(72 days)
The Anspach Minimal Access Spinal Attachment system is indicated for use as a nosepiece attachment with Anspach pneumatic and electric surgical drill systems for surgical cutting, shaping and removal of bones, including bones of the spine and cranium.
The Minimal Access Spinal Attachment system consists of three basic components: Angled Motor Adaptor (20° Driver Body); Nose-tube/bearing housings; and a vanety of bone dissection tools (cutters").
Angled Motor Adaptor (20° Driver Body): Two designs, one for the Black Max motor and one for MicroMax/XMax and eMax Motors.
The 20° Driver Body is a non-invasive and non-patient contact component of the Minimal Access Spinal Attachment system that connects to the surgical motor. Unlike other attachments, the Minimal Access Spinal Attachment is designed to provide a 3.0mm length adiustment of the nose-tube/bearing sleeves.
The 20° Driver Body is reusable, distributed clean and nonsterile. It is designed to be cleaned with (non-immersion) soapy-water and/or full immersion in isopropyl alcohol. Recommended cleaning and sterilization processes are provided with each device.
Nose tube/bearing sleeves: Four initial tube designs*
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- Long Curved (10+/- 2°)
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- Long Straight
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- Short Curved (10+/- 2°)
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- Short Straight
- Additional lengths to become available
The nose-tube/bearing sleeve is reusable, provided it is properly handled, cleaned, and maintained as directions for use (DFU), provided with each product. When increased bearing wear is observed (increased heat and/or noise), the bearing tube is removed from the Driver Body and discarded. A replacement nose-tube is then simply inserted and locked onto the Driver. Like the 20° Driver, nose-tuberbearing sleeves can be steam autoclaved before use in accordance with DFU.
Cutters (Bone Dissection Tools):
Minimal Access Spinal Attachment system cutters are the variety of pre-sterlized, single-use, disposable bone dissection tools. Minimal Access Spinal Attachment cutters are individually packaged and distributed pre-stenlized. A variety of cutting tip designs and diameters in lengths to fit all Nose tube/bearing housings are available with additional sizes and head configurations available in the future.
Cutters are of the same basic design and materials as other currently distributed cutters and are individual packaged and pre-sterilized. Terminal sterilization is achieved by Irradiation to a are interility assurance level (SAL) of 10 . User assembly instructions are provided with each component of the system and also in a variety of catalogs and surgical manuals.
The provided text is a 510(k) summary for a medical device called the "Minimal Access Spinal Attachment system." It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove performance against specific acceptance criteria. This type of submission (510(k)) generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria and performance studies for the device itself is not explicitly available in the provided document. The document primarily focuses on establishing substantial equivalence through a comparison of design, materials, and operational characteristics with existing devices.
Here's an analysis based on the available information:
Acceptance Criteria and Study for the Minimal Access Spinal Attachment System
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal quantitative acceptance criteria for the new device's performance (e.g., tensile strength, fatigue life, specific functional percentages). Instead, the "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to existing predicate devices. The device's performance is demonstrated by showing that its characteristics are similar to or better than the predicate devices.
| Characteristic | Acceptance Criteria (Implied - substantial equivalence to predicate) | Reported Device Performance (Minimal Access Spinal Attachment) |
|---|---|---|
| Use w/Electric motor | Yes (like predicate) | Y |
| Use w/Pneumatic motor | Yes (like predicate) | Y |
| Tool-Less attachment | Yes (like predicate) | Y |
| 20° angled driver | Yes (like Anspach MICRO/MDA) | Y |
| Length adjustable | Yes (like Midas Rex) | Y |
| Nose tube diameters | Similar to predicate ranges (e.g., 3-5mm) | 4-5mm (taper) |
| Nose tube lengths | Similar to predicate ranges (e.g., 8-16cm+) | 7-30cm |
| Curved nose tube radius | Similar to predicate (e.g., 10° +/- 2°) | 10+/- 2° |
| Cutter shaft diameter | Similar to predicate (e.g., 1.4-1.43mm) | 1.4mm |
| Operating temperature (Max) | ≤ 120°C (like predicate) | 120°C |
| Stainless steel construction | Yes (like predicate) | Y |
| Corrosion resistant bearings | Yes (like predicate) | Y |
| Immersion cleaning | Possible (like nose-tubes) or not (like 20° Driver) | Y (Nose tubes can be fully immersed. 20° Driver in Isopropyl alcohol) |
| 4 Min flash sterilization | Yes (like predicate) | Y |
| Sterrad sterilization | Yes (like Anspach MICRO/MDA) | Y |
| Pre-sterilized cutters | Yes (like predicate) | Y (SAL 10^-6) |
| Service/Repair (20° Driver) | Yes (like Anspach MICRO/MDA) | Y |
| Service/Repair (Nose-tubes) | Varies (N for new device, Y for Anspach predicate) | N (designed for disposal when worn) |
| Service/Repair (Cutters) | No (like predicate) | N |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a traditional "test set" in the context of clinical or performance testing with a specific sample size. The substantial equivalence argument is based on design, materials, and operational characteristics comparison to legally marketed predicate devices.
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The comparison is between the proposed device and specified predicate devices.
- Data Provenance: The data comes from the design specifications and declared characteristics of the Minimal Access Spinal Attachment system, compared against publicly available or manufacturer-provided information for the predicate devices (Anspach Angled Micro-nose Attachment and Medtronic (Midas Rex) "Micro-Telescoping System"). This is inherently retrospective in the sense that it's a review of existing device information and new device design. The country of origin data is also not specified for the predicates, though the submitting company (The Anspach Effort) is US-based (Florida).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not a study requiring expert consensus on a test set of data (e.g., image interpretation). The "ground truth" for the comparison is the published specifications and operating characteristics of the predicate devices and the design specifications of the new device.
4. Adjudication Method for the Test Set:
Not applicable. There was no "test set" in the sense of clinical or performance data requiring adjudication. The comparison is based on technical specifications. The FDA's review process itself acts as an adjudication of whether the substantial equivalence argument is valid.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating diagnostic or interpretive devices involving human readers, which is not the nature of this surgical attachment.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical surgical attachment, not an algorithm. Its function inherently involves a human operator (surgeon).
7. The Type of Ground Truth Used:
The "ground truth" for this 510(k) pertains to the design specifications, material properties, and intended functional characteristics of the Minimal Access Spinal Attachment system and the predicate devices. This involves engineering specifications and the declared features of the devices. It does not involve patient outcomes data or pathology results in the context of proving the device's performance.
8. The Sample Size for the Training Set:
Not applicable. The "Minimal Access Spinal Attachment system" is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).