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InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ 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 devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The InFill™ intervertebral body fusion device is a radiolucent implantable device The in in in - fine PEEK and tantalum (marker material). The implant is available in manatatored 110 11011 * 11011 * 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11

The InFill™ intervertebral body fusion device is provided sterile, for single use only.

The provided text is a 510(k) summary for the InFill™ Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device for a minor modification rather than presenting a novel device with extensive new performance data. Therefore, the information required for a detailed acceptance criteria and study description, especially for AI/ML devices, is largely absent.

Here's an analysis based on the provided text, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not specify quantified acceptance criteria (e.g., "tensile strength must be >X MPa" or "fatigue life >Y cycles"). Instead, it broadly states that "all specified criteria" were met, implying that the device was tested against established standards for intervertebral body fusion devices, and it performed comparably to the predicate device.

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

This information is not provided in the document.

• The document implies that "testing was performed on test units representative of finished devices," but states no specific sample sizes for mechanical, material, or other performance tests.
• The provenance of any data (e.g., country of origin, retrospective/prospective) is not mentioned.

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

This information is not applicable and not provided in the document.

• This device is a physical intervertebral body fusion device, not an AI/ML diagnostic or therapeutic device that would typically involve expert-established ground truth from a test set of medical images or patient data.
• The evaluation is focused on the device's physical and material properties, and its substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document.

• Similar to point 3, adjudication methods (like 2+1 or 3+1) are common in studies involving human interpretation or AI model performance on qualitative data. This device's evaluation does not involve such a process.

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

This information is not applicable and not provided in the document.

• MRMC studies are relevant for evaluating AI-assisted diagnostic tools. This submission is for a physical medical implant.

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

This information is not applicable and not provided in the document.

• Standalone performance studies are for AI algorithms. This is an implant.

7. The Type of Ground Truth Used

This information is not applicable in the context of typical AI/ML ground truth (expert consensus, pathology, outcomes data).

• For this device, the "ground truth" for its performance would be engineering specifications, material properties, biomechanical test standards, and successful performance against those standards and comparison to the predicate device. The document generally states "met all specified criteria."

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document.

• There is no AI/ML algorithm involved in this device submission, therefore no "training set."

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

This information is not applicable and not provided in the document.

• As there is no training set for an AI/ML algorithm, this question is irrelevant to this submission.

Summary of the Study (Based on the document):

The study described is not a clinical trial or an AI/ML performance study. It is a design verification and validation process for a minor modification to an already cleared intervertebral body fusion device. The "study" aims to demonstrate substantial equivalence to the predicate device (InFill™ Intervertebral Body Fusion Device, K103729).

• Objective: To verify that the modified InFill™ Intervertebral Body Fusion Device performs as intended and introduces no new safety or performance concerns, making it substantially equivalent to the predicate device.
• Methodology: "Performance Data: All testing was performed on test units representative of finished devices." The document implies that this testing included evaluations of the device's material properties, mechanical strength, and other relevant characteristics for an intervertebral body fusion device, against predetermined engineering specifications and industry standards.
• Proof: The key "proof" of meeting acceptance criteria is the statement: "The modified InFill™ intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions." This, coupled with the assertion that "The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device," forms the basis for the FDA's determination of substantial equivalence.

In essence, the "study" is a comparison of the modified device's characteristics and performance to existing requirements and the predicate device, rather than a novel investigation with detailed clinical or AI performance metrics.

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InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ 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 devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The InFill™ intervertebral body fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill™ intervertebral body fusion device is provided sterile, for single use only.

The provided text describes the InFill™ Intervertebral Body Fusion Device, its intended use, and the regulatory pathway. However, it does not contain information about a study proving the device meets acceptance criteria in the way a diagnostic AI device would.

This document is a 510(k) summary for a medical implant (spinal fusion device), not a diagnostic AI/ML system. The "performance data" section refers to mechanical and material testing to ensure the device's physical integrity and equivalence to predicate devices, not clinical efficacy or diagnostic accuracy.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, ground truth, experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and are not present in the provided text.

Here's an analysis based on the information that is available, and an explanation of why other requested information is absent:

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

For this device type, acceptance criteria are generally related to mechanical and material properties, demonstrating that the device is as safe and effective as previously cleared predicate devices. The document states:

Explanation: The document explicitly states that "All necessary performance testing, has been completed for the InFill™ intervertebral body fusion device including static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267) and expulsion. to assure substantial equivalence to the predicate devices." The acceptance criteria for these tests would be defined in the standards themselves and by comparison to the predicate devices. The reported performance is that the device met these criteria, thus assuring substantial equivalence. Specific numerical performance values are not typically included in a 510(k) summary for this kind of mechanical device but would be in the full submission.

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 device is a passive implantable medical device, not a diagnostic or AI system that processes data from a "test set" of patient cases, images, or records. The "test set" for this device would refer to the physical units of the device subjected to mechanical testing. The number of physical units tested is not specified in this summary.

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. Ground truth, in the context of diagnostic performance, is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and comparison to predicate devices, not expert human interpretation.

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

Not applicable. Adjudication methods are typically used in clinical trial settings or for establishing ground truth in diagnostic 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

Not applicable. MRMC studies are used to evaluate the diagnostic performance of systems, often AI-powered ones, by comparing human readers' performance with and without assistance. This is a physical implant, not a diagnostic tool.

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

Not applicable. The device is a physical implant; there is no "algorithm" to run in a standalone fashion.

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

For the mechanical performance, the "ground truth" is adherence to established ASTM standards (F2077, F2267) and demonstrating equivalence to predicate devices which have been previously cleared based on similar standards. It does not involve expert clinical consensus, pathology, or outcomes data in the sense of a diagnostic device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary regarding the device and its compliance:

The InFill™ Intervertebral Body Fusion Device is a Class II medical device, which achieved 510(k) clearance by demonstrating "substantial equivalence" to predicate devices (NuVasive CoRoent System, K071795; Globus Medical Patriot Transcontinental LLIF Spacer K093242). This means that its intended use, principle of operation, technological characteristics, and safety/effectiveness profiles were found to be similar enough to already-marketed devices. The "study" mentioned refers to mechanical and material performance testing (static/dynamic compression, static subsidence, expulsion) conducted according to established ASTM standards (F2077, F2267). The device met these engineering performance criteria, allowing it to be deemed substantially equivalent.

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