(114 days)
ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities and pelvis), and may be used without hydrated with blood. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
ReBOSSIS85 is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (8-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospining process used in manufacturing ReBOSSIS85 results in a glass wool-like physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text. It's important to note that this document is a 510(k) summary for a medical device (ReBOSSIS85), which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than strictly defining and meeting performance acceptance criteria in the same way a novel device might. Therefore, the "acceptance criteria" here are largely implied by demonstrating comparable performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | Passed biocompatibility testing using methods described in AAMI/ANSI/ISO 10993-1, 10993-5, 10993-10, 10993-11, and 10993-12. Pyrogenicity and bacterial endotoxin testing passed using methods described in USP 39-NF 34 and USP 39-NF 34 . |
| Effectiveness (Bone Void Filling & Resorption): | |
| Comparable radiographic appearance to predicate. | |
| Comparable histologic evaluation to predicate. | |
| Comparable histomorphometric analysis to predicate. | In a rabbit distal femoral condyle critical-sized defect model, the radiographic, histologic, and histomorphometric performance of ReBOSSIS85 was demonstrated to be equivalent to that of the predicate Actifuse ABX device (K071206). Histology sections were graded according to AAMI/ANSI/ISO 10993-6 (Annex E). |
| Material Characteristics: | |
| Chemical composition similar to predicate. | |
| Physical characteristics similar (or justified differences). | ReBOSSIS85: 40% beta-tricalcium phosphate (β-TCP), 30% siloxane-containing vaterite (SiV), 30% poly(L-lactide-co-glycolide). Approximately 0.7% Si by weight. |
| Primary Predicate (Actifuse ABX): Hydroxyapatite (HA), 0.8% Si by weight, resorbable polymer/aqueous gel carrier. | |
| Reference Predicate (REBOSSIS): 40% β-TCP, 30% SiV, 30% Poly(L-lactide). 1% Si by weight. |
Physical Form: ReBOSSIS85 and REBOSSIS are "glass wool-like, produced by electrospinning." Actifuse ABX is "Irregularly shaped granules premixed with an aqueous gel carrier." This difference is acknowledged but similarity to the reference predicate is highlighted. |
| Sterility & Shelf Life:
Sterile and stable over time. | Sterilization validation (AAMI/ANSI/ISO 11137-1, 11137-2), sterile barrier shelf life (ASTM F1140/F1140M, ASTM F2096), and product shelf life testing performed. Provided sterile (gamma irradiation). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Animal Study: Not explicitly stated in the document, but it was tested in "a rabbit distal femoral condyle critical-sized defect model." The number of animals used is not provided.
- Data Provenance: The animal study was conducted to demonstrate substantial equivalence. The country of origin is not specified for the animal study, but the manufacturer (ORTHOREBIRTH Co., Ltd.) is located in Japan. The study is prospective in nature, as it involves implanting the device into animals and observing outcomes over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document mentions "decalcified histologic evaluation, and histomorphometric analysis. Histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E)."
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, but implied to be qualified histologists/pathologists who can grade sections according to ISO standards.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method like 2+1 or 3+1. Histologic grading "according to AAMI/ANSI/ISO 10993-6 (Annex E)" suggests a standardized evaluation process, but details on how agreement or disagreement among multiple graders (if any were used) was resolved are not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a bone void filler, not an imaging analysis AI device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This question is not applicable. The device is a physical bone void filler, not an algorithm or AI. The performance studies evaluate the physical device's biological interaction and efficacy, not an algorithm's output.
7. The Type of Ground Truth Used
- The ground truth for the animal study was established through a combination of:
- Radiographic imaging: To assess bone regeneration.
- Micro-computed tomography (micro-CT) imaging: For detailed 3D assessment of bone architecture and defect filling.
- Decalcified histologic evaluation: Microscopic examination of tissue sections.
- Histomorphometric analysis: Quantitative measurement of tissue components from histological sections.
- These methods collectively provide a definitive biological and structural assessment of the device's performance in vivo.
8. The Sample Size for the Training Set
- This concept is not applicable to a physical medical device like a bone void filler. "Training set" refers to data used to train machine learning algorithms. The development of ReBOSSIS85 would have involved R&D, pre-clinical testing, and optimization, but not in the sense of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no "training set" in the context of an algorithm for this physical device. The understanding of appropriate materials and designs for bone void fillers would be based on established medical science, prior device development, and material science research, rather than a labeled training dataset.
§ 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.