(59 days)
The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
Dovice Bels.ipness are comprised of various size cannulated screws for the fixation of bone fractures. POGO screws are made of 316LVM Stainless Steel conforming to ASTM F138. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.
The provided text describes a 510(k) premarket notification for a medical device called the "POGO Screw." This submission aims to demonstrate substantial equivalence to an already legally marketed predicate device (K080649), rather than proving the device meets specific acceptance criteria through clinical or even extensive bench performance studies with stated numerical targets.
Therefore, the requested information regarding acceptance criteria, study details like sample sizes, expert involvement, ground truth establishment, and comparative effectiveness with AI assistance is largely not applicable or not present in the provided document.
Here's an explanation of why and what information is available:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not provided. The document states "Bench testing was conducted to support equivalency" but does not detail specific acceptance criteria (e.g., minimum tensile strength, fatigue life thresholds) or the numerical results of this testing. The focus is on demonstrating "substantial equivalence" to a predicate device, meaning it performs similarly, not necessarily meeting a predefined set of numerical performance targets.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This type of information is typically associated with clinical studies or extensive performance testing with defined test sets. For a 510(k) demonstrating substantial equivalence based on bench testing (as implied), these details are not usually required or disclosed in the summary.
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)
- Not applicable/Not provided. There is no mention of human expert involvement in establishing a "ground truth" for the testing in this submission, as it focuses on material and design equivalency, not diagnostic or clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here.
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
- Not applicable. This device is a bone fixation screw, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As a physical medical device (bone screw), there is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. Since no specific "test set" and outcome evaluation in the clinical sense is detailed, there's no ground truth type mentioned. The "truth" in this context is the performance of the predicate device, to which the new device is compared.
8. The sample size for the training set
- Not applicable. The concept of a "training set" applies to machine learning models. This device is a mechanical implant, not an AI system.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of available information from the document that is tangentially related to "performance":
- Study type: Bench testing was conducted to support equivalency with a predicate device.
- Predicate Device: POGO Screw cleared under K080649.
- Equivalency Statement: "The POGO Screw is substantially equivalent in design, materials, construction and intended use as those of the predicate."
- Safety and Efficacy: The risk analysis and test results demonstrate that the POGO Screw is substantially equivalent to the predicate device and is capable of safely and effectively performing the stated intended use.
- Device Description (relevant to equivalency): The device consists of various size cannulated screws for bone fracture fixation, made of 316LVM Stainless Steel conforming to ASTM F138. Available in 55mm to 130mm lengths, provided sterile or non-sterile.
- Intended Use: General management of fractures and reconstructive surgery.
In essence, the entire document serves as evidence of substantial equivalence to a device already on the market, not as a detailed report of a study proving a device meets specific, pre-defined quantitative acceptance criteria with associated ground truth from experts or large datasets.
§ 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.