(55 days)
The intended use for the MIIG® SR resultant paste is to be injected, digitally packed into open bone voids/gaps to cure in-situ, or molded into solid pellets that are gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
The MIIG® SR paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
MIIG® SR is provided sterile for single use only.
MIIG SR" bone void filler is supplied in paste and powder forms. MIIG® SR consists of a calcium sulfate/calcium phosphate composite bone void filler along with instruments for mixing and delivering the graft to the defect site.
The provided text is a 510(k) summary for the MIIG® SR bone void filler. It details the device's intended use, description, and the materials it's made from. However, it explicitly states that the safety and effectiveness are supported by "substantial equivalence information, materials data, compliance with the FDA guidance document), and biocompatibility testing results provided within this Premarket Notification."
This means the submission relies on demonstrating similarity to already cleared devices and general compliance, rather than presenting a comparative effectiveness study with specific performance metrics and acceptance criteria as would be found in a study designed to prove new performance claims.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.
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:
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical or in-vitro study. The acceptance criterion for this 510(k) submission is "substantial equivalence" to predicate devices.
- Reported Device Performance: No specific device performance metrics (e.g., healing rates, resorption times, mechanical strength) from a dedicated study are reported. The document focuses on material composition and intended use being equivalent to already cleared devices.
2. Sample sized used for the test set and the data provenance:
- Not applicable as no specific test set or clinical study data is presented to prove performance against acceptance criteria. The submission relies on "biocompatibility testing results" and "materials data" which are not detailed in terms of sample size or provenance in this summary.
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 as no specific test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set is described.
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:
- Not applicable. This device is a bone void filler, not an AI-assisted diagnostic or therapeutic tool with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (bone void filler), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific test set requiring a ground truth is outlined. The "safety and effectiveness" are supported by substantial equivalence to previously cleared devices, which implies that the predicate devices' established safety and effectiveness serve as the "ground truth" for the new device's regulatory pathway.
8. The sample size for the training set:
- Not applicable as there is no mention of a training set for an algorithm or a clinical trial in the context of this 510(k) summary.
9. How the ground truth for the training set was established:
- Not applicable as there is no mention of a training set.
§ 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.