(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.
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长094043
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PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)
AUG 1 7 2010
Date of Preparation: July 26, 2010
| Applicant: | AREX USA LLC1335 Merrybrook RdCollegeville, PA 19403 |
|---|---|
| Contact Individual: | Ellen Hokanson, President610-584-6870 |
| Trade Name: | AREX Ligamentotaxor (LTX) |
| Common Name: | PIP Joint External Distraction Device |
| Regulation Number: | 888.3040 |
| Product Code: | HTY |
| Classification Name: | Pin, Fixation, Smooth |
| Classification: | Class II |
| Predicate Device Name: | BioSymetRic external fixator (K980370) marketed byBiomet Inc and the Compass System (K970713) of Smithand Nephew |
| Device Description: | The Ligamentotaxor is an external fixation system intendedfor use in the treatment of complex fracture dislocations,stable and unstable dislocations, fracture luxations, andpilon fractures in the PIP joint. |
The External Fixation System is as follows:
| Description | Reference |
|---|---|
| Ligamentotaxor | LTX |
The Ligamentotaxor is an external fixation system intended for Intended Use: use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.
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Technology:
The fundamental scientific technology of the Arex Ligamentotaxor is substantially equivalent to the identified predicate device.
Substantial Equivalence:
The materials, design, and indications for use of the AREX Ligamentotaxor are similar to the identified predicate devices. In addition, distraction force testing of the Ligamentotaxor was performed; and, clinical data was provided to demonstrate outcomes similar to those of the identified predicate devices. No new technology or materials have been employed in the design.
To summarize the clinical data, the Ligamentotaxor was evaluated in a 10 site multicenter study in 4 countries. The device was used to treat 83 cases with various fractures and dislocations of the PIP. In 60 cases the Ligamentotaxor alone was used, other patients received additional tendon repair and/or osteosynthesis with additional pins or screws. There were 16 females and 67 males treated whose ages ranged from 17 to 89 years. The Ligamentotaxor was left in place for an average of 36 days. The mean follow-up for the patients was 15.2 months, ranging from 6 months to 38 months. For each patient, age, gender, mechanism of injury, dominant/non-dominant hand, Pelissier fracture class, duration of treatment, any further treatment, mode of rehabilitation, adverse events, flexion/extension range of motion, finger/thumb mobility, pain using the VAS 10 point scale, the quick DASH, job status, and patient satisfaction were reported and evaluated. Types of adverse events included mild or intermittent residual pain often triggered during exercise or cold, secondary subluxations, superficial infections, clinodactyly, two patients had stiff and painful fingers that led to fusion surgery, one patient had a completely stiff finger, and there were 2 swan neck deformations. One patient with diabetes mellitus, osteoarthritis resulted in a premature removal of the system at 18 days. It was reported that all fractures healed. Types and rates of adverse events compared favorably with types and rates reported in the literature for the predicate devices. Outcomes for pain, function, and patient satisfaction were also similar to those reported in the literature for the predicate devices and demonstrate the safety and efficacy of the Ligamentotaxor. The AREX Ligamentotaxor presents no new issues regarding safety and effectiveness as compared to legally marketed predicate devices.
7/26
/10
Ellen Hokanson Date President
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arex USA LLC % Ms. Ellen Hokanson President 1335 Merrybrook Road Collegeville, Pennsylvania 19403
AUG 1 7 2010
Re: K094043
Trade/Device Name: AREX Ligamentotaxor (LTX) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: August 13, 2010 Received: August 16, 2010
Dear Ms. Hokanson: -
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Ellen Hokanson
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Barbara Bneher
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K094043
Device Name:
AREX USA Ligamentotaxor (LTX)
Indications for Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smitu for mxm
(Division Sign-Off)
Division of Surgical Orthopedic, and Restorative Devices
510(k) Number K094043
§ 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.