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Memory 12 and Memory 20 staples are implants intended for fixation of the foot.

Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint.

The patient's anatomy and skeleton must be capable of receiving the selected implant.

The Memory Staple is a single-use, bone fixation appliance intended to be implanted in the foot. It is a bicortical compression staple manufactured from a Nickel-Titanium alloy.

The provided text is a 510(k) Summary for a medical device called the "Memory™ Staple." It details the device's description, intended use, indications for use, and a statement of substantial equivalence to a predicate device.

However, the document does not contain information related to acceptance criteria or a study proving the device meets acceptance criteria. This type of information would typically be found in a performance data section, which is absent from this summary.

Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details) because the provided text does not contain any of this information.

The document primarily focuses on establishing substantial equivalence to a previously cleared device (DePuy Memory Staple, K964226) based on similarities in intended use, indications for use, materials, and design. This suggests that the regulatory submission relied on the established safety and effectiveness of the predicate device rather than presenting new clinical or performance study data for the new device itself.

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