(101 days)
BIOSORB Resorbable Bone Void Filler is a resorbable calclum salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable BoneVoid Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.
In addition, when used with appropriate opening osteotomy system devices, plates and screws, BIOSORB Resorbable Bone Void Filler Is Intended to be used as a bone void filler in tiblal osteotomies.
BIOSORB bone void filler (K021963 and K071155) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βΤCP) indicated for Bone Void Filling.
BIOSORB bone void filler presents a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. BIOSORB bone void filler implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues.
To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of BIOSORB RESORBABLE BONE VOID FILLER will comprise:
- 9 shapes: stick, granule, cube, block (6 shapes) o
- 3 material specifications: BIOSORB 30, BIOSORB 45 and BIOSORB 70 o
- 3 packaging: box, vial, syringe 0
The design modifications of the new NEOTIS set of wedges with respect to OTIS set of wedges include a sharper anterior area and a wider posterior area more fitting the natural tibia anatomy. 3 letters are printed to help the surgeon with the wedge orientation: A stands for Anterior, M stands for Medial and P for Posterior.
There are 50 NEOTIS parts instead of 10 OTIS parts, so that the range is increased.
Here's a breakdown of the acceptance criteria and study information for the BIOSORB Resorbable Bone Void Filler, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conforms to Class II Special Controls Guidance: "Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA" (established for 21 CFR 888.3045). | The device "conforms to Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA" established for Resorbable calcium salt bone void filler (21 CFR 888.3045). |
| Offers enhanced anatomical fitting for HTO (High Tibial Osteotomy) opening filling compared to previous designs. (Implied acceptance criteria: The design modification should reduce the risk of inadequate filling and not generate new risks, demonstrating equivalent or better safety and effectiveness compared to the predicate.) | The new implant design offers "an enhanced anatomical fitting for HTO opening filling as verified by surgeons through cadaveric labs (RD837 - enclosed in Appendix 1)". The design modification reduces the risk of inadequate filling and does not generate new risks. The device is as safe, as effective and performs as well as or better than the predicate BIOSORB RESORBABLE BONE VOID FILLER. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "cadaveric labs" but does not specify the number of cadavers or individual tests performed.
- Data Provenance: The cadaveric labs likely involved human cadavers. The country of origin is not specified, but the submitter is based in France. The study was prospective in the sense that new tests were conducted for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated, however, the document refers to validation "by surgeons." This implies multiple surgeons were involved.
- Qualifications of Experts: "Surgeons" are the explicitly stated experts. No further details on their specific qualifications (e.g., years of experience, subspecialty) are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The document only states that the enhanced anatomical fitting was "verified by surgeons." It doesn't detail how consensus was reached or how discrepancies (if any) were handled among the surgeons.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The study focused on verifying the anatomical fitting of the device through cadaveric labs, not on comparing human reader performance with and without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No, this is not applicable. The device is a physical bone void filler, not an AI algorithm. The performance evaluation involved physical assessment by surgeons in cadaveric labs.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the device's enhanced anatomical fitting was based on expert assessment/consensus by surgeons through cadaveric labs.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The development of the device design would involve engineering and material science principles, possibly with iterative design and testing, but not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
§ 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.