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The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures.

The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market under K022935. To do this, the Light Sabre™ Spinal Access Device incorporates a collimating channel and light-dispersing element directly into the stylet assembly. When the Light Sabre™ Spinal Access Device is aligned with the laser beam of the SabreSource™ Targeting System, the laser will clearly illuminate the light-dispersing element. Whenever the device is moved out of the path, as defined by the laser beam, the light-dispersing element of the Light Sabre™ Spinal Access Device ceases to glow.

The provided 510(k) summary for the Light Sabre™ Spinal Access Device does not contain specific acceptance criteria or a detailed study proving the device meets performance criteria in the way typically discussed for AI/ML-based medical devices. This document describes a medical device (biopsy needle) and focuses on substantial equivalence to a predicate device, manufacturing standards, and biological safety.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.

Here's a breakdown of what can be derived from the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" or provide performance metrics in quantitative terms for the device's function (e.g., biopsy success rate, accuracy of guidewire placement). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device.

1. ASTM F1140-00
2. ANSI/AAMI/ISO 11137:1994
3. ANSI/AAMI/ISO 11737-1:1995
4. AAMI TIR 17:1997
5. AAMI TIR 27:2001
6. ANSI/AAMI/ISO TIR 15843:2000
7. ANSI/AAMI ST 72:2002
8. ASTM D-5276-98(2004)
9. ASTM F88-06
10. ISO 11607
11. ISO 9626:1991
12. ISO 594:1986
13. ISO 10993-1:2003
14. ISO 10993-5:1999
15. ISO 10993-10:2002 |
    | Sterility | Provided sterile for single use (Implies meeting sterility requirements, likely dictated by ANSI/AAMI/ISO 11137:1994 and related standards). |
    | Mechanical Features | Needle Length: 10 - 15cm
    Needle Gauge/Diameter: 8, 11, 13 Gauge
    Stainless Steel Material: Stainless Steel 304
    Stylet/Cannula Hub Material: Gamma Stable Polycarbonate
    Includes method to remove biopsy sample: Included in Packaging is Core Sampler made of Stainless Steel 304
    Able to connect Syringe for Aspiration or Injection: Luer Lock per ISO 594-2:1998 (E) on Luer Adapter Component |
    | Substantial Equivalence | Considered substantially equivalent to the Light Sabre™ Bone Biopsy Needle (K982735). |
    | Laser Targeting Integration | Integrates a collimating channel and light-dispersing element into the stylet assembly to work with the MINRAD SabreSource™ Targeting System (K022935). (Implies functional compatibility with the targeting system). |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a "test set" in the context of clinical performance data for an AI/ML device. The testing mentioned refers to material qualification and compliance with industry standards, not a clinical study on patient data.

3. 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 mention of a clinical test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. 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 medical device (biopsy needle), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device would relate to its physical properties, sterility, and biocompatibility, which are assessed through laboratory tests against established standards, not clinical ground truth like pathology for a diagnostic device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/ML product.

9. How the ground truth for the training set was established

Not applicable.

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