(94 days)
PALACOS® LV + G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Palacos® LV + G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.
The provided text is a 510(k) summary for PALACOS® LV + G bone cement. This document does not describe a study involving an algorithm or device performance in the context of diagnostic accuracy, image analysis, or similar applications where acceptance criteria and performance are typically measured with metrics like sensitivity, specificity, or AUC.
Instead, this 510(k) focuses on demonstrating substantial equivalence to a legally marketed predicate device (OSTEOPAL® K030903 and PMA P810020) for a medical device (bone cement). The primary "acceptance criteria" here is substantial equivalence to the predicate, with the main difference being the addition of gentamicin.
Therefore, many of the requested elements for describing an AI/algorithm study (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, how ground truth for training was established) are not applicable to this type of regulatory submission.
However, I can extract the relevant information from the provided text regarding the device and its claimed equivalence.
Here's an interpretation of the request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) of a bone cement, "acceptance criteria" typically refer to demonstrating that the new device is as safe and effective as a predicate device. This is often done by comparing technological characteristics and, if applicable, performance in terms of mechanical properties or elution rates for antibiotic-loaded cement.
| Acceptance Criterion (Implicit for 510(k) Substantial Equivalence for bone cement) | Reported Device Performance/Characteristics |
|---|---|
| Intended Use Equivalence | Indicated for use in the second stage of a two-stage revision for total joint arthroplasty after initial infection has been cleared. (Matches predicate's context, adjusted for antibiotic presence implied). |
| Technological Characteristics Equivalence (Composition, properties) | Acrylic bone cement (PMMA). Formed from powder and liquid by exothermic polymerization. Includes Gentamicin (difference to primary predicate OSTEOPAL). Performance "most similar to Osteopal." |
| Safety and Effectiveness Equivalence | Implied through substantial equivalence claim to OSTEOPAL® K030903 and PMA P810020. No specific performance metrics (e.g., mechanical strength) are listed in this summary, but would have been part of the full submission. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This summary does not describe a clinical study with a "test set" in the context of an algorithm's performance. The review is based on a comparison of the device's characteristics to a predicate.
- Data Provenance: Not applicable. The submission is from Heraeus Kulzer GmbH, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study assessing diagnostic accuracy or expert-adjudicated ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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 device is bone cement, not an AI or imaging diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for this type of device and submission. The "ground truth" for the 510(k) process is the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.”