(69 days)
Synthes 2.4 mm Titanium Locking Screws are intended for use in primary or secondary closure / repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The Synthes 2.4.mm Ti. Locking Screws feature a self-tapping tip, cruciform recess, and have a flat head profile with rounded edges. They are available in lengths ranging from 8 mm to 24 mm.
This document is a 510(k) summary for a medical device called "Synthes 2.4 mm Titanium Locking Screws". It does not contain information about acceptance criteria, study performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details that would typically be found in a study proving a device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for lower-risk medical devices in the US. This pathway generally relies on demonstrating that the new device is as safe and effective as an already legally marketed device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance.
Therefore, I cannot provide the requested information from the given text.
However, based on the provided text, I can extract the following relevant details about the device:
- Device Name: Synthes 2.4 mm Titanium Locking Screws
- Intended Use: For use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
- Classification: Class II, § 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener.
- Predicate Device: Synthes 2.4 and 3.0 mm Titanium Locking Screws
- Material: Titanium
To answer your specific questions, if this were a document about AI/ML device performance, the requested information would look something like this (hypothetically, not from the provided text):
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity | ≥ 90% | 92.5% |
| Specificity | ≥ 80% | 85.2% |
| AUC | ≥ 0.90 | 0.93 |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: 500 cases
- Data Provenance: Retrospective, collected from 3 hospitals in the United States and 2 hospitals in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 3
- Qualifications: All were board-certified radiologists with subspecialty training in musculoskeletal imaging, each with ≥ 10 years of experience reading chest radiographs.
4. Adjudication method for the test set
- Adjudication Method: 2+1. Initial labels were provided by two independent experts. In cases of disagreement, a third, senior expert independently reviewed the case and provided the tie-breaking decision.
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
- MRMC Study: Yes
- Effect Size: Human readers demonstrated a statistically significant improvement in AUC from 0.78 (without AI assistance) to 0.85 (with AI assistance), representing an average increase of 0.07 AUC (95% CI: 0.05-0.09, p < 0.001). This translated to a 15% reduction in missed findings and a 10% reduction in false positives.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, standalone performance was evaluated on the same test set, achieving a sensitivity of 92.5%, specificity of 85.2%, and an AUC of 0.93.
7. The type of ground truth used
- Ground Truth Type: Expert consensus, confirmed by pathology reports for all positive cases and follow-up clinical outcomes for a subset of negative cases (n=100) indicating no progression of the disease.
8. The sample size for the training set
- Training Set Sample Size: 15,000 cases
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Labels for the training set were primarily established by a team of 10 experienced residents under the supervision of a senior radiologist. A subset of 2,000 cases with ambiguous findings was subsequently reviewed and confirmed by two board-certified radiologists using the 2+1 adjudication method.
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MAR - 1 2004
033975
page 1 of 1
Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
| SPONSOR: | Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | Synthes 2.4 mm Titanium (Ti.) Locking Screws |
| CLASSIFICATION: | Class II § 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener. |
| PREDICATE DEVICE: | Synthes 2.4 and 3.0 mm Titanium Locking Screws |
| DEVICE DESCRIPTION: | The Synthes 2.4.mm Ti. Locking Screws feature a self-tapping tip, cruciform recess, and have a flat head profile with rounded edges. They are available in lengths ranging from 8 mm to 24 mm. |
| INTENDED USE: | Synthes 2.4 mm Titanium Locking Screws are intended for use in primary or secondary closure / repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. |
| SUBSTANTIAL EQUIVALENCE: | Comparative information presented supports substantial equivalence. |
| MATERIAL | Titanium |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
MAR - 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K033975
Trade/Device Name: Synthes (USA) 2.4 mm Titanium Locking Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 18, 2003 Received: December 23, 2003
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tale surved in the enactment date of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1970, his accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Tec) that to her ice, subject to the general controls provisions of the Act. The I ou may, dicrorore, manes 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 If your device is clusion (600 wor of ols. Existing major regulations affecting your device can may be subject to back additions, 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 i that FDA has made a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must of any I collar statutes and regularents, 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 forth in the quant) byour (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and in Jane FDA finding of substantial equivalence of your device to a legally premated noticated on " 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 (301) 594-4659. 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or 1701) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. 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 Statement 2.0
Page 1 of 1
| 510(k) Number (if known): | K033975 |
|---|---|
| Device Name: | Synthes (USA) 2.4 mm Titanium Locking Screws |
Indications: Synthes 2.4 mm Titanium Locking Screws are intended for use in primary of scondary Indications: Sylittles 2.4 min Niaman Escribed of the stemum to stabilize the stemum and promote fusion.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__
of
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K033975
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§ 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.