Search Results

IVA-C (ACIF):
The IVA-C Cage System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

AEON-C (ACIF):
The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF):
The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon's discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA & AEON Cervical and Lumbar Cage System are cervical and lumbar intervertebral fusion cages that are implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The cages are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method). The cages are manufactured from titanium alloy powder per ASTM F3001 or titanium alloy per ASTM F136 or PEEK per ASTM F2026. The screws are manufactured from titanium alloy per ASTM F136. They are provided non-sterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

This FDA 510(k) Clearance Letter is for the IVA & AEON Cervical and Lumbar Cage System, which are intervertebral body fusion devices. It is a Class II device.

Crucially, this document focuses on the substantial equivalence of a physical medical device (intervertebral cages) based on engineering performance tests, materials, and design features, not on the performance of an AI/ML software.

Therefore, most of the requested information regarding AI/ML device performance (acceptance criteria table, study details, human reader improvement, ground truth, training set, etc.) is not applicable to this specific submission.

The document states:

• "Summary of Performance Data (Nonclinical and/or Clinical):" and then lists "Non-Clinical Tests" such as Static/Dynamic Compression Bending, Static/Dynamic Compression Shear Bending, Static/Dynamic Torsion, and Subsidence, all referencing ASTM standards.
• "Clinical Tests: - N/A"

This means that the device was cleared based on non-clinical (laboratory/mechanical) testing, not on clinical performance studies involving patient data or AI/ML algorithm evaluation.

To answer your specific questions in the context of this document:

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

   • Not Applicable (N/A) for AI/ML performance.
   • For the physical device, the acceptance criteria would be defined by the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267) for specific mechanical properties (e.g., strength, durability, resistance to subsidence). The document states that the "Results of the non-clinical tests indicate that the device will perform within the intended uses," implying these criteria were met, but specific numerical performance data is not provided in this public summary.

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

   • N/A for AI/ML performance.
   • For the mechanical tests, the "sample size" would refer to the number of physical devices tested to ASTM standards. This information is not provided in this summary. Data provenance is also N/A as it's not patient data.

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

   • N/A. Ground truth establishment by experts is relevant for diagnostic or AI/ML interpretation performance, not for the mechanical testing of a physical implant.

4. Adjudication method:

   • N/A. Adjudication is relevant for expert consensus in AI/ML or clinical studies.

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:

   • N/A. This is a physical implant, not an AI-assisted diagnostic tool.

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

   • N/A. This is not an algorithm.

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

   • N/A for AI/ML. For the device, the "ground truth" would be established mechanical properties as defined by the ASTM standards (e.g., material properties, structural integrity under load).

8. The sample size for the training set:

   • N/A. There is no training set as no AI/ML algorithm is involved.

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

   • N/A. There is no training set.

In summary, the provided FDA 510(k) clearance letter pertains to a surgical implant, not an AI/ML software. Therefore, the questions related to AI/ML device performance and associated studies are not applicable to this document. The clearance is based on the substantial equivalence to predicate devices and adherence to mechanical performance standards, as indicated by the non-clinical tests section.

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The Medynus IVA (ACIF) PEEK Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The Medynis IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S 1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine. All the devices are non-sterile, single use - cages of multiple footprints, heights and lordosis options to fit the anatomical needs of a wide variety of patients and are made from PEEK and Tantalum. They have anti-migration features on the superior and inferior surfaces and can be packed with autograft to facilitate fusion.

The provided text describes a 510(k) premarket notification for a medical device called the Medynus IVA PEEK Cage. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new performance testing or clinical studies.

Therefore, the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not applicable to this submission.

