(105 days)
Smartset GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
SmartSet GMV Endurance Gentamicin Bone cement is a self-curing cement, containing one seating and securing of seating and securing of a metal or plastic prosthesis to I ving bone.
This document is a 510(k) summary for a medical device called "SmartSet GMV Endurance Gentamicin Bone Cement." It details the device's information, indications for use, and a claim of substantial equivalence to previously marketed predicate devices.
However, the provided text does not contain information about specific acceptance criteria or an associated study that proves the device meets those criteria.
Generally, for a 510(k) submission, the "study" would be a series of tests demonstrating that the new device performs as safely and effectively as a predicate device. These tests often include:
- Mechanical Property Testing: To ensure the cement has adequate strength, fatigue resistance, and other physical characteristics suitable for its intended use.
- Biocompatibility Testing: To confirm that the materials are not harmful to the body.
- Leaching Studies: To assess the release rate of the antibiotic (Gentamicin) and ensure it's effective without being toxic.
- Sterilization Validation: To confirm the sterilization process is effective.
The FDA's review letter confirms that the device was found substantially equivalent, implying that the submitted data (which is not fully included here) demonstrated this equivalence.
Therefore, with the provided text, I cannot complete the table or answer most of your specific questions as the detailed study information is absent.
Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:
1. Table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards." However, it does not specify what those "voluntary performance standards" were, what the acceptance criteria within those standards were, or the explicit results of the product testing against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "product testing" but provides no details on sample sizes, types of tests (e.g., in-vitro, in-vivo), origins of data, or whether it was retrospective or prospective.
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 for this type of device/submission. This question typically applies to AI/ML or diagnostic devices where human expert interpretation is used to establish a "ground truth" for evaluating algorithm performance. For bone cement, performance is usually assessed through objective physical, chemical, and biological tests, not expert consensus on image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, this pertains to expert review and consensus, which is not described or typically used for evaluating the performance of bone cement.
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 question is specific to AI-assisted diagnostic or interpretation devices. The SmartSet GMV Endurance Gentamicin Bone Cement is a therapeutic material, not a diagnostic tool, and does not involve human readers interpreting cases or AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is bone cement, it does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated, but inferred. For bone cement, "ground truth" would generally be established by:
- Mechanical Engineering Standards: Established benchmarks for strength, fatigue, working time, setting time, etc.
- Biocompatibility Standards: ISO standards for cytotoxicity, sensitization, irritation, etc.
- Pharmacological Standards: For antibiotic release profile and efficacy, likely in-vitro elution studies.
- These are based on scientific evidence and established testing methodologies, not typically "expert consensus" in the way it's used for diagnostic accuracy studies.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an algorithm is involved.
Conclusion:
The provided 510(k) summary is a high-level document stating intent and claiming substantial equivalence. It does not include the detailed technical reports, test protocols, specific acceptance criteria, or raw performance data that would be part of a full 510(k) submission. Therefore, it's impossible to fully answer your questions based only on this text. The FDA's letter simply confirms that the submitted information (which is not provided here) was sufficient to demonstrate substantial equivalence.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”