(76 days)
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No
The device description details a set of manual and powered surgical tools for bone grafting, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is a system of tools used for bone grafting, which involves harvesting bone material. It is a surgical instrument, not a therapeutic device designed to treat a disease or condition itself.
No
Explanation: The device is described as a surgical toolset for bone grafting, involving drills and extractors to harvest bone material. This is a procedural device, not one that identifies or characterizes a disease or condition.
No
The device description explicitly lists physical components such as drills, a Hudson adaptor, a starting punch, a bone plug extractor, and a removal key, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "Bone Grafting System" consisting of drills, extractors, and other tools used for harvesting bone material directly from the body. This is an in vivo procedure (performed within the living body), not an in vitro procedure.
- Intended Use/Indications for Use: While not explicitly stated, the description of the tools strongly suggests a surgical procedure involving bone.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with IVD devices.
Therefore, the Acumed Bone Grafting System is a surgical device used for bone harvesting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Acumed Bone Grafting System is a set of various size drills, a Hudson adaptor fitting, a starting punch, a bone plug extractor, and a removal key. A manual drill handle will be added to the system eventually so that the drills may be operated manually. The Hudson adaptor fitting attaches to a standard DC-powered surgical drill. The drill size is selected and attached to the adaptor. The starting punch dimples the bone so a reference point for the drill tip is made. After drilling and harvesting the bone, the drill assembly is removed. The drill piece is detached with the removal key and the bone material is extracted or pushed out by the plug extractor.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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Image /page/0/Picture/0 description: The image shows the word "ACUMED" in a bold, sans-serif font. The letters are black and have a slightly futuristic or technical appearance. There is a horizontal line underlining the word. To the right of the word, there is a superscript "TM" symbol, indicating a trademark.
Quality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary MAY - 7 1996
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
The Acumed Bone Grafting System is a set of various size drills, a Hudson adaptor fitting, a starting punch, a bone plug extractor, and a removal key. A manual drill handle will be added to the system eventually so that the drills may be operated manually. The Hudson adaptor fitting attaches to a standard DC-powered surgical drill. The drill size is selected and attached to the adaptor. The starting punch dimples the bone so a reference point for the drill tip is made. After drilling and harvesting the bone, the drill assembly is removed. The drill piece is detached with the removal key and the bone material is extracted or pushed out by the plug extractor.
The Acumed Bone Graft System is manufactured from 17-4 ph stainless steel. The instruments are provided non-sterile. Data that validates a set of recommended steam sterilization process parameters which obtain a resulting SAL 0f 106 are maintained on file at Acumed. Information regarding implantation, packaging, and labeling have been provided.
The Acumed Bone Graft System is similar to Wright Medical Technology's Precision Bone Grafting System in form, function, composition, and indications and is expected to perform as well as similar devices.