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510(k) Data Aggregation
(21 days)
SECUR-FIT MAX AND PLUS MAX HIP STEMS
The Secur-Fit™ Max and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The subject Secur-Fit™ Max Hip and Secur-Fit™ Plus Max Hip Stems are titanium alloy hip stems. The hip stems have a Commercially Pure Titanium arc deposited circumferential coating with a PureFix™ HA hydroxylapatite surface treatment. The stems are intended for cementless fixation and are available in stem sizes 4-14 and neck lengths ranging from 25mm to 40mm. The stems are available with either a 127° or 132° neck angle. The Secur-Fit" Max Hip stems have a tapered distal geometry. The Secur-Fit" Plus Max Hip Stems have a fluted and slotted distal geometry.
The provided text is a 510(k) Summary for a line extension to hip stems, not a study describing the acceptance criteria and performance of a device, especially not one that would involve AI or expert consensus. It describes a medical device (hip stems) and its intended use, rather than a diagnostic or AI-powered device. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not present in the provided document.
However, I can interpret what is available through the lens of a medical device submission, which uses "acceptance criteria" in the context of substantial equivalence to predicate devices and mechanical testing, rather than a diagnostic performance study.
Here's an attempt to answer the questions based only on the provided document, acknowledging that most questions cannot be fully answered.
Acceptance Criteria and Study to Prove Device Meets Criteria
1. A table of acceptance criteria and the reported device performance
Based on the provided 510(k) summary, the "acceptance criteria" are not explicitly stated in a quantitative table as one might find for sensitivity/specificity in a diagnostic device. Instead, the primary acceptance criterion for this 510(k) submission is substantial equivalence to predicate devices. The performance reported is in terms of this equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence in mechanical strength compared to predicate devices | "Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength." |
| Substantial Equivalence in intended use and design | "The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design." |
| Identity in manufacturing methods, packaging, and sterilization | "the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical." |
| Material consistency for the hip stems | "The material of the subject Secur-Fit™ Max and the Secur-Fit™ Plus Max Hip Stems remains unchanged." |
| Safety and efficacy for stated Indications for Use | (Inferred from FDA clearance) "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "mechanical testing" but does not detail the sample size (e.g., number of stems tested, number of cycles for fatigue testing) or the provenance of the data. This is typical for a 510(k) summary which focuses on demonstrating equivalence rather than providing full study protocols and results.
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 and not provided. This document describes a hip stem, which is an implantable medical device, not a diagnostic device that requires expert ground truth establishment in the traditional sense of image interpretation or disease diagnosis. The "ground truth" for a mechanical device is its physical and mechanical properties, assessed through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for diagnostic interpretation, which is not relevant to the mechanical testing of a hip stem.
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 and not provided. This document is for a medical implant and does not involve AI or human readers for diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. This document is for a medical implant and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be its physical and mechanical properties as determined by standardized engineering tests (e.g., fatigue testing, static strength testing, material characterization). The document states "Mechanical testing demonstrates substantial equivalence," implying these types of engineering measurements were used. No other ground truth types (like pathology or outcomes data from clinical trials) are mentioned or implied for this 510(k) submission's scope.
8. The sample size for the training set
This is not applicable and not provided. This document describes a medical implant and does not involve machine learning models that require a training set.
9. How the ground truth for the training set was established
This is not applicable and not provided. As above, there is no training set mentioned or implied for this medical device submission.
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