(342 days)
Palacos® G with gentamicin is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.
Palacos® G (with gentamicin) is a fast setting polymer (polymethylmethacrylate) bone cement. Mixing the two sterile components, consisting of a powder and a liquid, initially produces a paste, which is used to anchor the prosthesis or to fill an anatomical cavity. The hardened bone cement allows stable fixation of the prosthesis and transfers stresses produced on movement to the bone via the large interface. Insoluble zirconium (IV) oxide is included in the cement powder as an x-ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation. The gentamicin component is a broad-spectrum antibiotic.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Palacos® G Bone Cement with Gentamicin. It describes a medical device, and 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and studies in the way one might for a novel AI/software device.
Based on the information provided, it's clear that this is not a study of a software or AI device, but rather a submission for a medical device (bone cement) under the 510(k) pathway, which emphasizes substantial equivalence. Therefore, many of the requested categories (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable in the context of this specific document.
However, I can extract the relevant information and indicate where categories are not applicable.
Acceptance Criteria and Study for Palacos® G Bone Cement with Gentamicin
The core "acceptance criteria" for Palacos® G Bone Cement with Gentamicin, as per this 510(k) submission, is its substantial equivalence to a previously approved predicate device, Palacos® R (PMA No. P810020). The "study" proving this equivalence is a comparison of material composition and performance characteristics against the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Benchmark | Reported Device Performance (Palacos® G) |
|---|---|---|
| Substantial Equivalence to Predicate Device | Identical material components and manufacturing process to predicate Palacos® R, with the addition of Gentamicin. | "The components of Palacos® G (with gentamicin) are identical to the device Palacos® R and are identically processed and sterilized." The only difference is the addition of gentamicin. |
| Mechanical Characteristics | Must fulfill intended use, comparable to predicate Palacos® R. | "The results showed that Palacos® G (with gentamicin) possesses mechanical and chemical characteristics to fulfill its intended use." (Implies comparability to Palacos® R, though no specific metrics are given in this summary). |
| Chemical Characteristics | Must fulfill intended use, comparable to predicate Palacos® R. | "The results showed that Palacos® G (with gentamicin) possesses mechanical and chemical characteristics to fulfill its intended use." (Implies comparability to Palacos® R, though no specific metrics are given). |
| Set Time | Hard within 15 minutes. | "The bone cement hard within 15 minutes." (This is a general characteristic of the PMMA bone cement, not specific to Palacos G vs. R in this context, but describes its functional performance.) |
| Biocompatibility | Compatible with the body, long clinical history. | "These materials [of Palacos® R] have shown to be compatible and have a long clinical history of use." "Palacos® G (with gentamicin) is the same cement as Palacos® R... no toxicological studies have been conducted [for Palacos G specifically] because of the long clinical history of its components." |
| Intended Use | For arthroplasty procedures of hip, knee, and other joints to fix prosthetic parts to bone, specifically for revision of previous arthroplasty due to joint infection (second phase of two-stage revision after infection cleared). | Palacos® G is "indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared." |
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 (N/A) in the context of an AI/software device test set.
- The comparison is based on the known characteristics and regulatory approval of the predicate device (Palacos® R) and the material specifications of Palacos® G. It's a device submission, not a study involving patient data in the sense implied by this question.
- The document mentions "comparative testing to Palacos® R" but does not detail the nature or sample size of this testing.
- It notes that Gentamicin has been "used in Europe for approximately 20 years," indicating a historical clinical use provenance for one of the active ingredients.
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)
- N/A. This information is for AI/software device validation, not for a bone cement 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This information is for AI/software device validation, not for a bone cement 510(k) submission.
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
- N/A. This is a medical device (bone cement) submission, not an AI/software device. No MRMC study was performed or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a medical device (bone cement) submission, not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate device (Palacos® R), as well as the chemical and mechanical specifications for bone cements of this type, and the long clinical history of gentamicin-containing bone cements in Europe.
- The effectiveness and safety conclusions are drawn by comparing Palacos® G's characteristics and intended use to these established standards and the predicate device.
8. The sample size for the training set
- N/A. This information is for AI/software device validation, not for a bone cement 510(k) submission.
9. How the ground truth for the training set was established
- N/A. This information is for AI/software device validation, not for a bone cement 510(k) submission.
§ 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.”