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The C-PS is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The C-PS is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The C-PS is intended to be used with a supplemental internal fixation system.

The L-PS is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The L-PS System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used in patients who have had six months of non-operative treatment. The L-PS is intended to be used with a supplemental internal fixation system.

The C-PS comprises a closed annular ring, a hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces for resisting migration and expulsion.

The L-PS comprises a closed annular ring with integral anteroposterior cross-piece, a hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces for resisting migration and expulsion.

The provided text is a 510(k) Summary for the InterPlate™ C-PS and L-PS Interbody Spacers, which are medical devices. It details the device's description, materials, and intended use, along with a statement of substantial equivalence to previously cleared predicate devices.

However, the document DOES NOT contain information regarding acceptance criteria or a study that proves the device meets those criteria, as typically found in performance testing sections for AI/ML-driven devices or diagnostic tools.

This document pertains to an implantable medical device (interbody spacers), not a diagnostic or AI-enabled software device. Therefore, the questions about acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to the content provided here.

The "study" mentioned in this type of 510(k) is usually focused on substantial equivalence testing, which primarily involves comparing the new device's design, materials, intended use, and performance characteristics to legally marketed predicate devices to ensure it's as safe and effective. This often includes bench testing for mechanical properties (e.g., strength, fatigue) and biocompatibility, rather than clinical efficacy studies on human subjects for performance metrics.

In summary, based on the provided text, I cannot answer the specific questions related to acceptance criteria and a study proving performance, as this document is for an implantable hardware device and does not contain the type of data requested for diagnostic or AI-driven systems.

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The InterPlate™ C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.

In addition, the InterPlate™ C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

WARNING: The InterPlate™ C is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The InterPlate™ C consists of plates, bone screws and screw covers in a variety of sizes. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size. The InterPlate™ C components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.

The provided document is a 510(k) summary for a medical device called InterPlate™ C. It details the device's classification, description, intended use, and substantial equivalence to previously cleared devices. However, this type of document, a 510(k) summary for a Class II medical device, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a specific clinical study with detailed acceptance criteria and performance metrics against those criteria. It does not contain information about:

• Acceptance criteria and reported device performance in a table. The document asserts substantial equivalence, meaning it matches the predicate device’s performance characteristics, but doesn't specify new, quantifiable acceptance criteria or new study results for those criteria.
• Sample sizes for a test set or data provenance. Because it relies on substantial equivalence and mechanical testing, specific patient-based test set details are not included.
• Number of experts or their qualifications for ground truth. This typically pertains to studies involving human interpretation or diagnosis, which isn't the primary focus of this submission.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study. This is relevant for imaging or diagnostic AI devices, not for a spinal implant.
• Standalone (algorithm only) performance. Not applicable to a physical implant.
• Type of ground truth used for a clinical study.
• Sample size for a training set or how ground truth for a training set was established. These are concepts relevant to AI/ML device development, not a spinal implant and its 510(k) submission.

What the document does provide in relation to product performance and evidence is:

• Substantial Equivalence Statement: The primary "proof" is the statement that the InterPlate™ C is "substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, material of manufacture and mechanical performance." This implies that the device meets the same performance expectations as its predicate based on these factors.
• Mechanical Performance: The document explicitly mentions "mechanical performance" as a basis for substantial equivalence. While it doesn't quantify specific acceptance criteria or results here, it means that the device was likely subjected to various mechanical tests (e.g., fatigue, static strength, subsidence) to demonstrate that it performs as safely and effectively as the predicate device mechanically. The specific details of these tests and their criteria would be in the full 510(k) submission, not typically in the public summary.
• Material: Manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136, indicating compliance with recognized material standards.
• Intended Use & Indications: These are detailed, showing the specific clinical context for which the device is approved. The device is for intervertebral body fusion in the cervical spine (C3 to T1) for certain conditions, with specific warnings.

In summary, for this specific K092070 submission:

The "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than establishing new, detailed performance metrics for this specific device in a clinical study as might be done for novel AI or diagnostic technologies. The FDA determined that the device is substantially equivalent, allowing it to be marketed.

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The InterPlate™ Interbody Fusion Device (IFD) is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The InterPlate™ C, CGC and PEEK OPTIMA® Cervical Systems are intended for usc at onc level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.

The InterPlate™ L and LGC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used in patients who have had six months of non-operative treatment.

The InterPlate™ IFD System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.

This submission (K08/1994) is for the InterPlate™ Interbody Fusion Device, a spinal implant. The document states that "Documentation was provided which demonstrated the InterPlate™ to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This indicates that the device's acceptance criteria are met through a showing of substantial equivalence to predicate devices, rather than through a direct study outlining specific performance metrics for this particular device.

Therefore, the requested information elements cannot be fully generated as they pertain to a direct study proving specific performance metrics, which is not what is presented in the provided text. The submission relies on demonstrating similarity to already approved devices.

However, based on the provided text, here's what can be extracted and inferred:

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

Since this is a substantial equivalence submission, there are no explicit acceptance criteria for this specific device's performance defined in terms of efficacy or diagnostic accuracy. The criteria are based on its similarity to legally marketed predicate devices.

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

Not applicable. There is no specific "test set" or clinical trial data presented to assess the performance of this specific device in the provided document. The submission relies on comparison to predicate devices, which would have had their own studies.

