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The Lorenz Resorbable Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) when correction of oral (alveolar ridge), cranial, and maxillofacial deficiencies or post-traumatic defects require gradual bone distraction. The Lorenz Resorbable System also includes devices intended for use in bone stabilization and elongation (lengthening) when correction of mandibular deficiencies or post-traumatic defects require gradual bone distraction in patients two (2) years old or younger. The mid-face distractor is indicated primarily for LeFort III osteotomies.

This distractor system is identical to the one cleared in 510(k) Premarket Notification (K002083). This device is composed of the same Lactosorb® end plates and fixation screws, and stainless steel drive screws with the added indication of mandibular distraction. The Mandibular Distractor is the same as our previously cleared Alveolar Ridge Resorbable Distractor (K002083) with the added indication of mandibular distraction. The Alveolar Ridge Resorbable Distractor is an implantable device used to increase the height of the maxilla or mandible or to replace bone in the Alveolar Ridge, used for multiple tooth deficiencies. This device is composed of two resorbable plates and a stainless steel drive screw. Several lengths of drive screw can be selected to achieve up to 25 mm of distraction. The Mandibular Distractor can incorporate either of the two Alveolar Ridge resorbable devices with no design changes. In addition, a third device is included that is identical to the two Mandibular or Ramus lengthening devices with no design changes. Each device is composed of two resorbable Alveolar Ridge resorbable plates and a stainless steel drive screw with permanently attached shaft extension. The devices would be positioned internally with drive screws externalized on the external activated side of the advancement. Complete osteotomy would be completed prior to device placement. Lactosorb plates would be affixed to bone using Lactosorb screws. Distraction would be completed by turning the drive screw using the attached shaft extension, causing the plates to separate. After distraction and consolidation, the drive shaft is detached from the plates and removed while the plates and screws remain internal and are resorbed.

Walter Lorenz Surgical, Inc. manufactures and distributes distraction devices for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxillofacial deficiencies or post traumatic defects require gradual bone distraction. Each implantable distraction device has a titanium alloy drive screw mechanism and LactoSorb® resorbable connection plates, which are implanted by fixation with LactoSorb® bone screws. Each device is made from one of the following material(s): LactoSorb®, Titanium 6Al 4V Alloy, ASTM F-136, Stainless Steel, ASTM F-138. LactoSorb® is a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into lactic and glycolic acids that are then metabolized by the body.

This document is a 510(k) Premarket Notification for the Lorenz Resorbable Distraction System, which means it's a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It is not a clinical study report that establishes performance criteria through testing and provides acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as this information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a previously cleared device (K002083 and others) rather than presenting new performance data from a specific study.

The document states:

• "This distractor system is identical to the one cleared in 510(k) Premarket Notification (K002083)." (Page 0)
• "The Mandibular Distractor is the same as our previously cleared Alveolar Ridge Resorbable Distractor (K002083) with its added indication of mandibular distraction." (Page 0)
• "Lactosorb® Biocompatibility has been provided by 510(k) notifications for use in bone plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K981666, K960988) for cranial and maxillofacial use." (Page 0)
• The "Substantial Equivalence" section lists other Lorenz Distraction Systems and Resorbable Fixation Screws and Plates as comparators. (Page 1)

These statements indicate that the submission relies on the established safety and effectiveness of the predicate devices. The listed "RELATED ARTICLES" are general academic papers on distraction osteogenesis and resorbable fixation, not specific studies conducted by the manufacturer for this particular 510(k) submission to establish new performance metrics.

In summary, the provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or ground truth for a test set.
3. Details about expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
4. Information on training set size or how its ground truth was established, as this is not a machine learning device.

The document is a regulatory submission demonstrating equivalence, not a detailed technical report of a performance study.

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The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures.
A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:

1. Comminuted fractures of the naso-ethmoidal infraorbital areas
2. Comminuted fractures of the frontal sinus wall
3. Pediatric midface or craniofacial trauma
4. LeFort (I, II, II) fractures
5. Orbital floor fractures
6. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones.
7. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
   B. General Indication: reconstructive procedures of the midface or craniofacial Skeleton
   Specific Indications:
8. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
9. LeFort (I, II, II) osteotomies
10. Tumor reconstruction in midface or craniofacial procedures
11. Bone graft procedures in the midface or craniofacial skeleton
12. Pediatric reconstructive procedures
13. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
14. Craniotomy flap fixation
    This system is not designed for use in the mandible and/or full load bearing procedures.

The device is a screw having a non-threaded pin portion and a head portion. The Lactosorb® Tap Free Screw is designed with a slight helical groove that is cut into the major diameter. The head geometry, drive mechanism, major diameter, and tip geometry of the 1.5 x 4 mm Tap Free Screw is identical to that of the 1.5 x 4 mm Direct Drive Screw (K971870). The only difference between the two screws is the "thread" form.
Although the tap free screws are similar in design to the standard Lactosorb® direct drive screws (K971870), they function more like the Lactosorb® Push Screws (K002423). The push screws are designed with barbs that are pushed into a drilled hole that is slightly smaller than the diameter around the barbs. This press fit holds the push screw is place and provides adequate fixation. The tap-free screws are implanted by rotating the screws into a hole that is slightly smaller than the major diameter of the screws. The press fit between the implant and the hole provides the fixation.
Material: Lactosorb® (resorbable copolymer) - a polyester derivative of lactic and glycolic acids
Lactosorb® is made of 82% L-Lactide/18% Glycolide copolymer that degrades by hydrolysis into L-Lactic and glycolic acids. These hydrolytic products are then further degraded into carbon dioxide and water via the cellular Krebs cycle. Lactosorb® has been previously cleared by 510(k) notifications for use in bone plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K002423, K981666, K960988) for cranial and maxillofacial use.
The modifications made to this device are not anticipated to significantly affect its safety and effectiveness.

