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TriPore TDDHA, TDDBPS, and TDDgP15 is intended to be packed into bone defects of the skeletal system (extremities, posterolateral spine or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

TriPore TDD is an open bore syringe prefilled with TriPore synthetic bone graft granules in three different compositions: (1) 100% pure hydroxylapatite; (2) biphasic mixture of 90% hydroxlyapatite and 10% tri-calcium phosphate; (3) biphasic mixture of 15% hydroxlyapatite and 85% tri-calcium phosphate TriPore TDD comes in two sizes - containing 5cc and 10cc of TriPore granules.

The provided documents describe a 510(k) premarket notification for the TriPore TDD device, which is a synthetic, porous calcium phosphate bone graft. This submission is for demonstrating substantial equivalence to predicate devices, not for a de novo marketing authorization or a PMA. Therefore, the information typically found in a study demonstrating specific performance against acceptance criteria for a novel device, especially in the context of AI/ML or diagnostic performance, is not present.

The submission focuses on proving that the TriPore TDD is essentially the same as already approved devices, rather than testing new performance metrics.

Based on the provided text, here's what can be extracted and what cannot be answered:

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

This information is not applicable/not provided in this type of 510(k) submission. The acceptance criteria here are related to demonstrating substantial equivalence in terms of material composition and delivery mechanism to predicate devices, not specific performance metrics against a defined threshold.

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

This information is not applicable/not provided. There was no "test set" in the context of a new performance study. The data provenance refers to prior animal studies on the predicate device (TriPore, K070132), which were deemed applicable to the current device. The document explicitly states: "Extensive animal studies on TriPore, and recorded in K070132 apply to TriPore TDD and have not been repeated."

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/not provided. There was no study with a "test set" requiring expert-established ground truth.

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

This information is not applicable/not provided.

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

This information is not applicable/not provided. This device is a bone graft, not a diagnostic AI system or an imaging modality, so MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

This information is not applicable/not provided. As explained above, this is a physical medical device, not an algorithm.

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

For the prior animal studies referenced (K070132), the "ground truth" would likely be histological analysis and other biological assessments of bone ingrowth and material resorption, which are standard for evaluating bone grafts in animal models. However, the specifics for K070132 are not detailed in this document. For K110787, the "ground truth" for substantial equivalence relies on material identity.

8. The sample size for the training set

This information is not applicable/not provided. There was no training set in the context of the type of study typically associated with this question.

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

This information is not applicable/not provided.

Summary of the study and acceptance criteria from the provided document:

Acceptance Criteria for Substantial Equivalence (as implied by the submission):

The primary acceptance criterion for this 510(k) submission is that the TriPore TDD device is "substantially equivalent" to its predicate devices in terms of:

• Material Composition: The synthetic bone graft granules (TriPore HA, BP90, BP15) are identical to those in the predicate device TriPore K070132.
• Delivery Mechanism: The open bore syringe used is identical to the one in the predicate device FibriJet Graft Delivery Device K100754.
• Intended Use: The intended use is consistent with the predicate devices (packing into bone defects of the skeletal system for resorption and replacement with bone).
• Safety and Effectiveness: Demonstration that the device is safe, effective, and functions as well as the predicate devices based on the substantial equivalence argument.

Reported Device Performance / Determination of Substantial Equivalence:

The Orthogem Ltd concludes that the TriPore TDD is substantially equivalent based on the following:

• Non-Clinical Data: "Orthogem has determined that TriPore TDD is substantially equivalent to the predicate devices on the basis that the synthetic bone graft granules in TDD are exactly those in the predicate device."
• Animal Data: "Extensive animal studies on TriPore, and recorded in K070132 apply to TriPore TDD and have not been repeated. Animal data is not applicable to the TDD syringe." This means previous animal study data for the identical bone graft material (from K070132) was leveraged.
• Technological Characteristics Comparison: The submission explicitly states the TriPore TDD contains the exact same TriPore granules as K070132 and the exact same open bore syringe as K100754.

Conclusion by Orthogem:

"Orthogem concludes that the non-clinical tests carried out on TriPore TDD demonstrate that it is safe. Effective and function as well as the predicate devices."

The FDA's letter (K110787) confirms their agreement with this conclusion, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

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