(97 days)
The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including:
- Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures
- Diaphyseal fractures .
- Ankle fractures .
- Simple, comminuted and depression fractures ●
- Non-unions and malunions .
- Osteotomies and bone reconstruction t
- Fractures in normal or osteoporotic bone 9
The AngleFix T Locking Plate consists of plates to accommodate the patients' anatomy. Each plate has threaded holes and "finger holes" for the corresponding screws.
The provided text describes a 510(k) summary for a medical device called the "AngleFix T Locking Plate." However, it is important to note that a 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study in the way requested in the prompt.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
The document does not provide a table of acceptance criteria or reported device performance in the context of a clinical study or specific performance metrics. Instead, it states:
"The pre-clinical testing performed indicated that the AngleFix T Locking Plate is substantially equivalent to the predicate devices and is adequate for the intended use."
This statement indicates that the "acceptance criteria" were likely related to demonstrating similarity in design, materials, and mechanical performance to legally marketed predicate devices, rather than achieving specific clinical outcomes or accuracy thresholds.
Therefore, I cannot populate the table below with specific performance metrics as they are not present in the provided text.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document as distinct acceptance criteria for clinical performance. | "Substantially equivalent to the predicate devices and is adequate for the intended use." |
Here's a breakdown of the other requested information based on the provided text:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify a sample size for a test set or data provenance related to human or imaging data. The performance testing mentioned is "pre-clinical," suggesting bench testing or possibly cadaveric studies, not clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as there is no mention of a test set requiring expert-established ground truth (e.g., for image interpretation). The submission focuses on device equivalence through pre-clinical testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable for the same reasons as point 3.
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. The device is a T Locking Plate for bone fixation, not an image analysis or AI-driven diagnostic tool. Therefore, no MRMC study or AI assistance is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable for the same reasons as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The concept of "ground truth" as it relates to clinical outcomes, pathology, or image interpretation is not applicable here. The "ground truth" for demonstrating substantial equivalence for this type of device typically involves engineering specifications, material properties, and mechanical performance tests compared against predicate devices.
8. The sample size for the training set
- This is not applicable as there is no mention of a "training set" or AI model development.
9. How the ground truth for the training set was established
- This is not applicable for the same reasons as point 8.
Summary of what the document does indicate:
- Device Type: AngleFix T Locking Plate, a metallic bone fixation appliance.
- Purpose of Submission: 510(k) premarket notification to establish substantial equivalence.
- Predicate Devices: Howmedica VariAx Locking plate System (K060613), Synthes AxSOS Plus Locking Plate System (K061012), and Synthes 3.5mm LCP Distal Humerus System (K033995).
- Performance Testing: "Pre-clinical testing" was performed, which "indicated that the AngleFix T Locking Plate is substantially equivalent to the predicate devices and is adequate for the intended use." This typically involves mechanical and material testing to ensure the device meets engineering specifications comparable to existing devices, without involving patient data for "ground truth" in the diagnostic sense.
§ 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.