Here's why and what can be extracted from the document:

• No Acceptance Criteria or Performance Study: The document explicitly states: "The subject and predicate devices are identical and therefore, no performance testing is necessary to demonstrate substantial equivalence. Submission is only transferring name of a system that has already been cleared under K162220. No new testing was provided." This means there was no new study performed to generate device performance data against specific acceptance criteria.
• Substantial Equivalence: The foundation of this submission is that the Medynus IVA PEEK Cage is identical to a previously cleared predicate device (DIO Medical IVA PEEK Cage, K162220) in terms of intended use, indications, technological characteristics, and principles of operation. The FDA clears the new device based on the established safety and effectiveness of the predicate device.

Given this, I can fill in the table and explain why the other sections are not applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

Explanation: As stated in the document, "no performance testing is necessary to demonstrate substantial equivalence" because the device is identical to a previously cleared predicate device. Therefore, there are no new acceptance criteria or reported device performance from a new study generated for this 510(k) submission. The safety and effectiveness are based on the predicate device's prior clearance.

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

Not applicable. No new test set or data was used for a performance study. The submission relies on the established performance of the predicate device.

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. No new test set or ground truth establishment was required for this substantial equivalence submission.

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

Not applicable. No test set was 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 an intervertebral body fusion cage, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance 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 (expert consensus, pathology, outcomes data, etc.)

Not applicable. No ground truth needed to be established for this submission as it relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set

Not applicable. This device is a physical implant, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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The K&J IVA (ACIF) PEEK Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The K&J IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The K&J IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage consists of PEEK+Tantalum which is identical to its predicate devices. The design, material composition and manufacturing are same as the predicate.

This document is a 510(k) summary for the K&J IVA PEEK Cage. It asserts substantial equivalence to a previously cleared device (K162220).

Therefore, there is no acceptance criteria or study that proves this specific device meets acceptance criteria presented in this document. The manufacturer explicitly states: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K162220. No testing is required."

To answer your request, one would need to review the 510(k) submission for the predicate device, DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K162220), as that is where the original performance data and substantial equivalence arguments would have been presented.

Based on the provided text for K212038:

1. A table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data for this specific device are provided because it is considered identical to a predicate device.
2. Sample size used for the test set and the data provenance: Not applicable. No performance testing was conducted for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance testing was conducted for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance testing was conducted for this 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: Not applicable. This is a medical implant (intervertebral body fusion device), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant (intervertebral body fusion device), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance testing was conducted for this device.
8. The sample size for the training set: Not applicable. This is a medical implant and not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable. This is a medical implant and not an AI/ML device that requires a training set.

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The Stryker IVAS® Elite Inflatable Vertebral Augmentation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

The Stryker iVAS ® Elite Balloon Catheter is a bone tamp with an inflatable component at the distal end. The balloon is inflated to create a void within the vertebral body. It is used with various accessories during vertebral augmentation.

When the balloon is inflated with radiopaque fluid, the balloon expands axially and radially. Two radiopaque markers are fixed near the distal end of the balloon to show the location of the balloon during placement. The balloon is coated with silicone to assist with insertion of the catheter into the access needle.

This looks like a 510(k) summary for a medical device that isn't an AI/ML device. Therefore, the questions about acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC, human reader improvement with AI assistance, sample sizes for training/test sets, expert ground truth establishment, etc.) are not applicable here.

This document describes a conventional medical device (an inflatable vertebral augmentation system) and focuses on engineering and biological performance rather than diagnostic or analytical accuracy.

However, I can extract the acceptance criteria and the study details for the conventional device as presented in the document:

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

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

• Biocompatibility: No specific sample size is mentioned for biocompatibility testing in this summary, but it states "Biocompatibility testing... was performed following the recommendations of ISO 10993-1 and FDA Guidance."
• Bench Testing (Constrained Burst, Un-Constrained Burst, etc.): No specific sample sizes are mentioned, but it indicates "All bench testing pertaining to the subject device modifications met their respective acceptance criteria as specified per the individual test report." These tests are typically performed on a statistically relevant sample size of manufactured devices.
• Cadaveric Testing: "Cadaveric testing was completed to provide evidence..." The specific number of cadavers or test instances is not provided in this summary. The provenance is cadaveric (human anatomical specimens).

