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The Arthro-Surgimat-2000 ECU is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle and wrist joint cavities under optional voice-activation control during arthroscopic procedures. (21 C.F.R. & 888.1100).

The ARTHRO-SURGIMAT-2000 ECU is a high flow arthroscopic pump intended to distend joint cavities. The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the device Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. GmbH. W.O.M. also claims substantial equivalence to the Surgiflator-20 ECU (K981859) and the Linvatec Apex Universal Inrigation System (K933873).

With the exception of the following modifications, the ARTHRO-SURGIMAT-2000 ECU incorporates the same design features and accessories as the Arthro-Surgimat-1500 (K983910):

• A serial interface has been incorporated in the device to allow for surgeon selection of device settings ● utilizing the HERMES Operating Room Control Center (K980787). The external adjustment capability of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Surgiflator-20 ECU (K981859) manufactured by W.O.M. GmbH
• The maximum flow performance of the device has been increased from 1,5 Vmin. to 2 Vmin. The . flow performance of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Apex Universal Irrigation System (K933873) manufactured by Linvatec Corp.

The provided text is a 510(k) Summary for a medical device (arthroscopic pump) and does not contain the specific information required to complete the detailed table and answer the questions related to acceptance criteria, study design, and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) clearances.

This document is for a hardware device, the ARTHRO-SURGIMAT-2000 ECU, an arthroscopic pump. The review process for such a device primarily focuses on demonstrating substantial equivalence to predicate devices in terms of design, materials, and intended use, rather than rigorous performance metric studies or AI algorithm validation.

Therefore, most of the requested information, such as "acceptance criteria and reported device performance" in the context of diagnostic accuracy, "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set details," is not applicable to this type of device submission and is not present in the provided text.

The document states:

• The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the Arthro-Surgimat-1500 (K983910).
• Modifications include:
  • A serial interface for surgeon selection of device settings via the HERMES Operating Room Control Center (K980787).
  • Maximum flow performance increased from 1.5 l/min to 2 l/min, claimed to be substantially equivalent to the Apex Universal Irrigation System (K933873).

Essentially, the "study" proving the device meets acceptance criteria is the demonstration of substantial equivalence to predicate devices based on design and performance specifications (flow rate) for a physical pump, along with literature references describing the utility and safety of arthroscopic techniques.

Here's a breakdown of why the requested information is absent and what is available:

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

• Acceptance Criteria: Not explicitly stated as diagnostic performance metrics. The implicit acceptance criteria are that the device performs its intended function (fluid distention up to 2 l/min) safely and effectively, and is substantially equivalent to predicate devices.
• Reported Device Performance:
  • Maximum flow performance: 2 l/min (increased from 1.5 l/min of the previous version).
  • Integration with HERMES Operating Room Control Center for remote setting selection.

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 hardware device. No "test set" of data for diagnostic performance was used. The substantial equivalence relies on engineering specifications and comparison to existing devices.

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 for a diagnostic test was established.

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 not an AI/SaMD device.

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

• Not applicable. This is a hardware device, not an algorithm.

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

• Not applicable.

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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The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle, and wrist joint cavities during arthroscopic procedures.

The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended to distend joint cavities. The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114) manufactured by W.O.M. GmbH. The Arthro-Surgimat-1500 incorporates the same design features and accessories as the Arthro-Surgimat (K962114). The following modifications have been performed: 1. The device Arthro-Surgimat-1500 incorporates a software filter function referred to as the instrument recognition feature. The instrument recognition feature of the device measures the resistance of the tubing set and instrument being used and regulates the actual pressure accordingly. The instrument recognition feature of the device allows for a more accurate attainment of the desired intraarticular pressure. 2. The device Arthro-Surgimat-1500 incorporates an optional cable remote control for the adjustment of device parameters. Only those parameter which may be adjusted utilizing the user-interface (front panel) and the foot pedal may be adjusted utilizing the cable remote control.

The provided text is a 510(k) Summary for a medical device (Arthro-Surgimat-1500 arthroscopic pump) seeking substantial equivalence to a predicate device. It primarily discusses the device's function, modifications, and references existing literature on arthroscopic techniques. It does not contain information about acceptance criteria, specific device performance studies, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about a study demonstrating the device meets those criteria, as this information is not present in the provided document.

The document states:

• The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114).
• Modifications include a software filter for instrument recognition and an optional cable remote control.
• The utility and safety of arthroscopic techniques using modern electronic high flow pumps are discussed in referenced literature.

The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and indications for use, rather than conducting new performance studies that would involve acceptance criteria, test sets, experts, or ground truth as described in your request. Clinical performance studies with defined endpoints and statistical analyses are generally reserved for Pre-Market Approval (PMA) applications or when substantial equivalence cannot be demonstrated through non-clinical means.

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The Arthro-Surgimat is a high flow arthroscopic pump classified under 21 C.F.R. § 888.1100 intended to distend joint cavities during arthroscopic procedures.

The Arthro-Surgimat is a high flow arthroscopic pump designed to react very quickly to various influences, thereby maintaining constant intraarticular pressure. It has pressure measurement through multiple sensors at the pump head, 3 optional preselectable pressure levels (to be programmed by end-user), a max. flow rate of 1500 ml/min, and a foot pedal for temporary increase of preselected flow level for rinsing of joint after/during shaver use.

The provided text does not contain information about acceptance criteria for a medical device or a study detailing its performance against such criteria. Instead, it describes a 510(k) Summary for the Arthro-Surgimat, a high-flow arthroscopic pump.

The document discusses:

• Device Description: The Arthro-Surgimat is an arthroscopic pump for distending joint cavities.
• Substantial Equivalence: It claims substantial equivalence to two predicate devices: Linvatec Apex Universal Irrigation System (K933873) and Smith & Nephew InteliJET Fluid Management System (K912453).
• Key Differences from Predicate Devices: These include pressure measurement points, preselectable pressure levels, max flow rate, and foot pedal features.
• Safety and Utility References: It cites two books (Hempfling, 1995 and McGinty, 1995) to generally discuss the utility and safety of arthroscopic techniques and high-flow pumps, mentioning the importance of effective instrumentation.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and a study proving device performance because this information is not present in the provided text.

The text focuses on establishing substantial equivalence for a 510(k) submission, which typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance study results against specific acceptance criteria.

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