(275 days)
Mendec Spine is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, bening lesions (hemangioma), and malignant lesions (metastatic cancers, mylema)
Like the predicate devices. Mendec Spine acrylic resin is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabiliser and N.N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.
The provided text is a 510(k) summary for a bone cement device called "Mendec Spine." It details the device's substantial equivalence to predicate devices based on chemical composition and mechanical testing. However, it does not describe any acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostics or AI algorithm performance.
The document is for a traditional 510(k) submission for a medical device (bone cement), not an AI/ML powered device. The "acceptance criteria" and related study questions in your prompt are typically relevant for AI/ML devices, where performance metrics like sensitivity, specificity, or AUC are evaluated against pre-defined thresholds.
Since this is for a traditional bone cement, the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through comparison of chemical composition and mechanical testing according to established standards.
Here's how to address your numbered points based on the provided text, modified to fit the context of a traditional medical device submission:
1. A table of acceptance criteria and the reported device performance
For this bone cement, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to predicate devices, particularly regarding chemical composition and mechanical properties. The reported device performance is presented as direct comparison data.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicates) | Reported Device Performance (Mendec Spine) |
|---|---|
| Chemical Composition: Proportionality to predicate Kyphx HV-R (#K033801, #K041584) and Spineplex (#K032945) | Powder: Polymethymethacrylate (67.50% w/w), Barium sulphate (30.0% w/w), Benzoyl peroxide (2.5% w/w) – Compared directly to predicates, e.g., Kyphx HV-R powder is 68.0% PMMA, 30.0% BaSO4, 2.0% Benzoyl peroxide. |
| Liquid: Methylmethacrylate (monomer) (99.1% w/w), N.N-dimethyl-p-toluidine (0.90% w/w), Hydroquinone (75 ppm) – Compared directly to predicates, e.g., Kyphx HV-R liquid is 99.1% MMA, 0.90% N.N-dimethyl-p-toluidine, 75 ppm Hydroquinone. | |
| Mechanical Test Performance: Substantially equivalent to predicate device, as defined by ISO 5833:2002, "Implants for Surgery - Acrylic resin cements." | "Mechanical tests: Mendec Spine acrylic resin was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by ISO 5833:2002, 'Implants for Sugery - Acrylic resin cements'" |
| Biocompatibility: Compliance with ASTM F 451-99 point 10 and ISO 10993. | "The materials used in Mendec Spine complies with ASTM F 451-99 point 10 and ISO 10993" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for chemical composition analysis or mechanical testing. It states "Mendec Spine acrylic resin was tested in direct comparison to the predicate device." Given the nature of a 510(k) for bone cement, the "test set" would typically refer to batches of the material used for testing, but specific numbers are not provided. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the specific test data, beyond the manufacturer being Italian (TECRES S.p.A, Verona, Italia).
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 question is not applicable to this submission. "Ground truth" in the context of expert review is primarily relevant for diagnostic AI/ML devices where human interpretation is being benchmarked or assisted. For a bone cement, the "ground truth" is established by adherence to chemical formulations, physical properties measured in a lab, and compliance with recognized standards (ISO, ASTM). Human experts would be involved in protocol design, execution, and interpretation of these laboratory tests, not in establishing a medical "ground truth" based on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in diagnostic imaging or clinical assessments, which is not the subject of this 510(k).
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
Not applicable. This is not an AI/ML diagnostic or assistive device. MRMC studies are used to evaluate the performance of human readers, with or without AI assistance, on sets of cases, which is not relevant for bone cement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through:
- Chemical Analysis: Verifying the exact composition of the powder and liquid components against the stated formulation and in comparison to predicate devices.
- Mechanical Testing: Objective measurements of physical properties (e.g., tensile strength, compressive strength, fatigue life) under controlled laboratory conditions, as defined and specified by recognized international standards (ISO 5833:2002).
- Biocompatibility Testing: Compliance with established standards (ASTM F 451-99 and ISO 10993) to demonstrate the material's safety in biological systems.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML algorithm.
