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510(k) Data Aggregation
(178 days)
CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT
Cemex Genta / Cemex Genta System bone cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Cemex Genta System and Cemex Genta bone cement are substantially equivalent to the predicate Cemex System bone cement (#K000943). The physical and chemical characteristics of the individual components are identical to those of Cemex System, apart from the additional presence of gentamicin sulphate in the powder. The liquid component contains methylmethacrylate, N-N dimethyl p-toluidine, and hydroquinone. The dry powder component contains polymethylinethacrylate, barium subhate, benzoyl peroxide and gentamicin sulphate.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tecres Cemex® Genta bone cement.
This document describes a 510(k) premarket notification for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against novel acceptance criteria through extensive clinical studies. Therefore, many of the requested elements for a typical "acceptance criteria and study" may not be fully applicable or explicitly detailed in this type of submission.
Based on the provided text, the primary "acceptance criteria" is demonstrating substantial equivalence, and the "study" is a comparison to a predicate device and performance testing against recognized standards.
Acceptance Criteria and Study for Tecres Cemex® Genta Bone Cement
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrates Substantial Equivalence and Performance) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Cemex Genta System and Cemex Genta bone cement are substantially equivalent to the predicate Cemex System bone cement (#K000943). The physical and chemical characteristics of the individual components are identical to those of Cemex System, apart from the additional presence of gentamicin sulphate in the powder. (This difference is addressed by demonstrating that the addition of gentamicin does not negatively impact performance compared to the predicate, and that the physical and chemical characteristics are otherwise identical). |
| Compliance with ISO 5833 Standard | Performance testing shows that the proposed devices meet the requirements of ISO 5833. |
| Compliance with ASTM 451-99 Standard | Performance testing shows that the proposed devices meet the requirements of ASTM 451-99. |
| Sterility Assurance Level (SAL) for Powder Component | Powdered component is sterilized by ethylene oxide (EO) to a SAL of 10⁻⁶. |
| Sterility Assurance Level (SAL) for Liquid Component | Liquid component is sterilized by a membrane filtration technique to a SAL of 10⁻³. |
| Packaging Equivalence | Packaging design is identical to predicate devices (#K000943 for Cemex System, #K021715 for Cemex RX, ISOPLASTIC and XL) except for the addition of an aluminum bag that serves as a moisture barrier. |
| Intended Use | Indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. (This is an indication, not a performance criterion in the same way, but demonstrating that the device is suitable for this specific use is part of the substantial equivalence argument). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" sample size in terms of clinical cases or patient data. The evaluation is primarily based on laboratory performance testing (to ISO and ASTM standards) and a comparison of material characteristics to a predicate device. For material testing, sample sizes would typically be governed by the respective standards, but are not explicitly stated here.
- Data Provenance: The data provenance is from laboratory testing (conducted by the manufacturer or a contracted lab) and comparison against the specifications of the predicate device (Tecres S.p.A, Cemex System #K000943). There is no mention of clinical data, human subjects, or country of origin for such data. This is characteristic of a 510(k) submission for this type of device, which often relies on non-clinical performance data and comparison to established devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable in this context. Ground truth in the sense of expert clinical consensus on patient outcomes or diagnoses is not established from this document. The "ground truth" for the performance testing is adherence to the specified ISO and ASTM standards, which are internationally recognized and developed via expert consensus within their respective fields (e.g., materials science, biomechanics). The "ground truth" for substantial equivalence is the prior FDA clearance of the predicate device.
4. Adjudication Method for the Test Set
- Not applicable in this context. Adjudication methods like "2+1" are typical for clinical studies involving interpretation of medical images or patient outcomes by multiple readers. This submission relies on objective laboratory test results and regulatory comparison, not subjective expert adjudication of a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC comparative effectiveness study was not done. This type of study assesses the relative effectiveness of different diagnostic or interventional methods, often involving human readers' performance with and without AI assistance. This submission does not involve AI, diagnostic imaging, or the comparison of human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No. This is not an AI/algorithm-based device. It is bone cement. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" used for this submission is based on:
- Regulatory Standard Compliance: Adherence to established international (ISO 5833) and national (ASTM 451-99) standards for bone cement performance. These standards define the expected physical and mechanical properties.
- Predicate Device Characteristics: The known physical, chemical, and performance characteristics of the legally marketed predicate device (Cemex System #K000943).
- Sterility Assurance Levels: Defined and validated Sterility Assurance Levels for the manufacturing process.
8. The Sample Size for the Training Set
- Not applicable. This submission focuses on a medical device (bone cement), not a machine learning model or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML model, this question does not apply.
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