(48 days)
TheriLink™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and 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). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.
The TheriLink™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate (ß-TCP), a commonly found mineral in bone. The porosity and geometric features of ß-tricalcium phosphate create a network within the defect site that resorbs during healing and is replaced by native bone.
The provided text describes the TheriLink™ Bone Void Filler, a synthetic beta-tricalcium phosphate (ß-TCP) device for filling bone voids but does not include information about acceptance criteria or a study proving the device meets them in the context of performance metrics like sensitivity, specificity, or AI-assisted improvements. This is mainly because the document is a 510(k) summary for a medical device which relies on demonstrating substantial equivalence to a predicate device rather than clinical trial performance metrics as would be typical for an AI/ML diagnostic.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of performance targets for an AI/ML device (e.g., minimum sensitivity, specificity). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" described relates to the physical and chemical characteristics of the TheriLink™ Bone Void Filler, comparing it to a predicate device (TheriFil™).
| Characteristic | Acceptance Criteria (Implied for Substantial Equivalence via Predicate Range) | Reported TheriLink™ Performance | Predicate (TheriFil™) Performance |
|---|---|---|---|
| Porosity (%) | Similar to TheriFil™ (59 ± 5.3) | 58 ± 2.2 | 59 ± 5.3 |
| Pore Area (µm²) - Mean | Similar to TheriFil™ (3000 ± 1200) | 2500 ± 900 | 3000 ± 1200 |
| Pore Area (µm²) - Min* | Similar to TheriFil™ (40) | 40 | 40 |
| Pore Area (µm²) - Max | Similar to TheriFil™ (3.5 x10^5 ± 2.1 x10^5) | 4.9 x10^5 ± 1.9 x10^5 | 3.5 x10^5 ± 2.1 x10^5 |
| Pore Diameter (µm) - Mean | Similar to TheriFil™ (60 ± 12) | 55 ± 11 | 60 ± 12 |
| Pore Diameter (µm) - Min* | Similar to TheriFil™ (7) | 7 | 7 |
| Pore Diameter (µm) - Max | Similar to TheriFil™ (640 ± 220) | 770 ± 170 | 640 ± 220 |
| True Density (grams/mL) | Similar to TheriFil™ (1.5) | 1.5 | 1.5 |
| Crystallinity | Similar to TheriFil™ (ß-TCP > 75%) | ß-TCP > 75% | ß-TCP > 75% |
Note: The "acceptance criteria" here are implied by the substantial equivalence argument, meaning the device's characteristics must be sufficiently similar to the predicate to not raise new questions of safety or effectiveness. There are no explicit numerical acceptance thresholds stated in the document beyond the comparative data.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "SEM images (n = 18)" were used for estimating porosity and pore area. This constitutes the "test set" for physical characteristic evaluation.
- Sample Size (Test Set): 18 (for SEM images)
- Data Provenance: Not explicitly stated, but it would be from manufacturing batches of the TheriLink™ and TheriFil™ devices. This is a retrospective analysis of manufactured products. Country of origin not specified, but the company is US-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For physical/chemical characteristic measurements, the "ground truth" is typically established by standardized laboratory testing procedures performed by qualified technicians or engineers, rather than medical experts.
4. Adjudication Method for the Test Set
Not applicable. The measurements are objective physical characteristics, not expert interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, an MRMC comparative effectiveness study was not done. This device is a bone void filler, not an AI/ML diagnostic tool meant to assist human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done.
No, this is not an AI algorithm. Its "performance" is based on its physical and chemical properties and biological host response (resorption and replacement by bone), not an algorithmic output.
7. The Type of Ground Truth Used
For the physical and chemical characteristics, the ground truth is established by objective laboratory measurements using methods such as SEM imaging and pycnometry. For the biological performance (resorption and replacement by bone), the implicitly accepted ground truth is the known biological behavior of ß-TCP and the predicate device, as well as the intended biological response described for TheriLink™ ("resorbs during healing and is replaced by bone").
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The manufacturing process and formulation are based on scientific principles of material science and known biocompatibility of ß-TCP, not a data-driven training approach.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there's no training set for an AI/ML model.
§ 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.