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The EXPEDIUM, VIPER, and VIPER2 Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM, VIPER, and VIPER2 Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM® and VIPER® and VIPER® 2 Spine Systems consist of titanium rods, pedicle screws, connectors, hooks, and extended tab implants, which are terminally sterilized via gamma radiation. Previously, these devices were commercialized as clean, non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain implants will be packaged in sterile multi-packs for customer convenience.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided 510(k) summary, there is no performance data or studies provided to establish acceptance criteria for a device's performance. This submission is for modifications to an existing spinal system (EXPEDIUM®, VIPER®, and VIPER2® Spine Systems) where the primary change is the sterilization method.

The summary explicitly states: "Performance data is not provided in this submission."

Therefore, I cannot populate the requested table or answer the specific questions related to performance studies, acceptance criteria, sample sizes, ground truth, or expert involvement because this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices based on identical design, materials, indications, and technology, with the only modification being the terminal sterilization method via gamma radiation. In such submissions, the FDA typically accepts the existing safety and effectiveness profile of the predicate device if the changes are deemed not to alter these fundamental aspects.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

The EXPEDIUM Spine System is a 5.5mm rod-based and platebased system offered in both titanium and stainless steel. The system consists of monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, reduction hooks, hooks, extended tab implants, sacral extenders, lateral connectors, washers, fixed bolts, polyaxial bolts, closed screws, slotted connectors, plates, nuts, washers, drop-entry connectors, modular cross connectors, transverse rod connectors, and wires.

The proposed addition to the EXPEDIUM 5.5mm Spine System is an increased favored angle polyaxial screw. The polyaxial screw head opens posteriorly for placement of a rod which is secured to a screw by either a dual inner or unitized set screw. This additional component is available in various geometries and sizes to accommodate patient anatomy. It will be provided non-sterile.

Here's a breakdown of the acceptance criteria and study information for the K102249 submission, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a Special 510(k) submission for an addition to an existing spinal system, the EXPEDIUM® Spine System. The acceptance criteria and "device performance" (in this context, demonstrating that the new component meets the same performance standards as the predicate device) are based on mechanical non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size (number of devices/components tested) for each mechanical test. It only states that the tests were conducted in accordance with ASTM F1798-97.
• Data Provenance: The data is from non-clinical mechanical testing performed by the manufacturer, DePuy Spine, Inc., presumably in their labs. This is not patient-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable.

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

This question is not applicable to this submission. The "ground truth" for mechanical testing is established by the specified ASTM standard (F1798-97), which outlines the methodology and performance metrics. There are no "experts establishing ground truth" in the sense of clinical interpretation or diagnosis for this type of non-clinical mechanical evaluation.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication typically refers to the process of resolving discrepancies in expert opinions, often in clinical studies. For mechanical testing against an ASTM standard, the results are objectively measured and compared to the predefined criteria of the standard.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed."

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

This question is not applicable. This submission is for a physical medical device (spinal implant components), not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device meets acceptance criteria is adherence to established mechanical testing standards (ASTM F1798-97). The performance of the new components was compared to these standards to ensure they are equivalent to the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. This submission is for a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This question is not applicable. As there is no training set for a machine learning model, there is no ground truth for a training set to be established.

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The Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects resulting from compression fracture, in order to provide stabilization of the collapsed vertebral body and pain relief. The following modifications are being made: Change to the formulation of the bone cement liquid component.

The provided text is a 510(k) premarket notification for a medical device: Vertebroplastic™ Radiopaque Bone Cement. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and testing results as would be typical for software or AI/ML-based devices.

Therefore, much of the requested information cannot be extracted directly from this document. The device is a physical bone cement, not a software or AI/ML device, so concepts like "test set," "training set," "ground truth experts," "adjudication method," and "MRMC study" are not applicable in the way they would be for digital health technologies.

However, I can extract information related to the device description and the basis of substantial equivalence.

Here's an attempt to answer the questions based on the provided text, noting where the information is not applicable or available:

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

The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device based on "technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization)" and "intended use and indications for use."

Therefore, a table of acceptance criteria and reported device performance as commonly understood for digital health devices cannot be created directly from this text. The "performance" assessment is qualitative, comparing the modified device to its predicate.

