(30 days)
Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions.
The Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions. The CAD II accepts a variety of attachments and accessories. Synthes CAD II has a 3.2 mm cannulated center to accept a variety of wires and pins. The other accessories include drill bits, flexible shafts, adapters, saw blades, air hoses, screwdriver shafts, burrs, files, and a cleaning brush. The drill features both forward and reverse rotation with a variable speed of 0 - 900 rpm; maximum torque of 4 Nm; air consumption of 250 liters/minute. and has an air control valve and latex free double air hose connection. The push button release allows for quick exchange of various attachments.
The provided document is a 510(k) premarket notification for a medical device, the Synthes Compact Air Drive II (CAD II). This type of document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the way a clinical trial for a new drug or a novel medical AI device would.
Based on the provided text, here's what can be extracted:
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A table of acceptance criteria and the reported device performance
- The document states: "Based on the mechanical test results, Synthes CAD II is at least equivalent to the predicate devices."
- This implies the acceptance criterion was "at least equivalent" in mechanical performance to the predicate devices (Synthes Small Air Drill (SAD) and Synthes Universal Air Drill (UAD)).
- No specific numerical performance metrics are provided for either acceptance criteria or the CAD II's reported performance, beyond its general operating specifications (e.g., variable speed of 0-900 rpm, maximum torque of 4 Nm, air consumption of 250 liters/minute).
Acceptance Criteria Reported Device Performance At least equivalent in mechanical performance to predicate devices (Synthes SAD and UAD) "Synthes CAD II is at least equivalent to the predicate devices" based on mechanical test results. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document mentions "mechanical test results" but does not specify the sample size of devices tested or the data provenance. Mechanical testing typically involves a set number of units, but this detail is not present.
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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)
- This device is a mechanical drilling tool, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" established by human experts in a clinical context (like radiologists) does not apply here. The "ground truth" for mechanical equivalence would be derived from engineering standards and measurements. No information is provided about experts involved in validating the mechanical tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for mechanical device 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
- Not applicable as this is a mechanical device, not an AI-assisted diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device itself is a standalone mechanical tool.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a mechanical device like this, the "ground truth" for performance would likely be established through engineering specifications and direct measurements against known standards or the predicate device's measured performance. The document explicitly relies on "mechanical test results."
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The sample size for the training set
- Not applicable. This is a conventional medical device, not an AI model requiring a training set.
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How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. The logo and the word are the only elements in the image. The word "SYNTHES" appears to be a brand name or company name.
Attachment IX:
Summary of Safety and Effectiveness Information
Synthes (USA) 1690 Russell Road Paoli, PA 19301
Contact: Sheri L. Musgnung (610) 647-9700 April 1997
Synthes Compact Air Drive II (CAD II) is compared to Synthes Small Air Drill (SAD) and Synthes Universal Air Drill (UAD).
The Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions. The CAD II accepts a variety of attachments and accessories.
The Synthes SAD and UAD is also used for drilling, reaming, burring, and screwdriving functions and accepts a variety of attachments and accessories.
Synthes CAD II has a 3.2 mm cannulated center to accept a variety of wires and pins. The other accessories include drill bits, flexible shafts, adapters, saw blades, air hoses, screwdriver shafts, burrs, files, and a cleaning brush. The drill features both forward and reverse rotation with a variable speed of 0 - 900 rpm; maximum torque of 4 Nm; air consumption of 250 liters/minute. and has an air control valve and latex free double air hose connection. The push button release allows for quick exchange of various attachments.
Based on the mechanical test results, Synthes CAD II is at least equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1997
Ms. Sheri L. Musgnung Regulatory Affairs Associate Synthes (USA) -- - - -1690 Russell Road PO Box 1766 Paoli, Pennsylvania 19301
Re: K971544
Trade Name: Synthes (USA) Compact Air Drive II (CAD II) Regulatory Class: I Product Code: HWE Dated: April 25, 1997 Received: April 28, 1997
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further ansouncements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word.
SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301 Telephone 610-647-9700
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Synthes CAD II is an air powered drill. It is used for drilling, reaming, sawing, burring, filing, and screwdriving functions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |
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| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K971544 |
| Prescription Use(Per 21 CFR 801.109) | X |
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| ------------------------------------------ | --- |
OR
| Over-The-Counter Use | |
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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.