(97 days)
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.
When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
The K2M Fenestrated Tap System consists of surgical instruments designed to access vertebral bodies via a posterior surgical approach.
Function: The K2M Fenestrated Tap System can be used to access the vertebral body for obtaining bone biopsies. This system can also be used for the injection of bone cement into the vertebral body using vertebroplasty or kyphoplasty procedures.
The provided text is a 510(k) summary for the K2M Fenestrated Tap System, a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing extensive clinical trials with acceptance criteria, ground truth establishment, or multi-reader studies as one might find for AI/ML-based devices.
Therefore, much of the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth origin is not available in this document.
However, based on the provided text, here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or performance metrics in a table. The "performance" is implicitly evaluated against its intended use and comparison to predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Achieves intended use | "K2M Fenestrated Tap System was determined achieve its intended use." (in cadaver testing) |
| Substantially equivalent to predicate devices in design features (materials, number of fenestrations, diameters, thread lengths) | "The K2M Fenestrated Tap System was compared to predicate systems and design features such as the materials, number of fenestrations, diameters and thread lengths were found to be substantially the same as these systems." |
| No significant differences that would adversely affect use compared to marketed systems | "There are no significant differences between the K2M Fenestrated Tap System and other systems currently being marketed which would adversely affect the use of the product." |
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 mentions "cadaver testing" but does not specify the sample size (i.e., number of cadavers or tests performed). It also does not specify the provenance (country of origin, retrospective/prospective).
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 information is not provided in the document. Given it's a physical device and not an AI/ML algorithm, the "ground truth" would likely relate to the observed functional performance during cadaver testing, and any expert assessment involved is not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader multi-case study is typically relevant for interpretative devices, especially AI/ML. This is a physical device (biopsy tool/cement dispenser), and therefore, an MRMC study is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
"Standalone algorithm performance" is relevant for AI/ML devices. This is a physical device, so this concept is not applicable. The device itself is used by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document states "The functional characteristics were evaluated in cadaver testing." The "ground truth" for a physical device in cadaver testing would likely involve the observable physical outcomes and performance characteristics, such as successful biopsy sample removal or successful cement dispensing, assessed by those performing the tests. However, the specific method of determining this "ground truth" (e.g., whether success was confirmed by imaging, physical inspection, or expert assessment) is not detailed.
8. The sample size for the training set
This device does not involve a "training set" in the context of machine learning. Thus, this information is not applicable.
9. How the ground truth for the training set was established
As there is no "training set" for this physical device, this information is not applicable.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.