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The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

The Graft Delivery Device with Integrated Stylet is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

The Graft Delivery Device with Integrated Stylet consists of a syringe body, plunger with integrated stylet, tapered end cap, funnel, cap plug, and cannula. Hydration components (hydration tube or hydration adapter) are present in some configurations. Components are made of one or more of the following materials: acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, self-lubricating silicone, and 304 Stainless Steel.

The device is packaged in a thermoformed tray with a Tyvek Iid. Each tray is then packaged in a labeled individual poly/Tyvek pouch. Five (5) pouched trays are then put into a shelf box and then a cardboard shipper box. Like the graft delivery device from K100754, the Graft Delivery Device with Integrated Stylet is sterilized using ethylene oxide.

The provided text is for a medical device called "Graft Delivery Device with Integrated Stylet," which is classified as a piston syringe. The document describes a 510(k) premarket notification, indicating substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than clinical studies in most cases.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" will be derived from the non-clinical performance data and the concept of "substantial equivalence."

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the test articles met "pre-defined acceptance criteria," indicating a successful outcome for each test. However, the specific quantitative acceptance criteria values for each test are not provided in this summary. The "Reported Device Performance" is broadly stated as meeting these unquantified criteria.

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

The document does not explicitly state the sample sizes used for each non-clinical test. This information would typically be found in the full test reports, which are not included here.

• Sample Size (Test Set): Not specified in the provided summary.
• Data Provenance: The tests are internal non-clinical performance tests conducted by the manufacturer (Micromedics, Inc.) to demonstrate the device's mechanical integrity and suitability for its intended use. This is inherently prospective in nature, as the tests are performed specifically for regulatory submission on the device under review. The country of origin of the data is implied to be the USA, where Micromedics, Inc. is based.

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

For non-clinical, mechanical, and biocompatibility testing, "ground truth" is established through engineering specifications, validated test methods, and international standards (like ISO 10993). This typically does not involve a panel of human experts in the same way clinical data does. The "experts" would be the engineers, quality control specialists, and external laboratory personnel who designed and executed the tests and evaluated the results against objective criteria. Their qualifications are inherent in their roles and adherence to industry standards.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective human interpretation of outputs (e.g., medical images) needs consensus. For non-clinical, objective performance tests, adjudication is not typically performed in this manner. The results are compared directly against pre-defined engineering acceptance criteria. A test either passes or fails based on objective measurements.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Summary of Clinical Performance Data: None provided as a basis for substantial equivalence." This device relies on non-clinical data for its 510(k) submission.

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

This question is not applicable. The device is a physical medical instrument (a graft delivery device), not an algorithm or AI software. Therefore, there is no "standalone performance" in the context of AI without human-in-the-loop. The non-clinical performance tests evaluate the physical device's functionality.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is comprised of:

• Engineering Specifications: Designed performance parameters and tolerances for the device's physical and functional attributes.
• Validated Test Methods: Established procedures to objectively measure these attributes.
• International Standards: e.g., ISO 10993 for biocompatibility.
• Predicate Device Performance: Implicitly, the performance of the predicate devices informed the acceptable range for the new device's non-clinical performance to establish substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This question is not applicable, as there is no "training set" for a physical medical device.

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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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