(21 days)
AcuMatch L-Series Cemented Femoral Stem Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.
AcuMatch L-Series Cemented Femoral Stem Components are intended to be used with bone cement.
L-Series Femoral Stem Components are made from cast Cobalt Chromium Molybdenum alloy conforming to ASTM F 75-98. Mechanical properties for ultimate strength, ductility, and grain structure are controlled by this specification. The L-Series components have a satin finish and are intended for cemented applications only.
This document is a 510(k) Summary of Safety and Effectiveness for the Exactech AcuMatch L-Series Cemented Femoral Stem Component, which is a medical device. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a study in the way a new drug or novel medical device might.
Therefore, the information you've requested about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is not typically part of a 510(k) submission for a device like this femoral stem component.
Here's why and what information is provided:
- Device Type: This is a Class II medical device (femoral stem prosthesis). For these types of devices, the regulatory pathway focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than extensive clinical studies with specified performance acceptance criteria like those for diagnostic AI software or novel treatments.
- Substantial Equivalence: The primary "proof" is that the device is as safe and effective as existing legally marketed devices. This is established through comparisons of:
- Indications for Use: The L-Series has similar indications and contraindications to other legally marketed femoral components.
- Technological Features: The L-Series originated from design modifications to Exactech's AuRA femoral component and shares similarities with other predicate devices (e.g., "Conquest FX," "Spectron," "PFC") in terms of material (cast cobalt chrome), surface treatment (satin finish), and geometry (proximal to distal taper).
- Performance Data (Mechanical Testing): The document explicitly states: "Three-Point fatigue testing of the Exactech L-Series device places the strength of the stem in the range of other legally marketed devices." This is the core "study" mentioned for demonstrating performance for this type of device.
Therefore, an "acceptance criteria table" and studies as you typically describe for software or AI models are not directly applicable here.
However, I can extract the relevant information that is present in relation to performance and comparison:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, there isn't a formal "acceptance criteria" table in the sense of a diagnostic sensitivity/specificity. Instead, the performance is evaluated against predicate device characteristics and mechanical standards.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Exactech® AcuMatch L-Series) |
|---|---|---|
| Indications for Use | Similar to legally marketed femoral components. | Met: Indicated for primary hip replacement (osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems, proximal femoral fractures) and revision surgery, similar to predicates. |
| Contraindications | Similar to legally marketed femoral components. | Met: Contraindicated in active infection, insufficient bone stock, neuromuscular disorders, inappropriate weight/age/activity level, similar to predicates. |
| Material | Conformity to ASTM F 75-98 for cast Cobalt Chromium Molybdenum alloy. | Met: Made from cast Cobalt Chromium Molybdenum alloy conforming to ASTM F 75-98. |
| Surface Treatment | Similar to predicate devices (e.g., satin finish). | Met: Has a satin finish, similar to predicate devices. |
| Geometry | Similar to predicate devices (e.g., proximal to distal taper). | Met: Exhibits a proximal to distal taper, similar to predicate devices. |
| Sterilization | Sterility Assurance Level (SAL) of 10-6. | Met: Gamma radiation (Cobalt 60, 25-37 kGy) achieving SAL of 10-6. |
| Mechanical Strength | "In the range of other legally marketed devices." | Met: Three-Point fatigue testing places the strength of the stem "in the range of other legally marketed devices." |
2. Sample size used for the test set and the data provenance
- Sample Size for Mechanical Testing: Not specified in the provided text. Mechanical testing typically involves a set number of devices to demonstrate statistically significant strength, but the exact number isn't included here.
- Data Provenance: Not applicable in the context of a clinical test set. The data arises from engineering and material testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission relies on engineering specifications and mechanical testing against recognized standards and predicate devices, not on expert-adjudicated clinical ground truth from patient data.
4. Adjudication method for the test set
- Not applicable. See point 3.
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
- No. This is a physical orthopedic implant, not a diagnostic imaging or AI system. Therefore, an MRMC study or AI-assisted improvement metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical orthopedic implant.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on mechanical testing standards (e.g., ASTM F 75-98) and comparative engineering specifications against legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI model requiring a training set. The "design modifications" from the AuRA model might be seen as iterative design, but not a data-driven training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, this 510(k) submission demonstrates substantial equivalence for a physical implant by comparing its design, materials, indications, and mechanical properties to existing, legally marketed devices, rather than through extensive clinical studies with specific performance metrics and ground truth as might be expected for an AI or diagnostic device.
§ 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.