(228 days)
BIOSORB® Resorbable Void Filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.
BIOSORB® Resorbable Void 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.
BIOSORB® is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (ßTCP) indicated for Bone Void Filling.
BIOSORB® implants are available in various shapes and sizes in order to fill various bone defect. Shapes are basic such as granules, cylinders, blocks and cubes.
BIOSORB® presents a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. BIOSORB® implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of BIOSORB® resorbable void filler is intended to prevent premature resorption.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria in terms of specific numerical thresholds (e.g., "resorption rate must be X% by Y weeks"). Instead, the device is deemed acceptable through demonstrating substantial equivalence to predicate devices by meeting recognized standards and exhibiting similar performance for key characteristics.
Therefore, the table below reflects what appear to be the implicit acceptance criteria based on the comparisons made and the studies performed, and the reported performance.
| Criteria/Characteristic (Implicit Acceptance Criteria) | BIOSORB® Reported Device Performance | Predicate (VITOSS® / PRO OSTEON®) Performance (for comparison) |
|---|---|---|
| Biocompatibility | Conforms to ASTM F 1088-87 (reapproved 1992). Established (by meeting standards and extensive testing, found to be non-toxic, non-allergenic, biocompatible, no inflammation, no adverse systemic effects). | VITOSS®: ASTM F1088-87; Biocompatibility established. |
| Osseous Rehabilitation (New Bone Formation) | New bone formation clearly evident by 4 weeks and a quasi-complete (>90%) rehabilitation observed by 10 weeks (rabbit model). | VITOSS®: New bone formation clearly evident by 6 weeks - complete by 12 weeks (canine model). |
| In vivo TCP Dissolution (Resorption) | 35% at 6 months and 72% at 12 months in human (clinical trial data). Local mineralization process from dissolved calcium involved in bone healing (rabbit model). | VITOSS®: Significantly by 3 months in human (76% at 6 weeks, 86% at 12 weeks in canine). |
| PRO OSTEON®: About 6 months in human; 20% at 6 weeks, 45% at 12 weeks in canine. | ||
| Clinical Safety and Effectiveness | Clinical and radiological data demonstrate biocompatibility, osseointegration, and resorption, and replacement with osseous tissues. Absence of inflammatory or septic response, stable osseous fusion (human clinical trial). | The predicate devices also have established clinical safety and effectiveness through their prior market clearance. |
| Compliance with Standards | Conforms to ASTM F-1088-87; ISO 10993 (long-term implantable, bone/tissue contact). | VITOSS®: ASTM F1088-87. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Physical Characteristics (Porosity, Pore size) | Porosity: 40-50% & 60-80%. Pore size: 250-400 µm. Trabecular structure similar to cancellous bone with interconnected porosity. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | VITOSS®: Porosity 88-92%, Pore size 1-1000 µm. |
| PRO OSTEON®: Porosity 55%, Pore size 435 µm [280-779 µm]. | ||
| Mechanical Strength | Does not impart mechanical strength to surgical site; rigid fixation techniques recommended. | (Not explicitly stated for predicates, but implied for bone void fillers not intended for load-bearing.) |
| Sterility | Sterilized by Gamma radiation; Single use only. | (Implied for similar implantable devices.) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document describes several studies:
- Animal Studies:
- Osseous Rehabilitation: Rabbit condyles were used for histo-morphometric analyses. No specific number for "test set" sample size (i.e., number of rabbits or samples) is provided. This data is animal (rabbit) provenance.
- In Vivo TCP Dissolution: Rabbits were used to evaluate local calcium content around implants. No specific sample size is provided. This data is animal (rabbit) provenance.
- Human Clinical Trial: A human clinical trial investigated safety, effectiveness, achievement of stable osseous fusion, absence of inflammatory/septic response, and resorption/replacement by osseous tissues. No specific sample size for the test set (number of patients) is provided. This data is human, prospective clinical trial data.
- Retrospective Clinical Studies: Several published retrospective clinical studies support the use of BIOSORB beta-tricalcium phosphate ceramic. These include:
- "Use of β -tricalcium phosphate in foot and ankle surgery: a report of 20 cases" (reported as 20 cases).
- "Filling of bone defects with tricalcium phosphate beta in traumatology. In Ann Chir . 2000 Dec:125(10):972-81" (sample size not specified in this summary).
- "Beta-tricalcium phosphate ceramic as a bone substitute in orthopaedic surgery in Int . Orthop 2002;26(2):109-15" (sample size not specified in this summary).
Data Provenance:
- Animal studies: Rabbit models.
- Human Clinical Trial: Human, prospective.
- Retrospective Clinical Studies: Human, retrospective (France for the 2000 and 2002 publications, if the "Ann Chir" and "Int Orthop" are French journals, or broader European/international for "Int Orthop").
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish ground truth for the test sets.
- For the animal histo-morphometric analyses, it would imply qualified veterinary pathologists or histologists.
- For the human clinical trial and retrospective studies, the ground truth (clinical outcomes, radiological findings) would be established by the treating physicians and radiologists involved in those studies. Their specific qualifications are not detailed in this 510(k) summary but would be part of the full study protocols.
4. Adjudication Method
The document does not specify any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth in any of the described studies. The results from the clinical trial and published studies would likely rely on standard medical practice by the treating clinicians/radiologists.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size of human readers improving with AI vs. without AI assistance, is included. This device is a bone void filler, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study is mentioned, as this is a physical medical device (bone void filler), not an algorithm or software.
7. Type of Ground Truth Used
- Animal Studies:
- Osseous Rehabilitation: Histological and morphometric analysis of tissue samples from rabbit condyles, directly observing new bone formation and integration. This is a form of direct biological/pathological ground truth.
- In Vivo TCP Dissolution: Measurement of local calcium content in rabbit models, indicating biological activity and resorption. This is a biochemical/physiological ground truth.
- Human Clinical Trial: Clinical and radiological data, which includes patient outcomes, imaging findings (X-rays, etc.), and clinical assessment of inflammation, infection, fusion, and resorption. This combines clinical and imaging ground truth.
- Retrospective Clinical Studies: Patient case reports, clinical observations, and radiological follow-ups as documented in the published literature. This is clinical/imaging ground truth from real-world applications.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a physical medical device, not a machine learning model. The studies described are for validation and establishing substantial equivalence.
9. How Ground Truth for the Training Set Was Established
As there is no training set for a machine learning model, this point is 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.