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

• Cadaveric testing: "This cadaveric testing was completed by a physician..." The exact number of physicians is not specified, nor are their specific qualifications beyond being a "physician."

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

• Cadaveric testing: "Following the inflation of the balloon, the physician evaluated nearby anatomical structures for adverse events related to the high-pressure balloon inflations." This implies a single physician assessment; no adjudication method (like 2+1) is 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 is not an AI/ML device. No MRMC comparative effectiveness study was conducted or is applicable.

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

• This is not an AI/ML device. No standalone algorithm performance was assessed.

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

• Biocompatibility: Ground truth is established by standardized biological assays and regulatory guidelines (ISO 10993-1, FDA Guidance).
• Bench Testing: Ground truth is established by engineering specifications, physical measurements, and industry-accepted standards (e.g., burst pressure, tensile strength).
• Cadaveric Testing: Ground truth is established by direct visual inspection and assessment by a physician for damage to anatomical structures.

8. The sample size for the training set

• This is not an AI/ML device. There is no concept of a "training set" in the context of this submission.
• However, the submission does mention that "Biocompatibility testing... adopted per K172116" and "Catheter Flexibility Testing and Cold Age testing have been adopted from K093429. Accelerated Age testing has been adopted from K172116." These refer to prior submissions that likely involved biocompatibility testing and accelerated aging on a set of devices, which could be considered an analogous "training" or foundational dataset for these aspects, but not in the AI/ML sense.

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

• Not applicable as this is not an AI/ML device. The "ground truth" for the various engineering and biocompatibility tests would have been established through the methods and standards relevant to those specific test types in the original K093429 and K172116 submissions.

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The Stryker iVAS® 13G Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique.

The Stryker iVAS ®13G Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique. The subject device is disposable, intended for single use, and is provided sterile to the end user.

The provided document is a 510(k) summary for the Stryker iVAS® 13G Bone Biopsy Kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/human-in-the-loop diagnostic device.

Therefore, many of the requested elements for an AI medical device study (such as MRMC studies, expert consensus for ground truth, sample sizes for training sets, etc.) are not applicable to this specific document as it pertains to a mechanical biopsy device.

However, I can extract the information related to the acceptance criteria and the "study" (bench testing) that proves the device meets those criteria, as detailed in the "Non-Clinical" section.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states "All samples surpassed all acceptance criteria" for various bench tests, but does not specify the exact sample sizes (N). It implies that multiple units were tested for each criterion.
• Data Provenance: The testing was "non-clinical" (bench testing) performed by Stryker Instruments. The country of origin for the data is implicitly the USA, where Stryker is headquartered and testing would likely take place. The testing is prospective in the sense that it was conducted specifically to address the risks and demonstrate equivalence for this 510(k) submission.

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

• Not Applicable. For a mechanical device, "ground truth" as it applies to diagnostic accuracy (e.g., expert consensus on medical images) is not relevant. The "truth" for these tests is based on engineering specifications and physical measurements (e.g., how much force something can withstand).

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of data for diagnostic purposes. For mechanical bench testing, results are typically objective measurements against engineering specifications, not subject to subjective interpretation 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

• Not Applicable. This is a mechanical biopsy device, not an AI-powered diagnostic tool. No MRMC study was performed.

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

• Not Applicable. This is a mechanical biopsy device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical bench testing was based on engineering specifications and pre-defined acceptance criteria derived from risk assessment (EN ISO 14971:2012). This includes quantitative measurements of physical properties (e.g., force, torque limits). For biocompatibility, the ground truth was compliance with ISO 10993-1 and FDA guidance.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not an AI model, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of Relevant Information:

The study proving the device meets acceptance criteria was non-clinical bench testing and biocompatibility evaluation, as detailed in section 8 of the 510(k) summary. These tests were conducted according to established engineering and material standards to ensure the device's mechanical integrity and biological safety after design modifications (specifically, changes in gauge size and handle colorants). The acceptance criteria were based on the device's ability to withstand various physical stresses and to be biocompatible, and all tested samples reportedly met these criteria. The details regarding specific quantitative thresholds for "acceptance criteria" are not provided in this 510(k) summary, but it states "All samples surpassed all acceptance criteria", implying successful performance against pre-defined internal specifications.

