (interbody fusion cage), not an AI diagnostic tool. Ground truth in this context refers to established engineering standards (ASTM, ISO) and laboratory measurements, not expert human interpretation of images or clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Testing involves objective measurements against established standards, not human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not Applicable. This is a physical medical device, not an AI or diagnostic imaging device. No human readers or AI assistance are involved in the performance evaluation described.

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

• Not Applicable. This is a physical medical device. There is no algorithm.

7. The Type of Ground Truth Used

• Engineering Standards and Measurements: The ground truth for the performance testing is based on established international and American standards for medical device biocompatibility (ISO 10993-1) and mechanical testing (ASTM F2276). Performance is measured objectively and compared against the requirements specified in these standards or against predicate device performance.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of an AI model. Device design and development follow engineering principles and material science, not machine learning training.

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

• Not Applicable. See point 8.

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BEE® PLIF cages are indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplementation, which has been cleared by the FDA for use in the lumbar spine.

The subject BEE® PLIF Cage is a lumbar interbody fusion device. BEE® PLIF Cage is manufactured from titanium alloy per ASTM F3001 via additive manufacturing. The BEE® PLIF Cage is an intervertebral body fusion device for treatment of lumbar disc degeneration utilizing the posterior lateral approach. BEE®PLF Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The cranial and caudal side of the implant is rough to provide increased stability and to help prevent movement of the device. It is not allowed to use BEE® PLIF implants in contact with components of other manufacturers with the exception of autograft materials. BEE® PLIF Cage is intended for single use only and is provided sterile, using gamma irradiation.

This document is a 510(k) summary for the NGMedical GmbH BEE® PLIF Cage, an intervertebral body fusion device. It details the device's characteristics, indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device "met the predetermined acceptance criteria" without providing specific numerical criteria. It only lists the tests performed and confirms compliance.

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

The document describes bench testing for mechanical performance and biocompatibility. It does not involve a "test set" of patient data or clinical trials in the way an AI/software device would. Therefore, the concepts of sample size for a test set, country of origin, or retrospective/prospective data are not applicable here. The "sample" for testing would refer to the number of physical devices or material samples subjected to the mechanical and biocompatibility tests. This number is not specified in the document.

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

This information is not applicable. The device is a physical implant, not an AI/software device requiring human expert ground truth for a test set. Ground truth for mechanical testing is established by engineering standards and measurements.

4. Adjudication Method for the Test Set:

Not applicable, as this is a physical device and not an AI/software requiring human adjudication of its output.

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

Not applicable. This is a physical medical implant, not an AI/software system that assists human readers.

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

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

7. The Type of Ground Truth Used:

For the mechanical testing, the "ground truth" is defined by the objective measurements and engineering standards outlined in ASTM F2077 and ASTM F2276, as well as the specifications for biocompatibility in ISO 10993-1. These are physical and chemical properties measured against established benchmarks.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical implant. There is no "training set" in the context of an AI/software algorithm.

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

Not applicable. There is no training set for this type of device.

In summary, the provided document describes the FDA clearance for a physical medical device (interbody fusion cage) based on substantial equivalence to predicate devices and performance bench testing, not on clinical data involving patient cohorts or AI algorithm performance.

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BEE HA Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA Cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

The subject BEE HA Cage is an anterior cervical interbody fusion device. BEE HA Cage is manufactured from Hydroxyapetite (HA) Enhanced PEEK-OPTIMA™ HA Enhanced Optima. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Additionally, the device contains four (4) titanium alloy (Ti6Al4V per ASTM F136) pins to provide imaging visibility for device positioning.

BEE HA Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. BEE HA implants are not to be used with any components from other manufacturers with the exception of use with autogenous and/or allogeneic bone graft.

This document is a 510(k) premarket notification for the BEE HA Cage, an intervertebral body fusion device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader performance study. The provided text discusses mechanical and biocompatibility testing for a medical implant, not an AI or diagnostic software.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study involving human readers with AI assistance. The document refers to:

• Mechanical testing according to ASTM F2077 and ASTM F2276.
• Biocompatibility evaluation based on ISO 10993-1.

These tests are standard for a physical medical implant to ensure its safety and performance. The document states that "All tests confirmed that the product met the predetermined acceptance criteria." However, it does not specify what those criteria were (e.g., specific load capacities, displacement limits for mechanical tests) or detail the results of these tests in a table as requested for an AI device.

To answer your specific questions in the context of an AI/human reader performance study, the document:

1. Does not provide a table of acceptance criteria and reported device performance for an AI system.
2. Does not discuss sample sizes for test sets, data provenance, or training sets in the context of an AI system.
3. Does not mention experts or adjudication methods for ground truth because it's not an AI diagnostic device.
4. Does not include information on MRMC comparative effectiveness studies or effect sizes for human readers with and without AI.
5. Does not discuss standalone algorithm performance.
6. Does not mention the type of ground truth used for an AI system.
7. Does not specify training set size or how ground truth was established for a training set (as these concepts are not applicable to this physical device submission).

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BEE Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or two contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

The BEE Cervical Cage is an intervertebral body fusion device for treatment of cervical disc degeneration and/or cervical instability utilizing the anterior cervical discectomy and fusion surgical technique. The tapered nose design provides ease of insertion while the convex superior and flat inferior surfaces replicate the patient's vertebral anatomical architecture for maximum surface contact. The cranial and caudal surfaces have a honeycomb geometry that accepts packing of bone graft to help facilitate bony integration. The device consists of implants available in two widths, one depth, seven heights, and three lordotic angles.

The provided document is a 510(k) summary for a medical device called "BEE Cages" (Cervical Cages), seeking to demonstrate substantial equivalence to a predicate device. It details product information, intended use, and a summary of non-clinical and clinical testing.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to "non-clinical tests" and "clinical evidence" without specifying explicit test set sample sizes for the mechanical tests or the clinical evidence portion.

• Non-clinical (Mechanical) Tests: Performed on the BEE Cervical Cages. The sample size for these specific tests (ASTM F2077, ASTM F2267) is not explicitly stated, but these standards typically involve multiple samples to ensure statistical validity.
• Clinical Evidence: The document states that "Clinical evidence was provided to demonstrate that the lattice structure did not obstruct the development of fusion." No details are given regarding the country of origin, whether it was retrospective or prospective, or the number of patients/cases involved in this clinical evidence.

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

This information is not provided in the document. The document refers to "clinical evidence" but does not detail how the ground truth for this evidence was established, nor the involvement or qualifications of experts in that process.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study is not mentioned in the document. The document focuses on demonstrating substantial equivalence through non-clinical mechanical testing and general clinical evidence related to fusion, not a comparative analysis of human reader performance with or without AI assistance.

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

This question is not applicable as the device is a physical intervertebral body fusion device, not an AI algorithm. Therefore, a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used

• Non-clinical (Mechanical) Tests: The "ground truth" for the mechanical tests is based on the results obtained from standardized ASTM test methods (ASTM F2077 for intervertebral body fusion devices and ASTM F2267 for measuring load-induced subsidence). The acceptance criteria are implicitly derived from these standards and comparison to predicate device performance.
• Clinical Evidence: The ground truth for the "clinical evidence" regarding fusion development is based on clinical outcomes reported in the evidence provided. The exact nature of this outcome data (e.g., imaging reports, surgical reports, patient follow-up) that confirmed fusion is not detailed beyond the statement itself. Pathology or direct outcomes data details are not specified.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

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

This question is not applicable as the device is a physical medical implant.

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