(229 days)
The Ligamentotaxor is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.
The Ligamentotaxor is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.
The provided text is related to a 510(k) premarket notification for a medical device called the AREX Ligamentotaxor (LTX). This document describes the device, its intended use, and a study conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria in terms of numerical thresholds for device performance (e.g., minimum accuracy, sensitivity, specificity, or specific ranges for clinical outcomes that define "success"). Instead, it focuses on demonstrating that the device's performance, particularly in terms of adverse events and clinical outcomes (pain, function, patient satisfaction), is similar to or compares favorably with predicate devices as reported in the literature.
Therefore, I cannot create a table of "acceptance criteria and reported device performance" as no explicit acceptance criteria are stated in the provided text. The study's purpose was to show substantial equivalence, not to meet a predefined numerical performance benchmark.
Here's a breakdown of the information that can be extracted from the document, organized according to your request, with an emphasis on what is present and what is not:
Acceptance Criteria and Study Details for AREX Ligamentotaxor (LTX)
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, the document does not provide specific numerical acceptance criteria for clinical performance. The "acceptance criteria" were implied by the regulatory standard of "substantial equivalence" to predicate devices, meaning the device should not raise new questions of safety and effectiveness and should offer similar clinical outcomes. Therefore, a table of explicit acceptance criteria and corresponding device performance cannot be generated from the given text.
The study aimed to demonstrate that:
- The fundamental scientific technology is substantially equivalent.
- Materials, design, and indications for use are similar to predicate devices.
- Distraction force testing was performed (results not detailed clinically).
- Clinical data showed outcomes for pain, function, and patient satisfaction were similar to those reported for predicate devices in the literature.
- Types and rates of adverse events compared favorably with those reported for predicate devices in the literature.
- All fractures healed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 83 cases.
- Data Provenance:
- Country of Origin: Multicenter study conducted in 4 countries (specific countries not named).
- Retrospective or Prospective: The description "was evaluated in a 10 site multicenter study" and details about patient follow-up (mean 15.2 months, ranging from 6 to 38 months) strongly suggest a prospective study, where data was collected following the device's application.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number of experts used to establish a "ground truth" in the diagnostic sense, nor their qualifications. The study was a clinical evaluation of a treatment device. Clinical outcomes (e.g., adverse events, range of motion, pain, DASH scores, patient satisfaction) were reported by the study sites/investigators, and fractures healing was also stated. It doesn't mention an independent panel of experts reviewing cases for a "ground truth" diagnosis.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method (e.g., 2+1, 3+1) for the clinical outcomes. The reporting appears to be based on direct clinical observation and patient self-reporting at the participating study sites.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The study described is a clinical evaluation of the device's performance in treating patients, comparing its outcomes against literature-reported outcomes of predicate devices (not a direct head-to-head comparison with human readers or another device in the same patient group). There is no mention of "human readers" or "AI assistance."
6. Standalone Performance Study
- Yes, a standalone clinical performance study was done. The described multicenter study evaluated the AREX Ligamentotaxor (LTX) on its own, without human-in-the-loop assistance, to assess its clinical safety and effectiveness in the treatment of PIP joint fractures and dislocations. The results were then compared to literature for predicate devices.
7. Type of Ground Truth Used
- The "ground truth" in this context refers to the clinical outcomes and observations recorded during the study. It includes:
- Clinical Outcomes: Flexion/extension range of motion, finger/thumb mobility, pain (VAS 10-point scale), quick DASH scores, job status, patient satisfaction.
- Adverse Events: Documented occurrences like residual pain, secondary subluxations, superficial infections, clinodactyly, stiff/painful fingers, swan neck deformations, premature removal.
- Healing: Report that "all fractures healed."
- These are based on direct clinical assessment by healthcare professionals and patient-reported outcomes.
8. Sample Size for the Training Set
- The document does not refer to a "training set." This term is typically used in the context of machine learning or AI development. The study described is a clinical trial/evaluation of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a "training set" or AI in this document, this question is not applicable.
§ 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.