(219 days)
The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.
The Mesh Introducer Needle is a combination of a Bone Access Assembly (Single Step Instrument) and a Mesh Assembly. The Bone Access Assembly comprises a cannula (acting as a working channel), a dilator-reamer, and a K-wire. The Mesh Assembly comprises a fabric-made mesh (pouch) through which the bone cement is introduced into the treatment site, mounted on a small diameter injection cannula, provided with a blunt edge stylet.
The provided text is a 510(k) summary for the "Mesh Fenestrated Introducer Needle." This document is part of the FDA regulatory process for medical devices and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving performance against acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found within the provided text. The document describes the device's intended use and design, and states that its characteristics are substantially equivalent to predicate devices, but it does not include a performance study with acceptance criteria.
Here's a breakdown of why each requested point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: This type of information is typically found in a detailed performance study report. The 510(k) summary provided here does not contain such a table or specific performance results.
- Sample sizes used for the test set and the data provenance: No performance study details are provided, so no sample sizes or data provenance are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This relates to a performance study with a test set, which is not included in this summary.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Again, this refers to a performance study that is not detailed in the provided text.
- 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 type of study is specifically relevant to AI/diagnostic imaging devices. The device described (Mesh Introducer Needle) is a surgical instrument and not an AI-powered diagnostic device, so an MRMC study would not be applicable, and thus is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Similar to point 5, this is relevant to AI/algorithm-based devices, which this is not.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no performance study is detailed, no ground truth methodology is described.
- The sample size for the training set: This is relevant for machine learning models, which are not part of this device.
- How the ground truth for the training set was established: Again, this is relevant to machine learning models, which are not part of this device.
The 510(k) process for a device like the Mesh Introducer Needle primarily relies on demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) through comparisons of intended use, design, materials, and technological characteristics, as well as bench testing or sometimes limited clinical studies to ensure aspects like biocompatibility, sterility, and mechanical integrity. The provided text only covers the "substantial equivalence" argument, not a performance study against specific acceptance criteria.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”