(286 days)
For Fixing the osteotomies and arthrodesis of the mid fout bones, the metatarsals, the phalanges, and associated joints of the foot.
The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.
The provided text describes the "Memory Staple™" device and a study performed to demonstrate its substantial equivalence to predicate devices, but it does not detail acceptance criteria in the typical sense of a diagnostic device or AI algorithm, nor does it present a study that proves the device meets specific performance thresholds in that context.
Instead, the document is a 510(k) summary, focusing on demonstrating substantial equivalence for a medical device. The "study" mentioned here is a mechanical test and a clinical observation that supports this claim, rather than a clinical trial designed to prove diagnostic performance against set criteria for an AI tool.
Therefore, many of the requested categories for AI/diagnostic studies (like MRMC, ground truth establishment, training set details) are not applicable to this submission.
Here's an attempt to answer based on the provided text, adapted to the context of a medical device submission demonstrating substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable as an "AI/diagnostic acceptance criteria" table. The substantial equivalence argument for the Memory Staple relies on:
- Intended Use: Similar to predicate devices.
- Material: Nickel-Titanium shape memory alloy (similar to one predicate).
- Mechanical Strength: Demonstrated to be stronger than a predicate device.
- Clinical Use Observation: Successful in a reported series.
| Acceptance Criteria (Proxy for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Bone fixations of osteotomies and arthrodeses of specific foot bones and joints. | Memory Staple: Intended for bone fixations of osteotomies and arthrodeses of the mid-foot bones, the metatarsals, the phalanges, and associated joints of the foot. (Matches predicate devices: Landos Standard Staple, Stryker Osteoclasp, Mitek Anchor II™ for bone fixation). |
| Material: Similar to a predicate device. | Memory Staple: Made of shape memory Nickel-Titanium alloy. (Similar to Mitek Anchor II™). |
| Mechanical Strength: At least equivalent to predicate devices. | Memory Staple: "had more than twice the strength of the Landos Staple" in prong separation tests. |
| Clinical Performance: Effective in clinical application (similar to predicates). | Memory Staple: "Successful clinical use... in 315 osteotomies of the great toe between 1991-1994 was reported by Barouk in 1994." |
Since this is not an AI/diagnostic study, the following points are largely not applicable.
2. Sample size used for the test set and the data provenance
- Mechanical Test: "Prong separation tests were performed on the Memory Staple and the Landos Standard Staple." The sample size for these tests is not specified in the document.
- Clinical Observation: 315 osteotomies of the great toe.
- Data Provenance: The document does not specify the country of origin for the clinical observation data, but it refers to a report by "Barouk in 1994." It is retrospective, as it covers use between 1991-1994.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For the mechanical test, the "ground truth" is a measurement of force. For the clinical observation, "successful use" would likely be determined by the treating physician (Barouk). No panel of experts for ground truth establishment is mentioned.
4. Adjudication method for the test set
Not applicable. No adjudication method is mentioned for the mechanical tests or the clinical observation.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
- Mechanical Test: Direct physical measurement (prong separation strength).
- Clinical Observation: Physician-reported "successful clinical use," which implicitly refers to positive patient outcomes in the context of the device's function.
8. The sample size for the training set
Not applicable. This is not an AI device and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.