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K042415
JUN 9 – 2005
ﺎ
. : Mendec Spine
Company confidential
」
r
Traditional 510(k)
Summary of Safety and Effectiveness
| Official Correspondent: | Christine Brauer, Ph.D.Regulatory Affairs ConsultantOne Democracy Plaza6701 Democracy Boulevard, Suite 700Bethesda, MD 20817tel: 301-545-1990fax: 301-545-1992E-MAIL: chrisbrauer@earthlink.net | ||
|---|---|---|---|
| Trade Name: | Mendec Spine | ||
| Common Name: | Bone Cement | ||
| Classification Name: | Bone Cement, 888.3027 | ||
| Device code: | NDN, LOD | ||
| Manufacturer/Submitter: | TECRES S.p.A FDA Owner number: 9033624Via Andrea Doria 10,37066 Sommacampagna, Verona, ItaliaPhone: +39 045 9217311Fax: +39 045 9217330 | ||
| Contact person: | Massimo Grazioli, General Manager | ||
| Predicate device: | K033801: Kyphx HV-R Bone Cement (Kyphon Inc.).K041584: Kyphx HV-R Bone Cement (Kyphon Inc.).K032945: Stryker Spineplex Radiopaque Bone Cement (Stryker) | ||
| Indications for use: | Mendec Spine is indicated for the treatment of pathologicalfractures of the vertebral body using a vertebroplasty orkyphoplasty procedure. Painful vertebral compression fracturesmay result from osteoporosis, bening lesions (hemangioma), andmalignant lesions (metastatic cancers, mylema) | ||
| Device Description: | Like the predicate devices. Mendec Spine acrylic resin is providedas a two-component system. The powder component consists of aPMMA-styrene copolymer with barium sulphate as a radiopacifierand benzoyl peroxide as an initiator. The liquid component consistsof methylmethacrylate monomer, with the addition ofhydroquinone as a stabiliser and N.N-dimethyl-p-toluidine aspromoter. The powder and liquid components are mixed prior toSection 4Page 1/2 |
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Company confidential
Traditional 510(k)
Mendec Spine
Summary of Safety and Effectiveness
Table 4-1 compares the chemical composition of Mendec use. Spine to the predicate device.
Table 4-1 Chemical composition of Mendec Spine and Kyphx HV-R
| Chemical composition | KyphX HV-R#K033801#K041584 | Spineplex#K032945 | Mendec Spine |
|---|---|---|---|
| Powder | 20 g | 20 g | 20 g |
| Polymethymethacrylate | $68,0% w/w$ | $68,50% w/w$ | $67,50% w/w$ |
| Barium sulphate | $30,0% w/w$ | $30,0% w/w$ | $30,0% w/w$ |
| Benzoyl peroxide | $2,0% w/w$ | $1,5% w/w$ | $2.5% w/w$ |
| Liquid | 9 g | 9.96 ml (9.05 g) | 9.4 g |
| Methylmethacrylate (monomer) | $99,1% w/w$ | $97,4% w/w$ | $99.1% w/w$ |
| N.N-dimethyl-p-toluidine | $0,90% w/w$ | $2,60% w/w$ | $0,90% w/w$ |
| Hydroquinone | 75 ppm | 75 ppm | 75 ppm |
Mechanical tests: Mendec Spine acrylic resin was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by ISO 5833:2002, "Implants for Sugery - Acrylic resin cements" Non-clinical test results: Performance testing demonstrated that Mendec Spine is substantially equivalent to the Kyphx HV-R with regard to functional characteristics Clinical results; Clinical information demonstrates that the intended use is substantially equivalent to the predicate indication for the treatment of pathological vertebral body fractures and does not adversely impact safety and effectiveness. Biocompatibility:
The materials used in Mendee Spine complies with ASTM F 451-99 point 10 and ISO 10993
Sterilization: The Mendee Spine acrylic resin is sterile and non-pyrogenic. The solid components are sterilised with ethylene oxide (EO) gas to a Sterility Assurance Level (SAL) of 10th. The liquid components are sterilized with filtration methods to a SAL of 102. The outer packaging containing the liquid component is sterifised with ethylene oxide (EO) gas. The acrylic resin is intended for single use only.
Section 4 Page 2/3
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K042415
Mendec Spine
Company confidential
LONGLAND REPRENTWERSON ..... ... ... ... ... .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Traditional 510(k)
INSUL INCLUSION IN MARKET PURGE
BARRE BL. GELLERS AND AND AND BELLER
consistences ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Summary of Safety and Effectiveness
Substantial Equivalence: The chemical constituents in Mendec Spine acrylic resin are substantially equivalent to those in the predicates Kyphx HR-V (#K033801; #K041584) and in the predicate Spineplex (#K032945).
Section 4 Page 3/3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 9 - 2005
Tecres Spa C/o Christine L. Brauer, Ph.D Regulatory Affairs Consultant Brauer Device Consultants, LLC One Democracy Plaza 6701 Democracy Boulevard, Suite 700 Bethesda, Maryland 20817
Re: K042415
Trade/Device Name: Mendec Spine Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: May 18, 2005 Received: May 18, 2005
Dear Dr. Brauer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as sct
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.
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Page 2 -Christine L. Brauer, Ph.D
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
H.A. Chuds
- Miriam Provost, Ph.D.
Miriam Prov st. Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042415
Device Name: Mendec Spine
Indications For Use:
Mendec Spine is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporesis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Prescription Use ﺮ ﺍﻟﻤﺮﺍﺟﻊ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
H. Curtis
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number
§ 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.”