(115 days)
- Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- Fixation of proximal tibial metaphysis osteotomy
- Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
- Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
The Clench® Compression Staple is an implant for use in bone fixation and reconstructive surgical procedures for the management of bone fractures. The implant is designed to provide constant compression over a bone fracture site. Implants are made from Nickel-Titanium Alloy per ASTM F2063 and range in size from 7mm to 20mm wide with two equal length legs ranging from 5mm to 20mm long.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Clench Compression Staple, formatted as requested.
Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, rather than clinical efficacy studies often seen with AI/clinical decision support devices. Therefore, many of the requested categories related to human-in-the-loop performance, expert consensus on ground truth for clinical cases, and multi-reader multi-case studies are not applicable to this type of device submission.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Clench Compression Staple are based on demonstrating mechanical performance equivalent to or better than predicate devices, and conformance to recognized industry standards. The reported performance refers to the device meeting these established standards.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static axial pull-out (per ASTM F564-10) | Confirmed that the Subject device performed as intended. |
| Mechanical Performance | Static Four-Point bending (per ASTM F564-10) | Confirmed that the Subject device performed as intended. |
| Mechanical Performance | Dynamic Four-Point bending (per ASTM F564-10) | Confirmed that the Subject device performed as intended. |
| Material Properties | Corrosion Susceptibility (per ASTM F2129) | Confirmed that the Subject device performed as intended. |
| Material Properties | Transformation Temperature (per ASTM F2082) | Confirmed that the Subject device performed as intended. |
| Substantial Equivalence | Comparison to predicate devices (K142292, K002695) in intended use, indications for use, materials, technological characteristics, and labeling. | Documentation provided demonstrating substantial equivalence. |
Study Details:
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Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of clinical data or patient cases. The testing conducted was mechanical (bench testing) of the device itself.
- The sample size for each mechanical test (static axial pull-out, static four-point bending, dynamic four-point bending, corrosion susceptibility, transformation temperature) is not explicitly stated in this summary but would have been defined by the ASTM standards and validated through the testing.
- Data provenance is from bench testing of the manufactured 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. Ground truth for mechanical testing is established by the specified ASTM standards and measurement protocols, not by expert medical opinion. Engineers and lab technicians conduct and interpret these tests according to the standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication is typically used for clinical image interpretation or expert consensus on patient outcomes, not for mechanical bench testing.
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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 device is a bone staple, an orthopedic implant, not an AI or diagnostic imaging device. Therefore, an MRMC study is not relevant or performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (implant), not an algorithm or software. Standalone performance is evaluated through the mechanical and material tests described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical and material testing, the "ground truth" is defined by the established performance criteria and methodologies within the relevant ASTM standards (ASTM F564-10, ASTM F2129, ASTM F2082). These standards define how the device should behave under specific conditions.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design and manufacturing processes are refined through engineering principles, not machine learning training.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
§ 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.