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Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.

K2 Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs (Intervertebral Disk Rongeurs) are reusable manual stainless steel instruments. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use.

The devices are available with the following features:

Kerrison style Rongeur with a fixed and a sliding shaft and an angled footplate

• with different handles (Micro Handle, Spurling Handle, Ferris-Smith handle, Tarpon handle)
• with different surface treatments (mirror finish, satin finish, matt/dull finish, brush-finished and different coatings (ceramic, black, gold)
• different shaft overall length (6 " inch to 15 " inch) -
• different sizes (1mm to 6 mm)
• different angles (up 40°, up 90°, down 90° -
• without ejector or with different types of ejectors
• with straight shaft, curved (Foraminotomy style) or with Bayonet Shaft,
• traditional style or with special cleaning channel
• traditional style or with opening mechanism (convertible, take-apart)
• with rotating shaft angled 90° and 40°

IVD Rongeurs (Intervertebral disk Rongeurs) with one fixed shaft, one sliding shaft and a hinged mouthpart

• in different styles: Decker Forceps, MIS* Rongeurs/Micro-Pituitary, MIS* Cushing Rongeurs, -Spence iVD Rongeurs, Poppen IVD Rongeurs, Peapod IVD Rongeurs, Love-Gruenwald, Selverstone Rongeurs, Williams Dissecting Forceps, Spurling IVD Rongeurs, Sypert Rongeur, Wilde IVD Rongeurs, Hoen IVD Rongeurs, Oldberg Disc Rongeur, Jackson IVD Rongeurs, Schlesinger IVD Rongeurs, Caspar type Rongeur, Schlesinger Rongeur (MIS* Minimally Invasive Surgery)
• with different length and jaw sizes
• angled and straight
• with closed jaw and with fenestrated jaws
• with smooth jaw and with teeth

Laminectomy Rongeurs with double action joints and strong handle

• Fulton Laminectomy Rongeurs -

This document describes the regulatory clearance (K150468) for K2 Medical GmbH & Co. KG's Laminectomy Rongeurs, Kerrison Rongeurs, and IVD Rongeurs. These devices are manual surgical instruments intended for cutting or biting bone during skull or spinal column surgeries in patients aged two years or older.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the exact sample sizes (number of devices) used for each specific test. For the "Automatic Reprocessing Validation", "Sterilization testing", "Boiling Test", "Cytotoxic testing", and "Irritation testing", the tests were performed on "the devices" or "test specimens" or "finished devices from all the different materials and coatings configurations," implying representative samples of the product line were tested. For "Mechanical testing", "new instruments" and "worn out instruments" were tested.

The data provenance is not explicitly stated in terms of country of origin for the data collection, nor whether it was retrospective or prospective. However, the submitter is K2 Medical GmbH & Co. KG, located in Germany, suggesting the testing was likely conducted in Germany or a location aligned with their quality management system. Given the nature of these engineering and biocompatibility tests, they are inherently prospective, conducted specifically to demonstrate device performance for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This type of information is not applicable to the tests described in this document. The ground truth for these performance, reprocessing, and biocompatibility tests is established through objective, quantitative measurements against predefined standards (e.g., AAMI TIR 30, ASTM F1089-10, ISO 10993-5, ISO 10993-10) and performance comparisons with predicate devices, not through expert consensus or clinical interpretation.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the ground truth is established through objective measurements against standards, not through human interpretation requiring adjudication.

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 device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool that would involve human readers or an MRMC study.

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

Not applicable. This is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for these tests is based on:

• A-priori defined objective criteria derived from recognized standards: e.g., AAMI TIR 30 for reprocessing, ASTM F1089-10 for corrosion resistance, ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation.
• Quantitative measurements and observations: e.g., reduction in bacteria for sterilization, absence of corrosion, non-cytotoxicity, lack of irritation reaction, and comparison of mechanical forces (handle and bite force) against predicate devices.
• Material specifications: for biocompatibility and mechanical properties.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, there is no training set for this type of device.

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K2 Medical Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.

The K2 Medical Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows: - Some have ring handles with a ratchet closure to adjust the amount of tension applied to . the vessel for occlusion or partial occlusion. - Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross . action mechanism to apply tension to the vessel for occlusion. - The choice of iaw style depends on the surgeon's preference, based on the type and delicacy of . the vessel to be occluded. The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel. K2 Medical vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy. The instruments are offered in non-sterile condition.

The provided text describes a 510(k) summary for the K2 Medical Vascular Clamp, which is a reusable surgical instrument. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving specific acceptance criteria for a novel device or AI algorithm.

Therefore, many of the requested categories related to proving device meets acceptance criteria through a study (especially those concerning AI, ground truth, expert readers, and specific performance metrics like sensitivity/specificity) are not applicable to this document.

Here's the information that can be extracted or deduced from the provided text:

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

The document does not specify quantitative acceptance criteria or a direct performance study with numerical results. Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The "performance" assessment is qualitative, stating:

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

Not applicable. This document describes a 510(k) submission for a physical medical device (vascular clamp) and relies on bench testing and comparison to a predicate device, not a "test set" of clinical data in the context of an AI or diagnostic device.

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. "Ground truth" in this context would likely refer to engineering specifications or material standards, rather than expert interpretation of medical data.

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 device is a surgical instrument, not an AI or diagnostic imaging device.

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)

For a device like a vascular clamp, the "ground truth" for performance would be established through engineering standards, material specifications (e.g., Stainless Steel ASTM F 899-07 or Titanium Alloy), and bench testing against established performance parameters for temporary occlusion of blood vessels. It is not externally defined clinical ground truth.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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