(113 days)
OrthoSteady G Bone Cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.
The OrthoSteady G Bone Cement consists of Gentamicin sulphate antibiotic and a two component system consisting of separate, sterile and liquid powder components.
This document is a 510(k) summary for the OrthoSteady G Bone Cement, a polymethylmethacrylate (PMMA) bone cement. It addresses the substantial equivalence of the device to existing predicate devices. The information provided heavily focuses on the physical and chemical properties of the bone cement and its manufacturing processes rather than an AI/ML powered device. Therefore, many of the requested elements for an AI/ML powered device study cannot be answered from the provided text.
Here is the information that can be extracted or deduced from the document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format for device performance. Instead, it states that the performance testing results showed "comparable performances to the predicate devices" and were "in compliance with" various ASTM and ISO standards. The specific quantitative results are not provided in this summary.
| Acceptance Criteria Category | Reported Device Performance (OrthoSteady G Bone Cement) |
|---|---|
| Biocompatibility | Compliant with ISO 10993 standards (-3, -5, -6, -10, -11). Considered biological effects include cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, AMES, LAL, and bone implantation toxicity and effects. |
| Sterilization | Validated according to ISO 11135:2014, ISO 11138-1:2006, ISO 10993-7:2009, ISO 14161:2009, ISO 14937:2009, ISO 11737-1:2006, ISO 11737-2:2009, ISO 13408-1:2008, and ISO 13408-2:2003. |
| Compressive Strength | Comparable to predicate devices; in compliance with ASTM F451-08 and ISO 5833:2002. |
| Bending Strength | Comparable to predicate devices; in compliance with ISO 5833:2002. |
| Bending Modulus | Comparable to predicate devices; in compliance with ISO 5833:2002. |
| Cyclic Fatigue | Comparable to predicate devices; in compliance with ASTM F2118-14. |
| Tensile Properties | Comparable to predicate devices; in compliance with ASTM D638-14. |
| Creep | Comparable to predicate devices; in compliance with ASTM D2990-09. |
| Fracture Toughness | Comparable to predicate devices; in compliance with ASTM E399-12. |
| Shrinkage | Comparable to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide information about sample sizes for testing or data provenance (country of origin, retrospective/prospective). The performance data cited refers to mechanical and material property testing, not clinical studies involving human or patient data in the way an AI/ML device would.
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. The "ground truth" for bone cement performance is established through standardized laboratory testing against international and national standards (e.g., ISO, ASTM), not through expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for clinical or image-based studies where expert opinions might differ; for material science testing, the results are typically objectively measured by instruments and methods defined in the standards.
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 is not an AI-powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on standardized mechanical and material property testing against established ASTM and ISO standards for bone cements.
8. The sample size for the training set
Not applicable. This is not an AI-powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-powered device.
§ 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.”