(29 days)
The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table.
The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table. There are secondary back-up operating devices to allow operation of the table should the primary control or power supply fail.
This 510(k) summary describes a mobile operating table, the OPT 80, and asserts its substantial equivalence to a predicate device (AMSCO Quantum 3080 SP, K930493). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring clinical trials to establish new performance metrics. Therefore, many of the requested details regarding acceptance criteria and study design for performance are not typically included in these types of submissions, especially for Class I devices like operating tables.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
For a Class I device like an operating table, "acceptance criteria" primarily revolve around meeting recognized industry standards and demonstrating functional equivalence to a predicate device. Performance is largely described by its features and adherence to these standards.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Safety and Quality Standards: | |
| IEC 601-1 performance and quality standards | OPT tables are constructed under good manufacturing processes and meet IEC 601-1 performance and quality standards: VDE 0750 IMQ |
| Functional Equivalence to Predicate Device: | |
| Similar positioning capabilities | The devices have similar positioning capabilities. |
| Similar weight capacity | The table system is designed to hold a patient of 180 Kg. (400 Lbs.) |
| Similar primary and backup controls | The devices have similar primary and backup controls with manual override for emergency situations. There are secondary back-up operating devices to allow operation of the table should the primary control or power supply fail. |
| Similar caster locks | The devices have similar caster locks. |
| Similar base material | The devices have similar base material. |
| Similar overall size and weight | The devices have similar overall size and weight. |
| Ability to perform specified movements (trendelenburg, reverse trendelenburg, lateral tilt, back, leg, head plate) | The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. |
| Provision for additional accessories | It has side rails for fitting additional accessories as may be required by a particular procedure. |
| Instruction Manual and compliance with manufacturer's instructions | Officine di Protesi Trento S.p.A provides an instruction manual to inform the customer on how to properly install and start the surgical table. To avoid failure, the user must follow the manufacturer's instructions for installation, use, cleaning and maintenance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a device like an operating table, especially a Class I device seeking substantial equivalence, formal test sets with statistical sample sizes in the clinical sense are not typically required. The "testing" primarily refers to engineering verification and validation against design specifications and relevant standards, often using a limited number of prototypes or production units. The focus is on demonstrating that the physical device functions as intended and meets the technical characteristics of the predicate, not on a clinical performance study with human subjects.
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)
This information is not provided and is not applicable in the context of this 510(k) submission for an operating table. "Ground truth" from expert panels is relevant for diagnostic or screening devices where expert judgment is needed to validate algorithm outputs. For an operating table, functionality is verified against engineering specifications and industry standards by engineers and quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable. Adjudication methods are typically used in clinical studies or performance evaluations involving human interpretation (e.g., medical image analysis) where there might be disagreement among experts. For an operating table, functional tests have defined pass/fail criteria, not subjective adjudication among experts.
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
This information is not provided and is not applicable. MRMC studies are used for evaluating the impact of AI-assisted diagnostic tools on human reader performance. An operating table is a mechanical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. "Standalone performance" refers to the performance of an algorithm or AI system by itself. An operating table does not have an "algorithm" in this sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for an operating table's performance is its adherence to engineering specifications, recognized safety and quality standards (e.g., IEC 601-1, VDE 0750 IMQ), and direct comparison of functional and safety features to a legally marketed predicate device. There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the clinical sense for this device.
8. The sample size for the training set
This information is not provided and is not applicable. "Training set" refers to data used to train AI/ML models. Since this is a mechanical operating table, it does not involve AI or machine learning, and therefore no training set is used.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no training set for an operating table.
§ 878.4960 Operating tables and accessories and operating chairs and accessories.
(a)
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.