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The CoAlign Innovations AccuLIF TL Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF TL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL Cage is to be used with autogenous bone graft.

The AccuLIF TL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL Cage is manufactured from TI6A14V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870), The device is inserted in unexpanded state with an articulating delivery handle and expanded insitu to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands. The AccuLIF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. Each size also comes in an 11mm x 34mm footprint and a 13mm x 34mm footprint. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.

In addition, the AccuLIF TL Cage System includes distractor trials to aid in distracting the disc space and in selecting the appropriate size cage to use in the surgical procedure. The set also contains a variety of other instruments to aid in the implantation of the cages.

The provided text describes a 510(k) premarket notification for a medical device, the AccuLIF TL Cage. This submission is for an update to an existing device, specifically adding new instruments (distractor trials) to the system. Therefore, the "study" conducted is primarily focused on demonstrating that these new additions do not negatively impact the safety and effectiveness of the previously cleared device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for the Test Set: Not explicitly stated as a number. The text mentions "cadaver testing." For cadaver tests in medical devices, sample sizes can vary, but details like the number of cadavers or test repetitions are not provided.
• Data Provenance: The cadaver testing implies a prospective experimental setup. The country of origin for the cadaver data is not specified.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. For cadaver testing, it would typically involve surgeons or other medical professionals experienced in spinal procedures, but their specific qualifications (e.g., years of experience, specialization) are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. In cadaver testing, the "adjudication" would typically involve direct observation and assessment by the testing team and/or the participating medical professionals. There's no mention of a formal consensus method like 2+1 or 3+1.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This submission focuses on the safety and effectiveness of new instruments via cadaver testing, not on comparative effectiveness (e.g., human reader performance with/without AI assistance). The device itself is an implantable surgical device, not a diagnostic or AI-powered system that involves human interpretation of output.

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

• Standalone Study: No, a standalone performance study was not done. This is not an AI algorithm or software-only device. The "device" in question is a physical surgical implant system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the cadaver testing would be based on direct observation and surgical assessment of proper instrument function and implantation success within the cadaveric model. This would include evaluating ease of use, ability to distract the disc space, and proper selection of cage size, as intended by the new distractor trials.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This concept is not applicable here as there is no "training set" in the context of this 510(k) submission. This is not an AI/ML device that requires training data. The device's design and mechanical properties are pre-determined.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

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Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

The CoAlign Innovations AccuLIF TL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL Cage is to be used with autogenous bone graft.

The AccuLIF TL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL Cage is manufactured from TI6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with an articulating delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands. The Accul.IF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. Each size also comes in an 11mm x 34mm footprint and a 13mm x 34mm footprint. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid

The provided text describes the regulatory submission for a medical device called the AccuLIF® TL Cage, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

However, based on the discussion of testing section, we can infer the types of acceptance criteria being addressed by the non-clinical tests. The "reported device performance" would be the successful completion of these tests in accordance with the specified ASTM standards and the conclusion of substantial equivalence.

Here's an attempt to structure the information based on your request, with the understanding that direct quantitative acceptance criteria and performance values are not explicitly provided in the document for the device itself, but rather compliance with standards is indicated:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Note: The document does not provide specific numerical acceptance thresholds or the raw data for device performance. Instead, it states that tests were "conducted in accordance with" specific ASTM standards, implying successful completion to meet the standards' criteria. The overall conclusion is that these tests demonstrate "any minor differences do not impact device performance as compared to the predicates."

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

• Sample Size: Not specified. The document only mentions that non-clinical tests were conducted. Typically, such tests involve a certain number of samples for each test type, but these numbers are not disclosed.
• Data Provenance: Not applicable in the context of clinical data. These are non-clinical (mechanical and surgical technique) tests conducted in a laboratory setting.

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

• This question is not applicable. The study involves non-clinical engineering and mechanical testing, not a clinical study involving experts establishing ground truth for a test set in the conventional sense (e.g., radiologists interpreting images). The "surgical technique validation" would involve skilled personnel, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

• Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

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. The device is a physical spinal implant, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. The device is a physical spinal implant, not an algorithm. The non-clinical tests performed are inherently "standalone" in the sense that they assess the device's physical properties.

7. The type of ground truth used

• The "ground truth" for the non-clinical tests is based on established engineering principles and the requirements of the specified ASTM international standards (e.g., F2077-03, F2267-04, ASTM Draft Standard F-04.25.02.02). For the surgical technique validation, the "ground truth" would be the successful and safe deployment and function of the device as intended, in a similar manner to the predicate.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI study.

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

• Not applicable. This is not a machine learning or AI study.

Summary Explanation:

The provided document is a 510(k) summary for a medical device (AccuLIF® TL Cage), which aims to demonstrate "substantial equivalence" to existing legally marketed predicate devices. The "study" described consists of a series of non-clinical, biomechanical tests and surgical technique validation. The acceptance criteria for these tests are implicitly defined by compliance with the referenced ASTM standards. The reported device performance is that these tests were conducted "in accordance with" these standards and that the device's performance is comparable to the predicates, without explicitly listing raw data or specific numerical thresholds. The submission's goal is to show that the device meets safety and effectiveness requirements by being functionally equivalent to already approved devices, rather than through a novel clinical trial with quantitative performance metrics against a "ground truth" in a human study.

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