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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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