The provided document is a 510(k) premarket notification for a medical device, the Lorenz Lactosorb® 1.5 mm x 4 mm Tap Free Screw. It details the device's indications for use, description, and the materials it's made from. It also includes the FDA's letter of substantial equivalence.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with predefined acceptance criteria. The document explicitly states: "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..."

Therefore, I cannot provide the requested information from the given text. A robust study proving the device meets acceptance criteria and detailed performance metrics are typically part of a Premarket Approval (PMA) application or a more extensive clinical trial, neither of which appears to be documented here.

If this were a typical AI/ML device approval, such information would be mandatory. However, for this type of mechanical medical device, the focus of a 510(k) is heavily on demonstrating similarity to already approved devices.

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The BioSorb® SR-PDLA Endobrow Screw is intended for use in Endoscopic Browplasty surgery. The Endobrow Screw will be specifically indicated for use to reattach the subdermis to the cranial bone in endoscopic browplasty procedures. The Endobrow Screw is used as a post to tie an absorbable suture to the subdermis. In conjunction with adequate surgical technique, the Endobrow Screw holds the subdermis securely in place to allow for reattachment to the cranial bone. Use absorbable sutures that provide wound support for at least thirty (30) days.

The BioSorb® SR-PDLA Endobrow Screw is a biodegradable threaded fixation rod intended for use in endoscopic browplasty surgery. It is used as a post to tie an absorbable suture to the subdermis to reattach it to the cranial bone. The screw is inserted into the cranial bone after a drill hole is made. It is constructed of a blended copolymer of SR-PDLA.

This document is a 510(k) summary for the BioSorb® Biodegradable Threaded Endobrow Screw. It is a submission to the FDA seeking clearance to market the device based on its substantial equivalence to previously cleared predicate devices.

Based on the provided text, the document does not contain acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This means that instead of conducting a de novo study with strict acceptance criteria and performance metrics, the manufacturer is asserting that their device is as safe and effective as devices already on the market.

Therefore, many of the requested points regarding acceptance criteria, specific performance metrics, sample sizes for testing and training, expert ground truthing, and MRMC studies are not applicable or not provided in this type of regulatory submission.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not provided. The document is a 510(k) submission, which relies on demonstrating substantial equivalence to predicates rather than presenting de novo performance data against specific acceptance criteria for the new device. It discusses "technical characteristics" in comparison to predicates but doesn't set specific, quantitative performance targets for the BioSorb® screw itself and then show data meeting those targets.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. No specific test set data is presented. The submission relies on the established safety and efficacy of the predicate devices.

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)

• Not applicable / Not provided. No specific test set with ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. No test set or adjudication method is described.

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 / Not provided. This device is a physical medical implant, not an AI or imaging device with readers. Therefore, an MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not provided. This is a physical implant; the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. No specific ground truth establishment is described for performance testing of this device. The "ground truth" for this submission is essentially the legally marketed status and presumed safety/effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable / Not provided. No training set for a new algorithm or device development is mentioned.

9. How the ground truth for the training set was established

• Not applicable / Not provided. As no training set is mentioned, its ground truth establishment is also not applicable.

Summary of what the document does provide in relation to "proving" substantial equivalence:

The "study that proves the device meets acceptance criteria" in this context is the comparison to predicate devices and the argument of substantial equivalence, which is the core of a 510(k) submission.

• Basis for Substantial Equivalence: The primary "proof" is the detailed comparison of the BioSorb® SR-PDLA Endobrow Screw to four predicate devices:

  • Techmedica, Inc. TMP Micoplate System (K921458)
  • W. Lorenz Surgical, Inc. LactoSorb® System (K955729)
  • Bionx Implants, Inc. BIOFIX® SR-PLLA Threaded Rod (K952871)
  • Synthes, Inc. PDLA Polypin (K961608)

• Key Arguments for Equivalence (and implied "performance"):

  • Intended Use: The BioSorb® screw shares the same intended use (endoscopic browplasty surgery, reattaching subdermis to cranial bone) as some predicates. Even where specific indications differ slightly (e.g., holding a bone fixation plate vs. holding sutures), the underlying surgical procedure and anatomical site are similar.
  • Principles of Operation: They share similar operational principles (insertion into cranial bone for fixation).
  • Technical Characteristics:
    • Diameter: All are 2.0 mm in diameter (though predicates may offer other sizes).
    • Material: It is made of SR-PDLA. The Lorenz screw is bioabsorbable (PLA-PGA copolymer with similar degradation). The Synthes Polypin uses a blended copolymer, and FDA has recognized similar physical properties and biocompatibility of PLLA, PGA, and polydioxanon (which includes PDLA).
    • Degradation: BioSorb® screw degrades by hydrolysis over 12-24 weeks in vivo, with complete reabsorption in 2-4 years. The Lorenz predicate has a similar degradation period.
    • Self-tapping: Neither BioSorb® nor Lorenz screws are self-tapping.
    • Surgical Instruments: Uses the same instruments as the previously cleared 2.0 mm BIOFIX® SR-PLLA Threaded Rod.
    • Function: While some predicates hold bone plates, the BioSorb® screw's function (holding sutures for soft tissue approximation) is argued to be "less demanding" than fixing "low load" fractures (like the Polypin).
  • Safety/Effectiveness: The submission argues that "The minor differences in the technical characteristics of the devices, such as differences in the configuration, do not raise new questions of safety or effectiveness." This statement is the crux of the 510(k) "proof."

In conclusion, this document is a regulatory submission for premarket clearance based on substantial equivalence, not a scientific publication detailing a conventional study with quantifiable acceptance criteria for de novo device performance.

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