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. This is a physical bone cement, not a software or AI/ML device that would undergo testing with a "test set" of data. The "study" mentioned is a comparison of characteristics to a 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. The concept of "ground truth for a test set" is not relevant to the substantial equivalence review of this physical device.

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

Not applicable. This is not a study involving human readers or a test set requiring adjudication in this context.

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 not an AI-assisted device, and no MRMC study is mentioned.

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

Not applicable. This is a physical bone cement, not an algorithm.

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

Not applicable. The review focuses on material properties and chemical composition compared to a predicate, not on clinical outcomes or diagnostic accuracy requiring "ground truth" as typically defined for AI/ML devices.

8. The sample size for the training set

Not applicable. This is a physical bone cement, not an AI/ML device that requires a "training set."

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

Not applicable.

Summary of what can be extracted from the document regarding the "study" for this device:

The "study" or justification for this device meeting its criteria is a demonstration of substantial equivalence to previously cleared predicate devices.

• Predicate Devices:

  • Vertebroplastic™ Radiopaque Bone Cement (K043406) - This is the original version of the same device, with the current submission being a modification.
  • SmartSet GMV Endurance Gentamicin Bone Cement (K033382)

• Basis of Substantial Equivalence:

  • Technological Characteristics: Chemical composition, material properties, performance characteristics, manufacture, packaging, and sterilization. (The document mentions a "Change to the formulation of the bone cement liquid component" as the modification being made.)
  • Intended Use and Indications for Use: The intended use and indications for use are stated to be similar (identical) to the predicate Vertebroplastic™ Radiopaque Bone Cement (K043406).

In essence, the "acceptance criteria" here implicitly are that the modified device's characteristics and intended use are sufficiently similar to the predicate devices such that it raises no new questions of safety or effectiveness. The "study" involves comparing the modified formulation against the established properties of the cleared predicate devices. Specific quantitative performance data from a clinical trial or bench test proving performance against strict numerical acceptance criteria are not presented in this summary, as is typical for 510(k)s seeking substantial equivalence for material modifications.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The subject EXPEDIUM™ Spine System components are designed to accept a 4.5mm rod and are available in various geometries and sizes.

The provided text describes a Special 510(k) Submission for additions to the EXPEDIUM Spine System. This document is a premarket notification for a medical device and thus concerns the regulatory approval process rather than a study proving the device meets acceptance criteria through clinical or AI-related performance metrics.

The "Performance Data" section explicitly states: "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification." ASTM F1717 is a standard specification for spinal implant constructs in a vertebrectomy model, which tests mechanical properties like static and fatigue strength. This indicates that the "acceptance criteria" here are likely related to meeting specific mechanical performance standards as defined by ASTM F1717, rather than clinical or "AI-related" performance criteria.

Therefore, many of the requested details in your prompt (such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable or cannot be extracted from this type of regulatory submission. The device described is a physical spinal implant system, not an AI-powered diagnostic or therapeutic device.

Here's what can be extracted based on the provided text:

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

Explanation: The document does not provide specific numerical acceptance criteria values or detailed performance results (e.g., maximum load, cycles to failure). It only states that data per the ASTM F1717 standard were submitted, implying the device met the requirements of this standard for mechanical characterization.

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

• Sample size: Not specified. ASTM F1717 outlines testing methodologies, which typically involve a specified number of samples for mechanical testing, but the exact number used for this submission is not detailed.
• Data provenance: The testing was conducted to characterize the "subject EXPEDIUM™ Spine System components," implying in-vitro mechanical testing of the device itself.
  • Country of origin: Not explicitly stated, but the submission is to the U.S. FDA by DePuy Spine, Inc. (a U.S.-based company), suggesting the testing was likely conducted in the U.S. or by a lab that adheres to U.S. regulatory standards.
  • Retrospective or prospective: This is mechanical (in-vitro) testing of hardware, not clinical data, so the terms "retrospective" or "prospective" are not applicable.

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

Not applicable. This is not a study requiring expert-established ground truth. The "ground truth" for mechanical performance is defined by the physical properties measured according to the ASTM F1717 standard.

4. Adjudication method for the test set

Not applicable. This is not a clinical study involving human judgment or 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 device is a physical spinal implant system, not an AI-powered system that would involve human readers or AI assistance.

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

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

7. The type of ground truth used

The "ground truth" for this device is the objective, measurable mechanical properties determined through standardized in-vitro testing (ASTM F1717).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

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