(131 days)
Vitoss BA Injectable is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss BA Injectable is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Vitoss BA Injectable is intended to be used for filling bony voids and gaps of the skeletal system (i.e. the extremities and pelvis), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss BA Injectable bone graft substitute is a synthetic resorbable porous bone void filler for the repair of bony defects made from a combination of beta tricalcium phosphate and bioactive glass in a carrier of porcine gelatin and sodium carboxymethyl cellulose. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.
Vitoss BA Injectable is provided prepackaged in a syringe. At the time of use a specified volume of hydration fluid is combined with the dry component of the device. Mixing is facilitated by a syringe to syringe mixing system. The resulting material can be administered to the treatment site by injection through a cannula or by manual application. After injection or insertion into the defect site new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vitoss Bioactive (BA) Injectable device, formatted to address your questions.
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for novel acceptance criteria. Therefore, some information you're asking for (like multi-reader multi-case studies, detailed ground truth establishment for a training set, or effect sizes for human readers with AI assistance) is not applicable or detailed in this type of regulatory submission because the device is a bone void filler, not an AI diagnostic tool.
Device: Vitoss Bioactive (BA) Injectable
Device Type: Resorbable Calcium Salt Bone Void Filler
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that a "risk analysis was performed to demonstrate that Vitoss BA Injectable is substantially equivalent to its predicate devices." The acceptance criteria are broadly defined by the "predefined acceptance criteria" being met for several types of testing. The performance is summarized as demonstrating substantial equivalence to the predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Comparative Animal Performance | Met predefined acceptance criteria; demonstrated substantial equivalence to predicate. |
| Bioactivity Testing (in-vitro) | Met predefined acceptance criteria; exhibited calcium phosphate growth on the surface in simulated body fluid (phenomenon not observed in control samples without bioactive glass component). Note: Bioactivity not evaluated in human clinical trials. |
| Permeability Testing | Met predefined acceptance criteria. |
| Irrigation Testing | Met predefined acceptance criteria. |
| Usability Testing | Met predefined acceptance criteria. |
| Extrusion Testing | Met predefined acceptance criteria. |
| Packaging and Shelf Life Validations | Met predefined acceptance criteria. |
| Sterilization Validation | Met predefined acceptance criteria. |
| Biocompatibility | Met predefined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test in terms of number of subjects, samples, or tests performed. The document broadly refers to "comparative animal performance testing in a rabbit model" but does not give the number of rabbits or the specific endpoints measured.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified. Animal performance testing would be prospective in nature. In-vitro testing is laboratory-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given this is a medical device for bone void filling, and not an AI diagnostic system evaluating images, the concept of "experts establishing ground truth for a test set" in the context of human interpretation (like radiologists for an imaging AI) does not directly apply here.
The "ground truth" for this device would be established through:
- In-vitro testing standards: Laboratory tests demonstrating material properties, bioactivity, permeability, etc.
- Animal model outcomes: Histological analysis, imaging, and mechanical testing of bone formation and resorption in the rabbit model, interpreted by researchers/pathologists specializing in bone healing.
The number and specific qualifications of the experts or analysts who conducted these evaluations are not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable in the context of this device and the types of tests described. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in human-AI diagnostic studies, where there's potential for inter-reader variability in interpreting complex data. Performance testing for a bone void filler involves objective measurements (e.g., mechanical properties, biological response under controlled conditions).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks (e.g., radiology interpretation). This device is a bone void filler, not a diagnostic AI tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
This question is not applicable. The device is a physical medical implant, not an algorithm. Its performance is inherent to its physical and biological properties.
7. The Type of Ground Truth Used
The "ground truth" in this context is established through a combination of:
- Objective Laboratory Measurements: For physical properties (permeability, extrusion, packaging, sterilization).
- Biological Response in Animal Models: For comparative animal performance (e.g., histological evidence of bone ingrowth, resorption, and integration). This would involve standard pathological evaluation techniques.
- In-Vitro Bioactivity Assays: Chemical and structural analysis demonstrating calcium phosphate growth.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a "training set." The testing described (animal studies, in-vitro tests) is for validation of the device's performance against predefined criteria and comparison to predicate devices, not for training a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical device.
§ 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.