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The SPROTTE® SPECIAL NRFit™ anaesthesia conduction needle is intended to gain entry into the spinal canal to apply single shot spinal anaesthesia. It has an opening which will allow the introduction of a catheter which is used to inject anaesthetics to provide continuous spinal anaesthesia.

The device is intended for adult and pediatric patients.

The SPROTTE® Special NRFit™ anaesthesia conduction needle is intended to gain entry into the spinal canal to apply single shot spinal anaesthesia. It has an opening which will allow the introduction of a catheter which is used to inject anaesthetics to provide continuous spinal anaesthesia. The device is available in a range from 18G to 24G at a range of length from 90mm to 100mm. It is a disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to repackagers/medical device manufacturers. The materials used include Stainless Steel 1.4301 (X5CrNi18-10), AISI 304 (V2A) for the needle/cannula, introducer tubing, stylet tubing, and haemostylet. Polycarbonate PC is used for the needle hub, ramp in tip, introducer hub, stylet knob, and retaining plate. Epoxy resin is used for optional glue.

This document describes the 510(k) premarket notification for the PAJUNK® SPROTTE® Special NRFit™ anesthesia conduction needle. The submission aims to demonstrate substantial equivalence to a predicate device (K911221 ATRAUMATIC SPECIAL SPROTTE NEEDLE). The key differences highlighted are the material of the hub and the stylet's knob, which are deemed non-significant due to either historical changes with new material being tested, or no patient contact for the knob.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • For the subject devices, 5 types of SPROTTE® Special NRFit™ needles were tested, ranging from 18G to 24G in gauge and 90mm to 100mm in length.
  • For the predicate devices, 5 types of SPROTTE® Special needles were tested, with the same range of gauge and length.
  • Each of these device types was tested after sterilization and after accelerated aging (1 year, 3 years, 5 years). The specific number of individual units tested per type is not explicitly stated beyond these categorical breakdowns.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that the manufacturer is a German company (PAJUNK® GmbH Medizintechnologie) and the studies involve physical testing of medical devices, the data is likely generated in a laboratory setting, presumably by or on behalf of the manufacturer, and would be considered prospective for the purpose of this submission.

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

This submission does not involve clinical studies with human "ground truth" derived from expert consensus. The "ground truth" or acceptance criteria are based on recognized international standards for medical devices (e.g., ISO 9626, ISO 7864, ISO 80369-6, ISO 11135-1, ISO 10993-1/5/10), which define physical and material properties, performance characteristics, and safety aspects. Therefore, no human experts were used to establish "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of diagnostic outcomes. Performance is measured against engineering and safety standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a premarket notification for a physical medical device (anesthesia conduction needle), not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device does not involve an algorithm.

7. Type of Ground Truth Used

The ground truth used for performance and safety assessments is primarily engineering and safety standards (e.g., ISO 9626, ISO 7864, ISO 80369-6, ISO 11135-1, ISO 10993-1/5/10) and the physical and material characteristics of the predicate device. For tests like bonding strength and bending rigidity, the "ground truth" is adherence to predefined force thresholds or established methodologies in the standards. For biocompatibility, it's compliance with ISO standards through a series of conducted tests.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/algorithm. The "training" for this device's performance comes from historical data, design validation, and manufacturing processes perfected over time, as implied by the use of an already cleared predicate device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set. The "ground truth" for the device's design and manufacturing is established through compliance with established medical device regulations, design controls, and international standards. The substantial equivalence argument relies on the predicate device's established safety and effectiveness.

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The PAJUNK DeltaCut blopsy system is intended for obtaining biopsies from soft tissues ans soft tissue tumors. It is not appropriate for bone blopsies. The single use, sterile, seperately packaged DeltaCut cannulas are available seperately.

The PAJUNK DeltaCut blopsy system consists of a gun and a disposable cannula. It is intended for obtaining biopsies from soft tissues and soft tissue turnors. It is not appropriate for bone biopsies.

The Pajunk DeltaCut blopsy cannulas are single use sterile devices. They are intended for obtaining biopsies from soft tissues and soft tissue tumors. They are only to be used in combination with the DeltaCut biopsy gun, but they are available seperately. It is not appropriate for bone biopsies.

