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A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.

The A-CIFT™ SoloFuse™ consists of a PEEK or PEEK-OPTIMA HA Enhanced spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The A-CIFT™ SoloFuse™ PEEK-OPTIMA HA Enhanced implants are provided sterile and irradiated by gamma radiation. The A-CIFT™ SoloFuse™ PEEK implants are provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK or PEEK-OPTIMA HA Enhanced spacers are provided in various sizes. The lag and rigid screws are offered in various diameters and lengths.

This document is a 510(k) premarket notification for a medical device called A-CIFT™ SoloFuse™, an intervertebral body fusion device. The purpose of this submission is to introduce a new material (PEEK-OPTIMA HA Enhanced) for an already cleared device.

Based on the provided text, there is no information about acceptance criteria or a study demonstrating the device meets such criteria in terms of clinical performance or algorithm performance. The document focuses on showing substantial equivalence to a predicate device, primarily through a change in material and a "Failure Effects Analysis" (FEA) instead of mechanical testing.

Here's an analysis of what information is not present related to your request:

1. A table of acceptance criteria and the reported device performance: This is not provided. The submission focuses on substantial equivalence based on design changes (material), not a new performance evaluation against specific criteria.
2. Sample size used for the test set and the data provenance: Not applicable as no new performance testing study is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The document states, "No performance testing is being included as part of this submission."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an implantable medical device, not an AI/algorithm-based diagnostic or therapeutic tool.
7. The type of ground truth used: 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.

Summary based on the provided text:

The submission for the A-CIFT™ SoloFuse™ is a 510(k) premarket notification to introduce a new material (PEEK-OPTIMA HA Enhanced) for an existing device. It relies on the concept of substantial equivalence to previously cleared predicate devices (K151198 and K142026).

The document explicitly states: "No performance testing is being included as part of this submission. Failure Effects Analysis (FEA) was used in lieu of mechanical testing to show substantial equivalence to the previously cleared design."

Therefore, the submission does not include:

• Acceptance criteria for device performance.
• New studies with test sets, training sets, expert ground truth establishment, or MRMC studies.

Instead, the conclusion is based on "overall technology characteristics and mechanical performance data" (which, for this submission, appears to be primarily the FEA and comparison to the predicate) leading to the conclusion that the device is "safe and effective and substantially equivalent to the previously cleared product."

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A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.

The A-CIFT™ SoloFuse™ consists of a PEEK spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. System is provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm to 16mm.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. This document is a 510(k) premarket notification for a medical device (A-CIFT™ SoloFuse™ Intervertebral Body Fusion Device), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance acceptance criteria and a study to meet them.

Specifically, the document states:

• "No performance testing is being included as part of this submission." This explicitly indicates that no performance data or studies are presented.
• The entire submission is for the purpose of including "additional surgical instruments with an optional freehand surgical technique" for an already cleared device, not for proving new performance criteria.

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

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A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuseTM system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.

The A-CIFT™ SoloFuse™ consists of a PEEK OPTIMA LT1 spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The lordotic and nonlordotic PEEK-OPTIMA® LT1 spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm. The titanium bone screws traverse the PEEK-OPTIMA® LTI interbody device either through the body or a posterior/inferior flange to anchor into the patient's vertebral body, thereby securing the interbody into the final placement location. The cage has endplate teeth for additional fixation, ports for bone graft and an anti-screw backout.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text describes non-clinical testing on the device itself (mechanical and material tests), not clinical studies involving human patients or data derived from them. Therefore, there is no "test set" in the sense of clinical data or patient samples.

For the mechanical tests, the sample size is not explicitly stated, but it refers to the A-CIFT™ SoloFuse™ device itself undergoing various mechanical tests. The provenance is not explicitly stated as a country of origin for data; however, the testing standards (e.g., ASTM) are international standards often adopted globally. This was not a retrospective or prospective human data study.

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)

This information is not applicable as the studies described are non-clinical mechanical and material tests of the device, not studies requiring expert interpretation of diagnostic images or clinical outcomes to establish ground truth.

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

This information is not applicable as the studies described are non-clinical mechanical and material tests, which do not involve subjective interpretation or adjudication by multiple experts in the context of clinical ground truth.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (intervertebral fusion device), not an AI-assisted diagnostic or treatment planning tool. Therefore, there is no mention of human readers or AI assistance effect size.

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

No, a standalone algorithm-only performance study was not done. This submission is for a physical medical device, not an algorithm.

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

For the mechanical tests, the "ground truth" is established by the specified ASTM standards and material specifications. The device's performance is compared against the requirements and benchmarks set by these established engineering and material standards, rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

This information is not applicable as the studies described are non-clinical mechanical and material tests of a physical device, and not machine learning or AI models that require training sets.

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

This information is not applicable since there is no training set for an AI model.

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