(501 days)
Simplex™ P with Tobramycin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.
Simplex™ P with Tobramycin is an acrylic bone cement intended for the fixation of prostheses to living bone for use in second stage revision for total joint arthroplasty. The cement is packaged in two sterile components; a liquid monomer component and a powder copolymer component. The liquid monomer component is comprised of methyl methacrylate, N.N-dimethyl-p-toluidine, and hydroquinone. The powder copolymer component consists of methylmethacrylate-styrene copolymer, polymethylmethacrylate, barium sulfate U.S.P., and tobramycin sulfate U.S.P. The liquid and powder components are mixed together resulting in the exothermic polymeric formation of a soft, pliable, dough-like mass. As the reaction progresses, a cement-like complex is formed.
The provided text describes a 510(k) summary for a medical device, Simplex™ P with Tobramycin bone cement. It details the device's characteristics, intended use, and substantial equivalence to a predicate device. However, this document does not contain information on acceptance criteria or the specific study details that would prove the device meets such criteria in the way a clinical performance study for an AI medical device would.
The "Performance Data" section primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Surgical Simplex® P Radiopaque Bone Cement) in terms of safety and mechanical properties, not on an algorithm's performance against defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the given text. Below, I will address the points that can be gleaning from the document and explicitly state where information is missing.
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided document. The document focuses on demonstrating "substantial equivalence" to a predicate device.
- Reported Device Performance:
- "The cumulative results of extensive in vitro and in vivo test data show that a balance is achieved between antibiotic release and mechanical integrity without threats of systemic toxicity or compromised mechanical function."
- "The values predicted by the model correlate very well with clinical data from hemovac, serum, urine, and bone samples as reported by several clinicians."
- "In summary, the testing demonstrates that, in terms of safety and mechanical properties, Simplex™ P with Tobramycin bone cement is substantially equivalent to the legally marketed predicate Surgical Simplex® P Bone Cement."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance:
- "traditional literature searching"
- "unpublished details" from authors of relevant papers
- "arthroplasty registries"
- "additional in vivo studies were performed, which evaluated the antibiotic release from cement polymerized in situ in rabbits." (Animal study)
- "clinical data from hemovac, serum, urine, and bone samples as reported by several clinicians." (Implies human clinical data, but specifics are lacking).
- Retrospective or Prospective: Not explicitly stated for all data. The "in vivo studies in rabbits" would be prospective. The literature review and registry data would likely be retrospective.
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 as this is not an AI/algorithm performance study that relies on expert ground truth for a "test set" in the traditional sense of AI evaluation. The "ground truth" seems to be established through physical and chemical testing, and correlation with clinical outcomes or observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/algorithm performance study involving human adjudication of results.
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. This is not an AI-assisted device, so an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a PMMA bone cement, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device appears to be established through:
- In vitro testing for mechanical properties and antibiotic release.
- In vivo animal studies (rabbits) for antibiotic release and systemic levels.
- Correlation with clinical data (hemovac, serum, urine, bone samples) from "several clinicians", suggesting real-world patient outcomes or measurements.
- Comparison to the performance of the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI device, therefore there's no "training set" in the context of machine learning. The data gathered (literature, registries, in vitro/in vivo studies) informs the understanding of the device's properties and performance, but it's not a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI algorithm or training set, this question is not relevant to the provided document.
§ 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.”