(67 days)
The MIIG™ paste is intended to be injected into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremittes, spine, and pelvis) and to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The MIIGM paste provides a bone void filler that resorbs and is replaced with bone during the healing process.
The MIIG™ 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.
The MIIG™M II is provided sterile for single use only.
The MIIGTM II paste consists of pre-measured surgical grade calcium sulfate, premeasured mixing solution, and the tools necessary to the components into a paste and inject the material into the defect site. These products are provided sterile for single patient use. When mixed and injected according to directions. MIIG™ II paste will harden in situ and provide temporary intra-operative support to a site prior to the fixation of final hardware. The MIIGTM II product has been developed to address the identical indications as the MIIGTM product.
This document is a 510(k) Pre-market Notification for the MIIG™ II bone void filler. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with acceptance criteria in the traditional sense. Therefore, many of the requested categories are not applicable to this document.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
This document does not present a table of acceptance criteria and reported device performance in the manner typically seen for clinical studies demonstrating efficacy or safety with quantifiable metrics. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, the original MIIG™.
The core "performance" demonstrated is that the MIIG™ II is substantially equivalent to the MIIG™ regarding its intended use, material composition, and design features.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Identical to predicate device. | The MIIG™ II has identical indications for use as the MIIG™. |
| Material Composition: Substantially equivalent to predicate. | Materials used for MIIG™ II are substantially equivalent to MIIG™ (Surgical Grade Calcium Sulfate Hemihydrate Accelerator and Sterile Water for Irrigation). |
| Design Features: Substantially equivalent to predicate. | Design features of MIIG™ II are substantially equivalent to MIIG™. |
| Safety and Effectiveness: Adequately supported by substantial equivalence information, materials data, and testing results. | The safety and effectiveness of the MIIG™ II is adequately supported by the provided information establishing substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is not a study involving a test set of data from patients in the typical sense for evaluating algorithm performance. It's a regulatory submission demonstrating substantial equivalence based on material composition, intended use, and design features compared to a predicate device. The "data" refers to material science data and comparisons, not patient data in a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2. No ground truth in the context of expert consensus on patient data was established for an AI/algorithm test set.
4. Adjudication method for the test set:
- Not Applicable. See point 2.
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 document pertains to a medical device (bone void filler), not an AI algorithm for image analysis or diagnosis. Therefore, no MRMC study with human readers and AI assistance was conducted or discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This document pertains to a medical device (bone void filler), not an algorithm.
7. The type of ground truth used:
- Not Applicable. In the context of a 510(k) for a bone void filler, the "ground truth" is established through documented material specifications, chemical analysis, product design, and intended use as compared to the predicate device. It's about demonstrating equivalency to a known, cleared product, rather than establishing a new clinical outcome or diagnostic truth.
8. The sample size for the training set:
- Not Applicable. This document pertains to a medical device (bone void filler), not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This document pertains to a medical device (bone void filler), not a machine learning model requiring ground truth for 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.