(89 days)
REBOSSIS is a bone void filler 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 or osseous defects created from traumatic injury to the bone. REBOSSIS is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities and pelvis), and may be used without hydration or hydrated with bone marrow aspirate or blood. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
REBOSSIS 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). The electrospinning process used in manufacturing REBOSSIS results in a glass wool-like physical form. Due to its physical form, REBOSSIS is flexible and can easily fill defects in appropriate amounts.
The provided text is a 510(k) summary for the medical device REBOSSIS, a resorbable calcium salt bone void filler. It details the device's characteristics, intended use, and substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or a study with performance data in the format of acceptance criteria and reported device performance. The document focuses on pre-clinical testing for material characterization and animal studies to demonstrate substantial equivalence, rather than human clinical trials with defined performance endpoints.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define explicit acceptance criteria or report device performance against specific targets in a table format. It describes the scope of testing performed (material characterization, biocompatibility, and animal studies) to demonstrate substantial equivalence, not to meet pre-defined performance thresholds for clinical efficacy in humans.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for animal testing: The document mentions "Animal testing performed to demonstrate substantial equivalence included determination of radiographic, histologic and histomorphometric characteristics of the subject device and the predicate device in a rabbit distal femoral condyle critical-sized defect model." It further states, "The baseline (time 0) animals included REBOSSIS (dry) and Actifuse Shape (dry) to provide information on the initial amount of material implanted to fill the defects. Autograft bone filled defects (positive control) and empty unfilled defects (negative control) also were evaluated at 6 weeks and 12 weeks."
- Interpretation: While it specifies using a rabbit model and control groups, the exact number of animals per group or the total sample size is not explicitly stated.
- Data provenance: Not explicitly stated but the manufacturer is ORTHOREBIRTH Co., Ltd. from Japan, suggesting the studies could have been conducted there or through contract research organizations globally. The document does not specify whether the data is retrospective or prospective. Given it's a pre-clinical animal study, it would inherently be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This question pertains to clinical studies often involving human image interpretation or diagnostic outcomes. The provided document describes pre-clinical animal studies involving radiographic, histologic, and histomorphometric evaluations. While expert interpretation would have been involved in these analyses, the document does not specify the number or qualifications of experts for "ground truth" establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically used in clinical trials involving multiple human readers for diagnostic tasks. This document describes pre-clinical animal studies; therefore, an adjudication method in this context is not relevant and not mentioned.
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. An MRMC study is a clinical study involving human readers and typically an AI component. The provided document explicitly states: "No clinical data were included in this submission." Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This question is relevant for AI/algorithm-based devices. REBOSSIS is a physical medical device (bone void filler), not an AI algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For animal studies: The "ground truth" was established through standard scientific methods for pre-clinical animal models:
- Radiographic evaluation: Interpreting X-rays or micro-CT images.
- Histologic evaluation: Microscopic examination of tissue samples.
- Histomorphometric analysis: Quantitative analysis of microscopic tissue structures.
- In these types of studies, experienced veterinary pathologists and radiologists would typically establish findings, which serve as the "ground truth" for the animal model's response to the implant.
8. The sample size for the training set
- Not applicable/Not provided. This question pertains to machine learning algorithms. REBOSSIS is a physical device, not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set for an AI algorithm, this question 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.