(50 days)
The BONE-LOK™ HP Washer is an accessory intended for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System, in the general management of fractures and reconstructive surgery.
The BONE-LOK™ HP Washer is intended for use with BONE-LOK™ HP Cannulated Helical Compression Anchor System in the general management of fractures and reconstructive surgery. The washer provides a bearing surface for the screw head against the bone and also prohibits migration of the screw head into the cortex.
The BONE-LOK™ HP Washer is fabricated from Titanium 6AI-4V ELI, which meets the requirements of ASTM-136.
The BONE-LOK™ HP Washer is provided "NON-STERILE" and will require subsequent sterilization on site. The BONE-LOK™ HP Washer will be supplied as a part of the BONE-LOK™ HP Instrument Kit or as individual units packaged in a labeled poly bag. The Instrument Kit is distributed in a custom autoclavable compartmentalized tray with a locking lid. Both the BONE-LOK™ HP Washer and the Instrument Kit may be sterilized by moist heat. The sterilization validation method is in conformance with international standards (EN 554 and ISO/ANSI/AAMI 11134). Sterilization instructions are included in the Instructions for Use.
Here's an analysis of the provided text regarding the BONE-LOK™ HP Washer, focusing on acceptance criteria and supporting studies:
This medical device submission (K040250) is for a mechanical washer, not a software or AI-powered device. Therefore, many of the typical acceptance criteria and study components you'd expect for an AI/software device (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.
The acceptance criteria for a mechanical device like this often revolve around material properties, mechanical performance, and biocompatibility, typically demonstrated through in vitro testing or by leveraging existing knowledge about similar devices and materials.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from description) | Reported Device Performance (from text) |
|---|---|---|
| Material Composition | Fabricated from a biocompatible surgical-grade material suitable for implants. | Fabricated from Titanium 6Al-4V ELI, meeting ASTM-136 requirements. |
| Mechanical Functionality | Provides a bearing surface for a screw head against bone; Prohibits migration of the screw head into the cortex. | The BONE-LOK™ HP Washer "sole function... is to provide a bearing surface for the screw head against the bone and prohibit migration of the screw head into the cortex." |
| Design/Construction | Similar in basic design and construction to predicate devices. | "The BONE-LOK™ HP Washer is similar in basic materials, design, construction and mechanical performance to the predicate devices." |
| Intended Use | Suitable for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System in general management of fractures and reconstructive surgery. | "Intended for use with the BONE-LOK™ HP Cannulated Helical Compression Anchor System in the general management of fractures and reconstructive surgery." (Matches description of predicate) |
| Biocompatibility | Biocompatible and inert in the human body. | "Made from Titanium 6Al-4V ELI, which meets the requirements of ASTM-136. This material is currently being utilized in a myriad of legally marketed devices. Because its inertness and biocompatibility has already been established, additional testing is not required." |
| Sterilization | Capable of effective sterilization by moist heat. | "Provided 'NON-STERILE' and will require subsequent sterilization on site... may be sterilized by moist heat. The sterilization validation method is in conformance with international standards (EN 554 and ISO/ANSI/AAMI 11134)." |
Study Details (as applicable to this type of device)
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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)
- Not applicable in the sense of a test set for a software/AI device. The "testing" here refers to the inherent properties of the material and the established history of use for this type of device and material. No specific "test set" of cases or data is mentioned.
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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. There is no "ground truth" establishment in the context of image interpretation or diagnostic accuracy for this mechanical washer. The "truth" is based on material specifications and mechanical function.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is relevant for this type of device submission.
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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
- Not applicable. This is a mechanical washer, not an AI or software device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical washer, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the traditional sense. The "ground truth" for this device's safety and effectiveness is derived from:
- Material specifications: ASTM-136 for Titanium 6Al-4V ELI.
- Accepted engineering principles: For its function as a washer.
- Established clinical use: Of similar devices and the material itself for biocompatibility.
- Not applicable in the traditional sense. The "ground truth" for this device's safety and effectiveness is derived from:
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The sample size for the training set
- Not applicable. This is a mechanical device, not an AI model.
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How the ground truth for the training set was established
- Not applicable.
Summary of the "Study" for the BONE-LOK™ HP Washer:
The core of the submission's "performance data" and "biocompatibility" sections relies on demonstrating substantial equivalence to predicate devices and leveraging well-established material properties and clinical history.
The document explicitly states:
- "Because the washer is fabricated from a material with specified mechanical requirements, is of limited functionality, and washers have been previously utilized in this capacity, additional testing is not required." (Performance Data)
- "Because its inertness and biocompatibility has already been established, additional testing is not required." (Biocompatibility)
This means the "study" demonstrating the device meets acceptance criteria is primarily a literature review and comparison to legally marketed predicate devices and established material standards, rather than de novo experimental studies with test sets, expert ground truth, or statistical analysis typical for AI/software. The substantial equivalence argument is the primary "proof" used here.
§ 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.