(124 days)
MCS Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCS Bone Graft is indicated to be hydrated with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCS Bone Graft is to be used as an autograft extender. Following implantation, the graft resorbs and is replaced by host bone during the healing process.
MCS Bone Graft is a bone graft substitute comprising biphasic mineral granules suspended in a porous, bovine type I collagen matrix. The biphasic granules are 60% hydroxyapatite (HA) and 40% beta tri-calcium phosphate (betaTCP). The device is provided in a strip form and is supplied terminally sterile for single patent use. The device is designed to be combined with autologous bone marrow aspirate prior to facilitate packing into bony defects and is used with autologous bone in the posterolateral spine. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
The provided document is a 510(k) summary for the MCS Bone Graft device. It describes the device, its intended use, and provides a summary of performance testing and substantial equivalence. However, it does not contain specific acceptance criteria, a detailed study description with sample sizes, or information on human reader studies (MRMC or standalone), which are typically associated with artificial intelligence/machine learning devices. The MCS Bone Graft is a medical device, specifically a bone graft substitute, and its evaluation focuses on biocompatibility, material properties, and in-vivo animal studies, not AI performance.
Therefore, the requested information cannot be fully extracted from the provided text in the context of an AI/ML device. I will answer based on the information that is present about the MCS Bone Graft as a physical medical device.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in a table format, nor does it present device performance in terms of metrics like sensitivity, specificity, or accuracy that are typical for AI/ML devices. Instead, it refers to compliance with standards and successful outcomes in animal studies.
| Acceptance Criteria (Inferred/Compliance) | Reported Device Performance |
|---|---|
| Compliance with FDA guidance documents and recognized consensus standards. | Non-clinical testing performed in accordance with FDA guidance documents and recognized consensus standards. |
| Meet relevant requirements of ASTM F1185-03, F1088-04a, and F2212-11. | Physical and chemical characterization of implant raw materials and finished device meet these requirements. |
| Collagen raw materials meet essential safety requirements of ISO 22442. | Collagen raw materials meet essential safety requirements for medical devices utilizing animal tissues according to ISO 22442. |
| Meet biocompatibility requirements for permanent tissue/bone implants. | Met biocompatibility requirements as per "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". |
| Successful viral inactivation, sterilization, packaging, and shelf-life stability | Viral inactivation, sterilization, packaging, and shelf-life stability evaluations performed with passing results. |
| Demonstrates safety and performance compared to predicate devices (animal study). | In prior 510(k) (K142276), MCS Bone Graft was deemed substantially equivalent to Vitoss Scaffold Foam in a critical-size rabbit femoral defect study. In the current submission, it demonstrated substantially equivalent spine fusion performance compared to the predicate device and control group (iliac crest bone graft) in a rabbit posterolateral spine fusion study. |
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: The document mentions a "critical-size rabbit femoral defect study" and a "rabbit posterolateral spine fusion study." It does not specify the exact number of animals used in these studies.
- Data Provenance: The studies are animal studies (rabbits), specifically in vivo performance testing. There is no information on the country of origin of the data or whether it was retrospective or prospective, though animal studies are typically prospective by nature.
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)
This information is not applicable to this device submission. The MCS Bone Graft is a physical medical device, not an AI/ML diagnostic tool. Ground truth was established through scientific methods such as radiographic, microCT, biomechanical, and histological endpoints in animal models, not by human expert assessment of AI output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The device is a bone graft substitute, and its performance evaluation does not involve human adjudication of diagnostic outputs.
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 comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers interpret medical images with or without AI assistance. The MCS Bone Graft is a therapeutic bone graft substitute.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study (algorithm only) was not done. This is not relevant for a physical bone graft device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal in vivo performance testing, the ground truth was established using:
- Radiographic endpoints
- MicroCT (micro-computed tomography) endpoints
- Biomechanical endpoints
- Histological endpoints (examination of tissue microstructure)
8. The sample size for the training set
This information is not applicable. The MCS Bone Graft is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of medical device.
§ 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.