(73 days)
Parallax * Acrylic Resin with TRACERS® Ta is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myleoma).
Parallax Acrylic Resin with TRACERS Ta is an opacified polymethylmethacrylate (PMMA) bone coment.
The provided 510(k) summary for the ArthroCare Corporation Parallax® Acrylic Resin Kit with TRACERS* Ta Bone Cement Opacifier (K050864) does not describe a study involving acceptance criteria, device performance, sample sizes, expert ground truth, or adjudication methods for AI/software-as-a-medical-device (SaMD).
This 510(k) is for a material modification to an existing medical device, Parallax® Acrylic Resin with TRACERS (K042947), which is a polymethylmethacrylate (PMMA) bone cement. The core assertion is that the modification is not a substantial change and does not significantly affect the safety or efficacy of the device.
Therefore, most of the requested information regarding acceptance criteria, study design for performance, comparative effectiveness with AI, and ground truth establishment, which are typical for SaMD or new device clearances, are not applicable to this specific submission.
Here's a breakdown of the relevant (and non-applicable) points based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The provided document does not contain an acceptance criteria table or reported device performance data in the context of a clinical or performance study as it's a material modification filing. The submission argues that the modification in material is "not a substantial change or modification, and does not significantly affect the safety or efficacy of the device" by establishing substantial equivalence to a predicate device (K042947).
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. No explicit "test set" and its sample size are mentioned for a performance study. Clinical data or performance test on a specific sample set to demonstrate efficacy or safety against acceptance criteria is not provided in this 510(k) summary for this type of material modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. No "ground truth" establishment is described, as there's no performance study involving expert review of a test set.
4. Adjudication Method for the Test Set:
- Not Applicable. No adjudication method is described, as there's no performance study involving 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 is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a bone cement material modification.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. A standalone algorithm performance study was not done. This device is a physical medical device (bone cement), not a software algorithm.
7. The Type of Ground Truth Used:
- Not Applicable. No ground truth is mentioned, as there's no performance study in the context of this 510(k) summary. The claims are based on substantial equivalence to a predicate device, implying that the established safety and efficacy of the predicate device extend to the modified device due to the minor nature of the modification.
8. The Sample Size for the Training Set:
- Not Applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. There is no mention of a "training set" or its ground truth establishment.
Summary of the 510(k) Filing:
This 510(k) submission (K050864) is a "Special 510(k)" for a "material modification" to an already cleared device, Parallax® Acrylic Resin with TRACERS (K042947). The core argument for clearance is that the modification is not a substantial change and therefore does not significantly affect the safety or efficacy of the device. This type of submission typically relies on comparing the modified device's characteristics (e.g., material properties, biocompatibility) to the predicate rather than presenting new clinical or performance study data with defined acceptance criteria and ground truth. The FDA's letter confirms substantial equivalence to the legally marketed predicate.
§ 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.”