(109 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, pelvis, and posterolateral spine). In the extremities and pelvis ReBOSSIS85 may be used without hydrated with blood. In the posterolateral spine ReBOSSIS85 is to be used hydrated with bone marrow aspirate and mixed with autograft bone. The device provides a bone void filler that is resorbed 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 (B-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospinning 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.
This document describes a 510(k) premarket notification for ReBOSSIS85, a resorbable calcium salt bone void filler device. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in the form of specific performance thresholds for ReBOSSIS85. Instead, the "Performance Data" section details the types of non-clinical tests performed to demonstrate substantial equivalence, and the "Equivalence to Marketed Device" section presents a comparative table between the subject device and predicate devices. The ultimate "acceptance criterion" in a 510(k) context is demonstrating substantial equivalence to a predicate device, meaning it is as safe and effective.
However, we can infer performance areas assessed based on the tests conducted. The key performance comparison is drawn from the in vivo animal study.
| Acceptance Criteria (Inferred from study type) | Reported Device Performance (ReBOSSIS85 vs. Predicate K140375) |
|---|---|
| Radiographic characteristics (bone formation, defect filling etc.) | "performance of the subject ReBOSSIS85 device was equivalent to that of the predicate device K140375" |
| Histologic characteristics (tissue reaction, new bone formation, material resorption) | "performance of the subject ReBOSSIS85 device was equivalent to that of the predicate device K140375" |
| Histomorphometric characteristics (quantitative analysis of bone formation, material volume) | "performance of the subject ReBOSSIS85 device was equivalent to that of the predicate device K140375" |
| Chemical characterization | Detailed analysis of composition (B-TCP, siloxane-containing vaterite, poly(L-lactide-co-glycolide)), Si content, material properties (density, trace elements, residual solvents, surface microstructure, polymer properties). |
| Physical characterization | Glass wool-like form, nominal fiber diameter range (3 μm to 150 μm), max diameter (250 μm), approximately 98% porosity (dry). |
| Sterilization validation | Methods described in AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2. |
| Shelf life validation (sterile barrier and product) | Methods described in ASTM F1140/F1140M, and ASTM F2096. |
| Biocompatibility | Methods described in AAMI/ANSI/ISO 10993-1, -5, -10, -11, -12; Pyrogenicity and bacterial endotoxin (USP 39-NF 34 and ). |
| In vitro release kinetics | Release of Si, Ca, and P ions, pH of the solution, material imaging by SEM, polymer weight-average molecular weight by GPC. |
2. Sample size used for the test set and the data provenance
- Test Set Description: The primary test set mentioned for performance evaluation is an in vivo animal study in a rabbit posterolateral fusion model.
- Sample Size: The document does not specify the exact number of animals (sample size) used in this rabbit study.
- Data Provenance: The study was "Animal testing performed to demonstrate substantial equivalence." The document does not specify the country of origin but implies it was conducted by the manufacturer or a contracted lab for regulatory submission. It is by nature prospective observational for the purpose of evaluating the device's performance over time in a biological system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions histological analysis and grading according to AAMI/ANSI/ISO 10993-6 (Annex E). This implies expert evaluation of tissue samples. However, the document does not specify the number of experts or their specific qualifications (e.g., "pathologist with X years of experience") used to establish the ground truth (histologic grades, interpretations of radiographs/micro-CT) for the animal study.
4. Adjudication method for the test set
The document does not specify an adjudication method for the evaluation of the animal study results (radiography, manual palpation, biomechanical testing, micro-CT, histologic analysis, histomorphometric analysis). It only states that "Evaluation endpoints included radiography, manual palpation, non-destructive biomechanical testing, micro-computed tomography (micro-CT) imaging, non-decalcified histologic analysis, and non-decalcified histomorphometric analysis."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone void filler (a physical medical device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the question about human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. As mentioned, this is a physical medical device, not an algorithm or software.
7. The type of ground truth used
For the animal study:
- Radiographic characteristics: Likely based on expert review of X-ray images.
- Histologic characteristics: Expert interpretation of stained tissue sections by trained histologists/pathologists. Graded according to AAMI/ANSI/ISO 10993-6 (Annex E).
- Histomorphometric analysis: Quantitative measurements derived from histological sections, providing objective metrics about bone formation, material degradation, etc. This is based on direct measurement, not expert consensus in the same way as qualitative grading.
- Micro-computed tomography (micro-CT) imaging: Provides detailed 3D structural information that can be quantitatively analyzed.
- Manual palpation: A subjective assessment.
- Non-destructive biomechanical testing: Objective quantitative measurements of mechanical properties.
Overall, the ground truth for the in-vivo study appears to be a combination of expert interpretation (histology, radiography) and objective measurements (histomorphometry, biomechanics, micro-CT).
8. The sample size for the training set
Not applicable. This document is for a physical medical device (bone void filler), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context. The "ground truth" discussed in point 7 relates to the evaluation of the device's biological performance.
§ 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.