BONE BULLET SUTURE ANCHOR by LINVATEC CORP.

The Bone Bullet Suture Anchor is a titanium suture anchoring device with an attached coated non-absorbable braided suture size SP #2-0 used to attach soft tissue to bone.

AI/ML Overview

This appears to be a 510(k) premarket notification for a medical device (Bone Bullet Suture Anchor). These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with explicit acceptance criteria and performance metrics in the way a pharmaceutical trial or novel high-risk device might.

Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" will not be directly found in this document, as the regulatory pathway chosen doesn't require such a study for this type of device. The "acceptance criteria" here would be demonstrating substantial equivalence, primarily through material, design, and intended use comparison.

Here's an analysis based on the provided text, addressing the points where information is available and explaining why other points cannot be answered:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The performance is assessed by comparing design features and intended use.

Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance (vs. Predicate)
Intended Use Equivalence:	The Bone Bullet Suture Anchor (new device) has a highly overlapping intended use with the predicate devices (Mini-Revo Suture Anchor and UltraFix MicroMite). The new device is intended for soft tissue to bone fixation in foot, ankle, elbow, wrist, and hand surgical procedures. Both predicates include shoulder and knee indications as well, which the new device does not. This is a dissimilarity but not necessarily a failure of equivalence for the stated indications.
Material Equivalence:	ALL devices (new and predicates) are made of Titanium Alloy. This demonstrates equivalence.
Sterilization Method Equivalence:	ALL devices (new and predicates) use Gamma Radiation for sterilization. This demonstrates equivalence.
Single-Use/Reusable Equivalence:	ALL devices (new and predicates) are Sterile, Single-use. This demonstrates equivalence.
Technological Characteristics Equivalence:
- Design/Dimensions	New Device (Bone Bullet): Length 4.57mm, Diameter 1.3mm.
	Predicate 1 (Mini-Revo): Length 8.89mm, Diameter: 2.8mm (Major), 1.6mm (Minor).
	Predicate 2 (UltraFix MicroMite): Length 3.7mm, Diameter: 1.3mm (undeployed), 2.7mm (deployed).
	Comment: While dimensions differ, they are all small suture anchors designed for similar surgical applications. The FDA found these differences acceptable for substantial equivalence.
Safety and Effectiveness:	The FDA's finding of "substantial equivalence" implies that the device is considered as safe and effective as the predicate devices for its stated indications. No specific quantitative performance metrics related to biological outcomes were provided in this summary. Instead, the focus is on analogous design, materials, and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document. A 510(k) submission for a device like a suture anchor often relies on bench testing, material characterization, and comparisons to predicate devices rather than clinical trials with patient test sets.

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)

This information is not present. Ground truth in the context of clinical studies is not typically established for a 510(k) of this nature. The "ground truth" for the submission is the regulatory precedent set by the predicate devices and the technical comparison presented by the manufacturer.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present, as there is no mention of a clinical test set or adjudication process in this document.

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 information is not present. This type of study is entirely irrelevant for a suture anchor device, which does not involve "readers" or "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not present and is irrelevant for this mechanical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not describe the use of a "ground truth" in the context of a clinical study or diagnostic performance. For this 510(k) submission, the "truth" is established through:

Predicate Device History: The legal marketing history of the predicate devices establishes their safety and effectiveness.
Technical Comparison: Engineering specifications, material data, and intended use comparisons are used to demonstrate that the new device shares fundamental characteristics with its predicates.

8. The sample size for the training set

This information is not present. No training set akin to machine learning or diagnostic algorithm development is described.

9. How the ground truth for the training set was established

This information is not present, as no training set is described.

Summary of what the document does provide:

The provided text is a "Summary of Safety and Effectiveness" from a 510(k) premarket notification for the "Bone Bullet Suture Anchor." The purpose of this summary is to demonstrate substantial equivalence to already legally marketed predicate devices, not to present novel clinical trial data with explicit acceptance criteria related to efficacy outcomes.

The comparison table clearly outlines the key characteristics of the new device against its predicates:

Intended Use: Similar, with the predicate devices having broader indications (shoulder, knee) not claimed by the new device.
Material: Identical (Titanium Alloy).
Sterilization: Identical (Gamma Radiation).
Usage: Identical (Sterile, Single-use).
Design: Dimensions differ, but are within the scope of similar types of devices.

The FDA's letter (K991024) indicates that based on this submission, they found the device "substantially equivalent" to the predicate devices for its stated indications for use. This means they accepted the manufacturer's argument that the device is as safe and effective as the legally marketed predicate devices, without requiring new clinical outcome data or a study directly proving such.

Summary

Regulation Number and Section

§ 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.