(123 days)
The Resorbable No Profile Screw and Washer is indicated for the following procedures:
- ACL and PCL reconstruction
- Medial collateral ligament repair
- Lateral collateral ligament repair
- Posterior oblique ligament repair
- Iliotibial band tenodesis reconstruction
- Patellar ligament and tendon repair
This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.
The Resorbable No Profile Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer. This device is comprised of a PLLA/PGA copolymer. The device was designed to be used in conjunction with marketed devices such as resorbable or allograft interference screws in ACL reconstruction. The purpose of this back-up fixation will be to provide additional fixation strength in instances of questionable bone quality.
The provided 510(k) summary for the "Resorbable No Profile Screw and Washer" explicitly states:
"Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices."
Therefore, the device's acceptance criteria were based on non-clinical testing. Below is an interpretation of the available information based on the typical requirements for a 510(k) submission, particularly when clinical data is absent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance (Inferred from "Summary of Technologies" and "Non-Clinical Testing") |
|---|---|---|
| Biocompatibility | The safety of the PLLA/PGA copolymer material in biological environments must be demonstrated. (Typically, this involves ensuring the material is non-toxic, non-allergenic, non-pyrogenic, and does not cause adverse biological reactions). | Implied that the PLLA/PGA copolymer used in the "Resorbable No Profile Screw and Washer" is "similar to or identical to the predicate devices" in terms of materials. This suggests that the biocompatibility has been established for similar materials in existing legally marketed devices. |
| Mechanical Strength | The screw and washer must exhibit sufficient mechanical strength (e.g., tensile strength, torsional strength, bending strength, pull-out strength, fatigue strength) to withstand physiological loads for the duration of the healing process, comparable to or better than predicate devices. | "Mechanical testing was performed to establish substantial equivalence to the predicate devices." This implies that the device's mechanical properties met the performance standards demonstrated by the predicate devices. The specific values are not provided in this summary, but they would have been within the 510(k) submission. |
| Degradation Profile | As a resorbable device, its degradation characteristics (rate of resorption, products of degradation) must be well-characterized and shown to be safe and predictable, and comparable to or better than predicate devices made of similar materials. | "This device is comprised of a PLLA/PGA copolymer." This material is known for its resorbable properties. The statement "similar to or identical to the predicate devices" in terms of materials suggests that the degradation profile is also considered equivalent to established devices. |
| Dimensional Conformity | The specified dimensions (e.g., screw diameter, length range, washer diameter) must be consistently manufactured according to specifications. | "The Resorbable No Profile Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer." This indicates the specified dimensions. Conformance to these dimensions would have been verified through manufacturing quality controls and potentially inspection. |
| Sterility | The device must be supplied sterile, and its packaging must maintain sterility until the point of use. (Typically demonstrated via validated sterilization methods and packaging integrity tests). | Not explicitly mentioned but is a standard requirement for implantable devices. Implied to be met, likely through established sterilization methods comparable to predicate devices. |
| Packaging & Labeling | Labeling must be clear, accurate, and include all necessary information (e.g., indications for use, warnings, contraindications, instructions for use). Packaging must protect the device during transport and storage. | The 510(k) process reviews labeling as part of substantial equivalence. The provided document details the indications for use, device description, and contact information, essential for compliant labeling. |
| Functional Equivalence | The device must function as intended for its stated indications for use, demonstrating equivalence in performance to predicate devices for its primary and proposed secondary use (back-up fixation). | The "Summary of Technologies" states that the "technological characteristics (materials, design, sizes, and indications) are similar to or identical to the predicate devices." This implies functional equivalence was established through comparison to the predicate devices, supported by the mechanical testing. The additional indication for "back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality" suggests it functions effectively in this role. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The submission explicitly states "Clinical testing was not used to establish substantial equivalence to predicate devices." For non-clinical (mechanical) testing, sample sizes would typically be determined by statistical methods or industry standards for specific tests (e.g., ISO standards for biomaterials). This information is not provided in the summary.
- Data Provenance: Not applicable for clinical data. For non-clinical data, it would typically be generated in a lab setting (e.g., Biomet's own labs or contract testing labs). The document does not specify the origin of the mechanical test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical testing was performed, so no expert ground truth was established for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical testing was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. No clinical testing or human reader studies were mentioned or conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/algorithm device. It is a physical medical device (screw and washer).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" or reference for acceptance would be established engineering specifications, mechanical properties of predicate devices, and relevant ISO/ASTM standards for medical implants.
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/algorithm device that requires a training set.
In summary: The "Resorbable No Profile Screw and Washer" received 510(k) clearance based on substantial equivalence primarily demonstrated through non-clinical (mechanical) testing and a comparison of technological characteristics (materials, design, sizes, indications) to legally marketed predicate devices. No clinical studies or human performance evaluations were conducted or required for this particular submission.
§ 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.