(21 days)
The Compress® Segmental Femoral Replacement System is indicated for:
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
- Trauma.
The Compress® Segmental Femoral Replacement System components are intended for uncemented use.
The Compress® Seqmental Anti-Rotation Spindles are not joint replacements but rather a method of fixing a segmental joint replacement to the patient's host bone. It utilizes the same spring-enhanced, stress-sharing design as the predicate Compress® Segmental Femoral Replacement System to generate stress on the host bone which helps prevent bone atrophy and promotes bone growth. It is intended to be used in conjunction with a knee or hip implant.
The complete device consists of an anchor plug, a spindle and either a proximal or distal femoral component. This 510(k) addresses modifications to the spindles. Holes are being added to the collar of the spindles to allow placement of pins to prevent rotation of the initial weeks following implantation. Additional sizes of spindles are also being added to the line.
The provided text describes modifications to an existing medical device, the Compress® Segmental Anti-Rotation Spindles, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria against specific performance metrics involving human readers or a standalone algorithm. The device, which is a method of fixing a segmental joint replacement, underwent non-clinical testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Resistance to rotational torque (implied acceptance: comparable to predicate) | "demonstrated that the device will functional within its intended use compared to the predicate device." |
| Engineering analyses (implied acceptance: greater wall thickness, smaller pin holes met) | "demonstrated that the device will functional within its intended use compared to the predicate device." (Specific values not provided, only that they were analyzed and deemed functional) |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Non-Clinical Testing: Mechanical testing (resistance to rotational torque) and engineering analyses (greater wall thickness, smaller pin holes) of the Compress® Segmental Anti-Rotation Spindles demonstrated that the device will functional within its intended use compared to the predicate device."
- Test Set Sample Size: Not specified. The testing was mechanical and engineering analysis, not involving a population sample in the typical sense.
- Data Provenance: Not specified, but given it's mechanical and engineering testing, it would be laboratory-generated data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The testing was non-clinical, mechanical, and engineering analysis. Ground truth for such tests is typically established by engineering specifications and physical measurements, not expert consensus in the medical image interpretation context.
4. Adjudication Method for the Test Set
Not applicable. There was no human interpretation or ground truth establishment based on expert consensus for this non-clinical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
"Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, no MRMC comparative effectiveness study was done.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant, not a software algorithm.
7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was based on engineering specifications and physical testing results (e.g., measurements of rotational torque, wall thickness, pin hole size) compared to the predicate device's performance and design.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.