(41 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.
The BIO 1-KIT ® BIOSORB® filled cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with the BIOSORB ® Resorbable Void Filler and deliver the material to the orthopedic surgical site.
BIOSORB ® bone void filler (BIO1 range of products) (K021963) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βTCP) indicated for Bone Void Filling.
BIOSORB ® bone void filler presents a multidirectional interconnected porosity structure (45% and 70%), 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. The progressive resorption within 6-12 months prevents premature resorption and failed filling.
The impregnation of bone substitute with marrow is largely practiced by the surgeons. Usually this operation is done by immersion of the bone substitute in a container containing the osseous marrow. In order to facilitate this operation and to limit the contact of the mixture with the ambient air at the origin of the degradation of the cells and proteins contained in osseous marrow, S.B.M has developed a system allowing the and procession of autologous osseous marrow, the impregnation of the calcium phosphate pellets and the impaction of the mixture in the cavity to be filled. This system allows the impregnation of porous pellets with osseous marrow under aseptic conditions.
BIO 1-Kit® comprises :
- a pre-filled syringe of BIOSORB® (β-ΤCP porous ceramic pellets)
- a connector with an adapter and a needle
- a bone marrow aspiration needle
BIO 1-Kit® is delivered sterile and intended for a single use.
BIO 1-Kit® is available either with BIOSORB® granules (1.5 and 3.0 mm in diameter) or BIOSORB® blocks (4x4x4 mm) and in quantities ranging from 5 cc to 45 cc.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the BIO 1-KIT ® BIOSORB® filled cartridge:
Acceptance Criteria and Device Performance for BIO 1-KIT ® BIOSORB® filled cartridge
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting specific quantitative acceptance criteria for the BIO 1-KIT® BIOSORB® filled cartridge itself (the new device being reviewed). Instead, it relies heavily on the established safety and effectiveness of its main component, BIOSORB® bone void filler (which had its own prior 510(k) clearance, K021963), and the substantial equivalence of the new syringe system to a similar predicate.
Therefore, the "acceptance criteria" presented below are inferred from the types of tests performed and the claims made about the device's functionality and safety, especially regarding its new features (the cartridge system).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from tests/claims) | Reported Device Performance |
|---|---|
| For BIOSORB® (bone void filler component): | |
| Biocompatibility | Excellent biocompatibility; non-toxic, non-allergenic, no inflammation, no adverse systemic effects. |
| Material Characteristics | Conforms to ASTM F 1088-2004 (Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation). |
| Osseo-integration & Bone Replacement | Clinical and radiological data demonstrate osseo-integration and replacement by osseous tissues. |
| Resorption Profile | Progressive resorption within 6-12 months. |
| For BIO 1-KIT® (cartridge system component): | |
| Material Compatibility (syringe & contents) | Assessed by infra-red spectrometry. Results imply compatibility and absence of particle release. |
| Aspiration and Impregnation Functionality | Testing performed; implicit successful performance for aspiration of autogenous blood/marrow and impregnation of pellets. |
| Sterility | Delivered sterile. |
| Single Use | Intended for single use. |
| Substantial Equivalence | Substantially equivalent to VITOSS-Filled cartridge K032130 in terms of intended use, material, design, and function. |
2. Sample Size Used for the Test Set and Data Provenance
- For BIOSORB® (prior clearance K021963):
- Sample Size: A "human clinical trial" was performed. The specific number of subjects/cases is not provided in this 510(k) summary.
- Data Provenance: Not explicitly stated (e.g., country of origin). Since the submitter is French, it's possible this was an international or European trial, but no details are given. The trial was prospective, as it was conducted to investigate safety and effectiveness.
- For BIO 1-KIT® cartridge (new clearance K061022):
- Sample Size: Not specified for the "compatibility," "aspiration," and "impregnation" tests. These appear to be bench or lab-based tests, not clinical trials.
- Data Provenance: Not specified beyond being performed by S.B.M. (the manufacturer). Retrospective or prospective is not applicable for these bench tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- For BIOSORB® (prior clearance K021963):
- No information is provided on the number and qualifications of experts involved in establishing ground truth for the clinical trial data discussed. The text refers to "clinical and radiological data" but doesn't detail the expert review process.
- For BIO 1-KIT® cartridge (new clearance K061022):
- Not applicable as no clinical ground truth was established for the specific cartridge functionality tests described. These were likely internal engineering or quality control assessments.
4. Adjudication Method for the Test Set
- For BIOSORB® (prior clearance K021963): Not described.
- For BIO 1-KIT® cartridge (new clearance K061022): Not applicable, as there were no clinical test sets requiring adjudication described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence of a medical device (bone void filler cartridge) for its physical and functional properties, not on AI-assisted diagnostic or therapeutic interpretation by human readers. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant to this device submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone algorithm-only performance study was not done. This device is a physical medical product (a cartridge system for bone void filler), not a software algorithm or AI-driven tool.
7. The Type of Ground Truth Used
- For BIOSORB® (prior clearance K021963):
- Clinical and Radiological Data: The summary mentions "Clinical and radiological data demonstrate the biocompatibility, the osseo integration and the resorption of BIOSORB® bone void filler." This implies a combination of direct clinical observations (e.g., patient outcomes, inflammatory response) and interpretation of medical imaging (e.g., X-rays to assess bone consolidation and resorption). Pathology results or specific outcome measures (beyond "stable osseous fusion") are not explicitly detailed as the ground truth, but rather general clinical/radiological findings.
- For BIO 1-KIT® cartridge (new clearance K061022):
- Bench Test Results/Specifications: The ground truth for tests like "compatibility" (infra-red spectrometry) and "aspiration/impregnation" would be based on predefined physical or chemical specifications and successful functional operation, not clinical ground truth.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a physical medical device. There is no mention of an algorithm or machine learning component requiring a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set for an AI algorithm is involved.
§ 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.