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InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device 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® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

Device Description

The InFill® interbody 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® interbody fusion device is provided sterile, for single use only.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for the 'InFill® Interbody Fusion Devices'. It primarily discusses the substantial equivalence of the device to existing predicate devices, focusing on technical characteristics and intended use. The document does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific performance criteria in the way a clinical trial or a detailed performance study for an AI/CADe device would.

Instead, the "Performance Data" section specifically states: "An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions."

This means:

The study performed was a Finite Element Analysis (FEA), a computational modeling technique, not a human reader study or a standalone algorithm performance study with a test set and ground truth.
The purpose of the FEA was to compare the newly introduced sizes of the InFill device with the existing product family and predicate devices from a mechanical standpoint.
The "acceptance criteria" referred to are the unspecified "specified criteria" related to mechanical performance, which the FEA demonstrated the device met. The document does not explicitly list these criteria or their values.
There's no mention of sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or adjudication methods, as these concepts are not applicable to the type of study (FEA) described.
No MRMC or standalone performance study in the context of an AI/CADe device was conducted or reported.

Therefore, I cannot populate the table or answer most of your specific questions because the provided document does not contain the type of AI/CADe performance study results you are asking for.

However, I can extract the relevant information regarding the "Performance Data" section.

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance suitable for interbody fusion devices.	"met all specified criteria"
Mechanical performance substantially equivalent to predicate devices.	"demonstrated the substantial equivalence of the new device sizes to the predicate device."
Does not raise new safety or performance questions.	"did not raise new safety or performance questions."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study was a Finite Element Analysis (FEA), a computational simulation, not a study utilizing a "test set" of patient data.

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 ground truth was established by experts for this FEA study.

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
No, an MRMC comparative effectiveness study was not done. The study was a Finite Element Analysis.

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. The study was a Finite Element Analysis.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The FEA used computational models and simulations, not ground truth derived from clinical data.

8. The sample size for the training set
Not applicable. The study was a Finite Element Analysis.

9. How the ground truth for the training set was established
Not applicable. The study was a Finite Element Analysis.

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K Number

K150206

Device Name

InFill Interbody Fusion Devices

Manufacturer

PINNACLE SPINE GROUP, LLC

Date Cleared

2015-04-03

(64 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K133721

Intended Use

Device Description

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the InFill® Interbody Fusion Devices. The primary goal of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This type of submission does not typically involve clinical trials or studies to establish novel performance criteria or the effectiveness of a new technology. Instead, it relies on demonstrating that the new device is as safe and effective as a previously cleared device.

Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth for a new clinical study proving the device meets acceptance criteria is largely not applicable in the context of this 510(k) submission.

Here's an breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are based on demonstrating substantial equivalence to the predicate device (InFill® Interbody Fusion Device, K133721). The device performance is primarily assessed through a Finite Element Analysis (FEA), not a clinical study with performance metrics like sensitivity, specificity, or accuracy.

Acceptance Criteria (Demonstration of Substantial Equivalence to K133721)	Reported Device Performance (Summary from FEA)
Similar Indication/Intended Use	The Indication/Intended Use of the modified device is the same as the predicate device. For intervertebral body fusion of the spine in skeletally mature patients, used with autogenous bone graft to facilitate fusion. Intended for one or two contiguous levels in the lumbar spine (L2-S1) for treatment of DDD with up to Grade I spondylolisthesis, after at least six months of non-operative treatment, and used with supplemental internal spinal fixation systems. Compatible with anterior, lateral, and transforaminal approaches.
Similar Fundamental Scientific Technology	The fundamental scientific technology of the modified device has not changed and is the same as the predicate device.
Similar Physical and Technical Characteristics	The modified InFill® intervertebral body fusion device has similar physical and technical characteristics to the predicate device, with the addition of a 26mm length to the product family for 42-TLIF and 43-TLIF models. (Detailed comparison in Section 6. Technical Characteristics table).
No New Safety or Performance Questions Raised	The FEA identified the worst-case construct and characterized it. The results demonstrated that no new mechanical testing is required. The analysis concluded that the new device sizes are substantially equivalent to the predicate device and did not raise new safety or performance questions.

2. Sample size uses for the test set and data provenance:

Test Set Sample Size: Not applicable in the context of a clinical performance test. The "test set" here would refer to the designs analyzed in the FEA.
Data Provenance: The analysis was a Finite Element Analysis (FEA), a computational simulation. It is not based on patient data from a specific country or retrospective/prospective collection.

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

Not applicable. Ground truth, in a clinical sense, is not established for an FEA. Instead, the FEA relies on engineering principles, material properties, and design specifications.

4. Adjudication method for the test set:

Not applicable. This concept applies to human reader studies or clinical trials, not FEA.

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. MRMC studies are not performed for interbody fusion devices in a 510(k) submission.

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

Not applicable. This is not an algorithmic device. The "standalone performance" was the FEA, demonstrating mechanical equivalence.

7. The type of ground truth used:

For the FEA, the "ground truth" would be the fundamental laws of physics and material science, along with validated computational models and established engineering criteria for spinal implants. There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in this context. The FEA aims to prove mechanical equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a 510(k) submission for this type of device using FEA.

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

Not applicable, as there is no training set.

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