(60 days)
Simplex P SpeedSet with Tobramycin bone cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.
Simplex P SpeedSet with Tobramycin Bone Cement is a radiopaque bone cement premixed with antibiotic capable of being applied digitally and with a syringe. The cement will be available in 10-pack or 1-pack dispensers, with each individual pack containing one powder pouch of 41.1 g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex P SpeedSet with Tobramycin Bone Cement is approximately 5.36 minutes, with a dough time of 2 pouristian and a setting time of 9.6 minutes.
This document is a 510(k) Summary for a bone cement device, not a study report or clinical trial. Therefore, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study that proves the device meets them.
The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study proving specific performance acceptance criteria for the new device itself.
However, based on the provided text, I can extract and infer some information, and explicitly state what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Property | Acceptance Criteria (Inferred from Substantial Equivalence to Predicates) | Reported Device Performance (Simplex™ P SpeedSet with Tobramycin) |
|---|---|---|
| Indications For Use | Fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty (Same as predicate Simplex P with Tobramycin) | Fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty |
| Material Composition (Monomer) | Same liquid monomer as predicate Simplex P with Tobramycin | Same liquid monomer as predicate Simplex P with Tobramycin |
| Material Composition (Powder) | Similar powder component as predicate Simplex P with Tobramycin | Similar powder component as predicate Simplex P with Tobramycin |
| Working Time | Similar to predicate Simplex P SpeedSet (K053198) | Approximately 5.36 minutes |
| Dough Time | Similar to predicate Simplex P SpeedSet (K053198) | 2 pouristian (likely "pourable," typo in original) |
| Setting Time | Similar to predicate Simplex P SpeedSet (K053198) | 9.6 minutes |
| Radiopacity | Radiopaque | Radiopaque |
| Antibiotic Presence | Contains Tobramycin | Contains Tobramycin |
| Application Method | Capable of being applied digitally and with a syringe | Capable of being applied digitally and with a syringe |
Explanation of "Acceptance Criteria": The acceptance criteria are inferred from the statement of "substantial equivalence" to predicate devices. For a 510(k), the primary "acceptance criterion" is that the new device is as safe and effective as a legally marketed predicate device. This often means demonstrating that key performance characteristics are the same or similar within acceptable tolerances, or that any differences do not raise new questions of safety or effectiveness. The document states:
- "The Simplex P SpeedSet with Tobramycin bone cement has the same indications, same liquid monomer and similar powder component as Simplex P with Tobramcyin bone cement (K014199 cleared 06 May 2003)."
- "The handling properties of Simplex P SpeedSet with Tobramycin are the same as those with Simplex P SpeedSet (K053198 cleared 26 January 2006)."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. The document does not describe a "test set" in the context of a clinical study or performance evaluation with specific sample sizes. The "test" here refers to demonstrating equivalence, likely through bench testing, material characterization, and comparison of specifications, not a patient-based test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Available. As there's no described "test set" in the clinical evaluation sense, there are no experts establishing ground truth for such a set. The "experts" involved would be the engineers and scientists conducting the comparative analysis against predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Available.
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 device is bone cement, an implantable material, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferred based on 510(k) pathway: For a bone cement, "ground truth" for demonstrating substantial equivalence would primarily rely on bench testing and material property comparisons to established standards and the predicate devices. This would include tests for:
- Mechanical properties (e.g., compressive strength, fatigue strength)
- Biocompatibility
- Leaching of antibiotic
- Curing properties (working time, dough time, setting time)
- Radiopacity
- Sterility
- The document mentions "Indication For Use" and "Device Description" which are compared to the predicate's established performance and characteristics.
8. The sample size for the training set:
- Not Applicable/Not Available. The concept of a "training set" is relevant for machine learning algorithms. This document describes a medical device (bone cement), not an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable/Not Available.
Summary of what the document does provide regarding "proof":
The "proof" for this device's acceptance is its demonstration of substantial equivalence to existing legally marketed devices (Simplex P with Tobramycin and Simplex P SpeedSet). This is the core of the 510(k) premarket notification pathway. The manufacturer asserts that because the new device has:
- The same indications for use.
- The same liquid monomer and similar powder component as a predicate with Tobramycin.
- The same handling properties as a predicate SpeedSet cement.
Therefore, it is considered as safe and effective as these predicates. The document implies that data from bench tests (e.g., for working time, dough time, setting time) were used to demonstrate these handling properties are "the same" or within acceptable limits when compared to the predicate Simplex P SpeedSet, but the specific data and acceptance criteria for these tests are not fully detailed in this summary.
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510(k) Summary of Safety and Effectiveness Simplex™ P SpeedSet Bone Cement with Tobramycin
FEB 2 6 2007
| Proprietary Name: | Simplex™ P SpeedSet with Tobramycin Bone Cement |
|---|---|
| Common Name: | Antibiotic PMMA Bone Cement |
| Classification Name and Reference | Polymethylmethacrylate (PMMA) bone cement21 CFR §888.3027 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 MBB - Polymethylmethacrylate (PMMA) bone cement. |
| Device Manufacturer: | Howmedica International S. de R.L.Raheen Business Park, Limerick, Ireland |
| For Information contact: | Tiffani RogersRegulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, New Jersey 07432Phone: (201) 831-5612Fax: (201) 831-6038E-Mail: Tiffani.Rogers@stryker.com |
| Date Summary Prepared: | February 15, 2007 |
Device Description
116
Simplex P SpeedSet with Tobramycin Bone Cement is a radiopaque bone cement premixed with antibiotic capable of being applied digitally and with a syringe. The cement will be available in 10-pack or 1-pack dispensers, with each individual pack containing one powder pouch of 41.1 g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex P SpeedSet with Tobramycin Bone Cement is approximately 5.36 minutes, with a dough time of 2 pouristian and a setting time of 9.6 minutes.
P.1/2
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Indications For Use:
Simplex P SpeedSet with Tobramycin bone cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.
Substantial Equivalence:
The Simplex P SpeedSet with Tobramycin bone cement has the same indications, same liquid monomer and similar powder component as Simplex P with Tobramcyin bone cement (K014199 cleared 06 May 2003). The handling properties of Simplex P SpeedSet with Tobramycin are the same as those with Simplex P SpeedSet (K053198 cleared 26 January 2006). Howmedica Osteonics Corp. believes the Simplex P SpeedSet with Tobramycin bone cement to be substantially equivalent to Simplex P with Tobramycin and Simplex P SpeedSet bone cements.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2007
Stryker Orthopaedics % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K063857
Trade/Device Name: Simplex® P SpeedSet with Tobramycin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: MBB Dated: December 22, 2006 Received: December 28, 2006
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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 set 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 - Ms. Tiffany Rogers
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) 276-0210 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buchner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications
Simplex P SpeedSet with Tobramycin Bone Cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.
Prescription Use X (Per 21 CFR 801.109)
OR Over-the-Counter Use
(Please Do Not Write Below This Line - Continue on Another Page if Needed)
enbare buedun
(Division Sign-Off) Division of General, Restorative, and Neurological Device
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.”