(67 days)
The PLR Splined Revision Stem is indicated for use in patients requiring total reconstruction of the hip joint due to the following:
- a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- b.) Rheumatoid arthritis.
- c.) Correction of functional deformity.
- d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations.
The PLR Splined Revision Stem is intended for press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. This device is a single use implant
The PLR Splined Revision Stem is a one-piece, press-fit revision stem machined from wrought Titanium (Ti-6Al-4V). The region above the resection level has a machine finish and the remainder of the stem is a grit blast finished.
The distal portion of the stem has splines. The neck-shaft angle is 135 degrees. The lateral offset for a standard 28mm head is 42mm on all sizes. The stem is 270 mm in length measured from the medial resection level to the distal end. Sizes range from 14mm to 24mm in 1mm increments.
The stem has the standard Biomet, Inc. Type I taper to fit all sizes and types of modular femoral heads. Neck flats are present for stem removal if necessary. The proximal region of the stem has a lateral flare with three holes to use with CoCr cables/wires for attachment of the greater trochanter.
This document is a 510(k) premarket notification for a medical device called the "PLR Splined Revision Stem." It is a request for clearance from the FDA to market a new device by demonstrating its substantial equivalence to a legally marketed predicate device.
Here's an analysis of the provided text with respect to your questions:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of acceptance criteria or reported device performance in the manner you'd expect for clinical studies. This document is a premarket notification (510(k)), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data with specific acceptance criteria.
The substantial equivalence argument is the "performance" demonstrated for a 510(k):
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device "Performance" (Demonstrated in 510(k)) |
|---|---|
| Device is as safe and effective as predicate. | The PLR Splined Revision Stem is substantially equivalent to two predicate devices: |
- Wagner Revion Stem (K960588)
- Wagner Revisional Femoral Hip Prosthesis (K871347)
This substantial equivalence is based on the device's design, materials (wrought Titanium (Ti-6Al-4V) with machine finish and grit blast finish), intended use, and general characteristics being similar to the predicates. |
| Risks are the same as with any joint replacement. | Potential risks are listed and are considered "the same as with any joint replacement device." This implies that no new, unanticipated risks are introduced by the device compared to similar predicate devices. |
| Meets indicated uses. | The device's intended use matches the established applications for hip reconstruction, implying its design supports these uses in a similar manner to predicate devices. |
Regarding the remaining questions, the provided 510(k) document is a regulatory submission for premarket clearance and does not include detailed study data or methodologies typically found in clinical trial reports or academic papers. Therefore, most of the specific information requested about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not present in this type of document.
Here's why and what information can be inferred:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: A 510(k) submission generally does not require new clinical studies for mechanical orthopedic implants if substantial equivalence can be demonstrated through design, material, and performance testing (e.g., mechanical bench testing), or by referencing clinical data of predicate devices. This document does not mention any specific test set of patients for a clinical study of the PLR Splined Revision Stem itself. The "test set" here would implicitly be the body of evidence (including predicate device history and any non-clinical testing) used to support the substantial equivalence claim.
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)
- Not Applicable: As there's no mention of a clinical test set requiring ground truth establishment, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set details are provided.
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 a mechanical orthopedic implant (hip stem), not an AI/software as a medical device (SaMD). Therefore, MRMC studies or AI assistance metrics are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: As stated above, this is a mechanical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: No specific patient-level ground truth data is presented. The "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable: There is no mention of a "training set" in the context of this device. The development process for such a device would involve engineering design, finite element analysis, and mechanical testing, not machine learning training on data.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set mentioned, this information is not provided.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.