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The Stryker® iVAS® Elite Inflatable Vertebral Augmentation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

The Stryker iVAS ® Elite Balloon Catheter is a bone tamp with an inflatable component at the distal end. The balloon is inflated to create a void within the vertebral body. It is used with various accessories during vertebral augmentation.

When the balloon is inflated with radiopaque fluid, the balloon expands axially and radially. Two radiopaque markers are fixed near the distal end of the balloon to show the location of the balloon during placement. The balloon is coated with silicone to assist with insertion of the catheter into the access needle.

The patient contacting components of the device such as the balloon, catheter, catheter coating, lubricant and radiopaque material are externally communicating tissue/bone/dentin-limited contact ≤24 hrs.

Associated Accessories include:

• Access cannula/stylet
• Syringe
• Inflator
• Hand Drill
• Coaxial Cement Tube

The provided text describes the acceptance criteria and supporting studies for the Stryker iVAS® Elite Balloon Catheter. Here's a breakdown of the requested information:

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

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

The document does not explicitly state a sample size for test sets in the traditional sense of a clinical or human performance study. The studies primarily involve bench testing and cadaveric testing.

• Bench Testing: The sample sizes for each specific bench test (e.g., insertion force, tensile force, burst tests) are not provided.
• Cadaveric Testing: The sample size (number of cadavers or vertebral segments) for cadaveric testing is not specified.
• Data Provenance: This information is not directly applicable to the type of testing performed (bench and cadaveric, not human data).

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

This information is not applicable. The device is not an AI or diagnostic device requiring expert interpretation for ground truth establishment. The performance is assessed against engineering specifications, material properties, and physical capabilities.

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

This information is not applicable. There was no expert adjudication process as the testing involved physical and material properties rather than medical interpretations.

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. An MRMC comparative effectiveness study was not performed. This device is a medical instrument (balloon catheter), not an AI diagnostic or assistive technology.

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

No. This concept is not applicable as the device is a physical medical instrument, not an algorithm.

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

The "ground truth" for the device's performance is established by engineering specifications, material science standards, and mechanical testing results. For example, the "ground truth" for burst pressure is the specified pressure the balloon must withstand, and for biocompatibility, it's meeting the criteria of ISO 10993-1. Cadaveric testing provided practical validation of the device's ability to create a void in bone.

8. The sample size for the training set

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

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

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

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The IVA Cage (ACIF, Ti ACIF) are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage

The IVA Cage (PLF, TLIF, DLIF, Ti PLIF, Ti TLIF, Ti DLIF and Ti ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA Cage Ti (ACIF, PLIF, TLIF, DLIF and ALIF) is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine.

The provided text does not contain information about the acceptance criteria and performance of a device based on a study with AI in the loop. The document is a 510(k) premarket notification for an intervertebral body fusion device (IVA Cage Ti) and focuses on demonstrating substantial equivalence to a legally marketed predicate device.

The document discusses:

• Device Name: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
• Regulation Number: 21 CFR 888.3080
• Regulatory Class: Class II
• Product Code: MAX, ODP
• Indications for Use: Intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical and lumbar spine, with specific disc levels mentioned.
• Performance Data: States "The addition of components to the system did not introduce a new worst case construct as evaluated based on an engineering analysis. Dynamic axial compression test per ASTM F2077 was performed."
• Predicates: IVA (ACIF, PLIF, TLIF, DLIF, and ALIF) Cage (K162220) and SUSTAIN® & SUSTAIN® - R (K130478).
• Substantial Equivalence Determination: Based on technical characteristics, performance, and intended use to the predicate system(s).

