(70 days)
REPAIR/RECONSTRUCTION OF COLLATERAL LIGAMENTS, FLEXOR AND EXTENSION TENDONS AT THE PIP (PROXIMAL INTERPHALANGEAL), DIP (DISTAL INTERPHALANGEAL), AND MCP (METACARPAL INTERPHALANGEAL) JOINTS FOR ALL DIGITS
The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6AI 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal anchors. The Mitek Mini anchor design was first cleared to market by US FDA in K915089 and K930892. The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an Inserter.
The provided text describes the Mitek Micro Anchor, a medical device for fixing sutures to bone. The information about the study and acceptance criteria is extracted below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Mitek Micro Anchor) |
|---|---|
| USP Class I knot pull synthetic sterilized #3/0 suture, double strand, single knot: 4.22 lb | Cadaver Hand: 9.67 lb (SD 1.32) |
| Cadaver Skull: 7.97 lb (SD 1.92) | |
| Pig Metacarpals: 7.28 lb (SD 0.72) | |
| Suture with Bone Tunnels: 5.73 lb (SD 0.46) |
The acceptance criteria are implicitly set by the performance of the predicate device (USP Class I suture) and relevant historical data for tissue failure. The Mitek Micro Anchor's performance is presented as exceeding these values.
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "pull tests from cadaveric and porcine locations."
- Sample Size: Not explicitly stated as a number of samples, but the four categories tested are "Cadaver Hand," "Cadaver Skull," "Pig Metacarpals," and "Suture w/Bone Tunnels."
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: These appear to be prospective, controlled mechanical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This was a non-clinical test (mechanical pull tests), not involving human diagnostic interpretation or clinical ground truth as typically understood in AI/medical imaging studies. Therefore, no experts were used to establish "ground truth" in this context. The "ground truth" here is the measured failure load.
4. Adjudication Method for the Test Set:
- Not applicable as this was a non-clinical, mechanical test, not an expert-driven adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not performed. This device is a surgical implant, not a diagnostic imaging AI tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance presented in the table is a standalone mechanical performance of the device (pull-out strength) without human-in-the-loop interaction in the context of diagnostic interpretation.
7. Type of Ground Truth Used:
- The ground truth for the device's performance was empirically measured failure load (mechanical strength), reported in pounds (LBS). This is compared against the known strength of sutures and historical data on suture and tissue failure.
8. Sample Size for the Training Set:
- The document does not specify a training set. This is a characteristic of engineering/mechanical testing, not typical AI/machine learning development where a training set is used to "teach" an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set for an algorithm is mentioned or implied. The device's design is described as "similar in design to the Mitek GII Mini Anchor," suggesting a design based on prior engineering principles and existing devices, rather than an iterative machine learning training process. The "design criteria" mentioned in the conclusion refer to engineering specifications.
§ 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.