(70 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, 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 ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
The AcuMatch L-Series Bipolar is a modular two piece device consisting of a spherical cobalt chrome shell (ASTM 1537 or ASTM F75) and interchangeable polyethylene liner inserts (ASTM F638). The metal head components come in 24 sizes (38mm through 61mm). The liner options include 22, 26, 28 and 32 mm inside diameter (1.D.) offerings. The implants are supplied sterile to an assurance level (SAL) of 10°.
The provided text describes the Exactech® AcuMatch™ Integrated Hip System L-Series Bipolar Endoprosthesis. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the way requested (e.g., using metrics like sensitivity, specificity, or inter-rater reliability with statistical significance).
Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed performance study with quantitative acceptance criteria as might be expected for an AI/software as a medical device (SaMD).
Here's an analysis based on the provided text, addressing the requested points where information is available or inferring what's typical for this type of submission:
1. A table of acceptance criteria and the reported device performance
Based on the provided text for a physical medical device (hip endoprosthesis), the "acceptance criteria" are implied to be related to mechanical integrity and functional performance rather than diagnostic accuracy metrics. The "reported device performance" is a general statement about testing.
| Acceptance Criterion (Implied for this Device Type) | Reported Device Performance |
|---|---|
| Adequate for anticipated in vivo load applications | Functional testing and engineering analysis were conducted to verify that the implant performance would be adequate for anticipated in vivo load applications. |
| Resistance to "cam-out" | Cam-out testing was conducted. |
| Secure assembly | Assembly testing was conducted. |
| Sufficient range of motion | A range of motion evaluation was conducted. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. For a physical device like this, the "test set" would refer to the number of components or assemblies tested in the engineering evaluations. This information is typically found in the detailed test reports that are part of the full 510(k) submission, but not in the summary.
- Data Provenance: Not specified. Given it's a product from Exactech, Inc. based in Gainesville, Florida, the testing would likely have occurred in the US or under conditions compliant with US regulations, but no explicit origin is stated.
- Retrospective or Prospective: Not applicable in this context, as this refers to clinical study design, and the performance data mentioned refers to engineering testing.
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. The performance data described ("functional testing and engineering analysis") does not involve human interpretation or expert ground truth establishment in the way an AI/SaMD study would. The ground truth for mechanical testing is typically based on established engineering standards and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a concept used for establishing ground truth in human-centric evaluations (like image interpretation studies), not for mechanical product testing.
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 physical hip endoprosthesis, not an AI or software system intended to assist human readers (e.g., radiologists). Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance data mentioned would be based on engineering standards and physical measurements. For example:
- "Cam-out testing" would have defined failure points or thresholds based on force, displacement, or number of cycles.
- "Assembly testing" would verify fit, security, and integrity against design specifications.
- "Range of motion evaluation" would measure the achievable motion against design targets.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model that requires a training set. The design of the device is based on engineering principles and material science, not machine learning from a data set.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this physical device. The "ground truth" for its design and manufacturing would stem from engineering specifications, material properties, biomechanical analyses, and clinical experience with predicate devices.
Summary of the Document's Information Relevant to Performance:
The document is a 510(k) summary for a physical medical device. It states that:
- Performance Data: "Functional testing and engineering analysis were conducted to verify that the implant performance would be adequate for anticipated in vivo load applications."
- Specific Tests Mentioned: "This performance data includes cam-out testing, assembly testing, and a range of motion evaluation."
The purpose of this 510(k) submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than to present a novel performance study against specific, quantified acceptance criteria in the manner of an AI/SaMD. The "acceptance" by the FDA (as indicated by the clearance letter) is based on the determination of this substantial equivalence, which implies the device meets safety and effectiveness considerations akin to its predicates.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.