(183 days)
The IntraLock System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints of the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.
The IntraLock System is a three-part construct, consisting of a Locking Lag Screw of 2 diameters and lengths ranging from 22mm to 55mm, a Setting Screw of 1 diameter with lengths ranging from 14mm to 24 mm, as well as a mating washer component consisting of 1 diameter and lengths ranging from 20mm to 28mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are primarily made of surgical grade stainless steel (per ASTM F899) with certain components made from aluminum alloy (Al6061).
This FDA 510(k) summary describes a medical device, the IntraLock System, but does not include information about a study based on AI or software performance. Instead, it focuses on the device's substantial equivalence to predicate devices through non-clinical mechanical testing.
Therefore, I cannot provide an answer that includes acceptance criteria and study details related to AI or software performance, as this information is not present in the provided document.
Here's an analysis of what is available in the document, framed by your questions where applicable, and noting where the requested information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies that the acceptance criteria are met if the IntraLock System's mechanical performance is "equivalent to that of the predicate." However, specific numerical acceptance criteria (e.g., in terms of load capacity, fatigue cycles, or specific failure modes) are not provided.
- Reported Device Performance: Similarly, specific numerical reported performance data from the non-clinical tests are not provided. The document only states that "Both Static and Dynamic mechanical testing is presented to provided evidence that the IntraLock System is equivalent to that of the predicate."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This question is not applicable as the study described is non-clinical mechanical testing of a physical device, not an AI or software performance study using a test set of data. The document does not specify the number of samples used for the static and dynamic mechanical tests.
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 question is not applicable. Ground truth, in the context of AI/software performance, refers to expert-validated labels or outcomes. The described study is mechanical testing of a device where "ground truth" would be the measured physical properties or failure points, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are typically used in clinical studies or AI/software validation studies to resolve discrepancies in expert labeling or diagnoses.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This type of study is relevant for AI-assisted diagnostic tools, not for a bone fixation system's mechanical performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical bone fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This question is not directly applicable in the context of mechanical testing. The "ground truth" for the non-clinical mechanical tests would be the established engineering standards, material properties, and physical measurements (e.g., force applied, displacement, cycles to failure) observed during the testing, compared against the predicate device.
8. The sample size for the training set
- This question is not applicable. The device is a physical product, not an AI model, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- This question is not applicable for the same reasons as #8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.