(105 days)
The STROPP(TM) System is intended for use with a suture in metatarsal ligament and tendon repairs.
The STROPP™ System is sterile packaged kit to include implants and instruments for plantar plate repair. Implants are 3.0 mm or 3.5 mm diameters and range in length from 6 mm to 12 mm. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, an inserter, Kwires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system.
The provided text describes a 510(k) premarket notification for a medical device called the STROPP™ (Single Tunnel Repair of Plantar Plate) System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than a device's standalone performance compared to a set of acceptance criteria.
Therefore, the input text does not contain the information requested in sections 1-9 regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement in the context of a new device's performance validation against a defined set of criteria.
The information provided is specific to the regulatory process for demonstrating substantial equivalence for a Class II medical device, which typically involves comparing the new device's characteristics (design, materials, intended use, performance testing) to those of legally marketed predicate devices.
Here's what can be extracted, interpreted based on the context of a 510(k):
1. A table of acceptance criteria and the reported device performance
- The document does not explicitly state acceptance criteria for a new device's performance in a standalone study. Instead, it refers to demonstrating "statistical equivalence to current plantar plate repair options" for construct pull-through testing. This means the performance of the STROPP™ system was compared against existing methodologies or devices, rather than a predefined absolute threshold.
- Reported Device Performance:
- "The construct pull through testing demonstrated statistical equivalence to current plantar plate repair options and that the STRoPP™ System introduces no additional failure modes."
- "The cadaveric testing resulted in no damage to the bone, implant or suture."
- "All testing met the specified acceptance criteria and raised no new issues of safety or effectiveness." (This "acceptance criteria" likely refers to the equivalence criteria mentioned above or other internal design specifications, not external performance benchmarks specified in the document.)
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The text mentions "test samples that are representative of the finished device" for construct pull-through testing and "cadaveric simulated use testing" but does not give a number for either.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests appear to be laboratory-based ("simulated use model," "cadaveric simulated use testing").
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 and not mentioned. The studies focus on mechanical performance and simulated use, not diagnostic accuracy requiring expert interpretation.
4. Adjudication method for the test set
- This information is not applicable and not mentioned. The studies focus on mechanical performance.
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 information is not applicable and not mentioned. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a physical medical device, not an algorithm. Therefore, this question is not directly applicable. However, the performance testing described is analogous to a "standalone" mechanical performance evaluation of the device itself (construct pull-through, cadaveric testing).
7. The type of ground truth used
- For the construct pull-through test: It appears the "ground truth" was the mechanical strength or failure point, compared against existing "plantar plate repair options."
- For the cadaveric testing: The "ground truth" was the observation of "damage to the bone, implant or suture."
8. The sample size for the training set
- This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- This device is not an AI/ML algorithm.
§ 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.