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The NovaSpine Powered Suction Pump PRO-I is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside.

The NovaSpine Powered Suction Pump PRO-I is a lightweight, self contained, portable battery powered, aspiration pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous or intermittent negative pressure. The NovaSpine Powered Suction Pump PRO-I is available in only one model:

1. Suction: 9 liters/min,
2. Maximum Vacuum: 200 mmHg
3. Noise: 35 dba,
4. Weight: 2.8 kg
5. Operation: Continuous and Intermittent
6. Dimensions: 290mmX359mmX130mm
   The pump is powered with a rechargeable Nickel-metal Hydride (NiMh) battery. The unit includes a port for an external power supply and/or a battery charger.
   The NovaSpine Powered Suction Pump PRO-I is composed of two parts:
7. The pump and battery pack are all housed in a single unit. The charging unit is a separate stand alone device.
8. The consumable/disposable components such as:
   a. Collection canister (secretion container),
   b. Related hoses (tubing)
   c. Hose connectors
   d. Filters
   e. Other accessories as detailed in the operating manual

The NovaSpine Powered Suction Pump PRO-I is a medical device. The provided text, a 510(k) summary, describes its characteristics and regulatory clearance, but does not contain information about a study that proves the device meets specific acceptance criteria.

The 510(k) summary focuses on demonstrating "Substantial Equivalence" to other legally marketed devices, rather than presenting a performance study with detailed acceptance criteria and results. The "Device Description" section lists several specifications, which likely serve as the device's inherent design and performance characteristics, but these are not presented as "acceptance criteria" against which a study was performed.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study as requested, because the provided text does not describe such a study or associated acceptance criteria.

Here's what can be extracted from the text regarding the device specifications:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not present explicit "acceptance criteria" tested in a study. Instead, it provides the device's technical specifications. If we interpret these specifications as the intended performance characteristics, the table would look like this:

The following information cannot be provided as it is not present in the given text:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices, which typically involves comparing technical specifications, intended use, and safety/effectiveness profiles without necessarily requiring new clinical performance studies against formal acceptance criteria for every new device. It's a common pathway for Class I and II medical devices.

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The SIMEX Portable Suction / Aspirator / Vacuum system is indicated and used for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at patient's bedside.

The SIMEX Suction Pump is a lightweight portable or stationary suction/ aspirator pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous negative pressure. Applications range from hospital, medical practice, emergency care, ambulance, and in home usage. The SIMEX Suction Pumps have two Models. These Models have the same physically size and function but are differentiated in capacity as summarized below: 1. The SIMEX AC Model powered with alternating power. This Model has of three versions: a. SIMEX "AC20", i. Suction 18 1/min, ii. Noise 56 db (A), iii. Weight 3200 g, iv. Operation Continuous v. Color: Blue b. SIMEX "AC20K" i. Suction 18 1/min, ii. Noise 63 db (A), iii. Weight 3200 g, iv. Operation 20 Min v. Color: Blue c. SIMEX "AC30" i. Suction 28 1/min, ii. Noise 61 db (A), iii. Weight 3900 g, iv. Operation 30 Min v. Color: Green 2. The SIMEX DC Model using an on board battery. This Model has of three versions: a. SIMEX "DC20", i. Suction 20 1/min, ii. Noise 63 db (A), iii. Weight 3100 g, iv. Operation 20 Min v. Color: Red b. SIMEX "DC30", i. Suction 28 1/min, ii. Noise 63 db (A), iii. Weight 3500 g, iv. Operation 20 Min v. Color: Yellow c. SIMEX "DC30S" i. Suction 28 1/min, ii. Noise 62 db (A), iii. Weight 3500 g, iv. Operation 45 Min v. Color: Yellow Models designed for mounting on a panel and packaged with a special "wall holder" are so designated with the letter "W" after the model and version number, e.g., "SIMEX DC 20W". All moving and electrical components are housed in a moulded compact plastic housing (130 mmx359 mmx290 mm). The unit includes attachment for an external power supply and/or a battery charger. The vacuum is produced with a maintenance-free electrical piston or diaphragm vacuum pump. The vacuum pump transmits negative pressure throughout the tubing-system and the collection jar to a suction catheter that aspirates secretions or liquid from the body. The aspirated fluids are collected in the collection jar that is isolated from the pump by a hydrophobic filter. It also has a mechanical overflow protection in the lid of the collection jar to further prevent the fluids from being sucked into the pump. The filters are single use attachments that can be readily exchanged. The tubing and collection jar can either be replaced after use or sterilized using chemical disinfectants or can be autoclaved in accordance with the instructions supplied. Alternatively the collection jar can be replaced with a holder and a disposable aspiration bag. A secondary air valve placed in the suction system can regulate the degree of vacuum and flow rate. The actual suction capacity can be estimated from the analogue manometer mounted on the pump. The pump vacuum can be manually adjusted using the regulating valve and the vacuum gage. The device can be adjusted to low vacuum values for use in nasal, pharyngeal and tracheal areas. Note that all controls are manual and the pump does not require any electronic process control. The pump can be easily moved by hand or (versions that have a "W" designation) rapidly mounted to vehicle sides, room walls or wheel chairs. The SIMEX DC models have integrated electric supply enables charging and operation of the pump with the 12 to 24 Volts DC power supply. Also, if the units are used in home care, hospitals or clinical practices the SIMEX AC or DC models can be directly connected to AC power supplies for operation. Since neither the pump nor its components come in direct contact with the patient sterilization is not required. The SIMEX Suction Pump is composed of two parts: - 1. The pump, power unit and power supply all housed in a single unit - 2. The consumable components such as: - Collection jar (secretion container), - Related hoses (tubing) - Hose connectors The operating details of both models, SIMEX AC and SIMEX DC, are given in the operating manuals for the pumps (Product Inserts). These include detail list of all accessories that can be used with each suction pump, the part numbers, and the specifications for their use. Details regarding the assembly and disassembly of each model are given in Service Instructions. These Service Instruction are for use by trained technicians who are familiar with the product. They are not to be used by untrained end users. These instructions will not be packaged with the pump.

