(85 days)
CERAMENT G is a resorbable, gentamic bone void filler intended for use in defects in the extremntes of skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement as part of the standard treatment approach to bone infection and open fractures.
By eluting gentamicin, CERAMENT G can reduce the occurrence of bone infection from gentamicinsensitive microorganisms in order to protect bone healing.
CERAMENT G can augment provisional hardware 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. CERAMENT G resorbs and is replaced by bone during the healing process.
CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. It is composed of hydroxyapatite, calcium sulfate and gentamicin, and is identical to the device cleared in DEN210044.
This submission expands the device's indication to include use in patients with open fractures in need for bone void filling.
The provided text describes the 510(k) premarket notification for the CERAMENT G device. This document focuses on demonstrating substantial equivalence to a predicate device and expanding its indications for use. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in the context of clinical performance demonstrating safety and effectiveness for the expanded indication compared to the standard of care.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an expansion of an existing device's indication, the "acceptance criteria" are implied by a comparison to the standard of care for the new indication (open fractures). The device performance is then measured against these implicit benchmarks.
| Acceptance Criteria (Implicit) | Reported Device Performance (CERAMENT G) |
|---|---|
| Low rate of deep infection (compared to SOC) | 3.7% |
| High rate of limb salvage (compared to SOC) | 96.3% |
| High rate of bone union (compared to SOC) | 96% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 81 patients
- Data Provenance: Real-World Evidence ("Real World Evidence from the Manchester Cohort") from a retrospective (or prospectively collected clinical data analyzed retrospectively) consecutive series of patients treated by the Manchester Orthoplastic Group in the United Kingdom.
- Country of Origin: United Kingdom (Manchester)
- Retrospective/Prospective: The phrasing "consecutive series of 81 patients... treated by the Manchester Orthoplastic Group between June 2013 and April 2021" suggests a retrospective analysis of existing clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided in the document. The study refers to "Real World Evidence from the Manchester Cohort" and clinical outcomes. While these outcomes are likely assessed by medical professionals, their specific roles, number, or qualifications for establishing "ground truth" (e.g., confirming infection, assessing union) are not detailed in this submission summary. The study reference (Henry et al., 2023) would likely contain more details on this.
4. Adjudication Method for the Test Set
This information is not explicitly provided in the document. Given it's a retrospective analysis of clinical outcomes, a formal adjudication method (like 2+1 or 3+1) by independent experts is less common than in prospective clinical trials designed with such rigorous review protocols. The assessment would have been done as part of standard clinical practice.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The study evaluated the clinical performance of CERAMENT G as used in actual patient cases and compared its outcomes to published standard of care rates, rather than having multiple readers evaluate cases with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a bone void filler (a physical implantable product), not an AI or software algorithm. The concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the test set was based on clinical outcomes data from real-world patient treatment. This includes:
- Diagnosis of deep infection
- Assessment of limb salvage
- Assessment of bone union
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is an implantable bone void filler, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The "training data" for the device's development would refer to pre-clinical testing, material characterization, and prior clinical experience that led to its initial clearance.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated above (not an AI/ML device). For the development of the physical implant, ground truth would have been established through laboratory bench testing, animal studies, and prior clinical data for its initial indications, assessing properties like dissolution, pH, strength, antimicrobial activity, and biocompatibility.
N/A