(155 days)
Disposable cement spacer molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Palacos® R+G Bone Cement or Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the StageOne™ disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Palacos® R-G Bone Cement and Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.
The single-use cement spacer molds are sterile disposables made of medical grade silicone. They are intended to be filled with Palacos® R+G Bone Cement or Refobacin® Bone Cement R by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-shoulder prosthesis is to be removed from the mold and placed into the joint space. The hemi-shoulder prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional shoulder joint prosthesis.
The document describes the StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis and its substantial equivalence to predicate devices, but it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-enabled medical device.
This document is a 510(k) premarket notification for a medical device (a cement spacer mold), which is a physical product, not an AI/ML diagnostic or therapeutic tool. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, and associated sample sizes for training and testing are not applicable to the information provided.
The performance data mentioned (mechanical performance and gentamicin elution testing) is for the physical characteristics of the cement spacer and the bone cement combination, comparing it to an existing predicate device.
Here's a breakdown of the information that is available, and why the requested information is largely absent based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative targets for performance (e.g., sensitivity, specificity, accuracy) for an AI/ML system. For this physical device, "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices in terms of mechanical and elution characteristics.
- Reported Device Performance:
- Mechanical performance testing: "StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin® Bone Cement R were compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess mechanical... characteristics comparable to those of the predicate device."
- Gentamicin Elution testing: "...and Gentamicin Elution testing of StageOne™ ... compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess... elution characteristics comparable to those of the predicate device."
- Design validation: "Design validation test results confirm that the StageOne™ Shoulder Spacer Molds utilized with Palacos® R+G Bone Cement and Refobacin® Bone Cement R meet design requirements for use."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not mentioned. The "test set" here refers to the physical samples of the cement spacers and bone cement used for mechanical and elution testing, not a dataset for an AI/ML model. The document does not specify the number of samples tested or the provenance of these physical samples.
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. This question pertains to expert review for AI/ML model ground truth. The "ground truth" for this device is based on laboratory testing of physical properties (mechanical strength, drug elution) and comparison to a predicate device, not expert interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is relevant for resolving discrepancies in expert opinions for AI/ML ground truth. Not relevant for physical device testing.
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 study type is specific to evaluating AI/ML's impact on human performance in diagnostic tasks. The StageOne™ device is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to the standalone performance of an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth (for the physical device): The "ground truth" for this device's performance is established by objective, quantitative laboratory measurements of mechanical properties (e.g., strength, stiffness) and drug elution profiles, compared against established standards or performance of a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. There is no AI/ML training set for this device.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML training set for this device.
In summary, the provided document is a 510(k) submission for a physical medical device. The questions posed are primarily designed for AI/ML-enabled medical devices, and thus, most of them are not relevant to the information presented in this 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.”