(71 days)
The KFx Knotless Fixation System and Accessory Targeting Grasper are intended for the fixation of soft tissue to bone during rotator cuff repair.
The KFx Knotless Fixation System consists of:
- . KFx Nail Bone Anchor with two suture leads, mounted to a single use handle
- KFx Suture Lock Bone Screw Anchor mounted to a single use handle .
- Optional KFx Targeting Grasper. .
Here's an analysis of the provided text regarding the KFx Knotless Fixation System's acceptance criteria and studies:
The provided documents do not detail specific quantitative acceptance criteria or a dedicated study proving the device meets those criteria in a typical AI/software-as-a-medical-device (SaMD) context. Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, which is a common regulatory pathway for many medical devices that are not SaMDs.
Therefore, many of the requested points related to AI performance, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Met specifications, does not raise new issues of safety. Materials are biocompatible, identical to predicate devices and commonly used in similar medical devices. |
| Effectiveness | Met specifications, does not raise new issues of effectiveness. Intended use, design, and technology characteristics are substantially equivalent to existing FDA-cleared suturing devices. |
| Biocompatibility | Materials are biocompatible, identical to those in identified predicates and commonly used in similar medical devices. |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "physical bench testing." The results of this testing were used to demonstrate that the KFx Knotless Fixation System meets its specifications and does not raise new issues of safety or effectiveness.
Detailed Information (as applicable)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. "Physical bench testing" does not typically refer to patient data or a test set in the same way an AI model would have one. It refers to a series of mechanical or functional tests on the device itself.
- Data Provenance: Not applicable in the context of patient data. The tests were performed on the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device, not an AI/SaMD. "Ground truth" in this context would likely refer to engineering specifications or industry standards against which the bench tests were measured, not expert-labeled data.
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Adjudication method for the test set:
- Not applicable.
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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 physical medical device, not an AI system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an AI algorithm.
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The type of ground truth used:
- For the physical tests, the "ground truth" would be the pre-defined engineering specifications and performance standards for bone anchors and fixation systems (e.g., tensile strength, fixation strength, design tolerances). The document only broadly states the device "meets its specifications."
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The sample size for the training set:
- Not applicable. This is a physical device, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. This is a physical device.
Summary from the provided documents:
The KFx Knotless Fixation System gained clearance based on a 510(k) pathway, which relies on demonstrating substantial equivalence to already legally marketed predicate devices. The primary evidence presented for safety and effectiveness is:
- Physical bench testing to show the device "meets its specifications" and prevents new safety/effectiveness concerns.
- Biocompatibility assessment by confirming the use of materials identical to those in predicate devices and commonly used in similar medical devices.
- Comparison of intended use, design, and technology to predicate devices.
The document does not contain the type of detailed statistical study, expert consensus, or performance metrics that would be relevant for an AI/SaMD device's acceptance criteria and validation.
§ 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.