There is no mention of:

• Acceptance criteria for an AI-powered device.
• A study evaluating AI performance (standalone or with human-in-the-loop).
• Sample sizes for test or training sets related to AI.
• Experts or ground truth establishment for AI.
• MRMC comparative effectiveness study or related effect sizes.

Therefore, I cannot provide the requested information based on the given input text.

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The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique.

The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique. The subject device is disposable, intended for single use, and is provided sterile to the end user. The mechanism of action for obtaining a biopsy is manual and the principle of operation is through suction. The biopsy device will be sold in a kit configuration consisting of a coaxial biopsy needle, obturator and syringe. The subject biopsy kit is used with an access cannula and stylet of compatible size. The access cannula and stylet are sold separately and are Class I exempt per 21 CFR 888.4200, product code OAR (injector, vertebroplasty (does not contain cement).

The provided text describes the Stryker iVAS® Bone Biopsy Kit and its substantial equivalence to a predicate device, focusing on non-clinical (bench) testing. There is no information about a study proving the device meets acceptance criteria in the context of AI/ML performance, multi-reader multi-case studies, or human-in-the-loop performance.

The document is a 510(k) summary for a medical device and is primarily concerned with establishing substantial equivalence to a legally marketed predicate device, rather than assessing an AI's performance.

Here's the information extracted from the provided text, keeping in mind that the request is geared towards AI/ML device studies, and this document does not describe such a study:

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

The document mentions acceptance criteria but does not provide a table specifying the criteria values alongside reported performance for each test. It broadly states that "All samples surpassed all acceptance criteria" for each test.

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

The document states "All samples" passed the tests, but does not specify the exact number of samples (sample size) used for each bench test.

Data Provenance: Not applicable in the context of "country of origin of the data" or "retrospective or prospective" as these were bench tests performed on physical device samples, not clinical or historical data.

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

Not applicable. The tests are mechanical bench tests on the device's physical properties. There is no ground truth established by experts in the context of interpretation or diagnosis for these types of tests.

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

Not applicable. Adjudication methods are typically relevant for human interpretation of data, such as medical images. These were objective mechanical tests.

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 MRMC comparative effectiveness study was mentioned or performed. This document does not pertain to AI/ML software.

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

No standalone algorithm performance study was mentioned or performed. This document does not pertain to AI/ML software.

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

Not applicable. For the bench tests, the "ground truth" would be the engineering specifications and performance requirements that the device needed to meet.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As noted above, this document does not pertain to AI/ML software, so there is no training set or ground truth in that context.

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The DIO Medical IVA (ACIF) Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage consists of PEEK+Tantalum which is identical to its predicate devices. All of the heights, lengths, and widths are within range covered by its predicate devices.

The provided text describes a medical device, the DIO Medical IVA Cage, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to acceptance criteria, device performance, sample size, ground truth, expert adjudication, MRMC studies, and training/test sets are not applicable to this document. These questions are typically relevant for evaluating AI/ML models in medical imaging or diagnostics.

The document focuses on the mechanical and material properties of an intervertebral body fusion device and its comparison to existing devices to demonstrate substantial equivalence for regulatory approval.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Device Performance:

• Acceptance Criteria: The device underwent testing according to specific ASTM standards:
  • ASTM F2077: Static and dynamic axial compression testing, static and dynamic torsion testing, static compression shear testing.
  • ASTM F2267: Subsidence testing.
• Reported Device Performance: The document states that "Performance data demonstrate that the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is as safe and effective as [list of predicate devices]." However, specific quantitative performance metrics (e.g., exact load limits, displacement values, or fatigue life) from these tests are not provided in this summary. The summary only confirms that the testing was performed and deemed sufficient to show substantial equivalence.

