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510(k) Data Aggregation
(85 days)
Sweden
Re: K234008
Trade/Device Name: Cerament G Regulation Number: 21 CFR 888.3046 Regulation Name
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| Regulation: | 21 CFR 888.3046
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.
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(24 days)
Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, Product Code HWC)
**888.3046
The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 4 diameter sizes of 2.0mm, 2.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°.
The system instruments include guide wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants.
The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
The provided text describes the regulatory clearance for the "OSTEOMED ExtremiFuse System" and does not contain information about an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable.
However, based on the provided text, I can infer the "acceptance criteria" and "study" in the context of a medical device submission for substantial equivalence, which is a different type of evaluation from an AI/ML model.
Here's the information based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K130412, K111536) | "The device was evaluated to be safe and effective in performing as well or better when compared to the predicate devices for the intended use." |
| Meets required mechanical strength criteria | "The ExtremiFuse implants underwent verification to ensure that the design features met the required mechanical strength criteria for their intended use." |
| Similar indications for use, function, design, technology, operational principles | "Substantial equivalence was shown through the pullout test, and bending test to the predicate devices. The indications, design, technology and operational principles are similar between the subject and predicate..." |
| Similar material, function, performance, and operating principles | "...and similarities in material, function, performance, and operating principles to the OsteoMed Cannulated Screw System (K062863) and OsteoMed Foot Plating System, K-Wires (K091614)." |
| Does not raise new safety or effectiveness issues | "...OsteoMed believes that the addition of the 2.0mm implant to the scope of OSTEOMED ExtremiFuse System does not raise any new safety or effectiveness issues." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "sample size" for a traditional clinical "test set" in the context of an AI/ML device. Instead, it refers to mechanical testing.
- Sample Size for Mechanical Testing: Not explicitly stated. The document mentions "The ExtremiFuse implants underwent verification..." and references "pullout test, and bending test." It does not provide the number of implants tested.
- Data Provenance: Not applicable in the context of clinical data. This refers to mechanical performance testing of the device itself.
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. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images or diagnoses) was not established for this type of device submission. The "ground truth" here is adherence to mechanical performance standards and achieving substantial equivalence to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical assessment requiring adjudication by multiple experts. The evaluation was based on mechanical testing and comparison to predicate devices.
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 is designed for AI/ML devices involving human readers. This submission is for a physical orthopedic implant and does not involve AI/ML or human readers in that capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. It is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation was based on:
- Mechanical performance standards: The device's physical properties (e.g., strength, durability in pullout and bending tests) were verified against established criteria for its intended use.
- Comparison to predicate devices: The device's design, materials, function, and performance were compared to already legally marketed predicate devices to establish substantial equivalence.
8. The sample size for the training set
Not applicable. No AI/ML model was trained.
9. How the ground truth for the training set was established
Not applicable. No AI/ML model was trained.
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