(193 days)
The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones.
Leforte system bone screw is made of Titanium alloy (ASTM F136) and consists of common bone screw, self-drilling screw (auto screw) and dual head screw. The common bone screws are classified to 4 classes; Micro screw, Mid screw, Mini screw, Maxi screw. This device is manufactured and intended for small bone (toe, foot, finger, hand etc.) and mandibulofacial (mandible & Maxilla) fracture fixation. Also This device is intended for reconstruction & stabilization of small bone and mandibulofacial (mandible & Maxilla)
The provided text is a 510(k) summary for the Jeil Medical Corporation's "Leforte System Bone Screw." This document describes the device, its intended use, and compares it to legally marketed predicate devices to establish substantial equivalence.
However, the document does not describe a study with acceptance criteria and device performance results in the way typically expected for a clinical or performance study of an AI/software device. Instead, it focuses on demonstrating equivalence to existing hardware devices based on material, design, and intended use.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the information provided in this 510(k) summary.
I will fill in the available information and explicitly state when a requested piece of information is not present in the provided text.
Acceptance Criteria and Study Details for Leforte System Bone Screw
This 510(k) summary for the Jeil Medical Corporation's Leforte System Bone Screw focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria in the context of an AI/software device. The "acceptance criteria" here are implicitly met by demonstrating that the device is made of the same materials and has similar dimensions, characteristics, and intended use as legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a hardware device seeking substantial equivalence, specific quantitative "acceptance criteria" and "device performance" metrics typically associated with AI/software studies (like sensitivity, specificity, F1-score) are not provided. Instead, the "performance" is assessed by comparison to predicate devices across key attributes.
| Criteria/Attribute (Implicit Acceptance Criteria: Equivalent to Predicate) | Predicate Devices (Twist off™ Screw, Aesculap Titanium Alloy Bone Screws, K3 Bone Screw System) Performance/Characteristics | Reported Device Performance/Characteristics (LeForte System Bone Screw) |
|---|---|---|
| Device Classification Name | Screw, Fixation, Bone (for Aesculap); Smooth or Threaded Bone Fixation Fastener (for K3) | Screw, Fixation, Bone |
| Material | Titanium Alloy (ASTM F136-84 for K3) | Titanium Alloy (ASTM F 136-98) |
| Intended Use | Fixation of fracture, fusion of a joint or Bone (Twist off™); Long & small bone fracture fixation (Aesculap); Fixation/stabilization of small bones in hand or small bones in mid & forefoot (K3) | Fracture fixation, reconstruction & stabilization of small bones (toe, foot, finger, hand) and mandibulofacial (mandible & Maxilla) bones |
| Supplied Sterile? | No Comment (for all predicates) | Non sterile, steam sterilize before use |
| Design/Function | Not explicitly detailed for predicates, but implied similar based on conclusion | Common bone screw, self-drilling screw (auto screw), dual head screw; classified into Micro, Mid, Mini, Maxi screws. |
| Potential Adverse Effects | Identical to those of predicate devices | Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, infection, loosening, bending, cracking, fracture, nonunion, delayed union, migration, metal sensitivity, allergic reaction, stress shielding, pain, discomfort, abnormal sensation, increased fibrous tissue response, necrosis of bone, inadequate healing. |
Conclusion from the document: "In all respects, the Leforte System Bone Screws are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of predicate devices."
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable. This summary does not describe a clinical or performance test set for evaluating the device against ground truth data. The "test" is the comparison against existing, legally marketed predicate devices.
- Data Provenance: Not applicable. The "data" here refers to descriptions and specifications of the predicate devices and the proposed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on diagnostic or clinical outcomes, is not established as part of this submission's comparison. The "ground truth" for substantial equivalence is the regulatory clearance status and characteristics of predicate devices.
- Qualifications of Experts: Not applicable.
4. Adjudication method
- Adjudication Method: Not applicable.
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: No. This is a hardware device (bone screw), not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is not an algorithm or AI device.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the established regulatory status, material specifications, and intended uses of the identified predicate devices (Twist off™ Screw, Aesculap Titanium Alloy Bone Screws, K3 Bone Screw System). The LeForte System Bone Screw demonstrates "substantial equivalence" to these devices.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. There is no "training set" as this is a hardware device, not a machine learning model.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable.