The provided text describes a 510(k) premarket notification for SIMEX Suction Pumps. However, it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria, specifically in the context of an AI/algorithm-driven device performance.

The document is a regulatory filing for a physical medical device (suction pump) and focuses on its design, function, manufacturing, and a claim of substantial equivalence to existing predicate devices. It does not involve any artificial intelligence, machine learning, or software algorithm for diagnosis, prediction, or image analysis. Therefore, many of the requested points ("sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance study," "type of ground truth used," "sample size for training set," "ground truth for training set") are not applicable to this type of device and regulatory submission.

The "Performance Data" section merely states that "A summary performance data is provided in Table 1 above 'Device Description'". Table 1 lists physical specifications like suction capacity (18-28 l/min), noise (56-63 db(A)), weight (3100-3900 g), and operation duration (20-45 Min) for different models. These are descriptive specifications, not acceptance criteria for an algorithm's performance on a dataset.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance related to an AI/algorithm study, nor can I provide information on sample sizes, ground truth establishment, or expert adjudication for such a study, as that information is not present in the provided document.

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The NovaSpine Cement Restrictor device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

The NovaSpine Cement Restrictoris NOT intended for any spinal indications.

The NovaSpine Cement Restrictor "NSCR" is an implanted device for use as non-load bearing cement containment in orthopedic surgery. It will be used to contain standard bone cement such as Polymethylmethacrylate (PMMA) in the diaphysical canal of the femur or tibia.

The device is a straight or tapered rectangular hollow box construction with serrations on two opposite sides and flat surfaces on the remaining two sides. The device is fenestrated on all sides. The device is made in a variety of sizes the use of which will be determined by the responsible surgeon in accordance with the physical characteristics of each patient.

The NovaSpine Cement Restrictor is a Class II device intended for use as a non-load bearing cement containment in orthopedic surgeries, specifically within the diaphysical canal of the femur or tibia, to contain standard bone cement like Polymethylmethacrylate (PMMA).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the following information is not available or not applicable:

2. Sample size used for the test set and the data provenance:

• The document describes a 510(k) submission, which primarily relies on substantial equivalence to predicate devices rather than a direct clinical study of the device itself. Therefore, a "test set" in the context of clinical performance data for this device is not detailed. The design controls and material specifications are the primary "test" here, which are checked against industry standards and predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable, as there's no mention of a clinical test set requiring expert ground truth assessment. The FDA's review process involves expert staff, but not in the context of establishing ground truth for a device's performance data as one would for an AI/diagnostic device.

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 cement restrictor, not an AI-powered diagnostic tool.

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

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

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

• The "ground truth" for this device's acceptance is its compliance with material standards (ASTM F136/ISO 5832-3), classification as a non-load bearing Class II device, and its substantial equivalence to previously cleared predicate devices. There's no clinical "ground truth" established through a specific study described here.

8. The sample size for the training set:

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable.

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