(1032 days)
The Ascendx™M VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with AscendxTM Cement.
The Ascendx™ VCF Repair System consists of the Ascendx™ Acu-Cut Cutting Instrument, AscendxTM RDX Repair Device, and AscendxTM Inflation Syringe.
The Ascendx™ System is packaged with a previously cleared bone cement (Ascendx™ Cement, manufactured by TECRES S.p.A, K042415), as well as several class I tools, including manual orthopedic surgical instruments and cement mixing and dispensing tools.
Here's a breakdown of the acceptance criteria and study information for the Ascendx™ VCF Repair System, as derived from the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a discrete set of quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" values for the clinical study endpoints. Instead, it describes various tests and states that the device "conforms to its design specifications," "functioned as intended," and "met the necessary specifications for its intended use." For the clinical study, it concludes that the device achieved "pain and functional relief" and that its "safety and effectiveness supported substantial equivalence to the predicate."
Given the information, a table of the reported performance from the clinical study would look like this:
| Acceptance Criteria (Implied) | Reported Device Performance (Clinical Outcomes) |
|---|---|
| Procedural Success | Achieved (Details not quantified, but stated as successful) |
| Pain Relief | Achieved (Compared favorably to predicate and other treatments) |
| Functional Relief | Achieved (Compared favorably to predicate and other treatments) |
| Safety (Adverse Events, Leakage, Subsequent Fractures) | Acceptable (Compared favorably to predicate and other treatments, supporting substantial equivalence) |
For non-clinical/bench testing, the document states:
"All bench testing confirmed that the product met the necessary specifications for its intended use."
This implies that for each of the numerous tests listed (e.g., compressive strength, maximum balloon inflation pressure, bond strength, fatigue testing, radiopacity, etc.), the device performed within predefined acceptable limits. Specific numerical acceptance criteria and performance values are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Test Set Sample Size: 60 subjects treated with the Ascendx™ System and Ascendx™ Cement.
- Data Provenance: The document does not explicitly state the country of origin. It describes "clinical testing included evaluation of 60 subjects," which implies a prospective clinical study carried out by the manufacturer. It also mentions comparisons to "an investigation using the same cement without the Ascendx™ in 113 subjects" and "an investigation for 29 subjects undergoing treatment with the predicate device, and 31 subjects undergoing vertebroplasty." These comparison groups are likely from separate studies, but their temporal nature (retrospective/prospective) and provenance are not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. Clinical trials typically involve physicians assessing patient outcomes, but the specific number and qualifications of experts establishing "ground truth" (e.g., through blinded assessment of imaging or adjudicated outcomes) are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
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
This device is a medical device (VCF Repair System), not an AI/software device for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
As stated above, this is a medical device, not an AI/software algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the clinical study, the ground truth was based on patient outcomes data including:
- Acute procedural success
- Pain levels
- Functional status
- Adverse events (leakage, subsequent fractures)
These are typically assessed by treating physicians and reported by patients.
8. The Sample Size for the Training Set
This information is not applicable to this type of medical device. The device is a physical product, not an algorithm that requires a "training set" in the machine learning sense. The device was likely designed and refined through engineering iterations and bench testing, rather than an algorithmic training process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as it's not an AI/software algorithm. The "training" for such a device would involve engineering design, prototyping, and testing against design specifications, often in a lab setting (bench testing).
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510(k) SUMMARY
DEC 1 4 2012
AGE 1 OF 2
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AOI Medical, Inc.'s AscendxTM VCF Repair System
Submitter
AOI Medical, Inc. 7079 University Blvd Winter Park FL 32792
Phone: 321 280 4800 Facsimile: 321 280 4801
Contact Person: Julian Mackenzie, President and CEO
Date Prepared: July 1, 2011
Name of Device
Ascendx™ VCF Repair System
Classification Name
Arthroscope
Predicate Devices
Kyphon, Inc.'s Kyphx Inflatable Bone Tamps
Intended Use / Indications for Use
The Ascendx™M VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with AscendxTM Cement.
Technological Characteristics
The Ascendx™ VCF Repair System consists of the Ascendx™ Acu-Cut Cutting Instrument, AscendxTM RDX Repair Device, and AscendxTM Inflation Syringe.
The Ascendx™ System is packaged with a previously cleared bone cement (Ascendx™ Cement, manufactured by TECRES S.p.A, K042415), as well as several class I tools, including manual orthopedic surgical instruments and cement mixing and dispensing tools.
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K100404
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Performance Data
Comprehensive bench and clinical testing of the Ascendx™ System was conducted. The testing demonstrated that the System conforms to its design specifications. The testing also demonstrated the Ascendx™ VCF Repair System's ability to mechanically withstand insertion and deployment within a vertebral body. In all instances, the Ascendx™ VCF Repair System functioned as intended.
Nonclincial tests performed included biocompatibility testing in accordance with ISO 10993, sterilization validation, shelf life testing, and the following performance testing: Compressive strength and stiffness testing; maximum balloon inflation pressure testing; balloon inflation pressure testing post-sterilization; maximum balloon inflation pressure testing; balloon force comparison testing; balloon insertion and withdrawal force testing; balloon removal force postcement inscrtion testing; balloon assembly bond strength testing; balloon fatigue testing; balloon physical characteristics testing; tentacle pressure testing; flexural stiffness testing; radiopacity testing of marker bands; bond and pressure strength testing; cutting torque testing; weld strength testing; post-repair bone cement porosity testing; bone cement curing properties testing; and bone cement mixing testing. All bench testing confirmed that the product met the necessary specifications for its intended use.
In addition to the bench testing listed above, biocompatibility of the device has been confirmed in accordance with ISO 10993, and the company has conducted sterilization and shelf life validation in accordance with recognized industry standards.
Clinical testing included cvaluation of 60 subjects treated with the Ascendx™M System and the Ascendx™ Cement. Outcomes evaluated included acute procedural success, pain, function, and adverse events including leakage and subsequent fractures. Follow-up was performed at discharge and 1, 3, 6, and 12 months post-treatment. Results were compared to an investigation using the same cement without the Ascendx™ in 113 subjects, as well as an investigation for 29 subjects undergoing treatment with the predicate device, and 31 subjects undergoing vertebroplasty. The results of this investigation demonstrated that the device could be used as intended to achieve pain and functional relief, and that the safety and effectiveness supported substantial cquivalence to the predicate.
Substantial Equivalence
The Ascendx™ VCF Repair System is substantially equivalent to the predicate device. The Ascendx™ VCF Repair System has the same intended uses and indications as the predicate Kyphon Kyphx Inflatable Bone Tamp. Its technological characteristics and principles of operation are also similar to the predicate. The minor technological differences between the Ascendx™ VCF Repair System and its predicate device, e.g., with respect to dimensions, mechanism of coment delivery, etc., raise no new issues of safety or effectiveness, as confirmed by nonclinical and clinical testing.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is placed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The text is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
. Letter dated: December 14, 2012
AOI Medical, Incorporated % Mr. Julian Mackenzie President and CEO 7079 University Boulevard Winter Park, Florida 32792
Re: K100404
Trade/Device Name: Ascendx™ VCF Repair System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN Dated: October 9, 2012 Received: October 10, 2012
Dear Mr. Mackenzie:
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 r no general connous proctice, 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 r head be admised a determination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I eather of the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI ic rail 607); laboring (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Julian Mackenzie
forth in the quality systems (QS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):K100404
Device Name: Ascendx™ VCF Repair System
Indications for Use: .
The Ascendx™ VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with Ascendx™ Cement.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Dision of Orthopedic Device :0(k) Number K100404 Page __ of
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§ 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.”