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

Not applicable. Ground truth for a test set is not discussed in the context of this substantial equivalence claim.

4. Adjudication method for the test set

Not applicable. Adjudication methods for a test set are not discussed.

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

Not applicable. This device is a spinal implant, not an AI or imaging diagnostic device.

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

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

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

Not applicable. Ground truth data for performance evaluation of this specific device is not discussed.

8. The sample size for the training set

Not applicable. This device is a spinal implant, not an AI or machine learning model.

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

Not applicable. This device is a spinal implant, not an AI or machine learning model.

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The InterPlate™ IFD is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The InterPlate™ C and CGC Systems are intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.

The InterPlate™ L and LGC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, 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 lumbar device is to be used in patients who have had six months of non-operative treatment.

The InterPlate™ System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.

The provided document is a 510(k) summary for the InterPlate™ Interbody Fusion Device. It outlines the device description, intended use, materials, and claims of substantial equivalence to previously cleared devices.

However, the document is a regulatory submission for a medical device (an implantable spinal fusion system), not an AI/Software as a Medical Device (SaMD). As such, it does not contain the type of information requested about acceptance criteria, study data, ground truth, or expert involvement that would be relevant for an AI/SaMD product.

Medical devices like the InterPlate™ are evaluated based on their mechanical properties, biocompatibility, and clinical performance (e.g., fusion rates, complication rates) typically through bench testing, in vitro studies, animal studies, and sometimes human clinical trials, which are different from the SaMD-specific criteria you've listed.

Therefore, I cannot extract the requested information from this document because it is not applicable to the type of product described.

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The InterPlate™ GC VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.

The InterPlate™ GC VBR System consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.

The provided text describes a 510(k) premarket notification for a spinal intervertebral body fixation orthosis, the InterPlate™ GC VBR. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical study with specific acceptance criteria and performance data.

Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria, as it's not a de novo approval demonstrating novel performance.

Specifically, the following information cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance: This type of data is not presented as the submission is for substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set for performance evaluation is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as a test set with ground truth is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is a medical implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document explicitly states: "Documentation was provided which demonstrated the InterPlate™ GC VBR to be substantially equivalent to the previously cleared InterPlate™ VBR. The substantial equivalence is based upon equivalence in basic design, intended use, indications, anatomic sites, performance and material of manufacture." This indicates that the approval relies on a comparison to an existing device, not on new performance data against specific acceptance criteria.

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The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.

The InterPlate™ VBR consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.

The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. Instead, it is a 510(k) summary and FDA clearance letter for the InterPlate™ VBR System, focusing on demonstrating substantial equivalence to previously cleared devices rather than providing specific performance study results.

Therefore, I cannot populate the table or answer the questions as the required information is not present in the given text.

The document primarily states: "Documentation was provided which demonstrated the InterPlate™ VBR System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This indicates that the device was cleared based on its similarity to existing devices, not on a new performance study with explicit acceptance criteria.

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The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumber spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The InterPlate™ VBR device is intended to be used with a supplemental internal fixation system.

The InterPlate™ VBR consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.

The provided text is a 510(k) summary for the InterPlate™ VBR System, a spinal intervertebral body fixation orthosis. This type of document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study demonstrating the device meets quantitative acceptance criteria based on performance.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available in the provided text, as this is typically found in performance studies used for original device approvals or efficacy claims.

Here's a breakdown of what can be extracted and what is not present:

Acceptance Criteria and Device Performance

Not available. The document does not provide a table of acceptance criteria and reported device performance metrics in terms of clinical or technical outcomes. The substantial equivalence claim is based on equivalence in "intended use, indications, anatomic sites, performance and material of manufacture" compared to predicate devices, but no specific performance data or criteria are listed.

Study Details

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

   • Not available. The document does not describe a performance study with a test set. The 510(k) process for this device relies on demonstrating substantial equivalence to predicates, not on a new clinical or technical performance study with a specific test set.

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

   • Not applicable/Not available. Since no performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

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

   • Not applicable/Not available. No test set or corresponding adjudication method is discussed.

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

   • No. This is a medical implant (spinal fixation system), not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

   • No. This is a physical medical device, not a software algorithm.

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

   • Not applicable/Not available. No ground truth is established for a performance study in this document. The "ground truth" for the 510(k) process is typically the established safety and effectiveness of the predicate devices.

7. The sample size for the training set:

   • Not applicable/Not available. No training set is mentioned as this is not an AI/ML device that requires training.

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

   • Not applicable/Not available. As above, no training set is discussed.

Summary of Device Information Available in the Text:

• Device Name: InterPlate™ VBR System
• Intended Use: Replacement of a complete or partial vertebrectomy, used with a bone graft to facilitate fusion. Designed to restore biomechanical integrity of the thoracic and lumbar spine (T1 to L5) following damage from tumor or traumatic injury. Intended for use with a supplemental internal fixation system.
• Materials: Ti-6Al-4V titanium alloy (ASTM F136).
• Substantial Equivalence Claim: Based on equivalence in intended use, indications, anatomic sites, performance, and material of manufacture to predicate devices including:
  • MC+ Partial VBR (LDR Spine USA)
  • SynFix™ - LR (Synthes USA)
  • Stalif™ TT (Surgicraft, LTD)
  • Telescopic Plate Spacer (Interpore Cross International)

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