(90 days)
The ALLthread PEEK Suture Anchor devices are intended for soft tissue fixation.
The ALLthread PEEK Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
The ALLthread PEEK Suture Anchors are soft tissue anchors with preloaded nonabsorbable polyethylene surgical sutures used to repair and reattach soft tissue to bone and are supplied in both double and triple loaded suture configurations. The ALLthread PEEK Suture Anchors are designed to reattach soft tissue to bone in procedures in the shoulder.
The purpose of this submission is: To submit a 510(k) for cumulative changes: Line extension including device configurations with 2 or 3 suture options, a white/black suture option, a white/green suture option and a tapered needle option. To update labeling in order to narrow the Indications for Use statements, describe the third suture options, and bring the Instructions for Use up to current practices; To ensure that the all of the instrumentation/accessories for use with this system are appropriately associated with a 510(k).
The provided text describes a 510(k) premarket notification for a medical device called the ALLthread PEEK Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for an AI/algorithm-based diagnostic device.
However, based on the information provided, I can extract details about the performance testing conducted and how it relates to demonstrating the device's safety and effectiveness.
Here's an attempt to structure the information according to your request, adapting it to the nature of the device and the provided document:
Device: ALLthread PEEK Suture Anchor
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Suture Tensile Strength: Verification of the strength of the preloaded sutures. | "The test results indicate that the device modifications do not introduce any new risks to implant performance." (Implies the tensile strength is satisfactory and comparable to predicate, meeting safety and effectiveness requirements). |
| Cyclic Loading: Verification of the cyclic performance of the threaded anchor implant. | "The test results indicate that the device and accessory modifications do not introduce any new risks to implant performance." (Implies satisfactory cyclic performance, meeting durability and safety requirements). | |
| Static Load (Pull-out Strength): Verification of the pull-out strength of the device. | "The test results indicate that the device and accessory modifications do not introduce any new risks to device performance." (Implies satisfactory pull-out strength, ensuring secure fixation). | |
| Insertion Torque: Verification of the measured insertion torque of the anchors and taps. | "The test results indicate that the device and accessory modifications do not introduce any new risks to device performance." (Implies controllable and safe insertion, minimizing surgical complications). | |
| Needle Attachment Strength: Verification of the minimum force required to detach the suture from the needle. | "The test results indicate that the device and accessory modifications do not introduce any new risks to device performance." (Implies secure needle attachment, preventing premature detachment during surgery). | |
| Biocompatibility/Safety | Bacterial Endotoxins Test (BET) per ANSI/AAMI ST 72:2011: To demonstrate that the device meets pyrogenicity limits as part of cleaning validation. Acceptance Limit: ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter Medical Devices. | "demonstrating that the device meets the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter Medical Devices -Bacterial Endotoxin and Pyrogen Tests." (Explicitly states the device meets the specified acceptance criterion for endotoxins, confirming a critical safety aspect related to sterility and patient infection risk). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. The document mentions "test results indicate that the device modifications..." implying that the tests were conducted on a sample of the ALLthread PEEK Suture Anchors and their components.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). These are non-clinical tests performed in a laboratory setting, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this type of device and study. The "ground truth" for the non-clinical tests (like tensile strength or cyclic loading) is based on engineering specifications, industry standards, and established physical properties, not expert consensus on medical images or patient outcomes. The tests verify adherence to pre-defined performance characteristics.
4. Adjudication method for the test set
- This question is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple experts for interpreting medical data, which is not the nature of these mechanical and biological safety tests.
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
- This question is not applicable. This is a physical orthopedic implant (suture anchor), not an AI/algorithm-based diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used
- The "ground truth" for these performance tests is defined engineering specifications, material properties, and regulatory standards (e.g., tensile strength limits, cyclic loading cycles, endotoxin limits). The tests demonstrate compliance with these objective, measurable standards.
8. The sample size for the training set
- This question is not applicable. This is not an AI/machine learning device that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices.
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set for this device.
Summary of the Study:
The document describes a series of non-clinical bench tests (mechanical and biocompatibility) performed on the ALLthread PEEK Suture Anchor. These tests were conducted to verify that specific design modifications (e.g., line extension, new suture options) and accessories do not introduce new risks and that the device maintains comparable performance to its predicate devices. The "study" here is a set of engineering and safety validation tests aimed at demonstrating "substantial equivalence" for regulatory clearance. The acceptance criteria are implicit in the statement that "test results indicate that the device modifications do not introduce any new risks to implant performance" and explicitly stated for the Bacterial Endotoxins Test. No clinical data or human studies were provided.
§ 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.