(68 days)
The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).
The device described in this 510(k) is a sterile, disposable device designed for single patient use only. The crosspins are constructed of bioabsorbable Poly L-lactic Acid (PLA).
The provided text describes a medical device, the RigidFix™ Tibial Soft Tissue ACL Crosspin System, and its submission for FDA 510(k) clearance. However, it does not include detailed acceptance criteria or the specifics of a study proving the device meets those criteria in the way you've outlined for performance metrics (e.g., sensitivity, specificity, or improvement over human readers).
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on functional and integrity bench testing and biocompatibility testing. This is a common pathway for Class II medical devices in the US, where the aim is not to prove superiority, but rather that the new device is as safe and effective as a legally marketed predicate.
Here's an analysis based on the information provided, addressing your requested points as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria (e.g., specific tensile strength values, percentage reduction in failure rate) and corresponding reported device performance in the manner you'd expect for an AI/diagnostic device.
Instead, the "acceptance criteria" are implicitly met by:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional and Integrity Performance (Initial Fixation Strength) | Testing performed to determine initial fixation strength. Data supported substantial equivalence for Hamstring Grafted ACL Reconstructions. |
| Biocompatibility | Testing performed to ODE Blue Book Memorandum #G95-1 (ISO-10933) requirements. Data supported substantial equivalence. |
| Indications for Use Alignment | Indicated for tibial fixation of autograft or allograft ACL soft tissue grafts. Aligns with predicate devices. |
| Technological Characteristics Alignment | Crosspins constructed of bioabsorbable Poly L-lactic Acid (PLA). Aligns with predicate devices. |
Important Note: The document states, "Specifically, testing was performed to determine the initial fixation strength of the Tibial RigidFix CrossPin System when used for Hamstring Grafted ACL Reconstructions." However, it does not provide the specific numerical results of this testing or the pre-defined target values that would constitute "acceptance." The conclusion is that the data supported substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. This would typically refer to the number of biological samples or specimens used in the bench testing.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory environment, not on human subjects. Therefore, there is no country of origin for human data, and it is not retrospective or prospective in the clinical trial sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For bench testing of initial fixation strength and biocompatibility, "experts" in the sense of clinical specialists establishing a "ground truth" for diagnostic purposes aren't typically involved. The "ground truth" is derived from engineering measurements and established biological safety standards.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods (like 2+1) are typically used in clinical studies or diagnostic performance evaluations involving human interpretation. For bench testing, results are usually objectively measured and compared against engineering specifications or established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No, an MRMC study was not done.
- Effect Size: Not applicable, as no MRMC study was performed. MRMC studies are relevant for evaluating the impact of AI on human reader performance, which is not the type of evaluation described for this device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Was it done?: Essentially, yes. The "functional and integrity bench testing" and "biocompatibility testing" represent a standalone evaluation of the device's physical and biological properties. There is no "human-in-the-loop" component to how the device functions in these tests. The device's performance is measured directly (e.g., how much force it can withstand, its biological interaction with tissues).
7. Type of Ground Truth Used
- Ground Truth Type:
- Bench Testing (Functional/Integrity): The ground truth is based on engineering measurements and biomechanical properties, compared against established performance characteristics of predicate devices or industry standards for fixation strength.
- Biocompatibility Testing: The ground truth is based on biological safety standards as outlined in ODE Blue Book Memorandum #G95-1 (ISO-10933), which involves in-vitro and/or in-vivo tests to assess toxicity, irritation, sensitization, etc.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical implant, not an AI algorithm that requires a "training set" of data. The manufacturing process is validated, and the device itself is tested.
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
In summary: The provided document is a 510(k) summary for a medical device (a crosspin system) seeking clearance based on substantial equivalence. The "acceptance criteria" and "study" described are focused on bench testing for physical performance and biocompatibility testing against established regulatory standards, rather than clinical efficacy trials or AI algorithm performance evaluations. The key outcome is that the testing data supported the claim of substantial equivalence to predicate devices.
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ATTACHMENT H
SUMMARY OF SAFETY & EFFECTIVENESS
Pursuant to § 13(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Products is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Mitek Products choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the proposed RigidFix™ Tibial Soft Tissue ACL Crosspin System is as follows:
| Trade Name: | RigidFix™ Tibial Soft Tissue ACL Crosspin System |
|---|---|
| Sponsor: | Mitek Products |
| 249 Vanderbilt Avenue | |
| Norwood, MA 02062 | |
| Registration: 1221934 | |
| Device Generic Name: | Appliance for reconstruction of bone to soft tissue |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards. |
| Predicate Devices: | Mitek - 3.3mm ST Femoral RigidFix™ Crosspin System |
| Linvatec BioScrew® Absorbable Interference Screw |
All of the devices mentioned above have been determined substantially equivalent by FDA.
Device Description: The device described in this 510(k) is a sterile, disposable device designed for single patient use only. The crosspins are constructed of bioabsorbable Poly L-lactic Acid (PLA).
Indications for Use: The RigidFix™ Tibial Soft Tissue ACL Crosspin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts.
Safety and Performance: Functional and integrity bench testing and Biocompatibility testing to the FDA guidance document, ODE Blue Book Memoradum #G95-1, 1995, Use of International Standard ISO-10933, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" were performed, and the data supported the substantial equivalence of the 3.3mm ST Tibial RigidFix CrossPin System. Specifically, testing was performed to determine the initial fixation strength of the Tibial RigidFix CrossPin System when used for Hamstring Grafted ACL Reconstructions
Conclusion: Based on the Indications for Use, technological characteristics and safety and performance testing, the RigidFix™ Tibial Soft Tissue ACL Crosspin System has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
MAY - 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary P. LeGraw Manager, Regulatory Affairs Mitek Products 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K010633
Trade/Device Name: RigidFix Tibial ACL CrossPin System Regulation Number: 888.3040 Regulatory Class: II Product Code: HWC and MAI Dated: March 2, 2001 Received: March 2, 2001
Dear Ms. LeGraw:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Mary P. LeGraw
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Buhhollerma pa
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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Page __ 1__ of __ 1
510(k) Number (if known): Unknown K010633
RigidFix™ Tibial ACL CrossPin System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ammheller to Ckmu
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number KOI 00033
§ 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.