(87 days)
Indications for the MicroMax™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow and knee. Specific indications are as follows:
Shoulder Indications:
- Bankart repair
- SLAP lesion repair
- Acromioclavicular (ACL) separation
- Rotator cuff repair
- Capsule repair or capsuloabral reconstruction
- Biceps tenodesis
- Deltoid repair
Wrist Indications:
- Scapholunate ligament reconstruction
Elbow Indications:
- Tennis elbow repair
- Ulnar or radial collateral ligament reconstruction
- Biceps tendon reattachment
- Medial and lateral repairs
Knee Indications (Extra-capsular repair):
- Medial collateral ligament repair
- Lateral collateral ligament repair
- Posterior oblique ligament repair
- Joint capsule closure
- Iliotibial band tenodesis reconstruction
- Patellar ligament/tendon repair
- Vastus medialis obliquus (VMO) muscle advancement
The device is pre-loaded with suture for use at the discretion of the physician.
This device is a resorbable suture anchor designed to attach soft tissue to bone. The resorbable fixation anchor is comprised of L-Lactide / Glycolide material. The poly L-Lactic/polyglycolic acid copolymer 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. The material and rarer degraged into carron anonial and o the predicate device, LactoSorb® L15 Soft Tissue Screw and Washer, K012572.
The suture anchor measures 3.0mm in diameter and 9.0mm in length. It is a two-piece assembly, consisting of a body and a head portion. The body portion engages the bone, which is enhanced by means of seven circumferential ribs. The ribs measure 3.25mm in diameter. In addition, the body has two wings, that when deployed will flange outward into the bone. Upon deployment, the diameter at the flanged wings is 4mm.
The head portion provides a means to drive the anchor in as well as to attach suture to the anchor. The anchor has an eyelet through the head portion to allow suture to pass through which will be used to fasten the tissue to bone. The device will be pre-loaded with any legally marketed, size 2 suture.
Instrumentation is provided for proper use and placement of the device.
Here's an analysis of the provided text regarding the MicroMax™ Suture Anchor, focusing on acceptance criteria and supporting studies:
It is important to note that the provided document is a 510(k) summary for a medical device seeking substantial equivalence to a legally marketed predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a device already on the market, rather than proving efficacy from scratch with extensive clinical trials.
Acceptance Criteria and Reported Device Performance
The document states: "Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices." Implied acceptance criteria would revolve around these mechanical test results demonstrating equivalence.
Given the information, the specific numerical acceptance criteria (e.g., minimum tensile strength, degradation rate, etc.) and the precise reported performance values for the MicroMax™ Suture Anchor are not explicitly detailed in this summary. The summary broadly indicates that the characteristics are "similar to predicate devices."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Implied) | MicroMax™ Suture Anchor Performance (Implied) |
|---|---|
| Material composition and degradation properties | Similar to LactoSorb® L15 (L-Lactide / Glycolide material, degrades by hydrolysis) |
| Device dimensions (diameter, length, rib diameter, flanged diameter) | Matches specified dimensions (3.0mm dia, 9.0mm length, 3.25mm ribs, 4mm flanged) |
| Mechanical properties (e.g., strength, security of fixation) | Passed mechanical testing to establish substantial equivalence to predicate device. (Specific values not provided) |
| Suture compatibility | Pre-loaded with legally marketed, size 2 suture. |
Study Details:
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Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for mechanical testing.
- Data Provenance: Not specified, but generally, mechanical testing data for a 510(k) submission is generated in a laboratory setting, typically in the country where the manufacturer is located (USA in this case). It would be considered prospective data collection for the purpose of the submission.
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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. Mechanical testing does not typically involve human experts in establishing "ground truth" in the same way clinical or image-based studies do. The "ground truth" for mechanical testing is derived from established engineering standards and test methodologies.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for clinical studies or studies involving subjective human assessment. Mechanical testing results are objective measurements.
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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:
- No. This is a medical device for surgical fixation, not an AI-based diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical mechanical testing, the "ground truth" is defined by engineering standards and established test methods that evaluate properties like material degradation, dimensional conformity, and mechanical strength (e.g., pull-out strength, fatigue life, etc., although not explicitly listed in this summary). The comparison is against the performance of the legally marketed predicate device.
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The sample size for the training set:
- Not Applicable. This device did not use a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not Applicable. No training set was used.
Summary of what is present and absent:
- The document clearly states that non-clinical mechanical testing was performed.
- The purpose of this testing was to establish substantial equivalence to a predicate device (LactoSorb® Soft Tissue Screw and Washer, K012572).
- The material (L-Lactide / Glycolide) and general design are explicitly stated to be similar to the predicate.
- No clinical testing was used for this submission to establish substantial equivalence.
- Detailed numerical results of the mechanical tests or the specific acceptance thresholds for those tests are not provided in this summary. This level of detail is typically found in the full 510(k) submission, not the public summary.
- This submission method (510(k)) focuses on equivalence to a previously cleared device, rather than new efficacy claims from a de novo study.
§ 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.