(118 days)
The Active Knee® System is indicated to be used only with bone cement in patients suffering from the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, . traumatic arthritis, or avascular necrosis.
- Inflammatory degenerative joint disease including rheumatoid arthritis. ●
- Correction of functional deformity such as varus, valgus, or flexion . deformities.
- Revision procedures where other treatments or devices have failed. .
- . Treatment of fractures that are unmanageable using other techniques.
The device is intended for single use only.
The Active Knee® System is contraindicated for the following conditions:
- Acute or chronic infections, either local or systemic: .
- Severe muscular, nervous or vascular disease endangering the leg; .
- Defective bone structures, which could impede adequate anchoring of the ● implant:
- Patients who are younger than 60 years whose joint disease is such that . good results may be achieved by using other reconstructive procedures such as osteotomy and;
- . All associated diseases which could endanger the function and success of the implant.
The Active Knee System is a modular knee system consisting of a femoral component, a standard meniscal insert, an ultracongruent meniscal insert (tibial insert), a patella, and a tibial baseplate.
The provided document describes a 510(k) premarket notification for the Alaron Surgical Active Knee® System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving the device meets them in the context of AI/software performance.
Therefore, many of the requested sections about AI/software performance and ground truth cannot be answered from the provided text. The document describes a physical medical device (a knee prosthesis), not a software or AI device.
However, I can extract the relevant information regarding the performance testing and its intention from the document provided, even if it doesn't align with the specific AI-centric questions.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a pass/fail format, nor does it provide specific quantitative results of the "reported device performance." Instead, it states that the device performance was "similar" to contemporary knee designs and met recommendations.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Range of motion and constraint | Conform to existing standards/recommendations; comparable to predicate. | Tested as recommended by FDA Draft Guidance (April 1993, updated December 1998) for Cemented, Semi-Constrained Total Knee Prosthesis. "Demonstrated similar performance characteristics" compared to "other contemporary knee designs" and was "substantially equivalent" to the Sulzer Orthopedics Natural-Knee II Constrained Knee System (K973412) and "other similar marketed devices." |
| Surface roughness characteristics | Conform to existing standards/recommendations; comparable to predicate. | Tested as recommended by FDA Draft Guidance. "Demonstrated similar performance characteristics" compared to "other contemporary knee designs" and was "substantially equivalent" to the Sulzer Orthopedics Natural-Knee II Constrained Knee System (K973412) and "other similar marketed devices." |
| Contact areas and surface stress | Conform to existing standards/recommendations; comparable to predicate. | Tested as recommended by FDA Draft Guidance. "Demonstrated similar performance characteristics" compared to "other contemporary knee designs" and was "substantially equivalent" to the Sulzer Orthopedics Natural-Knee II Constrained Knee System (K973412) and "other similar marketed devices." |
| Resistance to lateral subluxation | Conform to existing standards/recommendations; comparable to predicate. | Tested as recommended by FDA Draft Guidance. "Demonstrated similar performance characteristics" compared to "other contemporary knee designs" and was "substantially equivalent" to the Sulzer Orthopedics Natural-Knee II Constrained Knee System (K973412) and "other similar marketed devices." |
| Fatigue strength | Conform to existing standards/recommendations; comparable to predicate. | Tested as recommended by FDA Draft Guidance. "Demonstrated similar performance characteristics" compared to "other contemporary knee designs" and was "substantially equivalent" to the Sulzer Orthopedics Natural-Knee II Constrained Knee System (K973412) and "other similar marketed devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of data. It refers to "Performance testing" conducted on the physical device components (femoral, tibial baseplate, standard meniscal insert, ultracongruent meniscal insert, and patella prostheses). The sample size for these physical tests (e.g., number of components tested for fatigue) is not provided. The data provenance is not applicable as this is a physical device testing, not a data-driven AI study.
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)
This is not applicable. "Ground truth" for a physical knee prosthesis would refer to the physical and mechanical properties of the device, established through engineering testing and material science, not through expert human interpretation of data for AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no "test set" or human adjudication involved in the performance testing described.
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 is not applicable. The device is a physical knee implant, not an AI software designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance testing of the physical device, the "ground truth" would be established by engineering standards, material specifications (ASTM F75, ASTM F648), and mechanical testing protocols recommended by the FDA Guidance (April 1993, updated December 1998). The conclusion of "substantially equivalent" indicates that its performance matched the established benchmarks from the predicate device and other contemporary designs.
8. The sample size for the training set
This is not applicable, as there is no "training set" for a physical device like this.
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set" for a physical device like this.
Summary of the Document's Core Information Regarding Performance:
The document describes the performance testing of the Alaron Surgical Active Knee® System, a physical knee prosthesis. The testing was conducted according to FDA Draft Guidance for Cemented, Semi-Constrained Total Knee Prosthesis (April 1993, updated December 1998). The tests covered:
- Range of motion and constraint (stability characteristics)
- Surface roughness characteristics
- Contact areas and surface stress
- Resistance to lateral subluxation
- Fatigue strength
The conclusion of the testing was that the Active Knee® System "demonstrated similar performance characteristics" when compared to other contemporary knee designs and was "substantially equivalent" to the Sulzer Orthopedics Natural-Knee II Constrained Knee System (K973412) and other similar marketed devices. This "substantial equivalence" is the primary acceptance criterion for a 510(k) submission, and the performance testing described served as the study to demonstrate this.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.