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The T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft).

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had six months of nonoperative treatment.

The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.

The T-PAL Spacer System is an interbody fusion device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following intervertebral discectomy. The T-PAL Applicator is used to insert the T-PAL Spacer into the disc space. The T-PAL Applicator is composed of an inner shaft and handle (outer shaft). The scope of this submission is to develop an additional T-PAL Applicator option for surgeons to facilitate insertion of the T-PAL Spacer and final positioning in the interbody disc space.

Here's an analysis of the provided text regarding the DePuy Synthes T-PAL Spacer System, focusing on the acceptance criteria and study information:

Based on the provided text, the device in question is the T-PAL Advanced Applicator which is a minor modification to the already cleared T-PAL Applicator. This submission (K181231) is for the modified applicator, not the T-PAL Spacer System itself, though the applicator is used with the spacer system.

The submission is a 510(k) for substantial equivalence. This means the device is being compared to a legally marketed predicate device (T-PAL Spacer System K100089 and DePuy Synthes T-PAL Ti Spacer System K151276) to demonstrate that it is as safe and effective.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The text mentions "mechanical testing simulated the insertion of the implant," but does not provide details on the number of tests, specific loads, cycles, or other parameters of the mechanical testing.
• Data Provenance: Not explicitly stated, but it is implied to be from internal lab testing conducted by the manufacturer, DePuy Synthes. There is no mention of country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) for a modified component, it's highly likely to be internal, prospective, laboratory-based testing.

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

• This information is not applicable and not provided in the document. The study described is mechanical testing, not a clinical study involving human assessment or expert review of images/data to establish ground truth.

4. Adjudication method for the test set

• This information is not applicable and not provided in the document. The study described is mechanical testing, which does not involve human adjudication.

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. The device is a surgical applicator (mechanical device), not an AI/software device that assists human readers in interpreting medical images or data.

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. The device is a mechanical surgical applicator, not an algorithm or AI.

7. The type of ground truth used

• The "ground truth" for the mechanical testing would be the engineering specifications and performance metrics defined by the manufacturer and relevant industry standards for surgical instruments. The device's performance was evaluated against these predefined mechanical acceptance criteria.

8. The sample size for the training set

• This information is not applicable and not provided in the document. As this is mechanical testing for a physical device, there is no "training set" in the context of machine learning or AI.

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

• This information is not applicable and not provided in the document. There is no training set mentioned or implied.

Summary of Device Performance Study and Conclusion:

The study performed was mechanical testing that simulated the insertion of the implant into an intervertebral body using the subject T-PAL Advanced Applicator. The purpose was to demonstrate that modifications to the applicator did not negatively impact its mechanical performance.

Conclusion: "The performance acceptance criteria was met." and "The insertion testing further demonstrates that the modifications to the design do not introduce any new questions of safety and effectiveness." The submission concludes that the T-PAL Advanced Applicator is substantially equivalent to the predicate devices.

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