(21 days)
The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, deformity or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. The Protrusio Cage is to be used in conjunction with any commercially available polyethylene acetabular cup.
This series of six anatomic protrusio cages is manufactured from Titanium. Each cage has two illac flanges positioned superiorly and one ischial flange positioned inferiorly that provide supplemental screw fixation holes for attachment to the ilium. These cages, once positioned in the acetabulum and attached to the ilium and ischium, provide structural integrity to an otherwise structurally compromised joint. The device is a single use implant intended for implantation with bone cement. In cases where bony defects or voids exist, optional augments can be utilized to help provide additional structural support. The augments are attached to the cage by means of a locking screw.
The provided document is a 510(k) premarket notification for a medical device (Patriot Protrusio Cage). It explicitly states:
"Clinical Testing: None provided as a basis for substantial equivalence."
This means that no clinical study was conducted or submitted to demonstrate the device meets any specific acceptance criteria. The submission relies on "substantial equivalence" to predicate devices, which means the manufacturer asserts the new device is as safe and effective as a legally marketed device that does not require premarket approval.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be provided from this document.
For completeness, I will explain why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: No acceptance criteria are stated, and no performance data from a clinical study is reported.
- Sample size used for the test set and the data provenance: No clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used.
- Adjudication method for the test set: Not applicable as no clinical test set was used.
- 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 a physical implant, not an AI-based diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical data was submitted.
- The sample size for the training set: Not applicable as no algorithm was developed or clinical training set used.
- How the ground truth for the training set was established: Not applicable as no algorithm was developed or clinical training set used.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.