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KC23365 Page V3
EXHIBIT 2. 510(K) SUMMARY
APR 1 8 2003
Jeil Medical Corporation 808, ACE Techno-Tower, 3rd 197-48, Kuro 3Dong Kuro-ku, Seoul, KOREA Telephone : 82-2-2109-6781~9 Fax: 82-2-2109-6791 January 30, 2002 Contact: N.K.Kim, R&D Director 510(k) Summary
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- Identification of the Device: Proprietary-Trade Name: Leforte System Bone Screw Classification Name: Screw, Fixation, Bone, Product Code HWC Common/Usual Name: Bone Screw
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- Indications for Use (intended use) . The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones
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- Description of the Device: Leforte system bone screw is made of Titanium alloy (ASTM F136) and consists of common bone screw, self-drilling screw (auto screw) and dual head screw. The common bone screws are classified to 4 classes; Micro screw, Mid screw, Mini screw, Maxi screw. This device is manufactured and intended for small bone (toe, foot, finger, hand etc.) and mandibulofacial (mandible & Maxilla) fracture fixation. Also This device is intended for reconstruction & stabilization of small bone and mandibulofacial (mandible & Maxilla) Jeil Medical Corporation utilizes the state of the art technology and apply the essential requirement of MDD (93/42/EEC) and ISO 14630, 1997 from the device design to manufacturing and QC ...
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- Potential Adverse Affects and Complications: (Common to all devices of this type)
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- Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, . or infection can cause loosening, bending, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
- Nonunion or delayed union which may lead to breakage of the implant. ●
- Migration, bending, fracture or loosening of the implant. .
- . Metal sensitivity, or allergic reaction to a foreign body:
- Decrease in bone density due to stress shielding. .
- Pain, discomfort, or abnormal sensation due to the presence of the device. .
- Increased fibrous tissue response around the fracture site and/or the implan". ●
- Necrosis of bone. ●
- Inadequate healing.
Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant
| Device Name | Twist off™Screw | AesculapTitaniumAlloy BoneScrews | K3 Bone ScrewSystem | Le forte System(Bone Screw) |
|---|---|---|---|---|
| DeviceClassificationName | No Comment | Screw, Fixation,Bone888.3030 | Smooth or ThreadedBone FixationFastener | Screw, Fixation, Bone888.3040 |
| Applicant | Medinov-AMP | Aesculp, Inc. | KMI(Kinetikos MedicalInc.) | Jeil MedicalCorporation |
| 510(K) Number | K971069 | K970549 | K960533 | (This submission) |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy(Ti-6Al-4V ELIAlloy: ASTM F136-84) | Titanium Alloy(ASTM F 136-98) |
| Intended use | Fixation offracture, fusionof a joint orBone | Long & smallbone fracturefixation | Fixation/stabilizationof small bones inhand or small bonesin mid & forefoot | Small bone andmandibulofacial(mandible & Maxilla)fracture fixation |
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- Comparisons to predicate devices:
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| reconstruction ofthe carpals,metacarpals &phalanges of thehand | fractures | reconstruction &stabilization of smallbone andmandibulofacial(mandible & Maxilla) | ||
|---|---|---|---|---|
| Supplied Sterile? | No Comment | No Comment | No comment | Non sterile, steamsterilize before use |
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- Conclusion: In all respects, the Leforte System Bone Screws are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of predicate devices. This device is manufactured from material of titanium alloy (ASTM 136-97) that is used generally in this kind of bone screw. Similar devices made from titanium alloy (ASTM 136-97) to this device are manufactured and sold around the world. This device, Le forte system bone screw is substantially equivalent in design, material, intended use and function to the products on the table above. These devices are certificated by notified body for CE.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20:350
APR 1 8 2003
Jeil Medical Corporation c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K023365
Trade Name: LeForte System Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 3, 2003 Received: February 4, 2003
Dear Mr. Kamm:
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 set forth in the quality systems (OS) 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 - Mr. Daniel Kamm, P.E.
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 (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 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/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Mark N Millman
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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j) Indications for Use
K023365 510(k) Number_
Device Name: LeForte System Screws (various models)
"The Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones."
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × OR (Per 21 CFR 801.109)
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Mark N Mlkern
for Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
10(k) Number K023365
§ 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.