2-9. Not Applicable (AI/ML Device):

The following questions are not applicable as the document describes a physical medical implant, not an AI/ML software device:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Summary of Relevant Information:

The DIO Medical IVA Cage is an intervertebral body fusion device. Its acceptance criteria are based on compliance with established ASTM standards for mechanical properties (ASTM F2077 and ASTM F2267). The study performed was a series of mechanical tests to demonstrate that the device performs equivalently to previously approved predicate devices in terms of safety and effectiveness. The specific numerical results of these tests and the test sample sizes are not detailed in this 510(k) summary but are implied to have met the necessary thresholds for substantial equivalence.

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The Stryker IVAS Bone Biopsy Kit can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.

The Stryker® Inflatable Vertebral Augmentation System (iVAS®) 8 Gauge Bone Biopsy Kit may be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.

The Stryker® iVAS® 8 gauge bone biopsy kit is a disposable device, intended for single-use, individually packaged and provided sterile. The biopsy device will be sold in a kit consisting of a coaxial biopsy needle, obturator and syringe. The biopsy kit is used with access cannula and stylet accessories of compatible size. The access cannula and stylet are sold separately and are Class I exempt under 21 CFR 888.4200, product code OAR (Injector, vertebroplasty (does not contain cement).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document consistently states that testing was performed to mitigate risk and ensure no new safety or effectiveness concerns, indicating that all acceptance criteria were met, even if the specific numerical results are not listed.

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

The document does not provide specific sample sizes for each non-clinical test. It generally refers to "verification and validation testing" without detailing the number of units tested for each criterion.

• Test Set Sample Size: Not specified.
• Data Provenance: The testing was non-clinical (laboratory/bench testing) performed by Stryker Instruments. The country of origin for the data is implicitly the USA (Kalamazoo, Michigan), where Stryker Instruments is located. The tests were prospective as they were performed to evaluate the modified device.

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

Given that this is a 510(k) submission for a physical medical device (bone biopsy kit) and involves non-clinical bench testing, the concept of "experts establishing ground truth for a test set" in the context of image analysis or diagnostic performance is not directly applicable.

The "ground truth" for the non-clinical tests is established by the engineering specifications and regulatory standards (e.g., ISO 14971, ISO 11137-1/2) that define the performance metrics and their acceptance limits. The experts involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists within Stryker who designed the tests, conducted them, and interpreted the results against these established standards. Their qualifications would be in engineering, materials science, and medical device regulations. The document does not specify the exact number of such individuals involved.

4. Adjudication Method for the Test Set

Again, for non-clinical bench testing of a physical device, an "adjudication method" as typically understood in studies involving human interpretation (e.g., 2+1 consensus) is not directly relevant.

The "adjudication" in this context would involve:

• Verification and validation testing protocols: These define how each test is to be performed and how results are to be interpreted.
• Quality control procedures: Internal company procedures ensure that testing is conducted correctly and documented accurately.
• Review and approval processes: Engineering and quality management teams would review the test results against the acceptance criteria. Any discrepancies or failures would lead to further investigation or device redesign.

The document states that a "Risk Management File (RMF), in compliance with EN ISO 14971:2012" was completed, indicating a structured process for risk assessment and verification activities.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance, as AI is not part of this device or its evaluation.

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

No, a standalone algorithm performance study was not done. This device is a physical bone biopsy kit, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Engineering specifications: Design requirements for physical strength, torque resistance, impact resistance, and functional performance (e.g., sample size retention).
• Regulatory standards: Compliance with international standards for sterilization (ISO 11137-1 and ISO 11137-2 for VDmax25, SAL 10-6) and risk management (EN ISO 14971:2012).
• Predicate device characteristics: The modified device's performance is compared to the established performance and safety profile of the predicate device (Stryker Bone and Vertebral Body Biopsy Kit K032943) to ensure substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This is not applicable, as there is no training set for this physical device.

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