(654 days)
Spacer-G is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).
Spacer-G is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-hip prosthesis.
This 510(k) summary for the Spacer-G device primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.
Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics are not explicitly detailed in this document. The core of this submission is to show that the modified Spacer-G is just as safe and effective as already approved devices by having similar design, materials, performance characteristics, and gentamicin release profile.
Here is an attempt to address your requests based on the provided text, highlighting where information is absent:
Acceptance Criteria and Study to Prove Device Meets Criteria: Spacer-G Modification
The provided 510(k) summary for the Spacer-G device demonstrates substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria directly linked to a novel performance claim for the modified device. The "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device must perform comparably to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Material Composition: Same as predicate Spacer-G | "incorporates the same materials" |
| Design: Same as predicate Spacer-G | "has the same design" |
| Mechanical Characteristics: Equivalent to predicate Spacer-G | "has equivalent performance and mechanical characteristics" |
| Shelf Life and Packaging: Same as predicate Spacer-G | "has the same shelf and packaging" |
| Gentamicin Release Profile: Similar to predicate Biomet Stage One Disposable Cement Spacer Mold (K052990) when used with predicate Biomet Cobalt G HV Bone Cement (K051532) | "has a similar gentamicin release profile as that of the predicate Biomet Stage One Disposable Cement Spacer Mold... when used with predicate Biomet Cobalt G HV Bone Cement" |
| Intended Use: Identical to predicate device | Same Indications For Use as described. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission relying on comparison to existing devices, it is unlikely a large "test set" in the sense of a clinical trial was used for this specific modification. The "performance" assessment appears to be based on engineering principles and potentially laboratory testing rather than human clinical outcomes data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. The submission focuses on substantial equivalence based on technical and material characteristics, not on a clinical ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable/provided. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.
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
This information is not applicable. This device is a temporary hip prosthesis, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance characteristics of the legally marketed predicate devices. The modified Spacer-G is evaluated against these established benchmarks. No pathology, outcomes data, or expert consensus specific to the modified device's novel performance is referenced as a "ground truth" to meet new performance criteria.
8. The Sample Size for the Training Set
This information is not applicable. This device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. This device is not an AI algorithm.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.