(74 days)
TheriGraft™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriGraft™ putty creates a network within the defect site that resorbs during healing and is replaced by bone.
The TheriGraft™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate granules (0.1 - 0.4 mm diameter) in a poloxamer based carrier.
The provided text describes a 510(k) summary for TheriGraft™ TCP Putty Bone Void Filler, focusing on its substantial equivalence to a predicate device, Orthovita's Vitoss™. The study conducted is a pre-clinical animal study comparing the new device to the predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list "acceptance criteria" with specific numerical targets. Instead, it presents a comparison table (Table 1) that assesses the substantial equivalence of the new device (TheriGraft™) to the predicate device (Vitoss™) across various characteristics and attributes. The "reported device performance" is summarized as "similar results" in pre-clinical testing, leading to a determination of substantial equivalence (SE).
| Characteristics or Attributes | Acceptance Criteria (Implied: Similarity to Predicate) | Reported Device Performance (TheriGraft™) |
|---|---|---|
| Indications for Use | Same as Vitoss™ | Same |
| Intended Use | Same as Vitoss™ | Same |
| Labeling | Same as Vitoss™ | SE (Substantially Equivalent) |
| Target Population | Same as Vitoss™ | Same |
| Design | Similar internal structures to Vitoss™ | Similar internal structures |
| Materials | Same as Vitoss™ | Same |
| Performance | Demonstrate performance characteristics (comparable to predicate) | Pre-clinical study demonstrated performance characteristics, "similar results" to Vitoss™ |
| Sterility | Same as Vitoss™ (Gamma irradiation) | Same |
| Biocompatibility | Tested according to ISO 10993 (similar to predicate's compliance) | Product tested according to ISO 10993 (Unknown for Vitoss™ but implies compliance) |
| Chemical Safety | Tested according to ISO 10993 (similar to predicate's compliance) | Product tested according to ISO 10993 (Unknown for Vitoss™ but implies compliance) |
| Anatomical Sites | Same as Vitoss™ | Same |
| Where Used | Same as Vitoss™ | Same |
| Design Control | Verification & Validation (similar to predicate's compliance) | Design Controls: Verification & Validation (Unknown for Vitoss™ but implies compliance) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions a "canine animal model" but does not specify the number of animals used in the pre-clinical performance testing.
- Data Provenance: The study was a "pre-clinical performance testing conducted on TheriGraft™ and Vitoss™ in a canine animal model." This indicates it was a prospective animal study. The country of origin of the data is not specified, but the submitting company is based in Princeton, NJ, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study was an animal model comparing the new device to a predicate device, and the evaluation criteria (tissue reaction, bone ingrowth, residual material, mechanical testing) would likely be assessed by veterinary pathologists or researchers with expertise in bone healing and material science. However, no details on the number or qualifications of experts are given.
4. Adjudication Method for the Test Set:
This information is not explicitly stated. "Adjudication method" is typically relevant in clinical studies where expert consensus is needed for ambiguous cases. In this pre-clinical animal study, the outcomes (tissue reaction, bone ingrowth, residual material, and mechanical testing) would likely be measured objectively or by a single expert/team following a predefined protocol.
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. This type of study is specifically for evaluating the impact of AI assistance on human reader performance, which is not applicable to a pre-clinical animal study of a bone void filler material.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
No. This is not an AI/algorithm-based device. It is a physical bone void filler. Therefore, a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used:
The ground truth was established through pre-clinical animal model outcomes, specifically:
- Tissue reaction: Histological analysis of surrounding tissues.
- Bone ingrowth: Histological and potentially imaging analysis of new bone formation.
- Residual material: Assessment of the remaining implanted material.
- Mechanical testing: Evaluation of the strength and integrity of the healed bone.
These are objective biological and biomechanical measures derived from the animal model.
8. The Sample Size for the Training Set:
This information is not applicable/not provided. The device is a physical bone void filler, not an AI model that requires a training set. The study describes pre-clinical testing, not algorithm development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided as there is no training set for an AI model. For the pre-clinical study, the outcomes listed in point 7 served as the ground truth.
§ 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.