(178 days)
TriPore HA, TriPore BP90 and TriPore BP15 is intended to be packed into bone defects of the skeletal system (extremities, 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. This device can also be used for maxillofacial surgery for the reconstruction of the facial skeleton. 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 HA is pure hydroxylapatite bone void filler, with a highly porous structure comprising three types of porosity which are interconnected: macropores (100 µm to 1-2mm), midipores (10-100 µm) and microspaces (1-10 µm).
TriPore BP90 and TriPore BP15 are a biphasic tricalcium phosphate:hydroxylapatite. The (X) designates the nominal hydroxyapatite composition of the mixture. TriPore BP bone void filler has the same structure as TriPore HA.
TriPore (HA or BP) is available in Blocks (D-shaped, cuboid and other shapes) and Granules (four different sizes)
The provided text describes a medical device called TriPore (HA, BP90, BP15), which is a resorbable calcium salt bone void filler. The document is a 510(k) summary, detailing its substantial equivalence to a predicate device for market clearance.
However, the text does not contain information about:
- Specific acceptance criteria expressed as performance metrics (e.g., sensitivity, specificity, accuracy).
- A "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or algorithm performance study with quantitative results.
- Sample sizes for test sets or training sets.
- Data provenance, number of experts, adjudication methods, or ground truth establishment for such studies.
- MRMC comparative effectiveness studies or standalone algorithm performance.
The document primarily focuses on non-clinical and animal data to establish substantial equivalence. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and performance metrics as they are not present in the provided text.
The closest relevant information, though not directly addressing your specific questions about modern AI/imaging device performance studies, is summarized below:
Acceptance Criteria and Device Performance (Based on "Determination of substantial equivalence" sections):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence (Non-Clinical Data) | Determined on the basis of chemical composition tests on both TriPore and the predicate device (Vitoss™) as prescribed in the 'Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device" (FDA Guidance Document 855, dated June 2, 2003). TriPore itself complies with the requirements of this Special Controls Document. |
| Substantial Equivalence (Animal Data) | Animal studies making direct comparison against the predicate device concluded that at 24 weeks implant, TriPore implants were structurally more integral with interconnecting walls and bone present within the macro pores, midi pores, and micro spaces compared to the predicate device. |
| Safety and Effectiveness Conclusion | Orthogem concludes that the non-clinical and animal tests demonstrate TriPore is safe, effective, and performs as well as or better than the predicate device. |
Missing Information:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The animal study mentions "animal studies" but gives no sample size or details about the cohort.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided, as this is not an imaging/AI study with expert-labeled ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
- 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: Not applicable. This is not an AI-assisted device in that context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical data, it was "chemical composition tests." For the animal data, it was histological or structural analysis of implants at 24 weeks, likely interpreted by animal scientists/pathologists, but the specifics are not detailed.
- The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.