DeltaCut consist of a non-sterile biopsy gun and a sterile biopsy cannula. The PAJUNK DettaCut biopsy gun is a reusable, spring-loaded, core biopsy device. It features adjustable penetration depths of 15 mm to 22 mm and is sold non-sterlie (see directions for cleaning, sterilization and lubrication). The Pajunk DeltaCut biopsy needle is a disposable needle intended for single use with the Pajunk DeltaCut biopsy gun. The DeltaCut biopsy needle is packaged individually and sterile. It is available in various diameters and lengths. For single patient use. Do not reuse. Do not resterilize. DeltaCut is a cannula system made by Pajunk®, which was developed specifically for the extraction of biopsies from soft tissue. The device is equipped with a visual and mechanical safety-system. Two triggers permit ergonomic handling for right and lefthanded application, regardless of the position of the extraction location. The puncture depth can be adjusted variable on a scale from 15 to 22 mm. The biopsy extraction is carried out in two steps and takes only seconds: 1. First, the inner cannula shoots out forwards and is filled with tissue. 2 Then the cutting cannula instantaneously sildes over it, thereby closing the biopsy chamber and protecting the biopsy material from contamination,

The provided submission for the DeltaCut Biopsy system does not contain specific acceptance criteria or a study that evaluates the device's performance against such criteria. The document is a 510(k) Premarket Notification Submission, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria.

The submission confirms the device's intended use, describes its components (biopsy gun and cannula), and highlights its similarity to the Bard® Magnum Biopsy system (K883469), which is the predicate device. It discusses sterilization, packaging, labeling, biocompatibility, and applicable standards (or lack thereof for specific standards for this type of device). The conclusion states that the comparison to predicate devices demonstrates the proposed device is safe, effective, and substantially equivalent.

Therefore, the tables and information requested below cannot be extracted from the provided text as the document does not contain this type of performance study data.

1. A table of acceptance criteria and the reported device performance:
Not available in the provided document. The submission focuses on substantial equivalence to a predicate device, not on meeting specific quantitative performance acceptance criteria in a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available in the provided document. There is no performance study described with a test set.

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 available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not available in the provided document.

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. The DeltaCut Biopsy system is a physical medical device (biopsy gun and cannula), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The DeltaCut Biopsy system is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not available in the provided document. There is no performance study described. The document relies on equivalence to a predicate device which is implicitly considered "ground truth" for safety and effectiveness.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device.

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The Pajunk insufflation cannula acc. Veress and the modular insufflation cannula acc. Veress is employed in minimal invasive surgery. The cannula is designed for the initial puncture with subsequent gas insuffation for laparoscopic operations. It is used to establish a pneumoperitoneum.

The insufflation cannulae according Veress were developed especially for the safe and efficient r rio moumation oannalae and insufflation cannulae are equipped with maintenance free cocks and a female LuerLock connector. Before application, a sharp outer cannula (sterile packed for modular Veress, reusable for Standard Veress) is mounted onto the reusable inner cannula and fastened by means of a LuerLock connector. Therefore within the modular system , a new, absolutely sharp disposable outer cannula is used for every application. In comparison with totally disposable Veress-cannulae, with the same advantages, the modular system offers a large potential to reduce cost.

This is a premarket notification for a Veress and Modular Veress Insufflation Cannula. This type of submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical study data with specific acceptance criteria and detailed device performance metrics. Therefore, many of the requested data points (e.g., sample sizes for test and training sets, number of experts for ground truth, MRMC study details, acceptance criteria table) are not applicable or explicitly provided in this document.

Here's the information that can be extracted or inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is generally not included in 510(k) submissions for devices like the Veress cannula, which are often cleared based on substantial equivalence to predicate devices rather than meeting specific performance criteria in a new clinical study. The device's performance is assumed to be equivalent to the predicate devices.

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

A formal "test set" in the context of a prospective clinical study with a defined sample size to prove performance against specific acceptance criteria is not described. The submission relies on substantial equivalence and "clinical evaluation and summarizing literature." Therefore, specific sample sizes for a 'test set' derived from a new study are not provided. The data provenance is described as "clinical evaluation and summarizing literature," suggesting a review of existing data rather than a new prospective study.

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

Not applicable. The submission does not describe a new clinical study with a ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. The submission does not describe a new clinical study with an adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is a surgical instrument (insufflation cannula), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related metrics are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's safety and effectiveness is primarily based on substantial equivalence to existing legally marketed predicate devices, which have a history of safe and effective use. Additionally, the submission mentions "clinical evaluation and summarizing literature," suggesting that the medical community's existing knowledge and published findings on similar devices serve as a form of "ground truth" regarding the general principles of Veress cannula use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set with established ground truth.

Summary of Device Rationale from the Submission:

The submission for the Veress and Modular Veress Insufflation Cannula focuses on demonstrating substantial equivalence to two predicate devices:

1. Cannula with sharp obturator & Veress Needle by Karl Storz (K800668)
2. Veress Cannula et al. by Richard Wolf Medical (K041321)

The rationale provided is that the proposed devices are "as safe and effective as and therefore substantial equivalent to the predicate devices" in terms of intended use, indication, and technical characterization. The document explicitly states: "The comparison between the predicate devices and the proposed devices... demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices." It also mentions "The cannula system acc. Veress has been used for years now. The clinical evaluation and summarizing literature, which is part of this submission (10.0), makes this aspects evident." This implies that prior clinical experience and published data on this type of device support its safety and effectiveness without requiring a new, formal clinical trial with specific performance criteria.

