(163 days)
The 2.8mm and 3.5mm BioROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:
SHOULDER
- Repair of rotator cuff tears
- Capsular instability
- Slap lesion repair
- Acromio-clavicular separation
- Capsule shift/capsulolabral reconstruction
- Biceps tenodesis
- Deltoid repair
KNEE - Extra-capsular repairs, and reattachment of medial collateral ligament, lateral ligament, posterior oblique ligament, joint capsule closure.
- Patellar ligament and tendon avuision repairs.
- Extra-capsular reconstruction, ITB tenodesis
ANKLE - Lateral instability
- Medial instability
- Achilles tendon reconstruction and repair
- Mid-foot reconstructions
FOOT - Hallux valgus reconstruction
ELBOW - Tennis elbow repair
- Biceps tendon reattachment
- Medial and lateral repairs
The BioROC EZ suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.
In addition to the Fastener, a stainless steel drill and drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.
The Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.
This document describes a 510(k) submission for the Innovasive 2.8mm and 3.5mm BioROC EZ Suture Bone Fastener, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive performance data as would be seen for novel devices. Therefore, the information you've requested regarding acceptance criteria and detailed study breakdowns for AI/software devices is not present in this document because it's a different type of medical device submission (a physical fastener) and predates the widespread use of AI in medical imaging interpretation.
Here's a breakdown of the available information based on your request, highlighting what is and isn't applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For the BioROC EZ Suture Bone Fastener, the "acceptance criteria" and "performance" are framed in terms of demonstrating equivalence to existing predicate devices.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device should perform its intended function of reattaching soft tissue to bone. | Demonstrated efficacy and adequate functioning for intended use. |
| Material Equivalence: Material properties should be suitable for the intended use and comparable to predicate devices in relevant aspects (e.g., biocompatibility, degradation profile if applicable). (Implied, as the new device uses L-PLA which is a resorbable polymer, while the predicate uses non-resorbable polymers). | BioROC EZ is comprised of L-PLA, a different material than the predicate's polyethylene and acetyl plastic. The submission likely addressed biocompatibility of L-PLA, which is a known biodegradable polymer used in medical devices. |
| Mechanical Strength (Holding Strength): Device should have comparable or superior holding strength in bone to the predicate device. | Bone Model Testing: "The Innovasive BioROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device." |
| Biological Response/Efficacy: Device should not cause adverse biological reactions and should effectively facilitate soft tissue reattachment. | Animal Testing: "The testing demonstrated the efficacy of the Innovasive BioROC EZ Suture Bone Fastener and confirmed that the device functions adequately to meet its intended use." |
| Deployment Mechanism: The deployment mechanism should be effective and comparable in principle to the predicate (radial compression/expansion). | BioROC EZ uses "an expander fitted on a shear pin which is drawn up into an expandable sleeve. The sleeve expands as the expander is drawn up into it. The shear pin then shears resulting in the device being fixed into the bone site," which is described as similar to the predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size (Bone Model Testing): Not specified.
- Sample Size (Animal Testing): Not specified.
- Data Provenance: The studies were conducted by the manufacturer, Innovasive Devices, Inc., and submitted to the FDA in the USA. They are retrospective to the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a physical bone fastener, not an AI or imaging device requiring expert ground truth for interpretation. The "ground truth" for this type of device is its physical performance (e.g., holding strength) and biological compatibility/efficacy, assessed through engineering tests and animal studies.
4. Adjudication method for the test set
This section is not applicable for the reasons stated above.
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 section is not applicable as the device is a physical bone fastener and not an AI-assisted diagnostic or interpretive tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical bone fastener and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this physical device was established through:
- Controlled Mechanical/Engineering Testing: For the "ultimate holding strength" using a "bone model." This involves objective measurements of force.
- In-vivo Biological Observation/Efficacy: Through "Animal Testing," demonstrating the device's function and efficacy in a living system. This would typically involve histological analysis, gross observations, and clinical assessments by veterinary professionals.
8. The sample size for the training set
This section is not applicable as the device is a physical bone fastener and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated above.
Summary regarding AI/Software relevance:
It's crucial to understand that the provided document is a 510(k) summary for a physical medical implant (a suture bone fastener) submitted in 1997. The requirements and types of studies for such a device are fundamentally different from those for AI/software as a medical device (SaMD). The concepts of "acceptance criteria," "test set," "ground truth," "experts," "adjudication," "MRMC studies," "standalone performance," and "training set" as you've defined them are primarily relevant to SaMD, particularly those involving image interpretation or clinical decision support where AI performance needs to be evaluated against human expertise or definitive diagnoses. This document fulfills the requirements for a physical device seeking substantial equivalence based on material properties, mechanical performance, and biological efficacy, as was typical for the regulatory environment of the late 1990s.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.