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Pajunk's anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Anesthesia conduction needles consist of a luer hub, a stainless steel cannula with various tip types, and a stainless steel stylet. These needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space for longer pain relief.

The Pajunk anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - are single use, sterile, non-pyrogenic and latex-free medical devices for transient delivery of anesthetics during regional anesthesia. The cannula is stabilized during puncture with use of an inner stylet (mandrin). This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for regional anesthesia. Then the anesthetics can be applied transiently (i.e. within minutes) by the professional anesthetist. Alternatively or additionally, an evidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.

This document is a 510(k) summary for Pajunk Anesthesia Conduction Needles (Tuohy, Quincke, Chiba, and Crawford). It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information cannot be extracted directly from the provided text.

Here's an attempt to answer the questions based on the available information:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance in terms of quantifiable measures are provided. The submission relies on demonstrating substantial equivalence to existing predicate devices.

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

Not applicable. This is a 510(k) submission for substantial equivalence based on material and design comparison, not a study involving a test set of 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. No "ground truth" was established in the context of a performance study.

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 medical 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. Substantial equivalence relies on comparing design, materials, and intended use to existing legally marketed devices, not on a ground truth derived from expert consensus or patient outcomes for this specific device. The closest concept to "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned as this device is a physical medical instrument.

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

Not applicable.

Summary of the Study / Basis for Acceptance (based on available text):

The "study" in this context is a demonstration of substantial equivalence to legally marketed predicate devices.

• Acceptance Criteria (Implied): The implied acceptance criteria for a 510(k) submission are that the new device is as safe and effective as a legally marketed predicate device. This is achieved by demonstrating that the new device has the same technological characteristics (design, physical dimensions, materials) and intended use as the predicate.
• Proof: The submission states:
  • "The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices."
  • "The Pajunk anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - have the same technological characteristics as the predicate devices identified above."
  • "The Pajunk anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - are equivalent in design, physical dimensions, luer hub, metal and plastics materials, and packaging to Pajunk's Sprotte needles cleared under 510(k) numbers K911202, K911221, K911260, and K923003."
  • Biocompatibility testing was also conducted and referenced in Section 7 (though not provided in this excerpt).

In essence, the device meets its "acceptance criteria" by being a direct technological and material equivalent to previously cleared devices.

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Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.

A spinal needle is an instrument used for the injection of local anesthetics into a patient to provide regional anesthesia. The needle consists of a luer hub, a stainless steel cannula, and a stainless steel stylete. The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The spinal needles are provided in three styles; Lancet Point (Quincke), Pencil Point (Whitacre), and European Style (Sprotte). The introducer needle is a simple hypodermic needle, either 18g or 20g, to make the initial puncture through the skin to aid in the placement of the spinal needle.

The provided document is a 510(k) Summary for Spinal Anesthesia Needles. It describes the device, its intended use, technical characteristics, and non-clinical data. It does not present acceptance criteria or a study designed to prove the device meets specific acceptance criteria as would be typical for an AI/ML medical device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through comparison testing of physical characteristics and performance attributes (like flow rate and penetration force). This is a regulatory pathway for traditional medical devices, not for AI/ML algorithms.

Therefore, for your request, I must state that the information you are asking for (acceptance criteria, specific study design, performance metrics, ground truth, expert involvement, MRMC studies, standalone performance, training set details) is not available in this document because it pertains to a different type of device evaluation (traditional medical device vs. AI/ML medical device).

The document's "study" is a comparison test, not a performance study against predefined acceptance criteria in the context of an AI/ML algorithm.

Here's a breakdown of why each specific point you asked for cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish explicit "acceptance criteria" for the device in the way an AI/ML device would, nor does it report performance against such criteria. Instead, it compares characteristics like "increased inside diameter" and "reduced outside diameter" to predicate devices, stating that the proposed device "compared well" and that the differences are "not significant."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "comparison testing between the proposed device and the predicate devices" and "unisis needles tested." However, it does not specify sample sizes for this testing, nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective nature of the test 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): Since this is a physical medical device and not an AI/ML system, the concept of "ground truth" established by experts for a test set is not applicable in the way it would be for an AI/ML device. The "truth" here is based on physical measurements and mechanical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device comparison test.

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 document is about spinal needles, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" in this context would be the physical properties and performance characteristics of the needles themselves (e.g., measured flow rates, penetration force), rather than clinical outcomes or expert consensus on interpretations.

8. The sample size for the training set: Not applicable. This device is 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.

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